LABORATORY UPDATE:  HCV real-time PCR assay

                              
Bendiner and Schlesinger, Inc., is proud to announce the availability of the real-time PCR, FDA-approved Hepatitis C viral load test from Roche Diagnostics.  The COBAS® AmpliPrep / COBAS® TaqMan® HCV Test is now available for you to utilize  during routine clinical monitoring of your chronic Hepatitis C patients’ viral loads. 

This fully automated, Real-Time PCR HCV viral load test offers a wide linear dynamic range that quantifies HCV RNA in human serum or plasma from 43 IU/mL to 69 million IU/mL. The test has a validated sensitivity capable of detecting HCV RNA down to 18 IU/mL across all six HCV genotypes. This new test from Roche Diagnostics utilizes real-time PCR and was clinically and analytically validated in large U.S. clinical trials where specific positive and negative predicative powers have been assigned to key medical decision points utilized during the treatment of chronically infected HCV patients.

The COBAS® AmpliPrep/COBAS® TaqMan® HCV Test generates one of four possible results on patient samples as stated in the package insert which is available from your local Roche Diagnostics representative or online at http://www.mylabonline.com. Specimen results are interpreted as follows:

 

Titer Results Interpretation
Target Not Detected No Ct value for HCV obtained. Report results as "HCV RNA not detected."
LT 4.30E + 01 IU/mL Below 4.30E+01 IU/mL (lower limit of quantitation, LLoQ); HCV RNA is not quantifiable.

GTE 4.30E + 01 IU/mL and
LTE 6.90E + 07 IU/mlL

 Results greater than or equal to 43 IU/mL and less than or equal to 6.90E + 07 IU/mlL are within the Linear Range of the assay.
GT 6.90E + 07 IU/mlL Results are above the range of the assay. Report results as "greater than 6.90E + 07 HCV RNA IU/mL." If quantitative results are desired, the original specimen should be diluted 1:100 with HCV-negative human serum or EDTA plasma, depending on the matirx of the original specimen, and the test repeated. Multiply the reported result by the dilution factor.



To order this test pleas order: 194 Hepatitis C PCR-Viral Load

If you have any questions about this new method and our internal validation studies please contact the laboratory directly.

Sincerely,

Shelley Melzer
Director of Operations