5 Pack Clungene Covid-19 Rapid Antigen Self Test Kit Nasal Swab

Description

Clungene
Features
COVID-19 rapid antigen test for unsupervised testing in the home
Results in 15 minutes
99.12% specificity and 95% sensitivity
Comprehensive instructions included
ARTG No.: 333341
Description A clinical evaluation was conducted comparing the results obtained using the COVID-19 Antigen Rapid Test Cassette (Nasal Swab) to PCR. Specimens were considered positive if PCR indicated a positive result.
For 103 cases of PCR positive, the Relative Sensitivity the COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is 93.2% (96/103).
For 250 cases of PCR negative, the Relative Specificity of COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is 99.2% (248/250).
For 103 cases of PCR positive and 250 cases of PCR negative, the Relative Accuracy of COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is 97.5% (344/353).

A usability study was performed by lay person, 150 subjected were enrolled and self-tested with package insert and quick reference guide only, relative sensitivity was 93.75% (30/32), relative specificity was 99.12% (112/113). The results showed that the labeling provided with the test kit was comprehensive for its intended population, the ease of use was suitable for its intended population.

Detection Limit: The detection limit for the COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is 1000 TCID50 /mL.

The nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable or tickly. If you feel pain, please stop the test and seek advice from a healthcare provider.

A procedural control is included in the test. A colored line appearing in the control line region (C) is considered an internal procedural control. It confirms adequate membrane wicking.

Clungene COVID-19 Antigen Test can detect Alpha, Beta, Gamma and Delta COVID-19 mutants based on the studies conducted so far.