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. 2021 Nov;26(44):2100442.
doi: 10.2807/1560-7917.ES.2021.26.44.2100442.

Establishment of a specimen panel for the decentralised technical evaluation of the sensitivity of 31 rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021

Andreas Puyskens  1 , Eva Krause  1 , Janine Michel  1 , C Micha Nübling  2 , Heinrich Scheiblauer  2 , Daniel Bourquain  1 , Marica Grossegesse  1 , Roman Valusenko  1 , Victor M Corman  3   4 , Christian Drosten  3 , Katrin Zwirglmaier  5 , Roman Wölfel  5 , Constanze Lange  6 , Jan Kramer  6 , Johannes Friesen  7 , Ralf Ignatius  7 , Michael Müller  7 , Jonas Schmidt-Chanasit  8 , Petra Emmerich  8   9 , Lars Schaade  1 , Andreas Nitsche  1
Affiliations

Establishment of a specimen panel for the decentralised technical evaluation of the sensitivity of 31 rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021

Andreas Puyskens et al. Euro Surveill. 2021 Nov.

Abstract

IntroductionThe detection of SARS-CoV-2 with rapid diagnostic tests (RDT) has become an important tool to identify infected people and break infection chains. These RDT are usually based on antigen detection in a lateral flow approach.AimWe aimed to establish a comprehensive specimen panel for the decentralised technical evaluation of SARS-CoV-2 antigen rapid diagnostic tests.MethodsWhile for PCR diagnostics the validation of a PCR assay is well established, there is no common validation strategy for antigen tests, including RDT. In this proof-of-principle study we present the establishment of a panel of 50 pooled clinical specimens that cover a SARS-CoV-2 concentration range from 1.1 × 109 to 420 genome copies per mL of specimen. The panel was used to evaluate 31 RDT in up to six laboratories.ResultsOur results show that there is considerable variation in the detection limits and the clinical sensitivity of different RDT. We show that the best RDT can be applied to reliably identify infectious individuals who present with SARS-CoV-2 loads down to 106 genome copies per mL of specimen. For the identification of infected individuals with SARS-CoV-2 loads corresponding to less than 106 genome copies per mL, only three RDT showed a clinical sensitivity of more than 60%.ConclusionsSensitive RDT can be applied to identify infectious individuals with high viral loads but not to identify all infected individuals.

Keywords: antigen test; evaluation; rapid diagnostic test (RDT).

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Conflict of interest statement

Conflict of interest: None declared.

Figures

Figure 1
Figure 1
Recommendation for panel usage to guarantee maximum comparability between different laboratories and points in time of validation, evaluation of the sensitivity of 31 rapid detection tests for SARS-CoV-2 diagnostics, Germany, September 2020–April 2021
Figure 2
Figure 2
Analytical sensitivity of rapid diagnostic tests for SARS-CoV-2, expressed as 50% detection probability, Germany, September 2020–April 2021 (n = 31)
Figure 3
Figure 3
Clinical sensitivities of rapid diagnostic tests for SARS-CoV-2 as determined by two to six laboratories using 50 pools from evaluation Panels 1V1 and 1V2, Germany, September 2020–April 2021 (n = 31)
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