Il test rapido VivaDiag™ PRO SARS-CoV-2 Ag serve per il rilevamento rapido e qualitativo dell’antigene della proteina nucleocapside da SARS-CoV-2 in campioni di tampone nasale umano, tampone orofaringeo o tampone nasofaringeo.
Tasso di corrispondenza VS RT-PCR: 98%
VivaDiag Pro SARS-CoV-2 Ag Rapid Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab, oropharyngeal swab or nasopharyngeal swab specimen. The test is for in vitro diagnostic use only. VivaDiag Pro SARS-CoV-2 Ag Rapid Test is designed with enhanced sensitivity as 97.06%.
VivaDiagTM Pro SARSCoV-2 Ag Rapid Test |
PCR (CT value<30) |
Positive |
Negative |
Total |
Positive |
99 |
0 |
99 |
Negative |
3 |
431 |
434 |
Total |
102 |
431 |
533 |
Sensibilità |
97.06%
(99/102, 95%CI, 91.71%~98.99%) |
Specificità |
100%
(431/431 95%CI, 99.12%~100%) |
Attendibilità / Accuratezza |
99.44%
(530/533 95%CI, 98.36%~99.81%) |
The VivaDiag™ PRO SARS-CoV-2 Ag Test showed a clinical sensitivity of 97.06%.
The VivaDiag™ PRO SARS-CoV-2 Ag Test showed a clinical specificity of 100%.
The VivaDiag™ PRO SARS-CoV-2 Ag Test showed a clinical accuracy of 99.44%.
Test Parameters: SARS-CoV-2 Ag
Test Principle: Immunochromatorgraphy
Sample Type: Nasal swab / Nasopharyngeal swab / oropharyngeal swab
Sample Volume: 60 μl
Test Time: 15 min
Operation Temperature: 15-30°C
Storage Temperature: 2-30°C
Shelf Life: 24 months