INTENDED USE OF THE WIZ BIOTECH RAPID TEST ANTIGEN KIT:
An in vitro diagnostic rapid test anitgen for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal and oropharyngeal swab specimens from individuals who meet COVID-19 clinical and / or epidemiological criteria. Rapid Test Device is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation.
The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The test is not intended to be used as a donor screening test for SARS-CoV-2.
- For patients suspected of current COVID-19 infection
- Rapid answers for patients: test results in 15–20 minutes
- Reliable, high performance*
– Sensitivity: 93.75%
– Specificity: 100%
- Deploy at point of care in a variety of settings
- Accessible solution enables large-scale testing
PERFORMANCE* rapid test antigen
- SENSIBILITY: 93.75%
- SPECIFICATIONS: 100%
- CLINICAL STUDY POPULATION: 288 individuals, including 48 PCR-positives and 240 PCR-negatives
- TEST TIME: 15-20 MINUTES
- STORAGE: 2°C-30°C
- TSAMPLE TYPE: Nasopharyngeal swab and/or Oropharyngeal swab
BIOHAZARD RISK REDUCTION FEATURES
Reduce the risk of facility contamination and healthcare worker exposure..
Consult Instructions for Use for complete procedure.