Antigen Test Kit (Saliva) (တံတွေးဖြင့်စစ်သောအရာ) Product
Antigen Test Kit (Saliva) (တံတွေးဖြင့်စစ်သောအရာ)
Price : 16000
The CLUNGENE® COVID-19 Antigen Rapid Test Cassette (Saliva) (hereinafter referred to as the CLUNGENE Device) manufactured by Hangzhou Clongene Biotech Co., Ltd. is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in saliva from individuals who are suspected of COVID-19 by their healthcare provider.
One nasopharyngeal swab and one saliva specimen were collected from individual symptomatic (within 7 days of onset) or asymptomatic patients who were suspected of COVID-19. At all locations, saliva specimen was tested directly with the COVID-19 Antigen Rapid Test Cassette (Saliva) according to product instructions for use, and the nasopharyngeal swab was eluted in 3 mL viral transport media and tested with RT-PCR assay for detection of SARS-CoV-2. Nasopharyngeal swabs and saliva specimens were tested by operators who were blinded to the RT-PCR test result.
CLUNGENE® COVID-19 Antigen Rapid Test Cassette (Saliva) had a positive percent agreement (sensitivity) of 96.8% (95% CI: 92.0%～98.7%) with specimens of a Ct count ≤30, 91.3% (95%CI: 85.9%～94.7%) with specimens of a Ct count ≤37, and negative percent agreement (specificity) of 99.6% (95% CI: 98.5%～99.9%).
COVID-19 Antigen Rapid Test
- CE certified
- Refundable according to TestV.
- Evaluated by Paul-Ehrlich-Institut PEI
- BfArM listed with the number AT 114/21 on the list of antigen tests for SARS-CoV-2
- PZN: 17292113 , PPN: 111729211309