HCV RNA Testing

To As of July 2002, the upper limit of the linear range for quantitation of HCV RNA with the COBAS AMPLICOR HCV MONITOR Test v2.0 was lowered from 850,000 IU/ml to 500,000 IU/ml. If a quantitative result is requested for a sample with >500,000 IU/ml, the sample is diluted 1:100 with negative human plasma and repeated. The test result is multiplied by 100 to obtain the titer of the sample.

Previously reported results >500,000 IU/ml and <850,000 IU/ml may be retested (upon request) if there is sufficient stored sample at -70°C. Due to inherent variability of the assay, replicate results may vary by ±3-fold. Retest results >3 fold higher than the original results suggest the original result was under quantified.

Questions regarding molecular HCV RNA testing should be directed to Dr. Gary Doern (356-8616) or Beth Alden (384-9568).