1 Test (1 Test per Kit Box)
Healgen Rapid COVID-19 Antigen Self-Test
The Healgen Rapid COVID-19 Antigen Self-Test is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swab specimens directly from individuals who are suspected of COVID-19 within the first ten days of symptom onset. This antigen test can be used to detect both wild and mutant SARS-CoV-2 variants, including UK B.1.1.7, South Africa B.1.351 and Brazil P.1.
• UK approved self-test
• Results produced in 15 minutes!
• No extra equipment or instruments required
• One of only a handful of UK Government-approved COVID-19 Test Kits
• Less invasive than a nasopharyngeal swab. The swab tip only needs to be inserted 2cm.
EU health preparedness: A common list of COVID-19 rapid antigen tests, including those whose test results are mutually recognised, and a common standardised set of data to be included in COVID-19 test result certificates
Nasal Swab – Clinical Performance
A total of 237 fresh nasal swab samples were collected and tested, which includes 109 positive samples and 128 negative samples. The coronavirus Ag Rapid Test Cassette (Swab) results were compared to results of USFDA Emergency Use Authorized RT-PCR assays for SARS-CoV-2 in Nasopharyngeal swab specimens. Overall study results are shown in Table 1.
Relative Sensitivity: 97.25%
Relative Specificity: 100%
Specimen: Nasal Swab
Time to Results: 15 minutes
Shelf Life: 24 months from date of manufacture
Storage: Room temperature or refrigerated between 2-30°C
Components for One Test Kit
• Test Cassettes: 1
• Sterile Swabs: 1
• Extraction Tubes: 1
• Dropper Tips: 1
• Buffers: 1
• Workstation: 1
• Package Insert: 1
1. Insert the swab into one nostril of the patient. The swab tip should be inserted up to 2-4 cm until resistance is met.
2. Roll the swab 5 times along the mucosa inside the nostril. Using the same swab, repeat this process for the other nostril.
3. Withdraw the swab from nasal cavity.
4. Insert the test extraction tube into the hole on the kit as marked.
5. Tear off the sealing film on the extraction tube gently to avoid spilling out the liquid.
6. Insert the swab into the extraction tube which contains 0.3 mL of the extraction buffer. Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction tube.
7. Leave the swab in the extraction buffer for 1 minute. Squeeze the tube several times from the outside to immerse the swab. Remove the swab.
8. Insert the tip into the extraction tube.