Assay Format: Lateral flow test Immuno-chromatographic in vitro test

Test Type: Qualitative

Instrument: Device-Free

Sample Material: Nasal, Nasopharyngeal and Oropharyngeal

Target Antigen: Nucleocapsid (N)

Readout Time: 15 minutes

Sensitivity: 97.54%

Specificity: 100.00%

Storage Temperature: 2-30° C

Clinical validation:
The clinical performance of the Novacheck® SARS-CoV-2 Rapid Antigen Test was determined by comparison with a na sopharyngeal RT-PCR assay. Samples were collected within 7 days of symptom onset. The performance of the SARS-CoV-2 Rapid Antigen Test Kit was assessed using 163 nasopharyn geal swabs from patients.

The 3in1 test is designed for professional use and the Home test is designed as a Lay test.

Independent review by the Paul Ehrlich Institute and EURO Surveillance came to a very similar conclusion.