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. 2021 Apr 6:8:650581.
doi: 10.3389/fmed.2021.650581. eCollection 2021.

SARS-CoV-2 Diagnostic Tests: Algorithm and Field Evaluation From the Near Patient Testing to the Automated Diagnostic Platform

Nicolas Yin  1 , Cyril Debuysschere  1 , Marc Decroly  2 , Fatima-Zohra Bouazza  3 , Vincent Collot  3 , Charlotte Martin  4 , Fanny Ponthieux  5 , Hafid Dahma  1 , Marius Gilbert  6 , Magali Wautier  1 , Cecile Duterme  5 , Nathalie De Vos  5 , Marie-Luce Delforge  7 , Stefano Malinverni  3 , Frédéric Cotton  5 , Magali Bartiaux  3 , Marie Hallin  1   8
Affiliations

SARS-CoV-2 Diagnostic Tests: Algorithm and Field Evaluation From the Near Patient Testing to the Automated Diagnostic Platform

Nicolas Yin et al. Front Med (Lausanne). .

Abstract

Introduction: Since the first wave of COVID-19 in Europe, new diagnostic tools using antigen detection and rapid molecular techniques have been developed. Our objective was to elaborate a diagnostic algorithm combining antigen rapid diagnostic tests, automated antigen dosing and rapid molecular tests and to assess its performance under routine conditions. Methods: An analytical performance evaluation of four antigen rapid tests, one automated antigen dosing and one molecular point-of-care test was performed on samples sent to our laboratory for a SARS-CoV-2 reverse transcription PCR. We then established a diagnostic algorithm by approaching median viral loads in target populations and evaluated the limit of detection of each test using the PCR cycle threshold values. A field performance evaluation including a clinical validation and a user-friendliness assessment was then conducted on the antigen rapid tests in point-of-care settings (general practitioners and emergency rooms) for outpatients who were symptomatic for <7 days. Automated antigen dosing was trialed for the screening of asymptomatic inpatients. Results: Our diagnostic algorithm proposed to test recently symptomatic patients using rapid antigen tests, asymptomatic patients using automated tests, and patients requiring immediate admission using molecular point-of-care tests. Accordingly, the conventional reverse transcription PCR was kept as a second line tool. In this setting, antigen rapid tests yielded an overall sensitivity of 83.3% (not significantly different between the four assays) while the use of automated antigen dosing would have spared 93.5% of asymptomatic inpatient screening PCRs. Conclusion: Using tests not considered the "gold standard" for COVID-19 diagnosis on well-defined target populations allowed for the optimization of their intrinsic performances, widening the scale of our testing arsenal while sparing molecular resources for more seriously ill patients.

Keywords: COVID-19; NAAT; PCR; SARS-CoV-2; antigen; diagnostic; immunoassay; point-of-care.

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Conflict of interest statement

Becton Dickinson, Coris BioConcept, and Fujirebio have offered reagents for this study. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Distribution and comparison of CT values in target populations according to the motivation of the order using Abbott RealTime SARS-CoV-2 solution (Comparisons using the Tukey-Kramer method).
Figure 2
Figure 2
Proposal for a SARS-CoV-2 direct diagnostic decision algorithm.
Figure 3
Figure 3
Diagnostic center set outside under a tent by a general practitioners group in Uccle, Belgium (October 22, 2020).
See this image and copyright information in PMC

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