Abstract
IntroductionNumerous CE-marked SARS-CoV-2 antigen rapid diagnostic tests (Ag RDT) are offered in Europe, several of them with unconfirmed quality claims.AimWe performed an independent head-to-head evaluation of the sensitivity of SARS-CoV-2 Ag RDT offered in Germany.MethodsWe 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.ResultsThe 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.ConclusionsThis 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.
Highlights
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-tohead evaluation of the sensitivity of SARS-CoV-2 Ag RDT offered in Germany
While dry swabs were directly eluted in phosphate-buffered saline (PBS), the residual amount of virus transport media (VTM) contained in moist swabs was diluted in PBS
Investigation of stability of the analyte SARS-CoV-2 antigen in panel members revealed a negative effect for additional freeze/thaw steps; in contrast, there was no obvious impact on the antigen content after 7 days experimental storage at 4 °C of the liquid 50 μL aliquots
Summary
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-tohead evaluation of the sensitivity of SARS-CoV-2 Ag RDT offered in Germany. Most of the evaluated Ag RDT appeared to be suitable for fast identification of acute infections associated with high viral loads. A large number of antigen-detecting rapid diagnostic tests (Ag RDT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are available on the European market, both for professional use and as self-tests. Rapid tests are based on lateral flow immunochromatography using antibodies against SARS-CoV-2 proteins (antigens), present in respiratory tract specimens. While PCR is still the gold standard for virus detection, there is increasing evidence that infectivity of respiratory secretions correlates with high viral loads present in the early phase of infection, e.g. before and 0–10 days after onset of symptoms. In addition to more complex and time-consuming PCR systems, Ag RDT allow rapid identification of acutely infected and potentially infectious individuals facilitating fast decisions on containment of virus spread, patient care, isolation and contact tracing [1,2]. Ag RDT may save limited reagents of more sensitive molecular diagnostics to serve other diagnostic needs, e.g. disease management or confirmation of Ag RDT reactive results
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