Utility of the Cobas® Plasma Separation Card as a Sample Collection Device for Serological and Virological Diagnosis of Hepatitis C Virus Infection.

Fernando Velásquez-Orozco,Adrián Najarro-Centeno,Paula Salmeron,Ariadna Rando-Segura,Josep Quer,Francisco Rodríguez-Frías,Tomás Pumarola-Suñe,Joan Martínez-Camprecios,María Buti,Àngels Esteban

doi:10.3390/diagnostics11030473

Abstract

Diagnosis and clinical management of people infected with hepatitis C virus (HCV) relies on results from a combination of serological and virological tests. The aim of this study was to compare the performance of dried plasma spots (DPS), prepared using the cobas® Plasma Separation Card (PSC), to plasma and serum from venipuncture, for HCV diagnosis. We carried out a prospective study using DPS and paired plasma or serum samples. Serum and DPS samples were analyzed by immunoassay using Elecsys® Anti-HCV II (Roche). Plasma and DPS samples were analyzed using the cobas® HCV viral load and cobas® HCV genotyping tests (Roche). All DPS samples that had high anti-HCV antibody titers in serum were also antibody-positive, as were five of eight samples with moderate titers. Eight samples with low titers in serum were negative with DPS. Among 80 samples with plasma HCV viral loads between 61.5 and 2.2 × 108 IU/mL, 74 were RNA-positive in DPS. The mean viral load difference between plasma and DPS was 2.65 log10 IU/mL. The performance of DPS for detection of serological and virological markers of hepatitis C virus infection was comparable to that of the conventional specimen types. However, the limits of detection were higher for DPS.

Highlights

Licensee MDPI, Basel, Switzerland.According to recent estimates, more than 71 million people worldwide are infected with the hepatitis C virus (HCV) [1]
Of the 101 patients who tested positive in serum, 90 tested positive in dried plasma spots (DPS); all 85 samples with high HCV Ab titer in serum were positive with
These 11 discordant samples belonged to patients who tested negative for HCV RNA in plasma

Summary

Introduction

More than 71 million people worldwide are infected with the hepatitis C virus (HCV) [1]. HCV causes both acute and chronic infection. Most infected individuals are not aware of their infection. Around 30% (15–45%) of infected persons spontaneously clear the virus within 6 months of infection without any treatment, the remaining

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