DESCRIPTION

The COVID-19 Antigen Rapid Test Kit is an immunochromatographic intended for the direct and qualitative detection of
SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swab and oropharyngeal swab from individuals who are suspected
of COVID-19 by their healthcare provider. The test is to be used as an aid in the diagnosis of coronavirus infection disease
(COVID-19), which is caused by SARS-CoV-2.

Components:
- 10 x Sterile Swabs
- 10 x Extraction tube
- 1 x Sample Lysis Solutuion
- 10 x Test Cassette

Sensitivity = 96,5% (95% CI: 93,7% ~ 99,3%)
Specificity = 99,7% (95% CI: 99% ~ 100%)
Positive predictive values = 99,4% (95% CI: 98,2% ~ 100%)
Negative predictive values = 98,0% (95% CI: 96,5% ~ 99,6%)
Total consistent: 98,5% (95% CI: 97,4% ~ 99,6%)

SPECIFICATIONS

Benefits:

Rapid answers for patients: test results in 15 minutes

Reliable, high performance: Sensitivity: 96.5% / Specificity: 99.7%

Deploy at point of care in a variety of settings

Accessible solution enables large scale testing

Room temperature storage or refrigerated (4-30⁰C)

Specifications:

Test time: 15 minutes

Sensitivity:96.5%

Specificity:99.7%

CE MARK

Sample type: Nasopharyngeal swab and oropharyngeal swab

Quantity: 10 tests/kit