CE-marked

Sensitivity: 94.4%

Specificity: 98%

ISO:13485

CE-marked

Sensitivity: 93.10%

Specificity: 100%

Specimen type: nasopharyngeal swabs

CE –marked

﹒BfArM Test-ID: AT981/21

﹒Specimen: Nasopharyngeal/nasal specimen

﹒Sensitivity(NP): 96.3%

﹒Specificity(NP): 100%

﹒Sensitivity(N): 95.5%

﹒Specificity(N): 99.6%

﹒Sensitivity: 93.64%

﹒Specificity: 100.00%

﹒Specimen: Nasal specimen

﹒ISO13485

Ultra Sensitive

INTENDED USE

The AQ+ COVID-19 Ag Rapid Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in the nasopharyngeal/ nasal specimen collected by swabs from individuals who are suspected of having COVID-19. The test is used as an aid in the diagnosis of SARS-CoV-2 infection. The test is suitable for use under healthcare professional supervision. Individuals should have appropriate training in how to administer the test correctly. Remote healthcare professional supervision can be used with appropriate clinical governance, once training has been completed and verified.

INTENDED USE

The AQ+ COVID-19 Ag Rapid Self-Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in the nasopharyngeal/nasal specimen collected by swabs from individuals who are suspected of having COVID-19. The test is used as an aid in the diagnosis of SARS-CoV-2 infection. The test is suitable for use under healthcare professional supervision. Individuals should have appropriate training in how to administer the test correctly. Remote healthcare professional supervision can be used with appropriate clinical governance, once training has been completed and verified.

The test is for self-test with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first seven (7) days of symptom onset. Or self-test with adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first seven (7) days of symptom onset.

INTENDED USE

The AQ+ Rapid COVID-19/Flu Combo Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of antigens to SARS-CoV-2 and Influenza A and influenza B present in human nasopharyngeal/nasal specimens. The test is used as an aid in the diagnosis of COVID-19 infection and/or Influenza A and Influenza B.