4th Annual POCT BuyersGuide

thAnnual POCT

4 Abaxis 3240 Whipple Rd. Union City, CA 94587 Contact: Ron Blasig (510) 675-6500 fax: (510) 441-6150 E-mail Address: [email protected] Web Site: www.abaxis.com Primary Product(s): Piccolo Type of Analyzer: Chemistry Size and Weight/Cost: 9.5"Hx6"Wx11.5"D 15lbs / $17000 Type of Design: Portable chemistry analyzer Cost to Operate/Cost per Test Performed: $0.70/analyte, volume dependent Length of Time on the Market: Medical market ~1 year Primary Area of Use: Routine point of care CLIA Complexity: Moderate Test Menu: ALB, ALP, ALT, AMY, AST, BUN, CA, CHOL, CHOL/HDL, CK, CL, CRE< DBIL, GGT, GLU, HDL, K, LDL, NA, PHOS, TBIL, TCO2, TP, TRIG, UA, VLDL Sample Type: Whole blood, serum or plasma CE Mark: Yes Number of Users: 500 Product Reference Methods: Request package insert Error Tolerances to Measure Performance: Request package insert

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BuyersGuide Editor’s Note: The 4th annual “ADVANCE Point-of-Care Testing Buyers Guide” represents a collaborative effort between laboratory administrators, POCT manufacturers and ADVANCE editorial staff. Here, respondents surveyed from February 1-February 22 offer POCT-related products for hospital and non-hospital laboratories. Designed for ease of use, this listing includes contact names, telephone/fax numbers, e-mail/Web site addresses, product and cost, type of analyzer, size and weight of device and type of design, and other POCT prod-

QC Features: Yes Security Features: Patient ID, operator ID, physician ID Sample Size Required: 100uL Analytical Principle for Each Analyte: Spectrophotometric Turnaround Time for Results: 13 minutes Downloading Capabilities: Yes Ability to Read Barcodes: Yes Internal or External Connectivity: Yes Connectivity Options: ASTM E1394 Utilization of NCCLS Technical Performance Standards: Yes Remote Lockout/Operation: No/Yes Distinguishing Features: Portable, self calibrates, onboard QC, self-contained reagent discs, looks like a CD player Abbott Laboratories MediSense Products 4A Crosby Dr. Bedford, MA 01730 Contact: PCX Glucose Meter: Steve Pemberton i-STAT: Joey Baugh (781) 276-7774; (781) 276-4797 fax: (781) 687-5234 E-mail Address: [email protected] [email protected]

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uct-specific information. The Distinguishing Features category identifies a product’s top features. ADVANCE relies on its readership to improve the quality of special sections. If you find this buyers guide useful or if you have suggestions to increase its effectiveness, please contact us or forward a letter to: Lynn Nace, Editor, ADVANCE for Administrators of the Laboratory, 2900 Horizon Drive, King of Prussia, PA 19406, or e-mail [email protected] Listings do not represent endorsement by ADVANCE.

Primary Product(s): PCX, i-STAT, i-STAT 1 Type of Analyzer: PCX Glucose Meter, i-STAT; Blood Gas/Chem/Coag Size and Weight/Cost: PCX: 7.7” x 2.9” x 2,” 10 oz./ $995 i-STAT: $7,900 i-STAT 1: $8,500 Type of Design: PCX: Handheld; glucose only; strip i-STAT, i-STAT 1: Handheld, multiassay; cartridge and strip Cost to Operate/Cost Per Test Performed: PCX: contracted price i-STAT, i-STAT 1: volume-based pricing Length of Time on the Market: PCX: 24 months i-STAT, i-STAT 1: Seven years Primary Area of Use: Hospital-wide CLIA Complexity: PCX: Waived testing i-STAT, i-STAT 1: Moderate complex Test Menu: PCX: Glucose i-STAT, i-STAT 1: Blood gas, chemistry, coagulation Tests Under Development: PCX: Ketones i-STAT, i-STAT 1: PT, PTT CE Mark: PCX: Yes i-STAT, i-STAT 1: No Number of Users: PCX: over 1,400 Product Reference Methods: PCX: YSI i-STAT, i-STAT 1: Traditional benchtop devices

QC Features: PCX: User-defined QC lockout; stores 4,000 patient results and 1,000 QC with full date and time; operator ID and patient ID; data review Security Features: i-STAT, i-STAT 1: Operator lockout; patient lockout; QC lockout Sample Size Required: PCX: 3.5 uL/ 2.5 uL i-STAT, i-STAT 1: 95 uL, 65 uL, 40 uL Analytical Principle for Each Analyte: PCX: Glucose oxidase Turnaround Time for Results: PCX: 20 seconds i-STAT, i-STAT 1: Maximum 2 minutes Downloading Capabilities: PCX: Hands-free data downloading i-STAT, i-STAT 1: Hands free Ability to Read Barcodes: Yes Availability of Monitoring System/System Interface: Yes Internal or External System Connectivity: Yes Connectivity Options: TCP/TP, RS-232, bi-directional, remote control of instrument and reagents Availability of Wireless Communication: Future development Utilization of NCCLS Technical Performance Standards: Yes Utilization of NCCLS Automation Standards: Yes

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4th Annual POCT BuyersGuide Distinguishing Features: Hands-free downloading; state-ofthe-art interfacing technology— sybase, interfacing to HIS and LIS systems Accumetrics Inc. 3985 Sorrento Valley Blvd. San Diego, CA 92121 Contact: Customer Support (858) 643-1600 fax: (858) 643-1605 E-mail Address: [email protected] Web Site: www.accumetrics.com Primary Product(s): Point-of care instrument, VeryNow (Ultegra) instrument system Type of Analyzer: Point-of-care or laboratory setting, utilizing unitized, disposable assay devices Size and Weight/Cost: 41 lbs., 9 1/2" width, 9 1/4" length, 4" height/ $5,000 for instrument system Type of Design: Monitors change in light transmittance/optical signal as a reflection of platelet function (aggregation) Cost to Operate/Cost Per Test Performed: $20-$25 Length of Time on the Market: November 1999 Primary Area of Use: Point-of-care or laboratory setting CLIA Complexity: Moderate Test Menu: VerifyNow Aspirin Assay VerifyNow IIb/IIIa Assay VerifyNow Clopidogrel Assay (Research use only) Sample Type: Whole blood CE Mark: Yes Product Reference Methods: The instrument was correlated to standard aggregometry as a predicate method. Error Tolerances to Measure Performance: Simple precision statistics VerifyNow Aspirin 3-5% CVs, VerifyNow IIb/IIIa 8.5-14% CVs. QC Features: The system incorporates electronic quality control and wet quality control. The system's internal quality control includes verification of sample filling, expiration date, optics performance, fluid transfer and mixing. Additionally, the system incorporates QC lockout, ability to identify, store, date, time stamp, print patient and QC results.

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Security Features: Patient ID, operator ID, pass code protection, etc. Sample Size Required: 2-3 ml whole blood Analytical Principle for Each Analyte: The assessment of platelet function based upon the ability of activated platelets to bind fibrinogen. Turnaround Time for Results: 3-10 minutes Ability to Read Barcodes: For new assay device lot information Internal or External Connectivity: Yes Connectivity Options: ASTM 1381-95 Availability of Wireless Communication: No Compliance with NCCLS-POCT1A: None Utilization of NCCLS Technical Standards: Yes Utilization of NCCLS Automation Standards: No Remote Lockout/Operation: N/A, Yes Distinguishing Features: The Instrument System: Designed to be compatible with point of care. Contains many built-in QC/security features. The assays: Utilize a patented technology in a disposable assay device. Deliver accurate, quality results. Rapid and easy to use 3 step process; 3 to 10 minutes. Cost-effective. Bayer Healthcare Diagnostics Division 511 Benedict Ave. Tarrytown, NY 10591 Contact: Amy Samaha (914) 366-1815 E-mail Address: [email protected] Web Site: www.bayerdiag.com Primary Product(s): RAPIDPOINT® 400 critical care analyzer series Type of Analyzer: pH/blood gas analyzer using multitest cartridges Size and Weight/Cost: 21.5”H x 11.5” W x 16” D; 34-44 lbs.; $38,000 to $44,000 (depending on configuration) Type of Design: Portable; 14 analytes and multiuse; self-contained measurement and waste/wash cartridges Cost to Operate/Cost Per Test Performed: $2-$4

Length of Time on the Market: Since March 2001 Primary Area of Use: Hospital, POC and lab CLIA Complexity: Moderate Test Menu: pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, Glu, tHb, O2Hb, COHb, MetHb, HHb Sample Type: Whole blood CE Mark: Yes Number of Users: Up to 1,000 Product Reference Methods: Hexokinase is the reference method for glucose; tonometry for gases; flamme and electrochemistry for Na and K; electrochemistry and coulometrie for Cl; CPG for COHb; EvelynMalloy for MetHb, MetHbCN for tHb; microspin for Hct QC Features: Automatic QC (as scheduled by user); unique aqueous method; QC lockout; self-contained AQC cartridge; 28-day life; initiate remotely via RAPIDLINK; storage and results Security Features: Patient ID, operator ID can be mandatory (3 levels of password protection for 250 users) Sample Size Required: 100 uL capillary; 200 uL syringe Analytical Principle for Each Analyte: pH, Na, pCO2, K, Ca, Cl— potentiometric (electrochemistry) using planar sensors; PO2— amperometry (electrochemistry) using planar sensor; Glucose— ampero-enzymatic sensor; Hct— conductivity; tHb, COHb, HHb, MetHb, O2Hb— spectrophotometry on dynamic whole blood Turnaround Time for Results: 1 minute Downloading Capabilities: Yes Ability to Read Barcodes: Yes, with barcode scanner Availability of Monitoring System/System Interface: RAPIDLINK® Information Management System Internal or External System Connectivity: Connection possible directly from instrument Connectivity Options: RS-232 serial, Ethernet Availability of Wireless Communication: Optional Compliance With NCCLS/POCT 1-A: None yet Remote Lockout/Operation: With RAPIDLINK

Distinguishing Features: High level of biosafety using a non-exposed sample probe; System designed for POCT with fully integrated co-oxymetry on board; real automatic QC using distinct materials (not internal reagents/calibrants); Highly intuitive user interface featuring multimedia technology (video with sound); Long-life measuring cartridges (4 weeks) and up to 750 tests; high performance connectivity Biosite Inc. 11030 Roselle St. San Diego, CA 92121 Contact: Lauren Geisbert (858) 455-4808 fax: (858) 623-1392 E-mail Address: [email protected] Web Site: www.Biosite.com Primary Product(s): Rapid Point of Care Diagnostic Testing Type of Analyzer: Triage® Meter Plus Size and Weight/Cost: 8"x6"x1.5lbs / $4,750 Type of Design: Immunofluorescence Assay Technology Cost to Operate/Cost Per Test Performed: Volume dependent Length of Time on the Market: 7 Years Primary Area of Use: Emergency Department CLIA Complexity: Moderate Test Menu: BNP, TnI, Myo, CK-MB, amphetamines, methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, pcp, tricyclic antidepressants Tests Under Development: hsCRP, d-dimer, stroke panel, sepsis panel Sample Type: Whole blood, plasma and urine CE Mark: Yes Product Reference Methods: I.A. Reference Analyzers Error Tolerances to Measure Performance: See package insert for test specifics QC Features: Unauthorized user lockout, QC lockout, storage of test results with user ID, date, time, patient ID, operator ID, lot number, onboard physical internal standard, 2 levels of daily QC on every

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4th Annual POCT BuyersGuide device, auto lot expiration date verification on every QC test Security Features: Patient ID, operator ID, operator functions, supervisor functions Sample Size Required: 250 microliters Turnaround Time for Results: Approximately 15 minutes Downloading Capabilities: Data manager/LIS connectivity available Ability to Read Barcodes: Optional barcode available for standard barcode formats Availability of Monitoring System/System Interface: Yes Internal or External System Connectivity: Yes Connectivity Options: Meter has integrated ASTM protocol: external data manager program available as well as connectivity solutions to most LIS solutions Availability of Wireless Communication: No Compliance with NCCLS-POCT1A: In progress Utilization of NCCLS Technical Performance Standards: Yes Utilization of NCCLS Automation Standards: Yes Remote Lockout/Operation: Feature available for operator management/ Yes Distinguishing Features: Expedite patient disposition decisions by addressing 10 of the top 20 reasons why patients present to the emergency department. Dade Behring Inc. 1717 Deerfield Road Deerfield, IL 60015 Contact: Debbie Whitehair (302) 631-9351 fax: (302) 631-8512 E-mail Address: [email protected] Web Site: www.dadebehring.com, www.chestpainperspectives.com Primary Product(s): Stratus CS Acute Care Diagnostic System Type of Analyzer: Stat and acute care testing for cardiac assays, D-dimer and BhCG Size and Weight: 18" x 27" x 22"; 140 lbs. Type of Design: Benchtop; transportable; singleuse TestPaks

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Cost to Operate/Cost Per Test Performed: Volume dependent Length of Time on the Market: 6 years (since June 1998) Primary Area of Use: Emergency departments, stat labs, coronary care units, urgent care centers, main laboratories CLIA Complexity: Moderately complex Test Menu: Troponin-I, myoglobin, mass CKMB, D-dimer, BhCG Tests Under Development: NT-proBNP Sample Type: Heparinized whole blood or plasma CE Mark: Yes Number of Users: > 1000 worldwide Product Reference Methods: Internal reference preparations for cardiac assays; 3rd IS(75/537) for BhCG Error Tolerances to Measure Performance: Microprocessor monitors all operating parameters to specific factory set tolerances QC Features: System check; system check lockout; QC lockout; result storage; printout includes instrument serial number, assay lot number, operator ID, date, time, patient or sample ID, method, result, reference interval; connectivity ready Security Features: Patient ID, sample ID, barcoded reagent, operator ID lockout, configuration password protected Sample Size Required: Minimum 2.7 mL whole blood; 200 uL of plasma Analytical Principle for Each Analyte: Solid-phase, two-site sandwich fluorometric immunoassay Turnaround Time for Results: Approximately 14 minutes to first result Downloading Capabilities: LIS compatible (RS-232) with unidirectional download Ability to Read Barcodes: Barcoded reagents to ensure calibration; expiration date of lot; barcode reader for patient sample IDs Availability of Monitoring System/System Interface: Yes Internal or External System Connectivity: Yes Connectivity Options: Instrument can interface directly to LIS; or instrument is

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connectivity ready via interface with Data Manager available from outside vendor and is compliant with NCCLS POCT 1-A document Availability of Wireless Communication: No Compliance with NCCLS-POCT1A: Stratus CS Acute Care Diagnostic System in conjunction with Data Manager from outside vendor Utilization of NCCLS Automation Standards: Yes Remote Lockout/Operation: Yes, when used with Data Manager/ Yes Distinguishing Features: Whole blood with no sample manipulation; first result in as little as 14 minutes; onboard centrifugation producing consistent, high-quality sample integrity; system check (electronic QC) allowing flexible liquid QC frequency; QC time lockout; QC range lockout; patient and sample ID barcode reader; sample collection date and time capture; barcoded reagents for calibration; QC and expiration date compliance; calibration stability of 60 - 90 days depending on assay; < 10% CV for troponin-I at the 99th percentile of the reference interval; troponin-I Intended Use includes risk stratification; singleuse packaging to prevent reagent waste; single assay packaging (not panels of tests) allowing test ordering flexibility; laboratory quality results available in the acute care environment; correlates to central laboratory instrument (Dade Behring Dimension RxL or Xpand with Heterogeneous Module); connectivity-ready HemoCue Inc. 40 Empire Drive Lake Forest, CA 92630 Contact: (949) 859-2630 fax: (949) 859-3066 E-mail Address: [email protected] Web Site: www.hemocue.com Primary Product(s): 1.) Hb 201+ Analyzer 2.) Glucose 201 Analyzer 3.) B-Hemoglobin Photometer; B-Hemoglobin Data Management Analyzer 4.) BGlucose Analyzer; B-Glucose Data Management Analyzer 5.) Plasma/Low Hb Analyzer Type of Analyzer: Hemoglobin and glucose testing for the point of care Size and Weight/Cost: 1.) 3.4"x6.3"x1.7"; .77 lbs. 2.)

3.4"x6.3"x1.7"; .77 lbs. 3.) 6.3"x8.3"x3.5"; 2 lbs. 4.) 6.3"x8.3"x3.5"; 2 lbs. 5.) 6.3"x8.3"x3.5"; 2 lbs./ 1.) $800 2.) $600 3.) $800; $950 with data management 4.) $800; $950 with data management 5.) $800 Type of Design: All are portable; single use testing; microcuvette; No. 1 and 2 are handheld instruments Cost to Operate/Cost Per Test Performed: 1.) $1.10 2.) $1.20 3.) $1.10 4.) $1.20 5.) $4.50 Length of Time on the Market: 1.) 3 months 2.) 2 years 3.) 17 years 4.) 12 years 5.) 4 years Primary Area of Use: 1.) physician office, hospital, blood bank, dialysis center 2.) physician office, hospital 3.) physician office, hospital, blood bank, dialysis center 4.) physician office, hospital 5.) surgery, laboratory, blood bank CLIA Complexity: 1.) waived 2.) waived 3.) waived 4.) waived 5.) moderate Test Menu: No. 3 and 4: Data management systems: Patient, 5 levels of QC, proficiency and linearity Tests Under Development: Urine Albumin Sample Type: 1.) whole blood 2.) whole blood 3.) whole blood 4.) whole blood 5.) plasma, serum, aqueous solutions, stored blood CE Mark: Yes Product Reference Methods: 1.) International Reference Method (ICSH) 2.) Wet chemical glucose dehydrogenase 3.) International Reference Method (ICSH) 4.) Wet chemical glucose dehydrogenase 5.) International Reference Method (ICSH) QC Features: No. 3 and 4: Data management systems: QC lockout, operator ID, control and reagent lot number, date/time, pass/fail Security Features: No. 3 and 4. Data management systems: operator ID and patient ID entry, settings and memory erase functions are password protected Sample Size Required: 1.) 10 µl 2.) 5 µl 3.) 10 µl 4.) 5 µl 5.) 20 µl Analytical Principle for Each Analyte: 1.) azidemethemoglobin 2.) glucose dehydrogenase 3.) azidemethemoglobin 4.) glucose dehydrogenase 5.) azidemethemoglobin Turnaround Time for Results: 1.) 15-60 seconds 2.) 40-240

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4th Annual POCT BuyersGuide seconds 3.) 15-60 seconds 4.) 40-240 seconds 5.) 60 seconds Downloading Capabilities: No. 3 and 4: Data management systems: RS232 serial connection to PC or laptop for full bidirectional communication providing downloading and configuration features Ability to Read Barcodes: No. 3 and 4: Data management systems offer optional barcode reader Availability of Monitoring System/System Interface: Yes Connectivity Options: No. 3 and 4: Data management systems: must purchase additional hard/software for interfacing Remote Lockout/Operation: No/Yes Distinguishing Features: Lab quality results at the point-of care. All instruments measure at two wavelengths to correct turbidity. No. 3 and 4: Data management systems: full data and analyzer management functionality (HC8013 and HC8019).

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Lippincott Williams & Wilkins 530 Walnut St. Philadelphia, PA 19106 Contact: Genevieve Alexander 215-521-8581 fax: 215-521-8495 E-mail Address: [email protected] Web Site: www.poctjournal.com Primary Product(s): Point of Care: The Journal of NearPatient Testing & Technology Cost: $107 for personal subscriptions

Length of Time on the Market: 3 years Medical Automation Systems Inc. 2300 Commonwealth Dr. Charlottesville, VA 22901 Contact: Steven Valorz (434) 971-7953 fax: (434) 951-0226 E-mail Address: [email protected] Web Site: www.medicalautomation.com Primary Product(s): RALS information management system for POCT Test Menu: Connectivity for blood gas, glucose, cardiac marker, coagulation and manual tests at the point of care Distinguishing Features: RALS®-Plus is a single-application information management system that provides total control of your point-of-care program. At the click of an icon you can view all results that have been downloaded, display all results that have been flagged based on setup criteria, electronically manage all system operators- by device, email weekly/monthly reports and more. Today, more POC device vendors trust their results to RALS-Plus. New for 2004 is RALS®-Web, a browser-based system that enables users to access POC test information where they want it, when they want it. Nova Biomedical 200 Prospect St. Waltham, MA 02454-9141 Contact: Harlan Polishook (781) 894-0800 fax: (781)-894-5915 E-mail Address: [email protected] Web Site: www.novabiomedical.com Primary Product(s): Stat Profile Critical Care Xpress Type of Analyzer: Blood gas/electrolyte/ chemistry Size and Weight/Cost: 17.2 x 22.3 x 17.3 in., 53 lbs./ $25,000-$59,000 Type of Design: Transportable, multi-use, microsensor-based Length of Time on the Market: 18 months Primary Area of Use: Laboratory, respiratory care, ICU, OR, ED CLIA Complexity: Moderately complex

Test Menu: pH, PCO2, PO2, SO2%, Hct, Hb, Na+, K+, Cl-, Ca++, Mg++, Glucose, Lactate, BUN, Creatinine, HHb, O2Hb, MetHb, COHb Sample Type: Whole blood, serum, plasma CE Mark: Yes Product Reference Methods: Conforms to accepted laboratory standards from a variety of industry organizations Error Tolerances to Measure Performance: 1-3 percent QC Features: Onboard liquid QC; QC lockout; ability to store, date, time stamp, print patient and QC results Security Features: Multiple layer; user configurable including patient ID, medical record number, operator ID, PIN number Sample Size Required: 60-210 microliters (depending on menu selected) Analytical Principle for Each Analyte: pH, Na+, K+, Cl-, Ca++, Mg++ -Direct ISE; glucose, lactate, creatinine -enzyme/amperometric; PCO2 -Severinghaus; PO2 -amperometeric; SO2% -- optical, reflectance; Hct -conductivity; Hb multi-wavelength, reflectance; BUN -- enzyme/direct ISE; HHb, O2Hb, MetHb, COHb -spectophotometry Turnaround Time for Results: 62 seconds (high throughput); 134 seconds (routine throughput) Downloading Capabilities: "Unlimited" patient and QC database onboard that is downloadable or direct connected to LIS/HIS Ability to Read Barcodes: Yes Availability of Monitoring System/System Interface: Yes Internal or External System Connectivity: Yes Connectivity Options: TCP/IP; Ethernet; USB; RF networks; serial RS-232; bidirectional communications; remote control for calibrations; QC, maintenance and troubleshooting; remote review of results prior to release Availability of Wireless Communication: Yes Compliance with NCCLS-POCT1A: Stat Profile Critical Care Xpress

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Laboratory Data Systems Inc. 16842 Harrierridge Place Tampa, FL 33547 Contact: Sean Field (813) 571-7400 fax: (813) 571-7440 E-mail Address: [email protected] Web Site: www.labdatasys.com Primary Product(s): Point-of-care and critical care connectivity and information management systems Type of Analyzer: n/a Cost: $25,000 avg. Type of Design: Web-based connectivity and information management system for point-of-care and critical care testing devices in the hospital environment. System can be operated from any PC with access to the internet or intranet. Devices can be connected via ethernet, wireless ethernet, serial, modem or IrDa. Cost to Operate/Cost Per Test Performed: n/a Length of Time on the Market: Launch is in May 2004 Primary Area of Use: Point-of-care coordinators, respiratory managers/therapists Test Menu: Manages instruments, patient

test data, QC data and user information for all POC and critical care instrumentation including: whole blood glucose, blood gas/electrolyte, coagulation, cardiac markers, and more. Sample Type: n/a QC Features: Manages QC for all instrument types complementing an instruments onboard functionality. Security Features: Secure patient, operator ID. Can utilize barcode, RFID or biometric identification tools. Downloading Capabilities: Can receive data from all instruments via ethernet, wireless ethernet, IrDa, serial port or modem Ability to Read Barcodes: Yes Availability of Monitoring System/System Interface: Yes Connectivity Options: Can receive data from all instruments via ethernet, wireless ethernet, IrDa, serial port or modem Availability of Wireless Communication: Yes Compliance with NCCLS-POCT1A: AegisPOC is compliant with the NCCLS-POCT1A standard. Remote Lockout/Operation: AegisPOC can initiate remote lockout and other remote operations for instruments. Distinguishing Features: True Web-based architecture/application. Full compliance with all interface communication standards (HL7, ASTM, POCT1A, etc). Connectivity with a wide scope of POC and critical care instrumentation. Uncompromised open connectivity with any vendor’s instrument. Functionality, which streamlines POCT and critical care testing workflow. Ensure complete data capture and enable billing for POCT testing.

4th Annual POCT BuyersGuide Utilization of NCCLS Technical Performance Standards: Yes Utilization of NCCLS Automation Standards: Yes Remote Lockout/Operation: Yes Distinguishing Features: Color touch screen; integrated cooximeter; open software architecture; onboard data management; automated, onboard quality control; sealed waste system; auto-monitoring of QC and reagent packs; tankless gas calibration; automated maintenance. NOVA-ONE Diagnostics 4987 Campo Rd. Woodland Hills, CA 91364 Contact: Technical Support (800) 810-7488 fax: (818) 348-9696 E-mail Address: [email protected] Web Site: www.nova-one.net Primary Product(s): Liquid HbA1c & Lipid Controls Type of Analyzer: Fits all models Type of Design: The controls are already liquid; they act just like a patient’s sample; therefore, nonprofessional POC users find it easier to understand and use. Length of Time on the Market: 2003 Primary Area of Use: Testing certification CLIA Complexity: Low Sample Type: All types CE Mark: Yes Number of Users: > 1,000 Quidel Corp. 10165 McKellar Ct. San Diego, CA 92121 Contact: Calvin Finley (303) 522-7267 fax: (303) 662-8624 E-mail Address: [email protected] Web Site: www.quidel.com Primary Product(s): UrinQuick Urine Chemistry Analyzer Type of Analyzer: Urine chemistry

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Size and Weight/Cost: 10.8” H x 19.5” W x 9.8” D; 16.5 lbs.; List price: $6,500 Type of Design: Benchtop; test strip Cost to Operate/Cost Per Test Performed: ~$.30 per urine test strips Length of Time on the Market: 18 months Primary Area of Use: Laboratory CLIA Complexity: Moderate Test Menu: Bilirubin, urobilinogen, ketones, ascorbic acid, glucose, protein, blood, pH, nitrite, leucocytes, special gravity Sample Type: Urine CE Mark: Yes Product Reference Methods: Assigned reflectance values determined by densitometry Error Tolerances to Measure Performance: +/– 2 percent of assigned reflectance value QC Features: QC lockout; ability to identify, store, date, time stamp, print patient and QC results Security Features: Patient ID; operator ID; pass code protection Sample Size Required: >10 mL in test tube Analytical Principle for Each Analyte: All methods are based on established wet chemistry clinical methods Turnaround Time for Results: Under 60 seconds Downloading Capabilities: Download results by date, time, patient ID, spec ID, operator ID Ability to Read Barcodes: Yes Availability of Monitoring System/System Interface: No Internal or External System Connectivity: Yes Connectivity Options: RS-232 serial port, parallel printer port and LIS ready Availability of Wireless Communication: Yes Compliance With NCCLS/POCT 1-A: Yes Utilization of NCCLS Automation Standards: Yes Remote Lockout/Operation: No

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Distinguishing Features: Fully automated QC; PC keyboard; barcode reader; standard features; patented optics and transport mechanism for earlier use/less maintenance Reichert Inc. 3374 Walden Ave. Depew, NY 14043 Contact: Michael Reimer (716) 686-4500 fax: (716) 686-4555 E-mail Address: [email protected] Web Site: www.reichert.com Primary Product(s): Bilirubinometer Type of Analyzer: Bilirubinometer Size and Weight/Cost: 15" X 10" X 10", 15 lbs./ $3,695 Type of Design: The Unistat Bilirubinometer is a photometric analyzer for measuring total bilirubin in neonates. Cost to Operate/Cost Per Test Performed: Less than $1.00 per test Length of Time on the Market: 25 + years CLIA Complexity: Moderate Sample Type: Plasma or Serum CE Mark: Yes Number of Users: >1000 Error Tolerances to Measure Performance: +/- 5% Sample Size Required: 20 microliters Analytical Principle for Each Analyte: Spectrophotometry Turnaround Time for Results: 15 seconds Spectral Diagnostics Inc. 60 First St. White Stone, VA 22578 Contact: Chris Wayne (888) 354-3278; ext. 477 E-mail Address: [email protected] Web Site: www.spectraldx.com Primary Product(s): Cardiac STATus Rapid Bedside Tests Type of Analyzer: Point of Care Cardiac Test Size and Weight: 4" X 2"

Cost to Operate/Cost Per Test Performed: Cost per test device only Primary Area of Use: Emergency Department CLIA Complexity: Moderately Complex Test Menu: Troponin I, CK-MB, Myoglobin (Singles or Multiple Combinations) Sample Type: Whole blood, plasma or serum CE Mark: Yes Sample Size Required: 150 microlitres Turnaround Time for Results: 15 minutes Wampole Laboratories LLC 2 Research Way Princeton, NJ 08540 Contact: Patricia Cathcart (609) 627-8082 fax: (609) 627-8013 E-mail Address: [email protected] Web Site: www.wampolelabs.com Primary Product(s): Rapid membrane POCT Size and Weight/Cost: Varies based on test Type of Design: Rapid membrane diagnostic tests Cost to Operate/Cost Per Test Performed: Varies based on test Length of Time on the Market: Multiple years Primary Area of Use: Point-of-care testing CLIA Complexity: Primarily waived Test Menu: Streptococcus A, Pregnancy, Mononucleosis, Chlamydia, H. pylori, C. difficile, Lyme Disease, Rubella Tests Under Development: HIV, RSV, Influenza A/B Sample Type: Varies based on test Product Reference Methods: Varies Error Tolerances to Measure Performance: Varies Sample Size Required: Varies based on test Analytical Principle for Each Analyte: Rapid membrane Turnaround Time for Results: Less than 10 minutes based on test

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