COVID-19 Antigen Rapid Test (For Self-testing)
COVID-19 Antigen Rapid Test (For Self-testing)

   COVID-19 Antigen Rapid Test (For Self-testing)

COVID-19 Antigen Rapid Test (For Self-testing)

Intended Use
The COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab from individuals with symptoms or other epidemiological reasons to suspect COVID-19 infection. This test is intended for self-use by individuals aged 15 years or older and, as applicable for an adult lay user testing another person under 15 years of age. Individuals over 65 years of age should seek assistance in performing test.

  • REF  : ICOV5002
  • For self-testing.
  • Easy handling, no instrument required.
  • Support the detection of nasal swab.
  • Instant results at 15-20 minutes.
  • Results are clearly visible and reliable.
  • High sensitivity and specificity. Sensitivity 97.1% Specificity 99.4%
  • Excellent performance compared to molecular methods.
  • 1 test/box, 5 tests/box, 25 tests/box
  • Certification: CE, ISO13485, FDA : T 6400403

   Sample Collection and Preparation

   Running the Test

TEST PROCEDURE

Performance Characteristics

The Self-testing product is transformed from the professional-testing product
(CLUNGENE COVID-19 Antigen Rapid Test) manufactured by Clongene.

Clinical Performance
617 nasal swabs were collected from individual symptomatic patients (within 7 days of onset) and asymptomatic patients who were suspected of COVID-19.
The swabs were detected by COVID-19 Antigen Test of Clongene and the RT-PCR. Summary data as below :

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