Summary
To evaluate the usefulness of a standardized commercial amplification assay for detection of hepatitis C virus (HCV) RNA, Amplicor® HCV Test (Roche), a total of 1,204 serum samples from 888 patients was examined. Seven out of 443 anti-HCV-negative samples, 638 out of 729 anti-HCV-positive samples and four out of 32 anti-HCV-indeterminate samples tested HCV RNA positive by Amplicor® in initial testing. One false-negative and five false-positive Amplicor® results were found in initial testing, giving an overall sensitivity and specificity of the Amplicor® HCV Test of 99.8% and 99.1%, respectively. Our study confirmed that the Amplicor® HCV Test is a practical, rapid, sensitive and specific assay for detection of HCV RNA. However, the results must be interpreted with some caution and with the patient's anti-HCV status and clinical data in mind.
Keywords: Hepatitis, Initial Testing, Diagnostic Laboratory, Specific Assay, Amplification Assay
Zusammenfassung
Ein standardisierter kommerzieller Amplifikationsassay zum Nachweis von Hepatitis C Virus (HCV)-RNA, der Amplicor® HCV Test (Roche) wurde an 1.204 Serumproben von 888 Patienten auf seine Brauchbarkeit geprüft. Sieben von 443 anti-HCV-negativen Proben und 638 von 729 anti-HCV positiven Proben sowie vier von 32 anti-HCV unbestimmten Proben ware mit Amplicor® positiv bei erster Testung. Die Ergebnisse der ersten Testung erwiesen sich in einem Fall als falsch negativ und in fünf Fällen als falsch positiv. Für den Amplicor® HCV-Test ergibt sich daraus eine Sensitivität von 99,8% und eine Spezifität von 99,1%. Unsere Studie bestätigte, daß der Amplicor® HCV-Test ein praktischer, rasch durchführbarer, sensitiver und spezifischer Test für den Nachweis von HCV RNA ist. Die Ergebnisse müssen jedoch mit Vorsicht bewertet werden, wobei immer der anti-HCV Status des Patienten und seine klinischen Daten herangezogen werden sollten.
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