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Predicting Direct-Specimen SARS-CoV-2 Assay Performance Using Residual Patient Samples.

Lee F Schroeder1, Michael A Bachman1, Allison Idoni1

  • 1Department of Pathology, University of Michigan, Michigan Medicine, Ann Arbor, MI, USA.

The Journal of Applied Laboratory Medicine
|November 10, 2021
PubMed
Summary

Direct SARS-CoV-2 testing on Abbott ID NOW and DiaSorin Simplexa assays showed similar performance. Modeling assay sensitivity using viral load and specimen type is crucial for accurate point-of-care diagnostics.

Keywords:
infectious diseaselaboratory methods and toolspoint-of-care testing systems

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Area of Science:

  • Clinical diagnostics
  • Virology
  • Point-of-care testing

Background:

  • Point-of-care SARS-CoV-2 assay sensitivity varies with specimen type and patient viral load.
  • Direct specimen testing is preferred for assay evaluation over residual specimens in viral transport media (VTM).

Purpose of the Study:

  • To evaluate and model the performance of three point-of-care SARS-CoV-2 assays: Abbott ID NOW, Quidel Sofia 2, and DiaSorin Simplexa.
  • To determine if residual specimens in VTM can be used to accurately predict direct specimen testing performance.
  • To compare the diagnostic sensitivity of assays using direct specimens versus VTM.

Main Methods:

  • Limit-of-detection and residual VTM studies were performed on Abbott ID NOW, Quidel Sofia 2, and DiaSorin Simplexa assays.
  • Cycle threshold (CT) values were adjusted to simulate direct-specimen testing.
  • Logistic regression modeled assay performance based on specimen CT, applied to symptomatic and asymptomatic populations, and confirmed with a 96-sample paired-swab study.

Main Results:

  • Predicted percent positivity for Abbott ID NOW and DiaSorin Simplexa were similar when using direct nasopharyngeal samples (symptomatic: 94.9%-97.8%; asymptomatic: 88.4%-91.1%).
  • Abbott ID NOW with direct nasal specimens showed similar performance to Quidel Sofia 2 with nasopharyngeal VTM specimens (symptomatic: 77.8% vs. 76.6%; asymptomatic: 64.5% vs. 60.3%).
  • A paired-swab study demonstrated 99% concordance between direct nasopharyngeal ID NOW testing and VTM Simplexa testing.

Conclusions:

  • SARS-CoV-2 assay performance can be accurately modeled based on viral load and adjusted for direct-specimen testing.
  • Direct testing on Abbott ID NOW and VTM testing on DiaSorin Simplexa show comparable performance when using nasopharyngeal specimens.
  • The study validates the use of modeling to predict assay performance and highlights the importance of specimen type in diagnostic sensitivity.