COVID-19 Serology Control Panel Using the Dried-Tube Specimen Method.

Area of Science:

• Clinical diagnostics and immunology
• Virology and infectious diseases

Background:

• Accurate serological testing for COVID-19 is crucial for disease surveillance and vaccine efficacy assessment.
• Existing control materials often require cold chain logistics, limiting accessibility for global laboratories.

Purpose of the Study:

• To develop and characterize a novel COVID-19 Serology Control Panel (CSCP) using dried-tube specimen (DTS) technology.
• To ensure the CSCP provides reliable reactivity for various serological test platforms and aids in external quality assurance.

Main Methods:

• Development of the CSCP utilizing the dried-tube specimen (DTS) procedure for sample preservation without cold chain requirements.
• Characterization of immunoglobulin subtypes (total Ig, IgM, IgG) and their reactivity against SARS-CoV-2 antigens (nucleocapsid, spike, RBD).
• Comparison of CSCP sample reactivity with the WHO International Standard to determine binding antibody units.

Main Results:

• The DTS procedure enabled the creation of a stable serology control panel from convalescent COVID-19 samples collected between March-May 2020.
• Detailed delineation of immunoglobulin subtype reactivity against key SARS-CoV-2 antigens was achieved.
• Established binding antibody units for each sample, ensuring comparability across different serological test platforms.

Conclusions:

• The developed CSCP, utilizing DTS, offers a stable, accessible, and standardized tool for global serological testing quality assurance.
• The panel facilitates harmonization of laboratory testing and serves as valuable training material for laboratory personnel.
• This innovation enhances the reliability and comparability of COVID-19 antibody testing worldwide.