BOSON Rapid Sars-CoV-2 Antigen Test Card (1 pc/box)
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Introduction
The BOSON rapid COVID-19 antigen test card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19. The rapid antigen self test detects the SARS-CoV-2 nucleocapsid protein (N protein). The COVID-19 antigen rapid test shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. Children under 14 years of age should be assisted by an adult.
Specification
Product name: Rapid Sars-CoV-2 Antigen Test Card
Specimen type: nasal (2,5 cm)
Kit size: 1 pc/box
Form: Cassette
Manufacturer: Xiamen Boson Biotech Co., Ltd.
Expiration date: 2023.07.
Certificates
Instructions
Main components
- 1 pc COVID-19 rapid antigen test card (sealed foil pouch)
- 1 pc sterile swab
- 1 pc extraction tube
- 1 pc sample extraction buffer
- Instructions for use
Performances
- Sensitivity (PPA) = 425/435×100% = 97.70% (95% CI: 96.29% – 99.11%)
- Specificity (NPA) = 627/628×100% = 99.84% (95% CI: 99.53% – 99.99%) NPV = 627/637×100% = 98.43% (95% CI: 97.46% – 99.40%)
- Accuracy (OPA) = 1052/1063×100% = 98.97% (95% CI: 98.36% – 99.57%) = 1052/1063×100% = 98.97% (95% CI: 98.36% – 99.57%)
PPV= 425/426×100% = 99.77% (95% CI: 99.31% – 99.99%)
NPV = 627/637×100% = 98.43% (95% CI: 97.46% – 99.40%)