News Bulletin April 2008

Transcription

1 News Bulletin April 2008 Combined HPV and Cytology Screening Several recent studies support the use of Human Papillomavirus (HPV) testing in conjunction with cytology as a primary screening test for women age 30 and older. HPV is implicated in nearly all cases of cervical cancer, although most HPV infections are only transient. However, a positive HPV test result in women age 30 and older is more likely to represent persistent infection and an increased risk of cervical disease. 1 Women with persistent high-risk HPV infection have been shown in a recent study to be 300 times more likely to develop HSIL. 2 The combination of cervical cytology and HPV testing provides over 99% sensitivity in detection of cervical cancer and important precursor lesions. If both tests are negative, this provides a high level of confidence that no disease is present (99% negative predictive value). Combined testing should not be ordered in women younger than 30. In younger women, transient HPV infections are extremely common and generally do not lead to significant disease. The specificity of HPV testing is much lower in young women; so frequent cytology screening (every 1-2 years) is recommended in this age group. However, if a woman over 20 is diagnosed with ASC-US, HPV testing is recommended as a reflex test if liquid-based cytology is available. Combined cytology and HPV testing has been available on our cytology requisition for the past few years and we would encourage you to consider it for patients age 30 and older. A single liquid cervical cytology specimen is required; a cervical cytology slide will be processed first, and the remainder submitted for HPV testing and if there is insufficient amount for both, you will be notified. (HPV testing can also be used in conjunction with any other method of cytology using a separate cervical collection placed in Digene s Specimen Transport Medium ). Summary of HPV Testing Recommendations: Women under 30 Women 30 and over Reflex HPV testing if ASC-US Combined HPV and cytology for primary screening If you have any questions or would like to speak to our lab representative to discuss implementing this testing protocol, please call (317) The Food and Drug Administration has approved the Digene HPV Test co-testing in women age 30+. The American College of Obstetricians and Gynecologists (ACOG) recognized HPV testing as more sensitive than cervical cytology in its 2005 practice bulletins. Several other major organizations, including the American Society of Colposcopy and Cervical Pathology (ASCCP) and the American Cancer Society, also endorse combined testing in women age 30 and older. 1. Saslow D, Runowicz C, Solomon D, et al. American Cancer Society guideline for the early detection of cervical neoplasia and cancer. CA Cancer J Clin, 2002;52: HPV & Cytology Screening HPV & Cytology Algorithms hcg, New Test, New Normal Ranges & Reminders Test Information PSC Chart Centrifuge Tubes New CLIA Updated Draw Order Chart 2. Bory JP, Cucherousset J, Lorenzato M, et al. Recurrent human papillomavirus infection, detected with the hybrid capture 2 assay, selects women with normal cervical smears at risk for developing high grade cervical lesions. A longitudinal study of 3,091 women. Int J Cancer, 2002; 102,

2 GYN Cytology Algorithms for HPV DNA Testing Standing Orders for HPV Reflex Testing and/or Adjunct HPV for Women 30 years and Older Standing orders are available for the following: 1) Paps with ASC-US reflex to HPV 2) Adjunct HPV testing on ALL women 30 years old and over If you are interested in setting up standing orders for reflex or adjunct testing, please contact your account representative (317)

3 Beta hcg vs Intact hcg Traditionally it has been recommended that quantitative serum intact hcg is used as the test used as a serum test for pregnancy. The beta-hcg test was recommended for use only as a tumor marker, primarily for testicular cancer. Over the last few years this protocol has completely changed. The trend nationally has been to completely phase out the stat quantitative test for intact hcg and use only the beta-hcg test for both a tumor marker and a pregnancy test. Clarian Pathology Laboratory will continue to offer both of these tests but plans to follow the national trend by encouraging practitioners to order the beta-hcg test, rather than the intact hcg test, as a serum test of pregnancy. Changes in lab technology are forcing labs in the direction of only doing the quantitative beta-hcg test. New Test Cytomegalovirus QN PCR (CMVQN) A new CMV quantitative test will be offered beginning January 21, This test will replace CMV Digene test currently offered. The CMV Digene test is being discontinued by the manufacturer. Because this is a test uses a different technology from the CMV Digene test, it is advisable to re-baseline existing patients. New Test: Cytomegalovirus QN PCR (CMVQN) Methodology: DNA extraction followed by real-time PCR and detection on the Roche LightCycler 2.0 using the Artus CMV LC ASR reagents. Source: Plasma Collect: 6mL pearl top or 6mL lavender top tube. Plasma must be separated within six hours of the draw. Spin pearl tube and ship refrigerated to lab. If collecting in a lavender tube, spin and separate plasma from cells. Transfer plasma to a plastic aliquot tube; store and ship plasma frozen. TAT: Test is run on Monday, Wednesday and Friday Performance Characteristics of the assay are as follows: Linear Range: ,000 copies/ml Lower limit of detection: 250copies/mL Clinical Sensitivity: 94.1% Clinical Specificity: 97.7% Predictive value of a positive test: 97% Predictive value of a negative test: 95.5% Efficiency of the test: 96/1% Interferences: Heparin PT: sec INR: aptt: sec Normal Range Changes Effective March 17, 2008 Critical Value < 18 seconds and >100 seconds aptt therapeutic range for UNFH: 52-84sec CRRT PTT: Fibrinogen: mg/dL TCT: sec D Dimer: <361ng/mL DDU Mixing study: This includes the PT/PTT/TCT MANPT: seconds MANPTT: seconds Reminders When the lab calls a critical value to a client, if no one answers the phone, the lab will refer to the after hours contact phone numbers for each specific client. If you have not already done so, please complete the client contact information form sent to outreach clients in November 2007 and fax to A mailing was sent out recently to outreach clients regarding use of the client number. Outreach clients should use their individual client number when calling for a courier pick up or submitting a client supply form. New reference range charts, CLIA License and outreach client supply forms are posted on the website at

4 Test Information Changes please update DOS Acetylcholinesterase RBC New Test-Send 5 ml Green Na Heparin tube. Ship refrigerated whole blood ASAP. Adrenal Ab Can Reflex Ttr Minimum volume 0.5 ml refrigerated serum Bile Acids Fast Ser QN No heparinized, hemolyzed samples or body fluids Bismuth Ur QN do not use acid preservatives, refrigerate during collection and ship refrigerated. Cadmium Ur QN do not use acid preservatives, refrigerate during collection and ship refrigerated. Catecholamines Frac Ur QN When ordering 24 hr for Catecholamines, HVA, and VMA, please send 50 ml urine. CMV DNA QN Digene test has been discontinued by manufacturer - replaced by Cytomegalovirus QN PCR. CMV DNA QL PCR No longer offered. Use Cytomegalovirus QN PCR. Cytomegalovirus QN PCR New test replaces CMV DNA QN, Digene test. Collect 6 ml in Pearl top tube. Spin and separate plasma from cells within 6 hrs of collection and ship spun Pearl tube refrigerated. Lavender tube is acceptable. If collected in Lavender, must separate plasma from cells and ship plasma frozen in aliquot tube. Cyclic AMP Ur QN TAT 3-11 days Cycloserine Level QN New Test-Collect 2 ml Red tube. Spin and separate ASAP. Ship 1.0 ml frozen serum Diphenhydramine Ser/Pl/Bld methodology GC F-V DNA Leiden Bld PCR Minimum volumes: adult, 2 ml whole blood; pediatric, 0.5 ml whole blood. Ship refrigerated within 48 hrs. Hepatitis C SerPl QL PCR Outreach clients collect in Pearl tube, spin and separate within 6 hrs of collection. Ship spun Pearl tube refrigerated. HCV Genotype SerPl Outreach clients collect in Pearl tube, spin and separate within 6 hrs of collection. Ship spun Pearl tube refrigerated Hepatitis B DNA Pl QN PCR Outreach clients collect in Pearl tube, spin and separate within 6 hrs of collection. Ship spun Pearl tube refrigerated Hepatitis C SerPl QN PCR Outreach clients collect in Pearl tube, spin and separate within 6 hrs of collection. Ship spun Pearl tube refrigerated HIV-1 Genotype-PCR PRI/RTI Outreach clients collect in Pearl tube, spin and separate within 6 hrs of collection. Ship spun Pearl tube refrigerated HIV-1 RNA CSF RT-PCR QN ship refrigerated; not frozen. HIV RNA Viral Load Outreach clients collect in Pearl tube, spin and separate within 6 hrs of collection. Ship spun Pearl tube refrigerated HSV 1,2 DNA Real-Time PCR Outreach clients collect in Pearl tube, spin and separate within 6 hrs of collection. Ship spun Pearl tube refrigerated. HVA Ur QN When ordering 24 hr for Catecholamines, HVA, and VMA, please send 50 ml urine. Iron Tissue QN Samples stored or shipped in saline are unacceptable. LD Isoenzymes SerPl QN Ship refrigerated serum. Do not freeze. Performed daily. Lipid Therapeutic Profile no longer offered Liver/Kidney Microsome Ab New Test-Collect 2 ml Red tube. Send 0.5 ml refrigerated serum. Mercury Ur QN do not use acid preservatives, refrigerate during collection and ship refrigerated. Molybdenum SerPl QN collect in Royal Blue (red band) or RoylBl EDTA (purple band). Spin and separate ASAP. Use trace element free transport tube. Do not use SST. Neutrophil ab Ser QL TAT 2-6 days, M,W,F set up. PT Gene Mutation PCR Minimum volumes: adult, 2 ml whole blood; pediatric, 0.5 ml whole blood. Ship refrigerated within 48 hrs. Rabies Ab ser ELISA QL Minimum volume 0.1 ml frozen serum, set up Tuesday, 2-9 day TAT Raji Cell Immun Compx set up Tuesdays, 3-10 day TAT Rubella IgG EIA QN discontinued. Replaced by Rubella IgG Ser QN Rubella IgG Ser QN replacing Rubella IgG EIA QN Selenium Ur QN do not use acid preservatives, refrigerate during collection and ship refrigerated. Serotonin Bld QN Contact send outs at for complete collection information BEFORE collecting specimen. A special tube is required and must be obtained prior to collecting specimen. T4 Free Eq Dial HPLC/MSMS 2 ml serum from Red tube, No SST, 0.5 ml serum min volume. HPLC/TDMS method. Test replaces T4 Free Eq Dial/RIA QN T4 Free Eq Dial/RIA QN Discontinued. Replaced by T4 Free Eq Dial HPLC/MSMS. Thallium Ur QN do not use acid preservatives, refrigerate during collection and ship refrigerated. VMA Ur QN When ordering 24 hr for Catecholamines, HVA, and VMA, please send 50 ml urine.

5 New Patient Service Center Mooresville

6

7

8