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.
Highlights
The detection of SARS-CoV-2 with rapid diagnostic tests (RDT) has become an important tool to identify infected people and break infection chains
We mainly used dry swabs resuspended in phosphate-buffered saline (PBS) and a small number of swabs obtained in viral transport medium, resulting in a final concentration of viral transport medium of ≤ 20% in each pool, ≤ 10% in 38 pools and 0% in 25 pools
To test whether pooling and freezing had an impact on the detectability of specimens, we compared 40–44 fresh clinical specimens, representing a Cq value range from 20 to 35 (1.8 × 107 to 7.0 × 103) genome copies per mL, with 32 pools of Panel 1V1, covering a comparable Cq value range using 10 RDT (#2, #3, #7, #8, #10, #11, #14, #21, #28 and #31)
Summary
The 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. Methods: While 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. Cq values in bold indicate that SARS-CoV-2 could be propagated in cell culture
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Schedule a callMore From: Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin
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