Assessment of SARS-CoV-2 rapid antigen tests

Mustafa Özcürümez,Roman Wölfel,Stefan Holdenrieder,Alexander von Meyer,Antonios Katsounas,Harald Renz

doi:10.1515/labmed-2021-0036

Abstract

Abstract Objectives Point-of-care antigen tests (PoC-AgTs) for the rapid detection of SARS-CoV-2 infection enable screening of additional populations with less effort, independent of laboratories and at a low cost. PoC-AgTs have therefore been included in national testing strategies with additional quality requirements to address limitations in specificity and sensitivity. Information given in the package inserts of the test providers should enable the user to evaluate the performance of a PoC-AgT in advance. The quality of this information has been independently assessed since the Corona Test Ordinance came into force in Germany in October 2020. Methods The completeness of analytical and diagnostic performance specifications was assessed for all package inserts publicly available via the Paul Ehrlich Institute (PEI). It was ascertained whether the minimum criteria, recommendations, and extended criteria of the PEI were comprehensibly fulfilled. The number of tests removed from the list by March 2021 was determined. Results By the closing date of the survey (17.11.2020), the PEI had listed 165 PoC-AgTs that formally fulfilled the minimum criteria and were thus reimbursed. A total of 78 identical systems were identified. Almost all providers were found to have gaps in the information on the validation results of their tests, meaning that an evaluation of performance is only possible to a limited extent. Until March 2021, 25 non-identical PoC-AgTs have been removed from the list. Conclusions Many PoC-AgTs could not be comprehensively evaluated based on the information provided by the provider. Users are therefore dependent on provider-independent sources of information.

Highlights

Since the beginning of the “corona pandemic” in spring 2020, the National Coronavirus Testing Strategy in Germany has been constantly adapted depending on the situation in order to meet the health, economic and social challenges of the COVID-19 pandemic
Point-of-care antigen tests (PoC-AgTs) for the rapid detection of SARS-CoV-2 infection enable screening of additional populations with less effort, independent of laboratories and at a low cost
The completeness of analytical and diagnostic performance specifications was assessed for all package inserts publicly available via the Paul Ehrlich Institute (PEI)

Summary

Introduction

Since the beginning of the “corona pandemic” in spring 2020, the National Coronavirus Testing Strategy in Germany has been constantly adapted depending on the situation in order to meet the health, economic and social challenges of the COVID-19 pandemic. In vitro diagnostics providers and users are involved in these challenges, but may be pursuing different interests In this context, rapid SARS-CoV-2 antigen tests (PoC-AgTs) have recently gained importance in the management of the pandemic. The RKI recently demonstrated the effects of these quality criteria with regard to the clinical significance of positive and negative test results as well as sensitivity, specificity and prediction probabilities The latter are dependent on the quality of the performance specifications in lowincidence situations [3]. Table : Availability of information on clinical performance characteristics in the test provider’s instructions for use. Table : Availability of information on analytical performance characteristics in the test provider’s instructions for use. It is noticeable that more detailed data on the level of tolerated virus concentrations are available much less frequently, possibly due to a lack of test preparations

Discussion

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Conclusions