ESPLINE® SARS-CoV-2 (CE / IVD) FUJIRIBIO (Japan) or CLINTEST®RAPID COVID-19 ANTIGEN TEST(CE / IVD), SIEMENS (Germany) and meets the following requirements and standards:
- meets WHO criteria for SARS-CoV-2 antigen testing: ≥ 80% sensitivity
- meets EU criteria for SARS-CoV-2 antigen testing: ≥ 90% sensitivity and ≥ 97% specificity, carries CE marking and is validated by a member state/s
- meets criteria for Germany: listed by Paul Ehrlich Institut and positively noted
- meets UK.GOV requirements for SARS-CoV-2 antigen testing: ≥97% specificity, ≥80% sensitivity at viral loads above 100,000 copies/mL
The example of our SARS-CoV-2 antigen test in English you can see via this link.