Development and Characterization of Dual-Platform Lyophilized Plasma-Based Quality Control Materials for Hepatitis C...

Area of Science:

• Clinical Chemistry
• Diagnostic Assay Development
• Quality Control Materials

Background:

• Reliable quality control (QC) is crucial for accurate hepatitis C virus (HCV) screening.
• Limited availability of standardized plasma-based internal quality control (IQC) materials for both rapid diagnostic tests (RDTs) and automated immunoassays.
• Need for versatile QC materials to ensure consistent analytical performance across different platforms.

Purpose of the Study:

• To develop and evaluate novel plasma-based QC materials for anti-HCV screening.
• To assess the applicability of these QC materials across multiple RDTs and automated immunoassays.
• To determine the stability and homogeneity of the developed QC materials.

Main Methods:

• Preparation of QC materials from pooled HCV-positive plasma (strong-positive, weak-positive, negative) in liquid and lyophilized formats.
• Lyophilized preparations included trehalose; liquid samples included a stabilizer.
• Performance evaluation using five anti-HCV RDT kits and the Elecsys Anti-HCV II automated immunoassay; stability assessed under accelerated and long-term storage conditions.

Main Results:

• All QC formulations showed consistent qualitative reactivity with RDT kits and stable responses on the automated immunoassay.
• Lyophilized plasma with trehalose demonstrated stable cut-off index (COI) values during accelerated and long-term storage.
• No significant time-dependent trends were observed for trehalose-stabilized lyophilized QC materials (p > 0.05).

Conclusions:

• Trehalose-stabilized lyophilized QC materials exhibit enhanced stability and acceptable homogeneity.
• These materials are practically applicable for anti-HCV RDTs under tested storage conditions.
• The QC materials are suitable for moderate-to-high positive analytical ranges on automated anti-HCV immunoassay platforms.