Eurosurv. Establishment of a specimen panel for the decentralised technical evaluation of the sensitivity of 31 rapid diagnostic tests for SARS-CoV-2

[tetano]

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

Introduction

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.

Aim

We aimed to establish a comprehensive specimen panel for the decentralised technical evaluation of SARS-CoV-2 antigen rapid diagnostic tests.

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 × 10[SUP]9[/SUP] to 420 genome copies per mL of specimen. The panel was used to evaluate 31 RDT in up to six laboratories.

Results

Our 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 10[SUP]6[/SUP] genome copies per mL of specimen. For the identification of infected individuals with SARS-CoV-2 loads corresponding to less than 10[SUP]6[/SUP] genome copies per mL, only three RDT showed a clinical sensitivity of more than 60%.

Conclusions

Sensitive RDT can be applied to identify infectious individuals with high viral loads but not to identify all infected individuals.



full article


https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2021.26.44.2100442