RAPID TEST COVID-19 Ag PRE-FILLED BUFFER 25T RIGHTSIGN
It has CE quality certification
Rapid Test to limit the spread of SARS-CoV-2 and COVID – 19
Extreme sensitivity & specialty …
A rapid test for the qualitative detection of COVID-19 Antigen in a Nasopharyngeal
swab. For professional in vitro diagnostic use only.
- 25 Individual aluminum packages each containing a Test cassette and a desiccant
- 25 extraction buffer
- 25 Sterile swabs
- 25 sample collection tubes with the corresponding dropper tips
- 1 tube holder
The COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) is a qualitative, lateral flow immunoassay for the detection of the N protein of SARS-CoV-2 in Nasopharyngeal swabs. In this test, antibodies specific to the N protein of SARS-CoV-2 are separately coated on the test line regions of the test cassette. During testing, the extracted specimen reacts with the antibodies to N protein of SARS-CoV-2 that are coated onto particles. The mixture migrates up the membrane to react with the antibodies to N protein of SARS-CoV-2 on the
membrane and generate one colored line in the test region. The presence of this colored line in the test region indicates a positive result. To serve as a procedural control, a coloured line will always appear in the control region if the test has performed properly.
The COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) has been evaluated with specimens obtained from different clinical sites where the specimens were collected with Nasal Swabs. The Nasopharyngeal Swabs were randomized and blind tested by operators following the instructions for use. RT-PCR was used as the reference method for the COVID-19 Antigen Rapid Test Cassette. Specimens were considered positive if PCR indicated a positive result.
Test sensitivity: 95,7% (95% CI *: 90,3% -98,6%)
Test specificity: 99,2% (95% CI *: 97,6% -99,8%)
Relative accuracy: 98,3% (95% CI *: 96,7% – 99,3%)
* Confidence Intervals