Clinical Information

Results with a Roche assay index reading predictive of 95% or greater probability of being true positives will be reported as Reactive. False positive results are expected to occur in less than 5% of specimens with such results.

Specimens with Reactive Hepatitis C Antibody results will be automatically reflexed to the quantitative Hepatitis C Virus RNA test, per a new mandatory Laboratory reflex testing policy which has been approved by the Medical Executive Committee. This test can be performed on the same specimen used for the Hepatitis C Antibody test, and no new physician order will be needed.

The quantitative Hepatitis C Virus RNA test may serve as a baseline for Hepatitis C Virus antiviral therapy. CDC (Centers for Disease Control) and other current guidelines recommend the Hepatitis C Virus RNA test as a follow-up for positive Hepatitis C Antibody results.

It should be noted that Hepatitis C Genotyping may be indicated for guidance of antiviral therapy in patients with newly diagnosed Hepatitis C Virus infection. A new physician order Hepatitis C Genotype with Amplification SH#4434 is required for this test.