intended use
An in vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal swabs from subjects meeting the clinical and / or epidemiological criteria for COVID-19
The product can be used in laboratories and in any other environment that meets the requirements specified in the instructions for use and local regulations
The test provides preliminary test results. Negative results do not preclude infection with SARS-CoV-2 and cannot be used as the sole starting point for treatment or other decision making. Negative results should 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
The (Point-of-Care) test must be performed by a healthcare professional. For the complete testing procedure, refer to the instructions for use
Content
25 Test Devices, 1 Buffer (9 ml / bottle), 25 Extraction Tubes, 25 Extraction Tube Caps, 1 Positive Control Swab, 1 Negative Control Swab, 25 Sterilized Nasopharyngeal Swabs for Sample Collection, 1 Tube Rack, 1 Quick Start Guide, 1 Instructions for Use
Properties
Sample type: nasopharyngeal swab
Fast test result: in 15-20 minutes
Reliable in results
Sensitivity: 93.3% (98.2% for cases with Ct values ≤33)
Specificity: 99.4%
Easily accessible solution enables large scale testing
Shelf life: 1 year
Storage temperature: 2-30 ° C
CE mark
Properties to reduce bio-risks for health care professional
Separate tube with 'break-off' cotton swab minimizes worker exposure
The extraction tube is completely enclosed for disposal
