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Pre-analytical considerations in the development of a prototype SARS-CoV-2 antigen ARCHITECT automated immunoassay.
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.
  • Hemken PM; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Israeli E; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Taylor R; Assay Development, Abbott Laboratories, Abbott Park, IL, USA.
  • Jacobson C; Assay Development, Abbott Laboratories, Abbott Park, IL, USA.
  • Datwyler M; Assay Development, Abbott Laboratories, Abbott Park, IL, USA.
  • Geissler R; Assay Development, Abbott Laboratories, Abbott Park, IL, USA.
  • Hadji A; Assay Development, Abbott Laboratories, Abbott Park, IL, USA.
  • Jeanblanc N; Assay Development, Abbott Laboratories, Abbott Park, IL, USA.
  • Pandya K; Assay Development, Abbott Laboratories, Abbott Park, IL, USA.
  • Marcinkus M; Assay Development, Abbott Laboratories, Abbott Park, IL, USA.
  • Piktel R; Process Design, Abbott Laboratories, Abbott Park, IL, USA.
  • Bogdan MF; Process Design, Abbott Laboratories, Abbott Park, IL, USA.
  • Rodgers M; ID Core Research, Abbott Laboratories, Abbott Park, IL, USA.
  • Anderson M; ID Core Research, Abbott Laboratories, Abbott Park, IL, USA.
  • Ziemann R; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Tieman BC; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Hawksworth D; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Moore J; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Otis KS; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Marohnic CC; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Corby J; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Tu B; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Lin Z; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Kar A; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Hartnett J; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Strobel C; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Gregory S; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Rae T; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Muerhoff AS; Biologics Discovery, Abbott Laboratories, Abbott Park, IL, USA.
  • Brophy S; Abbott Diagnostics, Abbott Park, IL, USA.
  • Hackett JR; Abbott Diagnostics, Abbott Park, IL, USA.
  • Daghfal D; Abbott Diagnostics, Abbott Park, IL, USA.
  • Faron ML; Department of Pathology, The Medical College of Wisconsin, Milwaukee, WI, USA.
  • Cruz A; Department of Pathology, The Medical College of Wisconsin, Milwaukee, WI, USA.
  • Mohr P; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Sokoll L; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Davis GJ; Assay Development, Abbott Laboratories, Abbott Park, IL, USA.
Clin Chem Lab Med ; 61(8): 1511-1517, 2023 Jul 26.
Article in English | MEDLINE | ID: covidwho-2262650
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Qualitative research / Randomized controlled trials Limits: Humans Language: English Journal: Clin Chem Lab Med Journal subject: Chemistry, Clinical / Laboratory Techniques and procedures Year: 2023 Document Type: Article Affiliation country: Cclm-2022-1292

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Qualitative research / Randomized controlled trials Limits: Humans Language: English Journal: Clin Chem Lab Med Journal subject: Chemistry, Clinical / Laboratory Techniques and procedures Year: 2023 Document Type: Article Affiliation country: Cclm-2022-1292