tetano
Editor, Senior Moderator
Heinrich Scheiblauer[SUP]1[/SUP] , Angela Filomena[SUP]1[/SUP] , Andreas Nitsche[SUP]2[/SUP] , Andreas Puyskens[SUP]2[/SUP] , Victor M Corman[SUP]3,4[/SUP] , Christian Drosten[SUP]3[/SUP] , Karin Zwirglmaier[SUP]5[/SUP] , Constanze Lange[SUP]6[/SUP] , Petra Emmerich[SUP]7[/SUP] , Michael Müller[SUP]8[/SUP] , Olivia Knauer[SUP]1[/SUP] , C Micha Nübling[SUP]1[/SUP]
Introduction
Numerous CE-marked SARS-CoV-2 antigen rapid diagnostic tests (Ag RDT) are offered in Europe, several of them with unconfirmed quality claims.
Aim
We performed an independent head-to-head evaluation of the sensitivity of SARS-CoV-2 Ag RDT offered in Germany.
Methods
We addressed the sensitivity of 122 Ag RDT in direct comparison using a common evaluation panel comprised of 50 specimens. Minimum sensitivity of 75% for panel specimens with a PCR quantification cycle (Cq) ≤ 25 was used to identify Ag RDT eligible for reimbursement in the German healthcare system.
Results
The sensitivity of different SARS-CoV-2 Ag RDT varied over a wide range. The sensitivity limit of 75% for panel members with Cq ≤ 25 was met by 96 of the 122 tests evaluated; 26 tests exhibited lower sensitivity, few of which failed completely. Some RDT exhibited high sensitivity, e.g. 97.5 % for Cq < 30.
Conclusions
This comparative evaluation succeeded in distinguishing less sensitive from better performing Ag RDT. Most of the evaluated Ag RDT appeared to be suitable for fast identification of acute infections associated with high viral loads. Market access of SARS-CoV-2 Ag RDT should be based on minimal requirements for sensitivity and specificity.
full article
https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2021.26.44.2100441
Introduction
Numerous CE-marked SARS-CoV-2 antigen rapid diagnostic tests (Ag RDT) are offered in Europe, several of them with unconfirmed quality claims.
Aim
We performed an independent head-to-head evaluation of the sensitivity of SARS-CoV-2 Ag RDT offered in Germany.
Methods
We addressed the sensitivity of 122 Ag RDT in direct comparison using a common evaluation panel comprised of 50 specimens. Minimum sensitivity of 75% for panel specimens with a PCR quantification cycle (Cq) ≤ 25 was used to identify Ag RDT eligible for reimbursement in the German healthcare system.
Results
The sensitivity of different SARS-CoV-2 Ag RDT varied over a wide range. The sensitivity limit of 75% for panel members with Cq ≤ 25 was met by 96 of the 122 tests evaluated; 26 tests exhibited lower sensitivity, few of which failed completely. Some RDT exhibited high sensitivity, e.g. 97.5 % for Cq < 30.
Conclusions
This comparative evaluation succeeded in distinguishing less sensitive from better performing Ag RDT. Most of the evaluated Ag RDT appeared to be suitable for fast identification of acute infections associated with high viral loads. Market access of SARS-CoV-2 Ag RDT should be based on minimal requirements for sensitivity and specificity.
full article
https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2021.26.44.2100441