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· AMP Rapid Test SARS-CoV-2 Ag is a rapid immuno-chromatographic test for qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in human nasal or throat swab samples as an aid in quick and efficient diagnosis of Corona Virus Disease 2019 (COVID-19)
· Clinical studies evidenced high sensitivity and
specificity of the test in comparison with RT-PCR.
Potential cross-reactivity was tested with a variety
of common pathogens and the concentrations at
which no cross-reactivity was observed are provided in the IFU.
· Kit size - 10 cassettes.
samples, as well as buffer and tubes for sample extraction are included in the kits.
· Reading time: 15 to max. 20 minutes
Detection limit: 1.15 x 102 TCID50/mL
Performance: compared with RT-PCR
Test Sensitivity: 97,3 % (95% CI: 90.0% - 99.8%)
Test Specificity: 100,00 % (95% CI: 96.6% - 100%)
Overall agreement: 98,8 % (95% CI: 91.8% - 99.9%)
· No special equipment required.
Please contact individual area sales managers for your country for further information.
