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

• Published in: Diagnostics (Basel) Vol. 11; no. 3; p. 473
• Main Authors: Velásquez-Orozco, Fernando, Rando-Segura, Ariadna, Martínez-Camprecios, Joan, Salmeron, Paula, Najarro-Centeno, Adrián, Esteban, Àngels, Quer, Josep, Buti, María, Pumarola-Suñe, Tomás, Rodríguez-Frías, Francisco
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 08-03-2021; MDPI
• Subjects: dried plasma spot; Hepatitis C; Infections; Medical laboratories; Performance evaluation; Plasma; plasma separation card; Serology; Statistical analysis; Substance abuse treatment; United States > US; Switzerland; dried plasma spot; hepatitis C; plasma separation card
• ISSN: 2075-4418; 2075-4418
• DOI: 10.3390/diagnostics11030473

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 × 10
IU/mL, 74 were RNA-positive in DPS. The mean viral load difference between plasma and DPS was 2.65 log
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.