Pre-analytical considerations in the development of a prototype SARS-CoV-2 antigen ARCHITECT automated immunoassay

Area of Science:

• Clinical diagnostics
• Virology
• Immunochemistry

Background:

• High-volume testing for SARS-CoV-2 is crucial for pandemic control.
• Centralized laboratory assays require robust pre-analytical procedures.
• Evaluating new automated immunoassays is essential for efficient diagnostics.

Purpose of the Study:

• To assess the pre-analytical challenges of a prototype SARS-CoV-2 antigen immunoassay.
• To evaluate the performance of this assay on the automated Abbott ARCHITECT instrument.
• To determine the suitability of the assay for high-volume central laboratory use.

Main Methods:

• The prototype qualitative SARS-CoV-2 antigen immunoassay was tested on the Abbott ARCHITECT.
• Analytical performance was evaluated using contrived and de-identified clinical specimens.
• Specimen and reagent stability, interference, and clinical performance were assessed.

Main Results:

• The assay demonstrated high sensitivity (≥89.5%) and specificity (≥98.5%) for SARS-CoV-2 detection.
• Reagents were stable on-board for 14 days, with good within-laboratory precision.
• Specimen stability was limited at room temperature but stable after freeze-thaw or -20°C storage.

Conclusions:

• The prototype SARS-CoV-2 antigen immunoassay on the ARCHITECT is a sensitive and specific diagnostic tool.
• Pre-analytical factors, such as mucus protease activity, can affect specimen stability and assay workflow.
• Further optimization of specimen handling protocols may be necessary for optimal performance.