Assessment of SARS-CoV-2 rapid antigen tests

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. 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. 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. 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. © 2021 Mustafa Özcürümez et al., published by De Gruyter, Berlin/Boston.

[SARS-CoV-2 antibodies in ICU and clinic staff : From Germany's region with the highest infection rate]. / SARS-CoV-2-Antikörper bei Intensiv- und Klinikpersonal : Aus der am höchsten durchseuchten Region Deutschlands.

BACKGROUND: Healthcare workers are a high-risk population for SARS-CoV­2 infection. For capacity planning of healthcare providers and to optimize protection of healthcare workers (HCW) in SARS-CoV­2 pandemics, it is essential to know the risk of infection and potential immunity status of staff dealing with COVID-19 patients. MATERIALS AND METHODS: We examined seropravalence of SARS-CoV­2 IgM/IgG antibodies (AB) in HCW of a region with the highest rate of infection (1570/100,000) during COVID-19 pandemic in Germany, 4 months after its start. Employees of a nonmedical company (MU) served as control group. Demographic data, medical history and working situation were recorded. RESULTS: A total of 1838 HCW and 986 MU volunteered to participate. Seroprevalence for SARS-CoV­2 in HCW was 15.1% and 3.7% in MU. Among HCWs, nurses had a seropositivity of 20.0%, ICU personnel 20.3%, housekeepers 19.3%, physicians 12.0%, medical services (e.g., radiology, physiotherapy) 11.3%, administration 7.1% and technical services 6%. Symptoms typical for COVID-19 were not experienced by 10% of seropositive HCWs. CONCLUSION: Seroprevalence of SARS-CoV­2 antibodies in HCW of a region heavily affected by COVID-19 is with 15.1% significantly higher than in a control group of nonmedical staff with 3.7%. Infection rate in HCW was higher in staff with close contact to infected patients. Seropositivity in ICU personnel is higher than in other clinical professions. The occupational risk for housekeepers seems to be underestimated.