SARS-CoV-2 & Influenza Antigen Test Kit (2 in 1 Kit)
•An alternative diagnostic method for SARS-CoV-2 (COVID-19); faster and easier to implement than PCR.
•High specificity and high sensitivity
•The FDA has granted EUA for antigen tests that can identify SARS-CoV-2; it is used in Korea, USA, Colombia at the community level, outpatient clinics, hospitals, occupational medicine, etc.
•Gene Science's antigen tests have a buffer that inactivates the virus so can be used without a biosafety cabinet.
•WHO Recommended the antigen tests
Information From CDC Guidance
Authorized assays for viral testing include those that detect SARS-CoV-2 nucleic acid or antigen. Viral (nucleic acid or antigen) tests check samples from the respiratory system (such as nasal swabs or saliva) to determine whether an infection with SARS-CoV-2, the virus that causes COVID-19, is present. Viral tests are recommended to diagnose acute infection of both symptomatic and asymptomatic individuals, to guide contact tracing, treatment options, and isolation requirements Some tests are point-of-care tests, meaning results may be available at the testing site in less than an hour. Other tests must be sent to a laboratory, a process that may take at least 1-2 days.
Features
•15-20 minutes to get the test results.
•The operation is simpler and faster, and the samples are easy to store.
•No other reagents are needed for the test•High sensitivity and high accuracy.
•Make up for the 7-14 day window of novel coronavirus antibody testing
Performance
•Positive reference for QC: use three positive corporate reference materials (P1-P3) for testing, and the result should be positive.
•Negative references for QC: Three types of negative reference materials (N1-N3) have been tested, and the results should be negative.
•Minimum detection limit: three corporate sensitivity reference materials (L 1, L2, L3) are used for testing, and each sample is repeated 3 times. The L1 test results should all be positive, and the L2 and L3 test results should both be negative.
•Repeatability: Tested the repeatability of three reference products. Each test is repeated 10 times and should be positive.
•Sensitivity: 92.11% (35/38, 95% CI, 78.62% - 98.34%)
•Specificity: 100.00% (50/50, 95% CI, 92.89% - 100.00%)
Operation Instructions
Sample collection :The applicable sample type was nasopharyngeal swab. It is recommended to use poly (vinyl acetate) sponge with PP rod for swabs.
1.The swab tip should be inserted up to 2.5 cm (1 inch) from the edge of the nostril.
2.Roll the swab 5 times along the mucosa inside the nostril to ensure that both mucus and cells are collected
3.Using the same swab, repeat this process for the other nostril to ensure that an adequate specimen is collected from both nasal cavities. Withdraw the swab from the nasal cavity.
Sputum sample collector:
1. 30 Min before collecting samples , Rinse the mouth with clean water and fast after gargling.
2. Relax and massage your cheeks. Spit saliva into the funnel until the amount of saliva (without bubbles) reaches the height of the saliva filling line.
3. Keep the collection tube upright, unscrew the bucket, and cover the collection tubewith a collection tube cap and tighten it.
4. Turn the tightened collection tube upside down 10-15 times to mix well, put it inthe packaging bag, and discard the funnel.
Interpretation of Results for COVID-19
Interpretation of Results for FLUA&B
Certifications
