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- Title
Pre-analytical considerations in the development of a prototype SARS-CoV-2 antigen ARCHITECT automated immunoassay.
- Authors
Hemken, Philip M.; Israeli, Eitan; Taylor, Russell; Jacobson, Chris; Datwyler, Maria; Geissler, Rene; Hadji, Abbas; Jeanblanc, Nicolette; Pandya, Kinnari; Marcinkus, Marilee; Piktel, Ryan; Bogdan, M. Felicia; Rodgers, Mary; Anderson, Mark; Ziemann, Robert; Tieman, Bryan C.; Hawksworth, David; Moore, Jeffrey; Otis, Kathy S.; Marohnic, Christopher C.
- Abstract
To evaluate pre-analytical challenges related to high-volume central laboratory SARS-CoV-2 antigen testing with a prototype qualitative SARS-CoV-2 antigen immunoassay run on the automated Abbott ARCHITECT instrument. Contrived positive and negative specimens and de-identified nasal and nasopharyngeal specimens in transport media were used to evaluate specimen and reagent on-board stability, assay analytical performance and interference, and clinical performance. TCID50/mL values were similar for specimens in various transport media. Inactivated positive clinical specimens and viral lysate (USA-WA1/2020) were positive on the prototype immunoassay. Within-laboratory imprecision was ≤0.10 SD (<1.00 S/C) with a ≤10% CV (≥1.00 S/C). Assay reagents were stable on board the instrument for 14 days. No high-dose hook effect was observed with a SARS-CoV-2 stock of Ct 13.0 (RLU>1.0 × 106). No interference was observed from mucin, whole blood, 12 drugs, and more than 20 cross-reactants. While specimen stability was limited at room temperature for specimens with or without viral inactivation, a single freeze/thaw cycle or long-term storage (>30 days) at −20 °C did not adversely impact specimen stability or assay performance. Specificity of the prototype SARS-CoV-2 antigen immunoassay was ≥98.5% and sensitivity was ≥89.5% across two ARCHITECT instruments. Assay sensitivity was inversely correlated with Ct and was similar to that reported for the Roche Elecsys® SARS-CoV-2 Ag immunoassay. The prototype SARS-CoV-2 antigen ARCHITECT immunoassay is sensitive and specific for detection of SARS-CoV-2 in nasal and nasopharyngeal specimens. Endogenous proteases in mucus may degrade the target antigen, which limits specimen storage and transport times and complicates assay workflow.
- Subjects
SARS-CoV-2; IMMUNOASSAY; ANTIGENS; PROTOTYPES; ANTIGEN analysis
- Publication
Clinical Chemistry & Laboratory Medicine, 2023, Vol 61, Issue 8, p1511
- ISSN
1434-6621
- Publication type
Article
- DOI
10.1515/cclm-2022-1292