AMP Rapid Test SARS-CoV-2 Ag Sputum
AMP Rapid Test SARS-CoV-2 Ag Sputum is a rapid immuno-chromatographic test for qualitative detection of SARS-CoV-2 antigen in human sputum samples as an aid in quick and efficient diagnosis of Corona Virus Disease 2019 (COVID-19). As the test is detecting SARSCoV-2 nucleocapsid protein (N-protein) antigen, mutations of the spike protein do not affect the performance of the test.
- Samples: Sputum
- Reading time: 15 to max. 20 minutes
- Detection limit: 1.15 x 102 TCID50/mL
- Performance: compared with RT-PCR
- Test Sensitivity: 92.2% (95% CI: 86.1% – 96.6%)
- Test Specificity: 100.0% (95% CI: 98.5% – 100.0%)
- Overall agreement: 96.7% (95% CI: 94.7% – 98.2%)
- Interferences: No interferences detected for EDTA blood, anti- viral drugs, antibiotics, anti-bacterial drugs, nasal sprays, nose drops, nasal corticosteroids
- Cross-reactivity: Concentrations of pathogens at which no cross- reactivity was observed are provided in the IFU
- Kit composition: Test cassette, funnel, sample tube & dropper tip, pipette, buffer portion, tube holder (RT3952 only), bag
