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

Author:

Hemken Philip M.1,Israeli Eitan1,Taylor Russell2,Jacobson Chris2,Datwyler Maria2,Geissler Rene2,Hadji Abbas2,Jeanblanc Nicolette2,Pandya Kinnari2,Marcinkus Marilee2,Piktel Ryan3,Bogdan M. Felicia3,Rodgers Mary4,Anderson Mark4,Ziemann Robert1,Tieman Bryan C.1,Hawksworth David1,Moore Jeffrey1,Otis Kathy S.1,Marohnic Christopher C.1,Corby Josie1,Tu Bailin1,Lin Zhihong1,Kar Alak1,Hartnett James1,Strobel Carolyn1,Gregory Svetoslava1,Rae Tracey1,Muerhoff A. Scott1,Brophy Susan5,Hackett John R.5,Daghfal David5,Faron Matthew L.6,Cruz Amorina6,Mohr Phaedre7,Sokoll Lori7,Davis Gerard J.2

Affiliation:

1. Biologics Discovery , Abbott Laboratories , Abbott Park , IL , USA

2. Assay Development , Abbott Laboratories , Abbott Park , IL , USA

3. Process Design , Abbott Laboratories , Abbott Park , IL , USA

4. ID Core Research , Abbott Laboratories , Abbott Park , IL , USA

5. Abbott Diagnostics , Abbott Park , IL , USA

6. Department of Pathology , The Medical College of Wisconsin , Milwaukee , WI , USA

7. Department of Pathology , Johns Hopkins University School of Medicine , Baltimore , MD , USA

Abstract

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 (<1.00 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. 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.

Funder

Abbott Laboratories

Publisher

Walter de Gruyter GmbH

Subject

Biochemistry (medical),Clinical Biochemistry,General Medicine

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