INOVA Diagnostics Global Affiliates Corporate Headquarters

North and South America

Asia

Europe

UNITED STATES OF AMERICA INOVA Diagnostics Inc. Tel. +1-858-586-9900 Toll free +1-800-545-9495 [email protected] www.inovadx.com

BRAZIL Werfen Medical Ltda Tel. +55 11 415 433 37 [email protected] www.werfengroup.com

CHINA Werfen Medical Intl. Trading (Shanghai) Co., Ltd. Tel. +86 10 59756031 customerservice01@ werfen-china.com www.werfen-china.com

AUSTRIA Instrumentation Laboratory GmbH Tel. +43 1 256 580040 [email protected] www.il-austria.at

MEXICO IL Diagnostics S.A. de CV Tel. +55 5262 1760 idiagnostics@ mexico.ilww.com www.ildiagnostics.com.mx

JAPAN Instrumentation Laboratory Japan Co. Ltd. Tel. +81 3 54191301 www.il-japan.jp SOUTH KOREA Werfen Medical IL, Ltd. Korea Tel. +82 2 571 9246 [email protected] www.werfenmedical.com

BELGIUM Instrumentation Laboratory N.V./S.A Tel. +32 2 7252052 [email protected] www.il-be.com CZECH REPUBLIC AND SLOVAK REPUBLIC Comesa spol.s.r.o. Tel. +42 (0) 246 090 911 [email protected] www.comesa.cz FRANCE Instrumentation Laboratory S.A. Tel. +33 (0) 1 823 086 00 www.il-france.com GERMANY Instrumentation Laboratory GmbH Tel. +49 (0) 89 909 070 [email protected] www.il-ger.de HUNGARY Comesa Hungary Kft. Tel. +36 1 4392910 [email protected] www.comesa.hu

ITALY Instrumentation Laboratory SpA Tel. +39 02 25221 [email protected] www.il-italia.it

Redefining Autoimmunity

LITHUANIA Instrumentation Lab. (Lietuva) B.I. Tel. +37 0 37313157 [email protected] www.illww.lt/anliskas POLAND Comesa Polska Sp.z.o.o. Tel. +48 22336 1800 [email protected] www.comesa.pl PORTUGAL Izasa Portugal, Lda Tel. +35 1 214247312 www.izasa.pt SPAIN Izasa, S.A. Tel. +34 902203090 www.Izasa.es THE NETHERLANDS Instrumentation Laboratory B.V. Tel. +31 76 5480100 [email protected] www.il-nl.com UNITED KINGDOM Instrumentation Laboratory Ltd. Tel. +44 192 581 0141 [email protected] www.il-uk.com

We proudly serve customers in over 90 countries worldwide. For more information on your local distributor please contact INOVA Diagnostics at [email protected]

INOVA Diagnostics, Inc. 9900 Old Grove Road • San Diego • CA • 92131-1638 Tel. 858-586-9900 • Toll free 800-545-9495 • Fax 858-586-9911 www.inovadx.com

690033 Rev. 3

2012 Catalog

Business Hours 6:30 am to 4:00 pm PT Monday thru Friday

To Order Product US toll free phone: +1-800-545-9495 INOVA Diagnostics, Inc. Tel. +1-858-586-9900 9900 Old Grove Road San Diego CA, 92131-1638, USA [email protected] customer service fax: +1-858-586-9905

Technical Assistance/Consultation Our professional staff is available to answer questions or discuss any aspect regarding the use and interpretation of our products. In addition to our own scientific staff, INOVA retains consultants from both the clinical and academic communities. These resources are available to help resolve any unusual cases involving autoimmune disease diagnosis. Email us for assistance at [email protected] or call us at +1-877-829-4745 (U.S. & Canada Only), or + 1-858-805-7950 (Outside the U.S.). Conditions of Sale „„ „„ „„ „„ „„ „„ „„ „„

ORDERS: Orders may be placed by fax or e-mail. Please specify the catalog number and product description. SHIPMENTS: All shipping charges will be prepaid FOB San Diego, CA and added to the invoice. Unless otherwise specified, shipments will be made via Federal Express or UPS. Customers requesting other carriers should specify at the time of order. TERMS: All invoices are net 30 days unless otherwise prearranged. All invoices are in U.S. dollars. TITLE: Title to the products passes to the customer upon delivery of items ordered to the carrier. LOSS OR DAMAGE: Claims for loss or damage of products are the responsibility of the customer and should be reported to INOVA at the earliest possible time. PARTIAL SHIPMENTS: INOVA will make every possible attempt to fill orders promptly and completely. When this cannot be done, we will make partial shipments unless otherwise notified at the time of order confirmation. RETURNS: Prior to returning any products, customers must contact INOVA technical services for approval. Please provide the reason for the return (ordering error, shipping error, technical problem, etc.). A restocking fee may apply. CONDITIONS: Unless otherwise indicated the products listed herein are for ‘in vitro’ diagnostic use only. Nothing disclosed herein is to be construed as a recommendation to use our products in violation of any patents. The information presented is believed to be accurate. However, said information and products are offered without warranty or guarantee since the ultimate conditions of use and the variability of the materials tested are beyond our control. We cannot be responsible for patent infringements or other violations that may occur with the use of these products.

QUANTA Lite, QUANTA Link, QUANTA Flash, NOVA View, NOVA Lite and NOVA Gel are registered trademarks of INOVA Diagnostics, Inc. QUANTA Chek is a trademarks of INOVA Diagnostics, Inc. DS2 and DSX are registered trademarks of DYNEX Technologies, Inc. QUANTA-Lyser, is a registered trademark of Biokit S.A. ©2011 INOVA Diagnostics, Inc. All rights reserved.

INOVA Diagnostics 2012 Catalog Company Overview������������������������������������������3

NOVA Lite®��������������������������������������������������36

Systems and Instrumentation�������������������������4

IFA Slide Kits����������������������������������������������������������������������44

QUANTA Link®������������������������������������������������������������������� 5

IFA Substrate Slides��������������������������������������������������������46

BIO-FLASH®������������������������������������������������������������������������ 6

IFA Antibody Controls���������������������������������������������������49

NOVA View®������������������������������������������������������������������������ 8

IFA Conjugates�����������������������������������������������������������������51

QUANTA-Lyser®���������������������������������������������������������������10

Common Components�������������������������������������������������53

QUANTA-Lyser® 2�����������������������������������������������������������11

Demo Slides����������������������������������������������������������������������53

DS2®������������������������������������������������������������������������������������12

NOVA Gel®��������������������������������������������������54

DSX®/best 2000��������������������������������������������������������������13

Connective Tissue Disease Kits����������������������������������55

QUANTA Flash®�����������������������������������������������14

Components���������������������������������������������������������������������55

Celiac Disease������������������������������������������������������������������15 Antiphospholipid Syndrome�������������������������������������16

Customer Support������������������������������������������ 56

Vasculitis����������������������������������������������������������������������������17 BIO-FLASH® Common Components�����������������������17

QUANTA Lite®�������������������������������������������������18 Gastrointestinal Disease����������������������������������������������19 Celiac Disease������������������������������������������������������������������22 Liver Disease��������������������������������������������������������������������24 Antiphospholipid Syndrome�������������������������������������26 Rheumatoid Arthritis����������������������������������������������������29 Connective Tissue Diseases����������������������������������������30 Vasculitis ���������������������������������������������������������������������������33 Autoimmune Thyroid Disease�����������������������������������33 QUANTA Chek™ Quality Control Panels������������������34 Calibration and Standard Sets�����������������������������������35

1

Redefining Autoimmunity

INNOVATIVE ASSAYS AND INSTRUMENTS INSTRUMENTS „„ BIO-FLASH® random access chemiluminescent analyzer „„ QUANTA-Lyser® automated EIA/IFA analyzer platforms „„ QUANTA Link® workflow management system „„ NOVA View® digital IFA „„ DS2® and DSX®/best 2000 automated EIA microtiter plate platforms 2

ASSAYS „„ QUANTA Flash® CIA „„ QUANTA Lite® ELISA „„ NOVA Lite® IFA „„ NOVA Gel® Ouchterlony

Company Overview

Redefining the boundaries of autoimmune testing with innovative systems and reagents INOVA Diagnostics, Inc., part of the Werfen Group, has been the trusted source for autoimmune disease diagnostics for over 20 years. Now, with more assays and instruments than ever, all made with the unmatched quality, reliable consistency, and excellent value you have come to expect from INOVA. Furthermore, our expertise and collaborative approach means you have a partner with extraordinary technical proficiency, product support and impeccable service ready to help ensure your lab is operating at its best. Together we are redefining autoimmunity, leveraging our innovative spirit to meet the quality and efficiency requirements of today’s dynamic healthcare setting. We are proud to serve customers in over 90 countries, many from the top healthcare institutions in the world, and we look forward to exceeding your expectations while meeting your autoimmune testing needs.

3

Systems and Instrumentation

INTEGRATING THE AUTOIMMUNE LABORATORY INOVA Diagnostics provides automation that anticipates the unique requirements of individual laboratories to improve the efficiency and quality of autoimmune testing.

4

QUANTA Link

®

Centralized Intelligent Network

Workflow management made easy QUANTA Link is a powerful, easy-to-use workflow management system that gives you immediate control of all your autoimmune IFA, EIA and chemiluminescence sample processing. • Seamlessly integrates instruments with your laboratory information system (LIS) • Efficiently controls instrument workflow • Optimizes quality control through trending and analysis • Delivers positive patient ID for IFA testing

Eliminates transcription errors in IFA sample processing and analysis 5

Systems and Instrumentation

® BIO-FLASH Rapid-Response Chemiluminescent Analyzer

A progressive solution to common problems Eliminates isotype batching and reagent waste • Stable on-board reagents allow for samples to be run as they arrive Improves turn-around time • S imultaneous random access processing of all isotypes and assays on a single sample • Delivers results, including STAT orders, in as little as 30 minutes • BIO-FLASH can generate up to 450 results in a single shift Helps reduce test send outs • M  akes even the most specialized assays efficient to perform with stable calibration curves Frees up floor space • S mall benchtop analyzer achieves excellent throughput

6

Description

Part Number

BIO-FLASH System

T3710-0344

QUANTA-Flash reagents • C  hemiluminescent technology delivers precise quantification and a broad dynamic range • C  artridge barcode is internally scanned to import the master calibration curve, lot number, expiration date and assay type

Reagent carousel • S tores up to 20 reagent packs with on-board refrigeration • Monitors reagent use and reports inventory • Dedicated reagent probe

Sample carousel • P  rimary samples placed directly onto the rack and scanned by internal barcode reader • Samples processed in random access with continuous load capability • STAT orders can be run at any time • Dedicated sample probe

• M  aster calibration curve uploaded through the reagent pack barcode • Calibrators are processed in the sample carousel • BIO-FLASH determines a stable working calibration curve

*

200k x x

170k 140k

RLU

Calibration curves

230k

110k

*

90k 60k 30k

x * 0 ** 0 60

* 130 190 250 310 380 440 500

IU/mL

Intuitive software and touchscreen • S implifies training and day-to-day operation • Status screen allows immediate access to system information

7

Systems and Instrumentation

® NOVA View Digital IFA

The new world of digital IFA testing NOVA View provides a platform designed to standardize the interpretation of IFA slides. This fully automated system has the potential to increase productivity while providing more consistent results. Step confidently into the future of digital IFA testing with NOVA View. • Reduces hands-on time • Supports standardization • Prompts appropriate analysis • Facilitates case review

8

Description

Part Number

NOVA View Instrument

AKL1000

® NOVA View Integrated Autoimmune Laboratory

Integration delivers positive patient identification for IFA samples and slides

Eliminates transcription errors in IFA sample processing and analysis

9

Systems and Instrumentation

® QUANTA-Lyser Automated EIA/IFA Analyzer Platform

Easy-to-use platform satisfies all  rocessing flexibility – different strengths for P different tasks • Both configurations process up to 6 EIA plates and 30 IFA slides per run • Allows you to meet future challenges without changing platforms • Operational flexibility – on-board scheduler determines optimal workflow sequence to maximize productivity • Sample flexibility – supports a wide range of sample tube sizes Efficiency • Automation efficiency – walk-away system minimizes hands-on time • Training efficiency – easy-to-use software and hardware components • Throughput efficiency – independent 4-probe system allows for rapid sample pipetting to maximize throughput

10

QUANTA-Lyser® 160/240 Description

Part Number

160 Sample EIA

GS0161

160 Sample IFA

GS0162

160 Sample EIA + IFA

GS0160

240 Sample EIA

GS0241

240 Sample IFA

GS0242

240 Sample EIA + IFA

GS0240

® QUANTA-Lyser 2 Automated EIA/IFA Analyzer Platform

your EIA and IFA processing needs  rocessing flexibility – three configurations to P maximize flexibility and efficiency • A combination 5 slide IFA, 1 plate EIA layout • A dedicated 15 slide IFA layout • A dedicated 2 plate EIA layout • Allows you to choose the configuration to meet your testing demands Operational flexibility – on-board scheduler maximizes productivity QUANTA-Lyser® 2 Description

Part Number

IFA Only

GS2002

EIA + IFA

GS2000

Sample flexibility – supports a wide range of sample tube sizes  utomation efficiency – offers walk-away capability A with minimal hands-on time  raining efficiency – easy-to-use software and T hardware components

11

Systems and Instrumentation

DS2®

Reliable sample in/result out microtiter plate processor • Compact design is ideally suited for laboratories where space is limited • Processes two 96-well microplates and up to 12 different assays simultaneously • Walk-away automation provides up to two hours of free time for other laboratory tasks

DS2 is a registered trademark of DYNEX Technologies, Inc.

12

Description

Part Number

DS2

D62010

DSX®/best 2000

A high-performance walk-away EIA processing system • A fully automated 4-plate processing system capable of performing up to 12 different assays simultaneously • Employs a modular design that provides flexible configuration and ease of use • Incorporates many features to ensure the quality and security of results • Ability to handle a wide variety of assay protocols Description

Part Number

With No Incubators

D65100

With 2 Incubators

D65200

With 4 Incubators

D65400

DSX is a registered trademark of DYNEX Technologies, Inc.

13

QUANTA Flash®

Chemiluminescent Immunoassays (CIA) QUANTA Flash Chemiluminescent Immunoassays (CIA) are indicated for semi-quantitative determination of autoantibodies. BIO-FLASH CIA technology offers a faster response and broader dynamic range than enzyme-based assays for more precise quantification and confidence in results. „„ Antiphospholipid Syndrome „„ Connective Tissue Diseases

14

„„ Celiac Disease „„ Vasculitis „„ Rheumatoid Arthritis

Celiac Disease QUANTA Flash celiac assays provide accurate results across multiple markers and isotypes.

NAME

DESCRIPTION

PRODUCT ITEM

PACKAGE

PART #

QUANTA Flash h-tTG IgA

This assay is designed for the semi-quantitative determination of IgA anti-human tissue transglutaminase (h-tTG) antibodies in human serum on the BIO-FLASH system.

Reagents Calibrators Controls

50 Test Cartridge 2 X 2 vials (0.3 mL each) 2 X 2 vials (0.5 mL each)

701103 701101 701102

QUANTA Flash h-tTG IgG

This assay is designed for the semi-quantitative determination of IgG anti-human tissue transglutaminase (h-tTG) antibodies in human serum on the BIO-FLASH system.

Reagents Calibrators Controls

50 Test Cartridge 2 X 2 vials (0.3 mL each) 2 X 2 vials (0.5 mL each)

701108 701106 701107

QUANTA Flash DGP IgA*

This assay is designed for the semi-quantitative determination of IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum on the BIO-FLASH system.

Reagents Calibrators Controls

50 Test Cartridge 2 X 2 vials (0.3 mL each) 2 X 2 vials (0.5 mL each)

701168 701166 701167

QUANTA Flash DGP IgG*

This assay is designed for the semi-quantitative determination of IgG anti-deamidated gliadin peptide (DGP) antibodies in human serum on the BIO-FLASH system.

Reagents Calibrators Controls

50 Test Cartridge 2 X 2 vials (0.3 mL each) 2 X 2 vials (0.5 mL each)

701173 701171 701172

QUANTA Flash DGP Screen

This assay is designed for the semi-quantitative determination of IgG and IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum on the BIO-FLASH system.

Reagents Calibrators Controls

50 Test Cartridge 2 X 2 vials (0.3 mL each) 2 X 2 vials (0.5 mL each)

701113 701111 701112

dynamic range1

ELISA

QUANTA Flash

In CIA technology, antigen covers the surface of magnetic particles offering increased surface area for detection of target antibodies. Magnetic separation and washing allows for highly specific capture resulting in highly accurate and reproducible results.

Measured units

Chemiluminescence immunoassay (CIA) technology can significantly increase the reportable dynamic range1

* Available Outside The USA Only 1. Martis, et al. Testing for Celiac Disease on the BIO-FLASH Random Access Analyzer. AMLI 2009.

15

QUANTA Flash® (CIA) Antiphospholipid Syndrome QUANTA Flash APS assays can bring clarity to the complicated diagnosis of Antiphospolipid Syndrome. NAME

DESCRIPTION

PRODUCT ITEM

PACKAGE

PART #

QUANTA Flash Cardiolipin IgG

This assay is designed for the semi-quantitative determination of anti-cardiolipin (aCL) IgG antibodies in human citrated plasma and serum on the BIO-FLASH system.

Reagents Controls

50 Test Catridge 2 X 3 vials (1 mL each)

701233 701232

QUANTA Flash Cardiolipin IgM

This assay is designed for the semi-quantitative determination of anti-cardiolipin (aCL) IgM antibodies in human citrated plasma and serum on the BIO-FLASH system.

Reagents Controls

50 Test Catridge 2 X 3 vials (1 mL each)

701238 701237

QUANTA Flash Cardiolipin IgA*

This assay is designed for the semi-quantitative determination of anti-cardiolipin (aCL) IgA antibodies in human citrated plasma and serum on the BIO-FLASH system.

Reagents Controls

50 Test Cartridge 2 X 3 vials (1 mL each)

701228 701227

QUANTA Flash β2 GPI IgG

This assay is designed for the semi-quantitative determination of anti-β2 glycoprotein-1 (β2GP1) IgG antibodies in human citrated plasma and serum on the BIO-FLASH system.

Reagents Controls

50 Test Catridge 2 X 3 vials (1 mL each)

701248 701247

QUANTA Flash β2 GPI IgM

This assay is designed for the semi-quantitative determination of anti-β2 glycoprotein-1 (β2GP1) IgM antibodies in human citrated plasma and serum on the BIO-FLASH system.

Reagents Controls

50 Test Cartridge 2 X 3 vials (1 mL each)

701253 701252

QUANTA Flash β2 GPI IgA*

This assay is designed for the semi-quantitative determination of anti-β2 glycoprotein-1 (β2GP1) IgA antibodies in human citrated plasma and serum on the BIO-FLASH system.

Reagents Controls

50 Test Catridge 2 X 3 vials (1 mL each)

701243 702242

Calibrators are included in the cardiolipin and β2 kits

testing for aCL and β2GP1 isotypes

ISTH criteria assays1

IgG and IgM

Re-test after 12 weeks

1 or more

+

All

–

IgA

Reflex test option 33 minutes

64 minutes

Simultaneous processing for multiple assays and isotypes including STAT orders. * Available Outside The USA Only

1. Miyakis S, Lockshin MD, Atsumi T, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost. 2006;4(2):295-306.

16

Vasculitis QUANTA Flash MPO, PR3 and GBM allow for rapid response in critical cases. NAME

DESCRIPTION

PRODUCT ITEM

PACKAGE

PART #

QUANTA Flash MPO*

This assay is designed for the semi-quantitative determination of IgG autoantibodies to myeloperoxidase (MPO) in human serum on the BIO-FLASH system.

Reagents Calibrator Controls

50 Test Cartridge 2 X 2 vials (0.7 mL each) 2 X 2 vials (0.5 mL each)

701133 701131 701132

QUANTA Flash PR3*

This assay is designed for the semi-quantitative determination of IgG autoantibodies to serine protease 3 (PR3) in human serum on the BIO-FLASH system.

Reagents Calibrator Controls

50 Test Cartridge 2 X 2 vials (0.3 mL each) 2 X 2 vials (0.5 mL each)

701138 701136 701137

QUANTA Flash GBM*

This assay is designed for the semi-quantitative determination of IgG autoantibodies to glomerular basement membrane (GBM) in human serum on the BIOFLASH system.

Reagents Calibrator Controls

50 Test Cartridge 2 X 2 vials (0.7 mL each) 2 X 2 vials (0.5 mL each)

701143 701141 701142

QuanTA Flash MPO, PR3 and GBM assays 1st result 2nd result 3rd result 30 minutes

31 minutes

32 minutes

Total time until result

Fully automated, random access processing with the first result in as little as 30 minutes

BIO-FLASH Common Components NAME

DESCRIPTION

PACKAGE

PART #

BIO-FLASH System Rinse

System rinse for use with the BIO-FLASH instrument. Approximately 240 results per bottle.

1 X 5L

T3000-8205

Trigger 1&2

Package of both triggers for use with the BIO-FLASH instrument. Approximately 1000 results per pair of triggers.

2 x 250mL

T3000-8204

Cuvettes

Cuvettes for use with the BIO-FLASH instrument.

1,400 per box

T3000-8206

System Cleaning Solution

Cleaning solution for BIO-FLASH instrument maintenance.

6 x 4mL

T3000-8211

Low Volume Cups

Low volume sample cups for use with the BIO-FLASH system.

500 Cups

T3000-8209

Low Volume Caps

Low volume sample cup caps for use with the BIO-FLASH system.

500 Caps

T3000-8210

* Available Outside The USA Only

17

QUANTA Lite®

ELISA QUANTA Lite ELISA tests are made of the highest quality components to enable semiquantitative† detection of autoantibodies for a variety of disease states: „„ Antiphospholipid Syndrome „„ Connective Tissue Diseases „„ Rheumatoid Arthritis †

„„ „„ „„ „„ „„

Gastrointestinal Disease Celiac Disease Liver Disease Vasculitis Autoimmune Thyroid Disease

QUANTA Lite ELISA tests are semi-quantitative unless otherwise indicated in the product description

18

Gastrointestinal Disease The cause of chronic intestinal upset can come from a number of sources, often making diagnosis difficult. The QUANTA Lite and NOVA Lite (in the case of ANCA) tests below provide reliable results to help clinicians assess the root cause.

CELIAC & GI DIAGNOSTIC PATHWAY

tTG, DGP, EMA (+)

(–)

Suggestive of Celiac Disease

ASCA, pANCA, H. pylori, GPA, Intrinsic Factor (+)

(–)

(+)

(+)

ASCA

pANCA

H. pylori

Suggestive of Crohn’s Disease

Suggestive of Ulcerative Colitis

Suggestive of Gastritis

(+)

GPA/intrinsic factor

Suggestive of Atrophic Gastritis/ Pernicious Anemia

Non-celiac gluten sensitivity testing Gliadin IgG (Non-celiac gluten sensitivity testing) (+)

(–) Suggestive of Irritable Bowel Syndrome

Abbreviations ANCA Anti-neutrophil cytoplasmic antibodies ASCA Anti-Saccharomyces cerevisiae antibody DGP Anti-deamidated gliadin peptide EMA Anti-endomysial antibody GPA Anti-gastric parietal antibody H. pylori Anti-Helicobacter pylori antibody tTG Anti-tissue transglutaminase antibody

Suggestive of Non-Celiac Gluten Sensitivity

Test

Associated disease state

Testing strategies provided for informational purposes only. Testing and diagnosis should be determined by a licensed clinician.

1. Green, P. H. (2009). "Mortality in celiac disease, intestinal inflammation, and gluten sensitivity." JAMA 302(11): 1225-1226. 2. Rubio-Tapia, A. and Murray, J. A. (2010). "Celiac disease." Curr Opin Gastroenterol 26(2): 116-122. 3. Leffler, D. A. and D. Schuppan (2010). "Update on serologic testing in celiac disease." Am J Gastroenterol 105(12): 2520-2524.

19

QUANTA Lite® (ELISA) Gastrointestinal Disease

IBD Differential Diagnosis of Crohn’s Disease or Ulcerative Colitis RESULTS: ASCA IgG + ASCA IgA + pANCA (atypical)

RESULTS: ASCA IgG ASCA IgA pANCA + (atypical) Inflammatory bowel disease diagnosis

ASCA LEVEL Suggestive of

Crohn’s Disease

overlap conditions

ANCA LEVEL Suggestive of

Ulcerative Colitis

Abbreviations ASCA Anti-Saccharomyces cerevisiae antibody pANCA Perinuclear anti-neutrophil cytoplasmic antibody

Testing strategies provided for informational purposes only. Testing and diagnosis should be determined by a licensed clinician.

1. Desplat-Jego, S., Johanet, C., et al. (2007). "Update on Anti-Saccharomyces cerevisiae antibodies, anti-nuclear associated anti-neutrophil antibodies and antibodies to exocrine pancreas detected by indirect immunofluorescence as biomarkers in chronic inflammatory bowel diseases: results of a multicenter study." World J Gastroenterol 13(16): 2312-2318. 2. Arai, R. (2010). "Serologic markers: impact on early diagnosis and disease stratification in inflammatory bowel disease." Postgrad Med 122(4): 177-185.

20

Gastrointestinal Disease NAME

ANTIGEN

PACKAGE

PART #

QUANTA Lite H. pylori IgA

A qualitative ELISA assay for the detection of anti-H. pylori (Helicobacter pylori) IgA antibodies in human serum. The presence of these antibodies can aid in the diagnosis of H. pylori infection in adult patients with clinical signs and symptoms of gastrointestinal disease.

Native

1 X 96 wells

708720

QUANTA Lite H. pylori IgG

A qualitative ELISA assay for the detection of anti-H. pylori (Helicobacter pylori) IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of H. pylori infections in adult patients with clinical signs and symptoms of gastrointestinal disease.

Native

1 X 96 wells

708715

QUANTA Lite ASCA (S. cerevisiae) IgA

This assay is designed for the detection of antiSaccharomyces cerevisiae IgA antibodies in human serum. The presence of these antibodies can aid in the diagnosis of patients with Crohn's disease.

Native

1 X 96 wells

708870

QUANTA Lite ASCA (S. cerevisiae) IgG

This assay is designed for the detection of antiSaccharomyces cerevisiae IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of patients with Crohn's disease.

Native

1 X 96 wells

708865

This assay is designed for the detection of anti-gastric parietal cell (H+/K+) ATPase IgG antibodies in human serum. QUANTA Lite GPA (Gastric The presence of these antibodies can aid in the diagnosis of Parietal Cell Antibody) conditions with elevated levels of anti-gastric parietal cell antibodies including pernicious anemia.

Native

1 X 96 wells

708765

Recombinant

1 X 96 wells

708780

QUANTA Lite Intrinsic Factor

DESCRIPTION

This assay is designed for the detection of anti-Intrinsic Factor IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of pernicious anemia.

21

QUANTA Lite® Celiac Disease Celiac disease remains highly under diagnosed, especially in children. INOVA is very proud to have introduced QUANTA Lite Gliadin II (DGP), the first commercial deamidated gliadin peptide (DGP) ELISA, in 2005. This assay is particularly useful in pediatric populations. NAME

ANTIGEN

PACKAGE

PART #

QUANTA Lite h-tTG IgA

This assay is designed for the detection of anti-tissue transglutaminase (endomysium) IgA antibodies in human serum. The presence of these antibodies can aid in the diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis.

Native (human red blood cell)

1 X 96 wells 10 X 96 wells

708760 708760.10

QUANTA Lite h-tTG IgG

This assay is designed for the detection of anti-tissue transglutaminase (endomysium) IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis. This test is intended for providing added sensitivity when testing IgA deficient patients.

Native (human red blood cell)

1 X 96 wells 10 X 96 wells

708755 708755.10

QUANTA Lite R h-tTG IgA

This assay is designed for the in-vitro measurement of specific IgA autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of celiac disease.

Recombinant

1 X 96 wells 10 X 96 wells

704605 704605.10

QUANTA Lite R h-tTG IgG

This assay is designed for the in-vitro measurement of specific IgG autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of celiac disease.

Recombinant

1 X 96 wells 10 X 96 wells

704610 704610.10

QUANTA Lite h-tTG Screen

This assay is designed for the detection of IgA and IgG human tissue transglutaminase (h-tTG) antibodies in human serum. The presence of these antibodies can be used to aid in the diagnosis of IgA sufficient and IgA deficient celiac disease.

Native (human red blood cell)

1 X 96 wells

704570

QUANTA Lite Gliadin IgA II (DGP)

This assay is designed for the detection of IgA antibodies to synthetic, deamidated gliadin-derived peptides (DGP) in human serum. The presence of these antibodies can aid in the diagnosis of celiac disease.

Synthetic, deamidated peptide

1 X 96 wells 10 X 96 wells

704525 704525.10

QUANTA Lite Gliadin IgG II (DGP)

This assay is designed for the detection of IgG antibodies to synthetic, deamidated gliadin-derived peptides (DGP) in human serum. The presence of these antibodies can aid in the diagnosis of celiac disease.

Synthetic, deamidated peptide

1 X 96 wells 10 X 96 wells

704520 704520.10

QUANTA Lite Celiac DGP Screen

This assay is designed for the detection of IgA and IgG antibodies to synthetic, deamidated gliadin-derived peptides in human serum. The presence of these antibodies can be used to aid in the diagnosis of celiac disease in both IgA sufficient and IgA deficient patients as well as dermatitis herpetiformis.

Synthetic, deamidated peptide

1 X 96 wells

704545

22

DESCRIPTION

Celiac Disease (continued) NAME

DESCRIPTION

ANTIGEN

PACKAGE

PART #

h-tTG native (human red blood cell); DGP peptide (synthetic, deamidated)

1 X 96 wells

704575

QUANTA Lite h-tTG/DGP Screen

This assay is designed for the detection of IgA and IgG antibodies to synthetic, deamidated gliadin-derived peptides (DGP) and human tissue transglutaminase (h-tTG) in human serum. The presence of these antibodies can be used to aid in the diagnosis of celiac disease in both IgA sufficient and IgA deficient patients as well as dermatitis herpetiformis.

QUANTA Lite Gliadin IgA

This assay is designed for the detection of anti-gliadin IgA antibodies in human serum. The presence of these antibodies can aid in the diagnosis of gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis.

Native

1 X 96 wells

708655

QUANTA Lite Gliadin IgG

This assay is designed for the detection of anti-gliadin IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis.

Native

1 X 96 wells

708650

QUANTA Lite F-Actin IgA

This assay is designed for the detection of IgA antibodies to the F-Actin component of smooth muscle in human serum. In patients with clinical findings consistent with celiac disease, the presence of anti-F-actin IgA antibodies may assist in estimating the likelihood of significant intestinal villous atrophy.

Native

1 X 96 wells

704500

23

QUANTA Lite® (ELISA) Liver Disease INOVA offers a comprehensive menu of tests to aid in the diagnosis of autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).

DIAGNOSTIC ALGORITHM Liver Disease of Unknown Cause

ANA+

SMA+

LKM+

PBC

AIH

F-actin+ (lgG)

SLA/LP+

AIH

LC1+

Additional assays to establish &/or clarify diagnosis**

Atypical ANCA+

AMA+

AIH

PSC

AMA specific antigens M2EP (MIT3)*+

gp210+ &/or sp100+

PBC

Abbreviations AIH autoimmune hepatitis AMA anti-mitochondrial antibodies ANA anti-nuclear antibodies ANCA anti-neutrophil cytoplasmic antibodies DGP deamidated gliadin peptide EMA endomysium antibody LKM liver-kidney microsomal antibody PBC primary biliary cirrhosis PSC primary sclerotic cholangitis SLA soluble liver antigen SMA smooth muscle antibody tTG tissue transglutaminase

EMA+ tTG+ DGP+

Celiac

Test

Negative

Cryptogenic chronic hepatitis

Associated disease state

Testing strategies provided for informational purposes only. Testing and diagnosis should be determined by a licensed clinician. From: A.J. Czaja & G.L. Norman, J. Clin. Gastrenterol, 2003, 37:315-327, modified by G.L. Norman 01/09 ** Other assays with possible prognostic value: chromatin and dsDNA * M2 EP (MIT3) ELISA contains immunodominant epitope of PDC-E2, OGDC-E2 & BCOADC-E2

24

AIC

Liver Disease NAME

DESCRIPTION

ANTIGEN

PACKAGE

PART #

QUANTA Lite Actin IgG

This assay is designed for the detection of IgG antibodies to the actin component of smooth muscle in human serum. The presence of these antibodies can aid in the diagnosis of autoimmune liver diseases such as autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).

Native

1 X 96 wells 10 X 96 wells

708785 708785.10

QUANTA Lite M2 EP (MIT3)

This assay is designed for the detection of anti-mitochondria IgG antibodies in human serum. The presence of mitochondria antibodies can aid in the diagnosis of primary Recombinant biliary cirrhosis. MIT3 recombinant antigen consists of PDC-E2, BCOADC-E2, and OGDC-E2.

1 X 96 wells 10 X 96 wells

704540 704540.10

QUANTA Lite gp210

This assay is designed for the detection of anti-gp210 IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of primary biliary cirrhosis (PBC).

Synthetic peptide

1 X 96 wells

708995

QUANTA Lite sp100

This assay is designed for the detection of anti-sp100 IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of primary biliary cirrhosis (PBC).

Synthetic peptide

1 X 96 wells

708990

QUANTA Lite PBC Screen IgG/IgA

MIT3 This assay is designed for the detection of antirecombinant; mitochondrial, -gp210 and -sp100 IgG and/or IgA antibodies sp100 & in human serum. The presence of these antibodies can aid in gp210 the diagnosis of primary biliary cirrhosis. synthetic peptides

1 X 96 wells

704560

QUANTA Lite SLA

This assay is designed for the detection of anti-SLA IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of conditions with elevated levels of SLA antibody including autoimmune hepatitis (AIH).

Recombinant

1 X 96 wells

708775

QUANTA Lite LKM-1

This assay is designed for the detection of anti-LKM-1 IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of autoimmune hepatitis, Recombinant type 2. Utilizes recombinant human cytochrome P450 2D6 antigen.

1 X 96 wells

708745

25

QUANTA Lite® (ELISA) Antiphospholipid Syndrome INOVA Diagnostics has long been at the forefront of laboratory tests that aid in the diagnosis of antiphospholipid syndrome. Offering a comprehensive menu of serological markers including criteria as well as specialty non-criteria markers. 1

aCL antibodies, IgG, IgM, IgA* β2GP1 antibodies, IgG, IgM, IgA* Lupus anticoagulant (LA)**

Tests are negative

aCL and/or β2GP1 IgG and/or IgM moderate positive or LA positive

APS is not confirmed

Repeat testing after 12 weeks

If clinical suspicion is high, repeat testing after 12 weeks

aCL and/or β2GP1 IgG and/or IgM moderate positive or LA positive

If no clinical criterion met, APS not confirmed, but risk of clinical event in the future

If clinical criterion met, APS confirmed

Abbreviations aCL anti-cardiolipin APS anti-phospholipid syndrome ß-2 GP1 beta-2 glycoprotein I LA lupus anticoagulant

Test

Associated disease state

Testing strategies provided for informational purposes only. Testing and diagnosis should be determined by a licensed clinician. * IgA aCL and β2GP1 antibodies are not part of the current APS classification criteria. ** Lupus anticoagulant test is not provided by INOVA 1. Bertolaccini, M. L., Amengual, O., Atsumi, T., Binder, W. L., de Laat, B., Forastiero, R., Kutteh, W. H., et al. (2011). “Non-criteria” aPL tests: report of a task force and preconference workshop at the 13th International Congress on Antiphospholipid Antibodies, Galveston, TX, USA, April 2010. Lupus, 20(2), 191-205. doi:10.1177/0961203310397082

26

Antiphospholipid Syndrome NAME

DESCRIPTION

ANTIGEN

PACKAGE

PART #

QUANTA Lite ACA IgG III

This assay is designed for the detection of anti-cardiolipin IgG antibodies in human serum. The presence of these antibodies can aid in assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) or lupus-like disorders.

Native

1 X 96 wells 10 X 96 wells

708625 708625.10

QUANTA Lite ACA IgM III

This assay is designed for the detection of anti-cardiolipin IgM antibodies in human serum. The presence of these antibodies can aid in assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) or lupus-like disorders.

Native

1 X 96 wells 10 X 96 wells

708630 708630.10

QUANTA Lite ACA IgA III

This assay is designed for the detection of anti-cardiolipin IgA antibodies in human serum. The presence of these antibodies can aid in assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) or lupus-like disorders.

Native

1 X 96 wells 10 X 96 wells

708635 708635.10

QUANTA Lite ACA Screen III

This assay is designed for the detection of anti-cardiolipin IgG, IgM and IgA antibodies in human serum. The presence of these antibodies can aid in assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) or lupuslike disorders.

Native

1 X 96 wells

708620

QUANTA Lite β2GPI IgG

This assay is designed for the detection of anti-β2GPI IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of certain autoimmune disease thrombotic disorders, such as those secondary to systemic lupus erythematosus (SLE) or other lupus-like thrombotic diseases.

Native

1 X 96 wells 10 X 96 wells

708665 708665.10

QUANTA Lite β2GPI IgM

This assay is designed for the detection of IgM anti-β2GPI antibodies in human serum. The presence of these antibodies can aid in the diagnosis of certain autoimmune disease thrombotic disorders, such as those secondary to systemic lupus erythematosus (SLE) or other lupus-like thrombotic diseases.

Native

1 X 96 wells 10 X 96 wells

708670 708670.10

QUANTA Lite β2GPI IgA

This assay is designed for the detection of anti-β2GPI IgA antibodies in human serum. The presence of these antibodies can aid in the diagnosis of certain autoimmune disease thrombotic disorders, such as those secondary to systemic lupus erythematosus (SLE) or other lupus-like thrombotic diseases.

Native

1 X 96 wells 10 X 96 wells

708675 708675.10

QUANTA Lite β2GPI Screen

A qualitative ELISA assay for the detection of anti-β2GPI IgG, IgM and IgA antibodies in human serum. The presence of these antibodies can aid in the diagnosis of certain autoimmune thrombotic disorders, such as those secondary to systemic lupus erythematosus (SLE) or other lupus-like disorders.

Native

1 X 96 wells

708660

27

QUANTA Lite® (ELISA) Antiphospholipid Syndrome (continued) NAME

DESCRIPTION

ANTIGEN

PACKAGE

PART #

QUANTA Lite Phosphatidylserine IgG

This assay is intended for the in-vitro measurement of IgG anti-phosphatidylserine antibodies in human serum, as an aid in the diagnosis of anti-phospholipid syndrome (APS).

Native

1 X 96 wells 10 X 96 wells

704625 704625.10

QUANTA Lite Phosphatidylserine IgM

This assay is intended for the in-vitro measurement of IgM anti-phosphatidylserine antibodies in human serum, as an aid in the diagnosis of anti-phospholipid syndrome (APS).

Native

1 X 96 wells 10 X 96 wells

704630 704630.10

QUANTA Lite Phosphatidylserine IgA

This assay is intended for the in-vitro measurement of IgA anti-phosphatidylserine antibodies in human serum, as an aid in the diagnosis of anti-phospholipid syndrome (APS).

Native

1 X 96 wells 10 X 96 wells

704635 704635.10

QUANTA Lite aPS/PT IgG

This assay is designed for the detection of IgG class antibodies to phosphatidylserine/prothrombin complex (PS/PT) in serum or plasma, as an aid in the diagnosis of autoimmune thrombotic disorders such as anti-phospholipid syndrome (APS), in conjunction with other laboratory and clinical findings. Contact your INOVA representative for availability details.

Native

1 X 96 wells

708835

QUANTA Lite aPS/PT IgM

This assay is designed for the detection of IgM class antibodies to phosphatidylserine/prothrombin complex (PS/PT) in serum or plasma, as an aid in the diagnosis of autoimmune thrombotic disorders such as anti-phospholipid syndrome (APS), in conjunction with other laboratory and clinical findings. Contact your INOVA representative for availability details.

Native

1 X 96 wells

708845

28

Rheumatoid Arthritis The revised classification criteria issued in 2010 for rheumatoid arthritis (RA) emphasize the need for early and accurate diagnosis. The QUANTA Lite® CCP3.1 IgG/IgA ELISA offers superior detection of early RA compared with CCP21. Clearly defined positive and high positive cut-offs provide results that rheumatologists require. NAME

DESCRIPTION

ANTIGEN

PACKAGE

PART #

QUANTA Lite CCP3.1 IgG/IgA

This assay is designed for the detection of anti-CCP 3.1 IgG and IgA antibodies in patient sera, citrated or EDTA plasma. The presence of these antibodies can aid in the diagnosis of rheumatoid arthritis (RA), including RA diagnosed within 2 years of presentation of symptoms.

Synthetic peptide

1 X 96 wells 10 X 96 wells

704550 704550.10

QUANTA Lite CCP3 IgG

This assay is designed for the detection of anti-CCP 3 IgG antibodies in patient sera, citrated or EDTA plasma. The presence of these antibodies can aid in the diagnosis of rheumatoid arthritis.

Synthetic peptide

1 X 96 wells 10 X 96 wells

704535 704535.10

QUANTA Lite RF IgG

This assay is designed for the detection of anti-rheumatoid factor (RF) IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of rheumatoid arthritis (RA).

Native

1 X 96 wells

708685

QUANTA Lite RF IgM

This assay is designed for the detection of anti-rheumatoid factor (RF) IgM antibodies in human serum. The presence of these antibodies can aid in the diagnosis of rheumatoid arthritis (RA).

Native

1 X 96 wells

708690

QUANTA Lite RF IgA

This assay is designed for the detection of anti-rheumatoid factor (RF) IgA antibodies in human serum. The presence of these antibodies can aid in the diagnosis of rheumatoid arthritis (RA).

Native

1 X 96 wells

708695

* Available Outside The USA Only 1. Source : QUANTA Lite CCP 3.1 IgG/IgA ELISA direction insert. Early RA defined as detection within 2 years of onset of symptoms.

29

QUANTA Lite® (ELISA) Connective Tissue Diseases Lupus and lupus-like diseases present clinicians with a tremendous diagnostic challenge. Tests which stand apart from the rest include the QUANTA Lite® ANA ELISA with a broad array of antigens as well as HEp-2 nuclear extracts, and the QUANTA Lite Chromatin ELISA with excellent performance. NAME

DESCRIPTION

ANTIGEN

PACKAGE

PART #

QUANTA Lite ANA

This assay is designed for the detection of anti-nuclear IgG antibodies (ANA) in human serum. The presence of these antibodies can aid in the diagnosis of rheumatic diseases such as systemic lupus erythematosus, Sjögren's Syndrome, scleroderma, and mixed connective tissue disease.

Native, recombinant, extracts from HEp-2 nuclei and nucleoli

1 X 96 wells

708750

QUANTA Lite dsDNA

This assay is designed for the detection of anti-dsDNA IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE).

Native

1 X 96 wells

708510

This assay is intended for the in-vitro measurement of specific IgG autoantibodies against dsDNA present in human serum, as QUANTA Lite dsDNA SC an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other clinical findings. Five calibrators allow for creation of standard curve (SC).

Native

1 X 96 wells

704650

This assay is intended for the in-vitro measurement of specific high avidity IgG autoantibodies against dsDNA present in human QUANTA Lite HA dsDNA serum, as an aid to the diagnosis of systemic lupus erythematosus (High Avidity) (SLE), in conjunction with other clinical findings. Five calibrators allow for creation of standard curve.

Native

1 X 96 wells

704615

QUANTA Lite Chromatin

This assay is designed for the detection of anti-chromatin IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of drug-induced lupus (DIL) and systemic lupus erythematosus (SLE).

Native

1 X 96 wells

708710

QUANTA Lite C1q CIC

This assay is designed for the in-vitro measurement of circulating immune complexes (CIC) that bind C1q, present in human serum. It is intended for the determination of CIC in serum of patients with various autoimmune and other CIC-related diseases, and is used in conjunction with other clinical findings.

Native

1 X 96 wells

704620

This assay is designed for the detection of anti-C1q antibodies in human serum. The presence of anti-C1q antibodies in patients QUANTA Lite Anti-C1q* with systemic lupus erythematosus can be used in conjunction with clinical findings and other laboratory tests to aid in detecting people at risk of developing glomerulonephritis.

Native

1 X 96 wells

704565

Recombinant

1 X 96 wells

708770

QUANTA Lite Centromere (CENP-A & CENP-B)

This assay is designed for the detection of anti-centromere IgG antibodies specifically reactive to the CENP-A and CENP-B antigens in human serum. Presence of these antibodies can aid in the diagnosis of certain connective tissue diseases such as the CREST variant of scleroderma.

* Available Outside The USA Only

30

Connective Tissue Diseases (continued) NAME

DESCRIPTION

ANTIGEN

PACKAGE

PART #

QUANTA Lite Histone

This assay is designed for the detection of anti-histone IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE), drug-induced SLE and related connective tissue diseases, such as rheumatoid arthritis, dermatomyositis and Sjögren's Syndrome. Determination of the patient's histone antibody status may be useful in the differential diagnosis between SLE and drug induced SLE.

Native

1 X 96 wells

708520

QUANTA Lite Jo-1

This assay is designed for the detection of anti-Jo-1 IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of polymyositis and other related connective tissue diseases.

Native

1 X 96 wells

708585

QUANTA Lite Ribosome P

This assay is designed for the detection of anti-Ribosome P IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE) and other related connective tissue diseases.

Synthetic peptide

1 X 96 wells

708600

QUANTA Lite RNA Polymerase III

This assay is designed for the detection of anti-RNA Polymerase III IgG antibodies in patient sera. The presence of these antibodies Recombinant can aid in the diagnosis of systemic sclerosis (scleroderma) with increased incidence of skin involvement and renal crisis.

1 X 96 wells

704555

QUANTA Lite RNP

This assay is designed for the detection of anti-RNP IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE) and related connective tissue diseases. Native purified RNP/Sm.

Native

1 X 96 wells

708565

QUANTA Lite Scl-70

This assay is designed for the detection of anti-Scl-70 IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of scleroderma.

Native

1 X 96 wells

708580

QUANTA Lite Sm

This assay is designed for the detection of anti-Sm IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE) and related connective tissue diseases.

Native

1 X 96 wells

708560

QUANTA Lite SS-A

This assay is designed for the detection of anti-SS-A (60kDa & 52kDA) IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE) and related connective tissue diseases, such as Sjögren's Syndrome.

SS-A 52 recombinant; SS-A 60 native

1 X 96 wells

708570

QUANTA Lite SS-A 52

This assay is designed for the detection of anti-SS-A 52 IgG antibodies in patient sera. The presence of these antibodies is an aid in the diagnosis of systemic lupus erythematosus (SLE), Sjögren's Syndrome (SS), systemic sclerosis (SSC), polymyositis (PM) and dermatomyositis (DM).

Recombinant

1 X 96 wells

704505

* Available Outside The USA Only

31

QUANTA Lite® (ELISA) Connective Tissue Diseases (continued) NAME

DESCRIPTION

ANTIGEN

PACKAGE

PART #

QUANTA Lite SS-B

This assay is designed for the detection of anti-SS-B IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE) and related connective tissue diseases, such as Sjögren's Syndrome.

Native

1 X 96 wells

708575

QUANTA Lite ssDNA

This assay is designed for the detection of anti-ssDNA IgG antibodies in human serum. When used in conjunction with QUANTA Lite dsDNA, can aid in the diagnosis of systemic lupus erythematosus (SLE) and certain other rheumatic diseases.

Native

1 X 96 wells

708525

QUANTA Lite ENA 4

SS-A 52 This assay is designed for the detection of anti-Sm, RNP, SS-A recombinant; (60kDa and 52kDA) and SS-B IgG antibodies in human serum. The SS-A 60 presence of these antibodies can aid in the diagnosis of systemic native; SS-B lupus erythematosus (SLE) and related connective tissue diseases, native; Sm such as Sjögren's Syndrome. native; RNP native

1 X 96 wells

708555

QUANTA Lite ENA 5

This assay is designed for the detection of anti-Sm, RNP, SS-A (60kDa and 52kDa), SS-B and Scl-70 IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE), and related connective tissue diseases, such as Sjögren's Syndrome.

SS-A 52 recombinant; SS-A 60 native; SS-B native; Sm native; RNP native; Scl-70 native

1 X 96 wells

708610

QUANTA Lite ENA 6

SS-A 52 recombinant; SS-A 60 This assay is designed for the detection of anti-Sm, RNP, SS-A (60kDa and 52kDa), SS-B, Scl-70 and Jo-1 IgG antibodies in human native; SS-B native; Sm serum. The presence of these antibodies can aid in the diagnosis native; RNP of systemic lupus erythematosus (SLE), and related connective native; Scl-70 tissue diseases, such as Sjögren's Syndrome. native; Jo-1 native

1 X 96 wells

708615

QUANTA Lite ENA Profile*

This kit is designed for the in-vitro qualitative screening of human serum for the presence of specific IgG autoantibodies against extractable nuclear antigens (ENAs) namely; SSA/Ro (60 and 52kD), SSB/La, Sm, Sm/RNP, Scl-70 and Jo-1, as an aid in the diagnosis of certain systemic rheumatic diseases.

1 X 96 wells

704715

* Available Outside The USA Only

32

Combined

Vasculitis Newly acquired technology has allowed for an important expansion in INOVA’s vasculitis menu with the addition of the QUANTA Lite PR3 SC and QUANTA Lite MPO SC, both offering 5 point standard curve calibration. NAME

DESCRIPTION

ANTIGEN

PACKAGE

PART #

QUANTA Lite MPO IgG

This assay is designed for the detection of antimyeloperoxidase (MPO) IgG antibodies in human serum. The presence of these antibodies can aid in assessing certain autoimmune vasculitides such as microscopic polyarteritis, and crescentic glomerulonephritis.

Native

1 X 96 wells 10 X 96 wells

708700 708700.10

QUANTA Lite MPO SC

This assay is intended for the in-vitro measurement of specific IgG autoantibodies against myeloperoxidase (MPO) present in serum, as an aid to the diagnosis of certain types of autoimmune vasculitis. Five calibrators allow for creation of standard curve.

Native

1 X 96 wells 10 X 96 wells

704655 704655.10

QUANTA Lite PR-3

This assay is designed for the detection of anti-serine protease 3 (PR-3) IgG antibodies in human serum. The presence of these antibodies can aid in assessing certain autoimmune vasculitides such as Wegener's granulomatosis.

Native

1 X 96 wells 10 X 96 wells

708705 708705.10

QUANTA Lite PR3 SC

This assay is designed for the in-vitro measurement of specific IgG autoantibodies against proteinase 3 (PR3) present in human serum, as an aid in the diagnosis of Wegener's granulomatosis and certain forms of autoimmune vasculitis. Five calibrators allow for creation of standard curve.

Native

1 X 96 wells 10 X 96 wells

704660 704660.10

QUANTA Lite GBM

This assay is designed for the detection of anti-glomerular basement membrane (GBM) IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome.

Native

1 X 96 wells 10 X 96 wells

708740 708740.10

DESCRIPTION

ANTIGEN

PACKAGE

PART #

QUANTA Lite Thyroid T

This assay is designed for the detection of anti-thyroglobulin IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of Hashimoto's Thyroiditis.

Native

1 X 96 wells

708595

QUANTA Lite TPO

This assay is designed for the detection of anti-thyroid peroxidase (TPO) IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of autoimmune thyroid diseases such as Hashimoto's Thyroiditis and Graves' Disease.

Recombinant

1 X 96 wells

708725

Autoimmune Thyroid Disease NAME

33

QUANTA Lite® (ELISA) QUANTA Chek™ Quality Control Panels NAME

DESCRIPTION

PACKAGE

PART #

QUANTA Chek ANA Panel

The QUANTA Chek ANA Panel is used for quality control of IFA and ELISA antinuclear antibody procedures. Each serum serves as both a pattern control and a titratable sensitivity control. The staining pattern and intensity for each serum has been calibrated by testing it on NOVA Lite HEp-2 slides and QUANTA Lite ANA kits.

10 X 0.15mL

708111

QUANTA Chek ANCA Panel

The QUANTA Chek ANCA Panel is used for quality control of IFA and ELISA autoantibody procedures. Each serum serves as both a pattern control and a titratable sensitivity control. The staining pattern and intensity for each serum has been calibrated by testing it on INOVA Diagnostics' Neutrophil slides and QUANTA Lite MPO and PR-3 kits.

8 X 0.15mL

708112

QUANTA Chek Celiac Panel

The QUANTA Chek Celiac Panel is used for quality control of IFA and ELISA autoantibody procedures. Each serum serves as both a pattern control and a titratable sensitivity control. The staining pattern and intensity for each serum has been calibrated by testing it on NOVA Lite Endomysial slides and QUANTA Lite h-tTG IgA, h-tTG IgG, Gliadin IgG II and Gliadin IgA II kits.

8 X 0.15mL

708113

QUANTA Chek Coagulation Panel

The QUANTA Chek Coagulation Panel is used for quality control of ACA and β2GPI autoantibody ELISA procedures. Each serum serves as both a sensitivity and specificity control. Each serum has been calibrated by testing it on QUANTA Lite ACA and QUANTA Lite β2GPI kits.

8 X 0.15mL

708114

QUANTA Chek ENA Panel

The QUANTA Chek ENA Panel is used for quality control of extractable nuclear antibody (ENA) assay in the QUANTA Lite ENA ELISA procedure. Each serum serves as both a sensitivity and a specificity control. Each serum has been calibrated by testing it on QUANTA Lite ENA ELISA kits.

8 X 0.15mL

708115

34

Calibration and Standard Sets NAME

DESCRIPTION

PACKAGE

PART #

IgG Sapporo Standard (HCAL)

The IgG Sapporo Standard (HCAL) is used as an international standard for the quality control of anti-cardiolipin IgG (aCL) and anti-β2 glycoprotein I (β2GPI) IgG antibody ELISA products. The IgG Sapporo Standard (HCAL) can be serially diluted in order to make a standard curve, or it can be used as a single point control.

1 X 0.1mL

508668

IgM Sapporo Standard (EY2C9)

The IgM Sapporo Standard (EY2C9) is used as an international standard for the quality control of anti-cardiolipin IgM (aCL) and anti-β2glycoprotein I (β2GPI) IgM antibody ELISA products. The IgM Sapporo Standard (EY2C9) can be serially diluted in order to make a standard curve, or it can be used as a single point control.

1 X 0.1mL

508673

QUANTA Lite dsDNA Standard Set*

Pre-diluted 5-point standard curve and positive curve to be used in conjunction with QUANTA Lite dsDNA (708510)

5 X 1.2mL

508512

QUANTA Lite Gliadin IgA II Calibrator Set*

Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite Gliadin IgA II ELISA (704525)

6 X 1.2mL

504528

QUANTA Lite Gliadin IgG II Calibrator Set*

Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite Gliadin IgG II ELISA (704520)

6 X 1.2mL

504524

QUANTA Lite h-tTG IgA Calibrator Set*

Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite h-tTG IgA ELISA (708760)

5 X 1.2mL

508763

QUANTA Lite GBM Calibrator Set

Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite GBM ELISA (708740)

6 X 1.2mL

508744

QUANTA Lite MPO Calibrator Set*

Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite MPO ELISA (708700)

6 X 1.2mL

508703

QUANTA Lite PR-3 Calibrator Set*

Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite PR-3 ELISA (708705)

6 X 1.2mL

508708

* Available Outside The USA Only

35

NOVA Lite®

IFA INOVA Diagnostics has developed world leading indirect immunofluorescent assays (IFA) for the screening and semi-quantitative determination of autoantibodies. The presence of autoantibodies can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of autoimmune conditions such as: „„ Connective Tissue Diseases „„ Vasculitis „„ Celiac Disease

36

„„ Inflammatory Bowel Disease „„ Liver Diseases „„ Autoimmune Thyroid Disease „„ Skin Disorders

IFA Slide Kits NOVA Lite® has long been synonymous with quality immunofluorescence assays. INOVA is commited to customer support and supplies training materials such as reference books written by Carol Peebles, MS, MT (ASCP). Proprietary methods used to craft our slides make NOVA Lite assays easy to read and interpret, helping your lab provide the reliable and consistent results demanded by the current healthcare environment.

ANCA IFA

pANCA or cANCA negative

atypical ANCA positive

pANCA or cANCA positive

Clinical suspicion of autoimmune small vessel vasculitis low

Clinical suspicion of autoimmune small vessel vasculitis low; consider testing for ASCA

Order PR3 and MPO ELISA

Abbreviations MPO myeloperoxidase PR-3 proteinase 3 ANCA anti-neutrophil cytoplasmic antibodies ASCA anti-Saccharomyces cerevisiae antibody

MPO positive ELISA

PR3 positive ELISA

Consider microscopic polyangiitis (60% positive) or granulomatosis with polyangiitis (Wegener's) (25% positive)

Consider microscopic polyangiitis (30% positive) or granulomatosis with polyangiitis (Wegener's) (60% positive)

Test

Associated disease state

Testing strategies provided for informational purposes only. Testing and diagnosis should be determined by a licensed clinician. Savige, J. et al, Am J Clin Path 112 (1), 1999

37

NOVA Lite® (IFA)

HEp-2

DIAGNOSTIC ALGORITHM

HEp-2 POSITlVE Nuclear staining

Coarse speckled

Fine speckled

Homogeneous

Nucleolar

Centromere

PCNA

Consider Progressive Systemic Sclerosis or Polymyositis/ Scleroderma overlap (mixed pattern with positive chromosomes may indicate ScI-70)

CREST variant of Progressive Systemic Sclerosis

Marker antibody for SLE

Nuclear Dots

Confirmatory Testing

dsDNA and/or chromatin

Histone

Sm

RNP

SS-A 52

SS-A

SS-B

Scl-70

RNA Pol III

Active SLE

Drug induced SLE

SLE marker antibody

MCTD or milder SLE

SLE, Sjögren's Syndrome, Systemic Sclerosis, PM/DM

SLE, Sjögren's Syndrome, Systemic Sclerosis

SLE, Sjögren's Syndrome, Neonatal SLE

Scleroderma marker antibody associated with Scleroderma

Scleroderma, especially diffuse cutaneous form; also associated with risk of renal crisis

Abbreviations CREST calcinosis, raynaud's phenomenon, esophageal dysmotility, sclerodactyly, telangiectasia ds-DNA double stranded DNA ENA extractable nuclear antibody MCTD mixed connective tissue disease PBC primary biliary cirrhosis PCNA Proliferating Cell Nuclear Antigen

PM/DM RNP Scl-70 SS-A SS-B Sm SLE

polymyositis/dematomyositis ribonucleoprotein scleroderma antigen (70kD) Sjögren’s syndrome A antigen Sjögren’s syndrome B antigen Smith antigen systemic lupus erythematosus

Testing strategies provided for informational purposes only. Testing and diagnosis should be determined by a licensed clinician.

38

No further follow-up testing indicated. (SS-A testing may be indicated if there is strong clinical evidence of connective tissue disease)

NEGATIVE

Cytoplasmic staining

Nuclear membrane (rim)

sp100

gp 210

Retest on rodent tissue

Primary Biliary Cirrhosis (PBC)

Mitochondrial

M2 EP (MIT-3)

Miscellaneous

Jo-1

Spindle

Ribosomal P

Jo-1

Various rheumatic diseases

Low % of SLE patients

PM/DM

Ribosomal

Golgi

Immunofluorescent (IF) major patterns Centromere

Reflex test Associated disease state

CREST

THE HEp-2 DIAGNOSTIC ALGORITHM For additional information on HEp-2 testing or to view additional images, please visit our website at www.inovadx.com. This diagnostic algorithm was assembled by a panel of experts and is based on years of experience in conjunction with published guidelines. It is provided as a guide to aid in the diagnosis of disease based on laboratory results and is not intended as a definitive diagnosis of any disease condition. Please consider all clinical findings when making diagnostic decisions.

39

NOVA Lite® (IFA)

ANCA PATTERNS

SUBSTRATE PATTERN CHART

ANCA ASSOCIATED PATTERN CHART

SUBSTRATE

HEp-2 SLIDE

FORMALIN FIXED SLIDE

ETHANOL FIXED SLIDE

Negative

Granular Cytoplasmic

Granular Cytoplasmic

Negative

Granular Cytoplasmic

Perinuclear

Negative

Negative

Very Perinuclear

Positive

Negative or Low Positive

Perinuclear or Homogeneous

Negative

Negative

Negative

C·ANCA*

P·ANCA*

ATYPICAL P-ANCA*

ANA POSITIVE

NEGATIVE

* Consider confirmatory testing with QUANTA Lite® or QUANTA Flash MPO and PR-3.

40

ADDITIONAL IFA SUBSTRATES

SELECTED IMAGES

Find below a collection of immunfluorescent (IFA) images highlighting a few of the substrate offerings available from INOVA. To review our complete product offering and to view additional images please visit our website at www.inovadx.com.

AMA on NOVA Lite Rat Kidney/Stomach/Liver

AMA on NOVA Lite ANA Plus

ASMA on NOVA Lite ANA Plus

F-Actin on IEC-6 NOVA Lite IgG F-Actin

GBM Primate Kidney on NOVA Lite GBM (Primate Kidney)

Endomysial on NOVA Lite Endomysial (Primate Distal Esophagus)

Pemphigus on NOVA Lite Endomysial (Primate Esophagus)

Pemphigoid on NOVA Lite Endomysial (Primate Esophagus)

Thyroid on NOVA Lite Thyroid

41

NOVA Lite® (IFA) NOVA Lite HEp-2 and ANCA HEp-2 cells as an immunofluorescence assay (IFA) substrate provide a valuable test for the screening and titration of circulating autoantibodies in human serum. The ability to identify key patterns will aid in the laboratory diagnosis of systemic lupus erythematosus (SLE), Sjögren’s Syndrome, Scleroderma and other connective tissue disorders.

HOMOGENEOUS

SPECKLED

Uniform, diffuse fluorescence of entire nucleus in interphase cells with pronounced fluorescence of mitotic cells.

Coarse speckles in interphase cells with nucleolar sparing and negative metaphase mitotic cells.

SS-A

Scl-70

DFS-70

Fine to discrete, uniformly distributed, speckles in the nuclei of the interphase cells. Unstained metaphase mitotic cells and possible weak cytoplasmic staining.

Homogeneous or dense fine speckling of nuclei with many of these cells having weak nucleolar staining. Positive mitotic cells.

Dense fine speckling of interphase nuclei with positive mitotic cells.

LAMIN

42

gp210

Homogeneous or fine, ground glass appearance of nuclei in interphase cells associated with staining of the nuclear rim and negative mitotic cells.

Rim like staining of the cell nucleus.

CENTRIOLE

RIBOSOMAL

Metaphase mitotic spindles display discrete fluorescent dots at each pole. Interphase cells adjacent to nucleus display 1 or 2 bright dots.

Fine, dense granular to homogeneous cytoplasmic staining with weak nucleolar staining.

RNA POL I

RNA POL I speckling of the nuclei in interphase cells with speckled nucleolar staining.

Jo-1

Fine cytoplasmic staining concentrated around the nucleus which diminishes towards the periphery of the cytoplasm.

IMMUNOFLUORESCENCE PATTERNS

CENTROMERE

NUCLEOLAR

Discrete speckles throughout the interphase cells. Condensed, speckled metaphase mitotic cells.

PCNA

Large, typically homogeneous clustered granules in nucleoli of interphase cells with surface staining of the mitotic cells. .

PM-Scl

AMA + sp100

Homogeneous nucleolar staining associated with weak, diffuse staining of the nuclei and negative mitotic cells.

Coarse granular staining throughout the cytoplasm. Multiple nuclear dots throughout the nuclei with negative metaphase cells.

CENP-F

PERICENTROSOMES

Diffuse fine speckled nuclear staining of the interphase cells. Fluorescence of the spindle poles and spindle fibers in metaphase and anaphase mitotic cells.

Fine speckling throughout nucleus in interphase cells; staining of centromeres in prophase and metaphase; spindle poles in metaphase; spindle and midbody of mitotic cells in anaphase and telophase.

1-2 large dots at the periphery of the nucleus in interphase cells.

GW BODIES

GOLGI

RODS AND RINGS

Large, discrete speckles throughout the cytoplasm of interphase cells with negative mitotic cells.

Speckled polar staining adjacent to one part of the nucleus with negative mitotics.

Multiform cytoplasmic structures. with negative mitotic cells.

Highly variable staining in both pattern and intensity of interphase cells. Fine to coarse speckling in approximately 30-60% of interphase cells (S phase cells).

NuMA

.

43

NOVA Lite® (IFA) IFA Slide Kits NAME

DESCRIPTION

PACKAGE

PART #

NOVA Lite ANCA (Ethanol Fixed)

An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-neutrophil cytoplasmic IgG antibodies (ANCA) in human serum. The presence of these antibodies can aid in the assessment of various systemic vasculitides. Fluorescein labeled anti-human IgG conjugate with Evan's Blue - ready to use.

10 X 6 wells (classic formulation) 20 X 12 wells (classic formulation)

708299 708290 708298 708296

NOVA Lite; ANCA (Formalin Fixed) Kit

An indirect immunofluorescent assay for the screening and titration of circulating anti- neutrophil cytoplasmic antibodies (ANCA). These antibodies are markers to aid in the diagnosis and treatment of various systemic vasculitides. Fluorescein labeled IgG conjugate with Evan's Blue ready to use.

10 X 6 wells 20 X 12 wells

708295 708297

NOVA Lite HEp-2

An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-nuclear IgG antibodies (ANA) in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE), or other connective tissue or rheumatic diseases. Fluorescein labeled anti-human IgG conjugate with Evan's Blue - ready to use.

5 X 12 wells 20 X 12 wells

708101 708100

10 X 6 wells 20 X 12 wells

704230 704235

NOVA Lite HEp-2 ANA with DAPI

An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-nuclear antibodies (ANA) in human serum. The presence of anti-nuclear antibodies can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of systemic lupus erythematosus (SLE) or other connective tissue or rheumatic diseases.

20 x 12 wells

708102

NOVA Lite ANA KSL Mouse Kidney/ Stomach/Liver

An indirect immunofluorescent assay for the screening and semi-quantitative determination of IgG anti-nuclear antibodies (ANA), anti-mitochondrial (AMA), anti-smooth muscle (ASMA) and gastric parietal antibodies (GPA) in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE), or other connective tissue or rheumatic diseases. Fluorescein labeled anti-human IgG conjugate with Evan's Blue - ready to use.

10 X 4 wells 25 X 8 wells

708390 708380

NOVA Lite ANA Plus Mouse Kidney & Stomach

An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-nuclear antibodies (ANA), anti-mitochondrial (AMA), anti-smooth muscle (ASMA) and gastric parietal IgG antibodies (GPA) in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE), or other connective tissue or rheumatic diseases. Fluorescein labeled anti-human IgG conjugate with Evan's Blue - ready to use.

10 X 4 wells 20 X 8 wells

708155 708150

NOVA Lite dsDNA Crithidia luciliae

An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-double stranded DNA (dsDNA) IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE). Fluorescein labeled anti-human IgG conjugate no Evan's Blue - ready to use.

10 X 6 wells 20 X 12 wells

708200 708205

An indirect immunofluorescent assay for the screening and titration of circulating antinuclear antibodies by means of an immunofluorescence NOVA Lite; HEp-2 ANA test. It is to be used as an aid in the diagnosis and treatment of systemic IgG (H+L) lupus erythematosus (SLE), Sjögren's Syndrome, rheumatoid arthritis and Immunoglobulin other connective tissue disorders. External Evans blue provided as optional counterstain.

44

IFA Slide Kits (continued) NAME

DESCRIPTION

PACKAGE

PART #

NOVA Lite IgG F-Actin*

An indirect immunofluorescent assay for the screening and semi quantitative determination of IgG anti-F-Actin antibodies in human serum The presence of IgG anti-F-Actin antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of autoimmune liver diseases such as autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).

5 x 6 wells

708255

NOVA Lite Monkey Esophagus (IgG and IgA conjugates)

Monkey esophagus sections are intended for use as a substrate for the screening of antibodies to intra-epidermal antigens or basement membrane zones in human serum, as an aid in the diagnosis of pemphigus and bullous pemphigoid 10 X 5 wells respectively. The sections can also be used for detection of endomysial 25 X 10 wells antibodies as an aid in the diagnosis of celiac disease. Fluorescein labeled antihuman IgG (H&L) conjugate and anti-human IgA conjugate - ready to use.

704145 704150

NOVA Lite Monkey Esophagus (IgA conjugate only)

Monkey esophagus sections are intended for use as a substrate for the detection of endomysial antibodies as an aid in the diagnosis of celiac disease. Includes 25 X 10 wells IgA conjugate only. Fluorescein labeled anti-human IgA conjugate - ready to use.

704155

NOVA Lite Monkey Esophagus (skin antibodies only)

Monkey esphagus sections are intended for use as a substrate for the screening of autoantibodies to intra-epidermal antigens or basement membrane zones in human serum, as an aid in the diagnosis of bullous pemphigus and bullous pemphigoid respectively. The sections may not contain endomysial tissue and therefore, should not be used for detection of endomysial antibodies. Fluorescein labeled anti-human IgG (H&L) conjugate - ready to use.

10 X 5 wells 25 X 10 wells

704160 704165

NOVA Lite Rat Liver, Kidney, Stomach

This product is intended for use in the screening and titration of circulating autoantibodies in human serum as an aid in the diagnosis and treatment of various autoimmune diseases. The four major autoantibodies detected are antinuclear antibodies (ANA), antimitochondrial antibodies (AMA), antismooth muscle antibodies (ASMA) and antigastric parietal cell antibodies (AGPCA). Fluorescein labeled anti-human IgG (H&L) conjugate - ready to use.

10 X 5 wells 25 X 10 wells

704170 704180

NOVA Lite Skin Antibody Primate Esophagus

An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-skin IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of autoimmune skin diseases, especially pemphigus and pemphigoid. Fluorescein labeled anti-human IgG conjugate (FC specific) with Evan's Blue - ready to use.

10 X 8 wells

708330

NOVA Lite Thyroid

An indirect immunofluorescent assay for the screening and semi-quantitative determination of antithyroid microsomal and colloid/thyroglobulin IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of autoimmune thyroid disease. Fluorescein labeled primate absorbed anti-human IgG conjugate (FC specific) with Evan's Blue - ready to use.

10 X 8 wells

708350

NOVA Lite Monkey Kidney*

This product is intended for use in the screening of circulating antiglomerular basement membrane (GBM) autoantibodies in human serum. Anti-human IgG (H&L) biotin conjugate and fluorescein labeled-strepavidin conjugate - ready to use.

10 X 5 wells

704240

* Available Outside The USA Only

45

NOVA Lite® (IFA) IFA Substrate Slides With a comprehensive offering of slide configurations and robust quality standards, INOVA stands ready to meet your IFA substrate slide needs. NAME

DESCRIPTION

PACKAGE

PART #

NOVA Lite ANA (HEp-2 actin)

HEp-2 (human epithelial cell) substrate slide fixed to detect actin fibers

1 X 6 wells 1 X 12 wells

508095 508090

NOVA Lite ANA (Mouse Kidney)

ANA (Mouse Kidney) tissue section slide

1 X 8 wells

508170

Mouse kidney and stomach tissue substrate slide

1 X 4 wells 1 X 8 wells 10 X 4 wells 30 X 8 wells

508155 508150 508155.10 508150.30

Mouse kidney, stomach and liver tissue substrate slide

1 X 4 well 1 X 8 wells 10 X 4 wells 30 X 8 wells

508385 508380 508385.10 508380.30

Ethanol-fixed human neutrophil substrate slide

1 X 6 wells 1 X 12 wells 10 X 6 wells 20 X12 wells

508299 508298 508299.10 508298.20

Formalin-fixed human neutrophil substrate slide

1 X 6 wells 10 X 6 wells 1 X 12 wells 20 X 12 wells

508295 508295.10 508297 508297.20

Crithidia luciliae substrate slide

1 X 6 wells 1 X 12 wells 10 X 6 wells 20 X 12 wells 80 X 12 wells

508200 508205 508200.10 508205.20 508205.80

HEp-2 (human epithelial cell) substrate slide

1 X 6 wells 1 X 12 wells 10 x 12 wells 20 x 12 wells 80 x 12 wells 10 X 6 wells

508105 508100 508100.10 508100.20 508100.80 508105.10

NOVA Lite Monkey Esophagus

Monkey esophagus substrate slide

1 X 5 wells 1 X 10 wells 10 X 5 wells 25 X 10 wells

504145 504150 504145.10 504150.25

NOVA Lite Monkey Esophagus (skin antibodies only)

Monkey Esophagus (skin antibodies only) IFA Slide (the sections may not contain endomysial tissue)

1 X 5 wells 1 X 10 wells 10 X 5 wells

504160 504165 504160.10

NOVA Lite ANA (Mouse Kidney/Stomach)

NOVA Lite ANA KSL (Mouse Kidney/ Stomach/Liver)

NOVA Lite ANCA (Ethanol Fixed)

NOVA Lite ANCA (Formalin Fixed)

NOVA Lite dsDNA (Crithidia luciliae)

NOVA Lite HEp-2 ANA

46

IFA Substrate Slides (continued) NAME

DESCRIPTION

PACKAGE

PART # 504170 504180 504170.10 504180.25

NOVA Lite Rat Liver, Kidney, Stomach

Rat Liver, Kidney, Stomach IFA slide

1 X 5 wells 1 X 10 wells 10 X 5 wells 25 X 10 wells

NOVA Lite Thyroid (Primate)*

Primate thyroid tissue substrate slide

1 X 4 wells 1 X 8 wells

508355 508350

NOVA Lite Adrenal (Primate)*

Primate adrenal tissue substrate slide

1 X 4 wells 1 X 8 wells 10 X 4 wells

508375 508370 508375.10

NOVA Lite ANCA (Methanol Fixed)*

Methanol-fixed human neutrophil substrate slide

1 X 6 wells

508280

NOVA Lite Cerebellum (Primate)*

Primate cerebellum tissue substrate slide

1 X 4 wells 10 X 4 wells

508357 508357.10

NOVA Lite Cerebrum (Primate)*

Primate cerebrum tissue substrate slide

1 X 4 wells

508362

NOVA Lite Ear (Primate)*

Primate ear tissue substrate slide

1 X 4 wells

508358

NOVA Lite Endomysial (Primate Distal Esophagus)

Primate distal esophagus tissue substrate slide

1 X 4 wells 1 X 8 wells

508336 508337

NOVA Lite GBM (Primate Kidney)*

Primate kidney tissue substrate slide

1 X 4 wells

508345

NOVA Lite Heart tissue (Primate)*

Primate heart tissue substrate slide

1 X 4 wells 10 X 4 wells

508356 508356.10

NOVA Lite ICA (Primate Pancreas)*

Primate pancreas tissue substrate slide

1 X 4 wells 1 X 8 wells 10 X 4 wells

508315 508310 508315.10

NOVA Lite Lip (Primate)*

Primate lip tissue substrate slide

1 X 4 wells

508364

NOVA Lite Liver (Primate)* Primate liver tissue substrate slide

1 X 4 wells

508373

NOVA Lite Monkey Cerebellum/Cerebrum & Mouse Stomach *

1 X 5 wells 10 X 5 wells

504225 504225.10

NOVA Lite Monkey Ovary, Monkey ovary, testis, adrenal tissue section slide Testis, Adrenal *

1 X 5 wells 10 X 5 wells

504220 504220.10

NOVA Lite Ovary (Primate)*

1 X 4 wells 10 X 4 wells

508366 508366.10

Monkey cerebellum/cerebrum & mouse stomach tissue section slide

Primate ovary tissue substrate slide

* Available Outside The USA Only * Available Outside The USA Only

47

NOVA Lite® (IFA) IFA Substrate Slides (continued) NAME

DESCRIPTION

PACKAGE

PART #

NOVA Lite Ovary (Primate)*

Primate ovary tissue substrate slide

1 X 4 wells 10 X 4 wells

508366 508366.10

NOVA Lite Salivary Gland (Primate)*

Primate salivary gland tissue substrate slide

1 X 4 wells 10 X 4 wells

508367 508367.10

NOVA Lite Sciatic Nerve (Primate)*

Primate sciatic nerve tissue substrate slide

1 X 4 wells

508368

NOVA Lite Skeletal Muscle Primate skeletal muscle tissue substrate slide (Primate)*

1 X 4 wells 10 X 4 wells

508320 508320.10

NOVA Lite Skin Antibody (Primate Esophagus)

Primate esophagus tissue substrate slide

1 X 4 wells 1 X 8 wells

508335 508330

NOVA Lite Stomach (Primate)*

Primate stomach tissue substrate slide

1 X 4 wells

508369

NOVA Lite Testes (Primate)*

Primate testes tissue substrate slide

1 X 4 wells

508372

NOVA Lite Urinary Bladder (Primate)*

Primate urinary bladder tissue substrate slide

1 X 4 wells

508360

NOVA Lite Monkey Peripheral Nerve*

Monkey peripheral nerve tissue substrate slide

1 X 5 wells 10 X 5 wells

504210 504210.10

NOVA Lite Monkey Espohagus/Jejunum*

Monkey esophagus/jejunum tissue substrate slide

1 X 5 wells 10 X 5 wells

504215 504215.10

NOVA Lite Monkey Kidney

Monkey kidney tissue substrate slide

1 X 5 wells 10 X 5 wells

504240 504240.10

NOVA Lite IgG F-Actin*

Optimally fixed rat epithelial cell substrate slide

1 X 6 wells

508255

NOVA Lite Rat Kidney/ Stomach/Liver*

Rat kidney, stomach and liver tissue substrate slide

1 X 4 wells 1 X 8 wells

508392 508393

* Available Outside The USA Only

48

IFA Antibody Controls NOVA Lite® antibody controls are designed for use with the NOVA Lite slides. Convenient volumes and ready to use dilutions make these a sensible choice for any laboratory. NAME

DESCRIPTION

PACKAGE

PART #

ANA Homogenous Pattern Control

Pre-diluted human serum antibodies to the cell nucleus

1 X 0.5mL 1 X 1.0mL

508101 504054

ANA Homogenous/ dsDNA Pattern Control

Pre-diluted human serum antibodies to the cell nucleus and dsDNA

1 X 0.5mL

508181

ANA Speckled Pattern Control

Pre-diluted human serum antibodies to the cell nucleus

1 X 0.5mL

508182

ANA Nucleolar Pattern Control

Pre-diluted human serum antibodies to the cell nucleus

1 X 0.5mL

508183

ANA Centromere Pattern Control

Pre-diluted human serum antibodies to the cell nucleus

1 X 0.5mL 1 X 1.0mL

508184 504089

ANA Scl-70 Pattern Control

Pre-diluted human serum antibodies to the cell nucleoli

1 X 0.5mL

508185

Autoantibody Control Panel of five vials of pre-diluted controls including ANA Homogeneous/ Panel (includes 508181 to dsDNA Pattern, ANA Speckled Pattern, ANA Nucleolar Pattern, ANA 508185) Centromere Pattern and ANA Scl-70 Pattern

5 X 0.5mL

708180

ANA Nuclear Dot Pattern Control

Pre-diluted human serum antibodies to the cell nucleus

1 X 0.5mL

508193

ANA PCNA Pattern Control

Pre-diluted human serum antibodies to PCNA

1 X 0.5mL

508192

ANA Ribsomal Pattern Control

Pre-diluted human serum antibodies to ribosomes in cell cytoplasm

1 X 0.5mL

508195

cANCA Positive Control

Pre-diluted human serum antibodies to cANCA antigens

1 X 0.5mL 1 X 1.0mL

508191 504087

dsDNA Positive Control

Pre-diluted human serum antibodies to dsDNA

1 X 0.5mL

508211

Gastric Parietal Cell (GPA) Pattern Control

Pre-diluted human serum antibodies to gastric parietal cell

1 X 0.5mL

508190

1 X 0.5mL 1 X 1.0mL

508194 504085

Basement *Glomerular Available Outside The USA Only Membrane Pattern Pre-diluted human serum antibodies to GBM Control Yo Purkinje Cell Positive Control*

Pre-diluted human serum antibodies to Yo (Purkinje cell)

1 X 0.5mL

504009

Hu ANNA-1 Positive Control*

Pre-diluted human ANNA-1 positive control

1 X 0.5mL

504073

* Available Outside The USA Only * Available Outside The USA Only

49

NOVA Lite® (IFA) IFA Antibody Controls (continued) NAME

DESCRIPTION

PACKAGE

PART #

IFA System Negative Control

Pre-diluted negative control

1 X 0.5mL 1 X 1.0mL

508186 508007

IgG F-Actin Positive Control*

Pre-diluted human serum antibodies to F-Actin

1 X 0.5mL

508251

MAG (Myelin Associated Glycoprotein) Positive Control

Pre-diluted human serum antibodies to MAG (Myelin Associated Glycoprotein)

1 X 0.5mL

504003

Mitochondrial (AMA) Pattern Control

Pre-diluted human serum antibodies to the cell mitochondria

1 X 0.5mL 1 X 1.0mL

508187 504052

Atypical ANCA Positive Control

Pre-diluted human serum antibodies to aANCA antigens

1 X 0.5mL

508292

Endomysial (Celiac) Positive Control

Pre-diluted human serum antibodies to endomysium

1 X 0.5mL 1 X 1.0mL

508154 504050

pANCA Positive Control

Pre-diluted human serum antibodies to pANCA antigens

1 X 0.5mL 1 X 1.0mL

508291 504086

Pancreatic Islet Cell Positive Control *

Pre-diluted human serum antibodies to pancreatic islet cell

1 X 0.5mL

504005

Skeletal Muscle Positive Control

Pre-diluted human serum antibodies to skeletal muscle

1 X 0.5mL

508321

Skin (Pemphigoid) Positive Control

Pre-diluted human serum antibodies to pemphigoid

1 X 0.5mL 1 x 1.0mL

508331 504055

Skin (Pemphigus) Positive Pre-diluted human serum antibodies to pemphigus Control

1 X 0.5mL 1 X 1.0mL

508332 504051

Smooth Muscle (ASMA) Pattern Control

Pre-diluted human serum antibodies to smooth muscle

1 X 0.5mL 1 X 1.0mL

508188 504053

Thyroid Positive Control

Pre-diluted human serum antibodies to thyroid

1 X 0.5mL

508351

Titratable ANA Pattern Control

Pre-diluted human serum antibodies to the cell nucleus

1 X 0.5mL

508171

Homogeneous Pattern Control

Pre-diluted homogeneous pattern controls for use with conjugate 504070 or 504088

1 X 1.0mL

504090

* Available Outside The USA Only

50

IFA Conjugates Conjugates are arguably the most critical component of the immunofluorescence assay process. The vast menu of NOVA Lite conjugates provides a host of concentrations, specificities and contrast levels to fit individual laboratory needs.

Undiluted Antibody Conjugates NAME

DESCRIPTION

PACKAGE

PART #

FITC IgA Monkey Absorbed Conjugate

Fluorescein labeled anti-human monkey absorbed IgA conjugate

1 X 1.0mL

504016

FITC IgA Conjugate

Fluorescein labeled anti-human IgA conjugate

1 X 1.0mL

504034

FITC IgG (gamma) Monkey Absorbed Conjugate

Fluorescein labeled anti-human monkey absorbed IgG (gamma) conjugate

1 X 1.0mL

504014

FITC IgG (H&L) Monkey Adsorbed Conjugate*

Fluorescein labeled anti-human monkey adsorbed IgG (H&L) conjugate

1 X 1.0mL

504012

FITC IgG (H+L) Conjugate*

Fluorescein labeled anti-human IgG (H+L) conjugate

1 X 1.0mL

504032

FITC IgGAM (H+L) Conjugate*

Fluorescein labeled anti-human IgG, IgA and IgM (H+L) conjugate

1 X 1.0mL

504031

FITC IgG Conjugate*

Fluorescein labeled anti-human IgG conjugate

1 X 1.0mL

504033

PACKAGE

PART #

Prediluted Antibody Conjugates NAME

DESCRIPTION

FITC High Sensitivity IgG Conjugate with EB

Fluorescein labeled high sensitivity anti-human IgG conjugate with Evan's Blue

1 X 7.0mL

508126

FITC High Sensitivity IgG Conjugate no EB*

Fluorescein labeled high sensitivity anti-human IgG conjugate no Evan's Blue

1 X 15.0mL

504022

FITC IgA (Monkey Absorbed) Conjugate no EB*

Fluorescein labeled anti-human IgA (Monkey Absorbed) conjugate no Evan's Blue

1 X 7.0mL

504015

FITC IgA Conjugate with EB

Fluorescein labeled anti-human IgA conjugate with Evan's Blue

1 X 4.0mL 1 X 7.0mL

508152 508153

* Available Outside The USA Only

51

NOVA Lite® (IFA) IFA Conjugates (continued) Prediluted Antibody Conjugates (continued) NAME

DESCRIPTION

PACKAGE

PART #

FITC IgA Conjugate no EB*

Fluorescein labeled anti-human IgA conjugate no Evan's Blue

1 X 7.0mL 1 X 15.0mL

504045 504023

FITC IgG (H+L) Conjugate no EB

Fluorescein labeled anti-human IgG (H+L) Conjugate no Evan's Blue

1 X 15.0mL

504021

Anti-Human IgG(H&L) AFF FITC, 7ml

FITC IgG (H&L) chain Conjugate - ready to use

1 X 7.0mL

504072

FITC IgG (H+L) HEp-2 Conjugate no EB

Fluorescein labeled anti-human IgG (H+L) HEp-2 Conjugate no Evan's Blue

1 X 7.0mL

504070

FITC IgG (H+L) Monkey Adsorbed Conjugate no EB

Fluorescein labeled anti-human monkey adsorbed IgG (H+L) conjugate no Evan's Blue

1 X 7.0mL 1 X 15.0mL

504011 504071

FITC IgG Conjugate EB

Fluorescein labeled anti-human IgG conjugate with Evan's Blue

1 X 4.0mL 1 X 7.0mL 1 X 15.0mL

508123 508125 508113

FITC IgG Conjugate no EB Fluorescein labeled anti-human IgG conjugate no Evan's Blue

1 X 4.0mL 1 X 15.0mL

508124 508114

FITC IgG Conjugate Primate Absorbed EB*

Fluorescein labeled primate absorbed anti-human IgG conjugate with Evan's Blue

1 X 7.0mL

508128

FITC IgG (Mky Abs) Conjugate,NEB*

FITC IgG (Monkey Absorbed) Conjugate - ready to use

1 X 7.0mL

504013

FITC IgG/A/M Conjugate no EB

Fluorescein labeled anti-human IgG, IgA and IgM conjugate no Evan's Blue

1 X 4.0mL 1 X 15.0mL

508127 508117

FITC IgM, NEB

FITC IgM Conjugate

1 X 15.0mL

504018

Streptavidin FITC Conjugate*

Streptavidin FITC Conjugate (as used with the NOVA Lite Monkey Kidney Kit 704240)

1 X 3.0mL

504082

Biotin FITC Conjugate*

Biotin FITC Conjugate (as used with the NOVA Lite Monkey Kidney Kit 704240)

1 X 3.0mL

504083

* Available Outside The USA Only

52

Common Components NAME

DESCRIPTION

PACKAGE

PART #

10 each 20 each

508122 508112

Coverslips

10 coverslips 20 coverslips

Evan's Blue 0.5%

0.5% Evan's Blue Stain

1 X 2.5mL

508115

Evan's Blue 1.0%

1.0% Evan's Blue Stain

1 X 2.5mL

504049

High Contrast Diluent

High contrast diluent - ready to use

1 X 25.0mL

508003

PBS Concentrate (40X)

40X concentrate of PBS

1 X 25.0mL

508002

Mounting Medium

Mounting medium - ready to use

1 X 3.0mL 1 X 7.0mL 1 X 10.0mL

508006 508001 508005

Mounting Medium-PVA

Mounting medium polyvinyl alcohol (PVA) - ready to use

1 X 3.0mL 1 X10.0mL

504046 504047

IFA System Negative Control

IFA System Negative Control

1 X 1.0mL

508007

Urea Buffer*

Urea Buffer (as used with the NOVA Lite Monkey Kidney Kit 704240)

1 X 13.0mL

504084

Anti AB Neutralising Reagent *

Anti AB Neutralising Reagent

1 X 5.0mL

504056

PACKAGE

PART #

Demonstration Slides NAME

DESCRIPTION

HEp-2 Demonstration Slide

HEp-2 Demonstration Slide. 12 wells/slide pre-stained with antibodies/ patterns

1 X 12 wells

518100

HEp-2 Demonstration Slide Actin

HEp-2 Demonstration Slide. HEp-2 Actin specific 12 wells/slide pre-stained with antibodies/patterns

1 X 12 wells

518090

ANCA Demonstration Slide

ANCA Demonstration Slide. 1 Ethanol and 1 Formalin, 2x6 wells

2 X 6 wells

518290

Distal Esophagus Demonstration Slide

Primate distal esophagus substrate slide pre-stained with antibodies/ patterns (pemphigus, pemphigoid, ASMA, endomysial)

1 X 4 wells

518336

NOVA Lite; ANA Plus (Mouse Kidney/Stomach)

Mouse kidney/stomach substrate slide pre-stained with antibodies/patterns (ANA homogenous, speckled, nucleolar, dsDNA, negative control, AMA, ASMA, GPA)

1 X 8 wells

518150

* Available Outside The USA Only

53

NOVA Gel®

OUCHTERLONY INOVA Diagnostics produces double diffusion test systems for the screening and semiquantitative determination of autoantibodies to extractable nuclear antigens (ENA) in human serum. The presence of antibodies can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of connective tissue diseases.

54

Connective Tissue Disease Kits NAME

DESCRIPTION

PACKAGE

PART #

NOVA Gel Jo-1 "T"

A double diffusion test system for the titering and semi-quantitative determination of autoantibodies to Jo-1 in human serum. The presence of these antibodies can aid in the diagnosis of polymyositis and other related connective tissue diseases.

8 X 6 wells

708495

NOVA Gel Scl-70 "S"

A double diffusion test system for the screening and semi-quantitative determination of autoantibodies to Scl-70 in human serum. The presence of these antibodies can aid in the diagnosis of scleroderma.

8 X 6 wells

708470

NOVA Gel Scl-70 "T"

A double diffusion test system for the titering and semi-quantitative determination of autoantibodies to Scl-70 in human serum. The presence of these antibodies aid in the diagnosis of scleroderma.

8 X 6 wells

708475

NOVA Gel Sm/RNP "S"

A double diffusion test system for the screening and semi-quantitative determination of autoantibodies to Sm/RNP in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE) and other related connective tissue diseases.

8 X 6 wells

708410

NOVA Gel Sm/RNP "T"

A double diffusion test system for the titering and semi-quantitative determination of autoantibodies to Sm/RNP in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE) and other related connective tissue diseases.

8 X 6 wells

708415

NOVA Gel SS-A/SS-B "S"

A double diffusion test system for the screening and semi-quantitative determination of autoantibodies to SS-A/SS-B in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE) and other related connective tissue diseases, such as Sjögren’s syndrome.

8 X 6 wells

708450

NOVA Gel SS-A/SS-B "T"

A double diffusion test system for the titering and semi-quantitative determination of autoantibodies to SS-A/SS-B in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE) and other related connective tissue diseases, such as Sjögren’s syndrome.

8 X 6 wells

708455

PACKAGE

PART #

Components NAME

DESCRIPTION

NOVA Gel "S" Plates

Pre-punched screening gel plate

8 X 6 wells

508400

NOVA Gel "T" Plates

Pre-punched titering gel plate

8 X 6 wells

508401

NOVA Gel Jo-1 Antigen

Lyophilized Jo-1 antigen

1 X 0.4mL

508490

NOVA Gel Jo-1 Control

Pre-diluted Jo-1 control

1 X 1.4mL

508491

NOVA Gel RNP Control

Pre-diluted RNP control

1 X 0.7mL

508412

NOVA Gel Scl-70 Antigen

Lyophilized Scl-70 antigen

1 X 0.4mL

508470

NOVA Gel Scl-70 Control

Pre-diluted Scl-70 control

1 X 1.4mL

508471

NOVA Gel Sm Control

Pre-diluted Sm control

1 X 0.7mL

508411

NOVA Gel Sm/RNP Antigen

Lyophilized Sm/RNP antigen

1 X 0.4mL

508410

NOVA Gel SS-A Control

Pre-diluted SS-A control

1 X 0.7mL

508451

NOVA Gel SS-A/SS-B Antigen Lyophilized SS-A/SS-B antigen

1 X 0.4mL

508450

NOVA Gel SS-B Control

1 X 0.7mL

508452

Pre-diluted SS-B control

55

Customer Support

Ser vice is impor tant to us. We believe that we have some of the finest customer ser vice professionals in the industr y. But don' t take our word for it-give us a call at +1-800-545-9495 or +1-858-586-9900, email us at ser [email protected] or visit us at w w w.inovadx.com for produc t information.

56

Business Hours 6:30 am to 4:00 pm PT Monday thru Friday

To Order Product US toll free phone: +1-800-545-9495 INOVA Diagnostics, Inc. Tel. +1-858-586-9900 9900 Old Grove Road San Diego CA, 92131-1638, USA [email protected] customer service fax: +1-858-586-9905

Technical Assistance/Consultation Our professional staff is available to answer questions or discuss any aspect regarding the use and interpretation of our products. In addition to our own scientific staff, INOVA retains consultants from both the clinical and academic communities. These resources are available to help resolve any unusual cases involving autoimmune disease diagnosis. Email us for assistance at [email protected] or call us at +1-877-829-4745 (U.S. & Canada Only), or + 1-858-805-7950 (Outside the U.S.). Conditions of Sale „„ „„ „„ „„ „„ „„ „„ „„

ORDERS: Orders may be placed by fax or e-mail. Please specify the catalog number and product description. SHIPMENTS: All shipping charges will be prepaid FOB San Diego, CA and added to the invoice. Unless otherwise specified, shipments will be made via Federal Express or UPS. Customers requesting other carriers should specify at the time of order. TERMS: All invoices are net 30 days unless otherwise prearranged. All invoices are in U.S. dollars. TITLE: Title to the products passes to the customer upon delivery of items ordered to the carrier. LOSS OR DAMAGE: Claims for loss or damage of products are the responsibility of the customer and should be reported to INOVA at the earliest possible time. PARTIAL SHIPMENTS: INOVA will make every possible attempt to fill orders promptly and completely. When this cannot be done, we will make partial shipments unless otherwise notified at the time of order confirmation. RETURNS: Prior to returning any products, customers must contact INOVA technical services for approval. Please provide the reason for the return (ordering error, shipping error, technical problem, etc.). A restocking fee may apply. CONDITIONS: Unless otherwise indicated the products listed herein are for ‘in vitro’ diagnostic use only. Nothing disclosed herein is to be construed as a recommendation to use our products in violation of any patents. The information presented is believed to be accurate. However, said information and products are offered without warranty or guarantee since the ultimate conditions of use and the variability of the materials tested are beyond our control. We cannot be responsible for patent infringements or other violations that may occur with the use of these products.

QUANTA Lite, QUANTA Link, QUANTA Flash, NOVA View, NOVA Lite and NOVA Gel are registered trademarks of INOVA Diagnostics, Inc. QUANTA Chek is a trademarks of INOVA Diagnostics, Inc. DS2 and DSX are registered trademarks of DYNEX Technologies, Inc. QUANTA-Lyser, is a registered trademark of Biokit S.A. ©2011 INOVA Diagnostics, Inc. All rights reserved.

INOVA Diagnostics Global Affiliates Corporate Headquarters

North and South America

Asia

Europe

UNITED STATES OF AMERICA INOVA Diagnostics Inc. Tel. +1-858-586-9900 Toll free +1-800-545-9495 [email protected] www.inovadx.com

BRAZIL Werfen Medical Ltda Tel. +55 11 415 433 37 [email protected] www.werfengroup.com

CHINA Werfen Medical Intl. Trading (Shanghai) Co., Ltd. Tel. +86 10 59756031 customerservice01@ werfen-china.com www.werfen-china.com

AUSTRIA Instrumentation Laboratory GmbH Tel. +43 1 256 580040 [email protected] www.il-austria.at

MEXICO IL Diagnostics S.A. de CV Tel. +55 5262 1760 idiagnostics@ mexico.ilww.com www.ildiagnostics.com.mx

JAPAN Instrumentation Laboratory Japan Co. Ltd. Tel. +81 3 54191301 www.il-japan.jp SOUTH KOREA Werfen Medical IL, Ltd. Korea Tel. +82 2 571 9246 [email protected] www.werfenmedical.com

BELGIUM Instrumentation Laboratory N.V./S.A Tel. +32 2 7252052 [email protected] www.il-be.com CZECH REPUBLIC AND SLOVAK REPUBLIC Comesa spol.s.r.o. Tel. +42 (0) 246 090 911 [email protected] www.comesa.cz FRANCE Instrumentation Laboratory S.A. Tel. +33 (0) 1 823 086 00 www.il-france.com GERMANY Instrumentation Laboratory GmbH Tel. +49 (0) 89 909 070 [email protected] www.il-ger.de HUNGARY Comesa Hungary Kft. Tel. +36 1 4392910 [email protected] www.comesa.hu

ITALY Instrumentation Laboratory SpA Tel. +39 02 25221 [email protected] www.il-italia.it

Redefining Autoimmunity

LITHUANIA Instrumentation Lab. (Lietuva) B.I. Tel. +37 0 37313157 [email protected] www.illww.lt/anliskas POLAND Comesa Polska Sp.z.o.o. Tel. +48 22336 1800 [email protected] www.comesa.pl PORTUGAL Izasa Portugal, Lda Tel. +35 1 214247312 www.izasa.pt SPAIN Izasa, S.A. Tel. +34 902203090 www.Izasa.es THE NETHERLANDS Instrumentation Laboratory B.V. Tel. +31 76 5480100 [email protected] www.il-nl.com UNITED KINGDOM Instrumentation Laboratory Ltd. Tel. +44 192 581 0141 [email protected] www.il-uk.com

We proudly serve customers in over 90 countries worldwide. For more information on your local distributor please contact INOVA Diagnostics at [email protected]

INOVA Diagnostics, Inc. 9900 Old Grove Road • San Diego • CA • 92131-1638 Tel. 858-586-9900 • Toll free 800-545-9495 • Fax 858-586-9911 www.inovadx.com

690033 Rev. 3

2012 Catalog