Change in Tube Type for HCV Quantitative PCR

Beginning April 6, 2009, Hepatitis C virus (HCV) quantitative PCR will require EDTA anti-coagulated 7 ml pink top tubes as the preferred specimen collection due to a change in the specimen processing using the FDA approved Roche COBAS Ampliprep/Taqman real time PCR assay.

The FDA approved version uses automated specimen processing which requires a greater amount of plasma (minimum of 1.5 ml) than the current method. EDTA tubes (pink, lavender, and white) are all approved and validated; however, a full pink top EDTA tube is preferred.

In addition, the quantitative linear detection will decrease to 43 IU/ml (instead of 200 UI/ml). Positive results less than <43 IU/ml will be reported as 43 IU/ml and negative results will continue to be reported as "HCV RNA not detected". Also, the result will be listed alpha-numeric so that it can appear in the tabular and graph profiles of IPR. Prior results cannot be changed to this format.

Questions may be directed to Aaron Bossler, M.D., Ph.D. Director of the Molecular Pathology Laboratory at 4-9566, pager 4703.