학술논문
Pre-analytical considerations in the development of a prototype SARS-CoV-2 antigen ARCHITECT automated immunoassay
Document Type
research-article
Author
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.; Corby, Josie; Tu, Bailin; Lin, Zhihong; Kar, Alak; Hartnett, James; Strobel, Carolyn; Gregory, Svetoslava; Rae, Tracey; Muerhoff, A. Scott; Brophy, Susan; Hackett, John R.; Daghfal, David; Faron, Matthew L.; Cruz, Amorina; Mohr, Phaedre; Sokoll, Lori; Davis, Gerard J.
Source
Clinical Chemistry and Laboratory Medicine (CCLM). 61(8):1511-1517
Subject
Language
English
ISSN
1434-6621
1437-4331
1437-4331
Abstract
Objectives 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. Methods 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. Results 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 (1.0 × 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. Conclusions 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.