COVID-19 Testing Solutions

Malaysia Certificate Self test Antigen Rapid Test kits

SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) is intended for the qualitative detection of SARS-CoV-2 Antigen (Nucleocapsid protein) in nasal swab specimens in vitro.

  • Storage temperature ::

    2-30°C
  • Specimen: :

    nasal swab
  • Valid Time ::

    12 months

Malaysia Certificate Self test Antigen Rapid Test kits 

INTENDED USE

 

SARS-CoV-2 Antigen Rapid Test is intended for the qualitative detection of SARS-CoV-2 Antigen in oropharyngeal swab and nasopharyngeal swab specimens in vitro. 

selftest package

ASSAY PROCEDURE

Sample preparation

1. Remove one specimen extraction tube from the kit before testing.

2. Label one specimen extraction tube or write specimen number on it.

3. Place the labeled specimen extraction tube in a rack in the designated area of the workspace.

4. Add 10 drops of extraction solution to the specimen extract tube.

5. Dip the swab head into the extraction solution in the extraction tube and rotate the swab close to the specimen extraction tube wall for about 10 seconds or 10 times to dissolve the specimens in the solution as much as possible.

6. Squeeze the tip of the swab along the inner wall of the specimen extraction tube to keep the liquid in the tube as much as possible, remove and discard the swab.

7. Tighten tube cover and stand by.

POSITIVE VALUE/LIMIT OF DETECTION 

Positive value/limit of detection: 1.7×102 TCID50/mL

 

Select the confirmed inactivated SARS-CoV-2 medium, (concentration 3.4×105 TCID50/mL), use gradient dilution method to find out the virus medium to reach the critical value of the detection. Repeat the action for 20 time and the test result is positive for at least 19 times.

 

how to use antigen

clinic report

 

wiz CE certificate

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