Abstract
ABSTRACT.The dried-tube specimen (DTS) procedure was used to develop the COVID-19 serology control panel (CSCP). The DTS offers the benefit of shipping materials without a cold chain, allowing for greater access without deterioration of material integrity. Samples in the panel were sourced from COVID-19 convalescent persons from March to May 2020. The immunoglobulin subtypes (total Ig, IgM, and IgG) and their respective reactivity to severe acute respiratory syndrome coronavirus 2 nucleocapsid, spike, and receptor-binding domain antigens of the samples were delineated and compared with the WHO International Standard to elucidate the exact binding antibody units of each CSCP sample and ensure the CSCP provides adequate reactivity for different types of serological test platforms. We distribute the CSCP as a kit with five coded tubes to laboratories around the world to be used to compare test kits for external quality assurance, for harmonizing laboratory testing, and for use as training materials for laboratory workers.
Highlights
A standardized panel composed of well-characterized plasma/serum specimens can bridge serosurveillance studies, compare test kits, serve as external quality assurance, harmonize tests that measure vaccine efficacy, be used as a training tool for laboratory workers, and be used for postmarket monitoring
Identifying the appropriate test kit for a use case has been made more complicated with more than 120 severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) serological test kits listed by the U.S Food and Drug Administration under Emergency Use Authorized and/or registered with the Conformite Europeenne-marked European market
A dried-tube specimen (DTS) vial was rehydrated with 200 mL phosphatebuffered saline (PBS) with 0.2% Tween (PBS diluent), was allowed to solubilize overnight at 4C before use
Summary
A standardized panel composed of well-characterized plasma/serum specimens can bridge serosurveillance studies, compare test kits, serve as external quality assurance, harmonize tests that measure vaccine efficacy, be used as a training tool for laboratory workers, and be used for postmarket monitoring. We have established a COVID-19 serology control panel (CSCP) using the dried-tube specimen (DTS) protocol[1] so that the panel can be shipped globally without a cold chain, allowing greater access to materials in all resource settings while maintaining sample integrity. Colorado School of Public Health, Anschutz Medical Campus, Aurora, CO.
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