News Bulletin

September 2007

With Pap Alone, You Don’t See the Whole Picture… Clinicians can order four tests from one ThinPrep vial! Liquid-base cytology allows direct-from-vial testing. Screening is vital for the prevention of disease and offers peace of mind for women. • Pap test • HPV • Chlamydia • Gonorrhea Human Papilloma Virus (HPV) - HPV is the primary cause of cervical cancer. There are two distinct avenues available for screening.

• •

DNA with Pap test for women over 30 Triage of ASCUS

DNAwithPap—The Digene HPV test used in conjunction with a Pap is becoming the new standard of care for cervical cancer screening of women 30 and older. The DNA with Pap offers an unprecedented sensitivity of 100% for high-grade disease and cancer.

• • •

Prevalence of HPV decreases over time, while the incidence of cervical cancer increases. The point at which HPV prevalence meets cervical cancer incidence is around the age of 30. Persistent HPV infection is seen most often in women in this age group. These women are 300 times more likely to develop HSIL. Women in this age category with normal cytology and a positive HPV test have a 116-fold risk for developing high-grade lesions compared with HPV negative women.

Sensitivity for Detection of HGSIL (high grade squamous intraepithelial lesion): Conventional Pap: 57.7% Liquid Cytology: 84.4% Digene HPV Test: 100% Triage for ASCUS (atypical squamous cells of undetermined significance) - The standard of care for ASCUS triage is to request an HPV test. • Helps determine the need for colposcopy • Provides objective results and enables HPV–negative women to be returned efficiently to routine screening • Reduces anxiety of HPV–negative women with ASC–US • Reduces unnecessary consultations and procedures

Reference: http://www.digene.com/healthcare/healthcare_hpvtest_04.html http://www.digene.com/healthcare/healthcare_hpvtest_07.html Chlamydia & Gonorrhea • Chlamydia is the most common sexually transmitted disease in the U.S. today. • Gonorrhea is very common (700,000 new cases per year) • Do not always cause symptoms • Untreated can develop PID (leads to infertility or ectopic pregnancy) Who should be screened? • All sexually active women age 25 or younger • Women over 25 who are at high risk for infection (more than one sex partner who do not use condoms or women who have had an STD in the past) • Pregnant women (to prevent newborn infection) • Newborn whose mother had infection at time of delivery Reference: http://www.cdc.gov/std/chlamydia/STDFact-Chlamydia.htm http://www.cdc.gov/std/Gonorrhea/STDFact-gonorrhea.htm Clarian Laboratory offers “standing orders” requests for any of the above tests to be automatically performed. For example: • Perform HPV on all women over 30 • Perform HPV on all ASCUS results • Perform Chlamydia/Gonorrhea on all patients under 25 • Perform GC/C on all pregnant patients To request this service, call 491-6338.

IMPORTANT FACTS Clarian Cytopathology Lab uses the ThinPrep Imaging System, designed to reduce false negative test results and human error, providing a more accurate diagnosis. Please use CPL GYN requisition when ordering these tests, complete with patient and clinical information to: • Ensure quick turn around time • Save you from receiving phone calls from our staff • Promote quality patient care

Test Information Changes (please make changes to the Directory of Services) AFP4 Screening—New test. Preferred tube Gold Antiphospholipid Ab Panel—New Test—preferred tube Red, Yellow (ACD A or ACD B) is acceptable, Gold is not acceptable, ship room temperature Endomysial Ab IgA Ser Ttr—No longer available—Replaced by TTG Ab IgA w/Reflex. First Screen—New test. Preferred tube Gold Hepatitis C SerPl QN PCR—preferred tube Lavender, Gold or Pearl acceptable, 1 ml ser/plas minimum vol Histoplasma Ag QL—2 ml urine, serum, plasma, CSF, bronchial fluid or other sterile body fluids. HIV-1 Genotype-PCR PRI/RTI—preferred tube changed from Lavender to Pearl, Lavender is acceptable, Yellow is no longer acceptable tube type. HIV RNA Ultrasensitive—preferred tube Pearl HIV RNA Viral Load—preferred tube Pearl—details on page 4 IGF-1 Ser QN—performed 7 days/week. Preferred tube Gold, Green acceptable. Frozen ser/plas critical. Cont’d on page 6 2

NEW TEST—MRSA PCR A new test will be offered beginning September 17, 2007. This test will be offered in addition to the MRSA Screen and should be used as an adjunct to nosocomial infection control efforts to identify patients needing enhanced precautions. This test is not intended to identify patients with Staphylococcus infection. Results should not be used to guide or monitor treatment for MRSA infections.” Information on both tests are provided below. New Test: MRSA PCR Source: Nasal only (additional sources may become available at a later date) Collect: routine swab (stuart’s transport media) Performed: M-F, 2X daily TAT: 8-72 hours Advantage: If patient has been treated, can still test for presence of residual bacterial DNA Interferences: excessive mucous, blood, decongestants and nasal spray False negative: inadequate sample MRSA Screen Source: any source Collect: routine swab (stuart’s transport media) Performed: 7 days/week TAT: 48-96 hours Advantage: test provides an isolate that can be used for additional susceptibility testing and/or typing False negative: inadequate sample or if received after treatment has been initiated

NEW TEST—Rasburicase Uric Acid Test is for inpatients only Patients receiving chemotherapy can have very high uric acid levels due to destruction of large numbers of cells. High uric acid levels cause gout. Rasburicase is a drug given to increase the breakdown of uric acid in vivo and avoid the symptoms of gout. This reaction continues in vitro. A special test called Rasburicase Uric Acid was created for those circumstances where a uric acid is requested on a patient receiving rasburicase. To avoid reporting a falsely decreased uric acid level, the specimen must be immediately placed on ice and kept chilled until analysis. Please contact client services at 491-6000 for more information

NEW TEST: HIV Viral Load A new HIV viral load test will be offered beginning September 24, 2007. This test will replace both the Standard method HIV viral load and the Ultra Sensitive Method HIV viral load test currently offered. Methodology: Automated sample preparation on the Roche COBAS AmpliPrep followed by real-time PCR and detection on the COBAS TaqMan Source: Plasma Collect: 2x6mL pearl top or 2x6mL lavender top tube. Plasma must be separated within six hours of the draw. Minimum volumes for pediatric patients to follow at a later date. TAT: 5 days of receipt Linear Range: 48 - 10,000,000 copies/mL Advantages: Consolidation of the previous HIV-1 Standard and Ultra Sensitive methods into one FDA-approved assay. This viral load test continues to deliver full Group M subtype coverage, including the rare non-B subtypes. Roche Diagnostics has determined that there is no need to re-baseline or recalibrate existing patients because they have demonstrated a high correlation between the new COBAS AmpliPrep/COBAS TaqMan HIV1 test and other HIV viral load methodologies. See letter from Roche regarding this new test. Interferences: Heparin False negatives: Failure to separate plasma within 6 hours of the draw. 3

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Normal Range Chart Changes (see red type) You can print the new charts from our website at www.clarian.org/pathologylab,under the ‘Test Information’ selection. Test Name CMV DNA QN Copper Ur QN Creatinine Clearance CRP High Sensitiv SerPl QN Factor V DNA Leiden by PCR Glucose 2 HR PP SerPl QN Glucose Bld QN Hepatitis C Genotype Hepatitis C QN PCR Hepatitis C SerPl QL PCR HIV-1 Genotype-PCR PRI/ RTI Manual PT Manual aPTT Manual TCT Microalbumin/Crt Ran QN

Male or All 0 0 - 10 91-140 < 3.00 mg/L Homozygous normal 70-140 40-200 Negative 0 Negative

< 50 >500 < 50 >500

mg/dL mg/dL

seconds seconds seconds mcg/mg Cr mg/24hr; mcg/mg Cr

0 - 29 0-150; ratio 0 - 29 Negative < 35 4-43 therapeutic: 1-5; coma: 25 - 35 62-149 Homozygous normal

coma: > 40

IU/mL ng/mL mcg/mL % ng/mL/90 min

Supine: 40

mcg/mL seconds

> 100

mcg/mL

Calcium Ionized QN

Test Component

10-60

Units mcg/dL mL/min

72 - 110

11.1-13.6 24-33.2 15-21.0

823724

-Adult 0-12

Critical

Negative

Microalbumin/Crt Tm QN MRSA PCR QL PAI-1 Activity PAI-1 Antigen Pentobarbital SerPl QN Protein S Clottable PT Gene Mutation PCR Renin Pl QN Resp VirAg Prfl Secobarbital SerPl QN Staclot LA Syphilis RPR Syphilis VDRL Treponeme Ab Valproic Acid SerPl QN VDRL CSF

Female

mcg/dl

5

Units

mmol/L

686008

Immunuglobulin M (IGM)

686211

Lipid Therapeutic Profile

Age

Value

Units

Test Name

>=18 yrs

60-300

mg/dl

ALT SerPl QN

4-18 yrs

56-242

mg/dl

HDL

>40

mg/dl

2-4 yrs

41-242

mg/dl

Triglyceride

0-150

mg/dl

9 mo-2 yrs

35-242

mg/dl

LDL Calculated

0-100

mg/dl

5-9 mo

24-167

mg/dl

0 day-5 mo

14-142

mg/dl

686379

Value 0-45

Units U/L

Protein Electrophoresis Age

Total

Albumin

Alpha1

Alpha2

Beta

Gamma

0 day-1 week

5.2 - 6.8

3.82 – 5.12

0.13 - 0.42

0.34 - 0.42

0.27 - 0.49

0.59 - 1.10

4.6 - 6.7

2.69 – 4.13

0.15 - 0.33

0.50 - 0.98

0.39 - 0.79

0.42 - 0.90

4 mo - 11 mo

5.2 - 6.8

3.06 – 4.02

0.16 - 0.36

0.63 - 1.03

0.55 - 0.85

0.41 - 1.03

1 - 4 yrs

6.0 - 7.6

3.08 – 4.66

0.15 - 0.39

0.60 - 1.16

0.50 - 0.94

0.78 - 1.38

4 - 14 yrs

6.3 - 7.8

3.46 – 4.66

0.16 - 0.32

0.52 - 0.90

0.62 - 0.96

0.96 - 1.64

6.3 - 8.2

3.50 – 5.00

0.10 - 0.40

0.50 – 1.10

0.70 - 1.15

0.70 - 1.40

1 week-4 mo

>/= 14 yrs

Test Information Changes

Cont’d from page 2

Integrated Scrn—1st Tri—New test. Preferred tube Gold Integrated Scrn—2nd Tri—New test. Preferred tube Gold Itraconazole SerPl QN—Preferred tube Gold, any plasma type acceptable, ship refrigerated. Metanephrines Frac Ur Tm QN —Turnaround time, 2-4 days MRSA PCR—New Test—see details on page 4 PTH C Terminal—is no longer offered Rasburicase Uric Acid—Special handling is required—Call 491-6000—See page 4 for details. Sequential Scrn—1st Tri—New test. Preferred tube Gold Sequential Scrn—2nd Tri—New test. Preferred tube Gold Sperm Abs—seminal fluid is NOT acceptable Strongyloides IgG Ser QL—Preferred tube Gold Sulfonamides—ship refrigerated instead of room temperature Synovial Fluid Count—preferred tube Green Na Heparin, collect 3 ml fluid, mix well T4 Free Eq Dial/RIA QN—New Test—preferred tube Gold. Testo F+T Male 14 yr/older— Ship frozen ser/plas; refrigerated ser/plas is stable for 1 week. Testo F+T Female/Children- Ship frozen ser/plas; refrigerated ser/plas is stable for 1 week. Trifluoperazine Ser/Pl Bld— use Red, Green, Lavender or Grey. SST or PST not acceptable (Lt. Green/ Gold). TTG Ab IgA w/Reflex—New Test—Preferred tube Gold. Tissue Transglutaminase Ab IgA if positive reflexes to Endomysial Ab IgA titer. Tumor Necrosis Fact Alpha —Gold or Red. Frozen serum critical. No Green, Lt. Green or Lavender Urine for Arsenic, Bismuth, Cadmium, Heavy Metals, Mercury, Selenium, Thallium—submit in two trace element free transport tubes. Vitamin B2 Bld QN—Turnaround time within 14 days. 6

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS Certificate Information provided by

Indiana State Department of Health 2 N. Meridian St. Indianapolis, IN 46204 Phone: (317) 233-1325

Certificate Information: Clarian Pathology Laboratory 350 W. 11th Street Indianapolis, IN 46202-4108 CLIA Provider #: 15D0902829 116 Received Date: 07031995 Phone: 317-491-6677 Fax: 317-491-6639 Director: Kenneth W. Ryder, MD APP Type: 3 ACCR Cert Expiration Date: 04012008

Active 116

Note to Clients: The majority of clinical and anatomic/surgical pathology testing consolidated into one, new testing site (name and address above) in the summer of 2006. Clarian Pathology Laboratory performs testing in the following specialties/subspecialties: Bacteriology (110) Mycobacteriology (115) Mycology (120) Parasitology (130) Virology (140) Syphilis Serology (210) General Immunology (220) Routine Chemistry (310) Urinalysis (320) Endocrinology (330) Toxicology (340) Hematology (400) ABO & Rh Group (510) Antibody Transfusion (520) Antibody Non-Transfusion (530) Antibody Identification (540) Compatibility Testing (550) Histopathology (610) Oral Pathology (620) Cytology (630)