HCV RNA quantification using the Cobas Plasma Separation Card as an alternative to EDTA plasma: a prospective...

Area of Science:

• Virology
• Clinical Diagnostics
• Public Health

Background:

• Global efforts aim to eliminate hepatitis C virus (HCV) by 2030, necessitating simplified diagnostic strategies.
• Current HCV diagnostics often rely on conventional venous blood collection, posing challenges in resource-limited settings.

Purpose of the Study:

• To evaluate the diagnostic accuracy of dried plasma spots collected on Cobas® Plasma Separation Cards (PSC) compared to traditional ethylenediaminetetraacetic acid (EDTA) plasma for HCV RNA detection and quantification.
• To assess the feasibility of using finger-prick capillary blood collected on PSCs for HCV testing.

Main Methods:

• A prospective, multicenter study involving 224 individuals with known HCV status.
• HCV RNA was detected and quantified using the Cobas HCV nucleic acid amplification test on both EDTA plasma and Cobas PSC samples (capillary and venous blood).
• Clinical sensitivity and specificity were determined against EDTA plasma, with a threshold of 1000 IU/mL RNA.

Main Results:

• Cobas PSC capillary samples demonstrated 100% clinical sensitivity and specificity compared to EDTA plasma.
• Cobas PSC venous samples showed 97.8% sensitivity and 100% specificity.
• Quantitative HCV RNA viral loads obtained from PSC samples were comparable to those from EDTA plasma.

Conclusions:

• Cobas PSC, when used with the Cobas HCV assay, provides accurate HCV RNA detection and quantification, comparable to conventional EDTA plasma.
• The use of Cobas PSC, particularly with capillary blood, can eliminate the need for venipuncture, potentially improving access to HCV testing in remote or under-resourced regions.