DIAGNOSTIC PARAMETERS | COVID-19/ INFLUENZA A/ INFLUENZA B INFECTION |
TEST TIME | 15 MINUTES |
SENSITIVITY COVID-19/ FLU A/ FLU B | 98.23%/ 99.42%/ 99.14% |
SPECIFICITY COVID-19/ FLU A/ FLU B | 99.58%/ 99.11%/ 99.39% |
ACCURACY COVID-19/ FLU A/ FLU B | 98.58%/ 99.03%/ 97.03% |
EU CE MARKING | FULLY REGISTERED |
US FDA EUA | SUBMISSION PREPARARTION |
ISO 13485 | REGISTERED |
TEST SAMPLE | NASOPHARYNGEAL/ OROPHARYNGEAL SWAB |
TEST TYPE | QUALITATIVE- POSITIVE/NEGATIVE |
READER ANALYZER | NOT REQUIRED |
PACKING SPECIFICATION | 20 TEST/ BOX |
ACCESSORIES | SWABS/ BUFFERS/ SAMPLE HOLDING TUBES |