HEALGEN RAPID ANTIGEN TEST

The Healgen Rapid COVID-19 Antigen test has been trialled and tested by Public Health England. The Healgen Test is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab from individuals who are suspected of COVID-19. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.

The point of care test is designed for use by clinical specialists and healthcare professionals only.

The test is taken to:
⦁ Diagnose infection
⦁ Test following infection to see if the virus has been cleared
⦁ Screen asymptomatic individuals to detect if they carry virus and are potentially infectious

This is a 'Point of Care Test', meaning the results are provided to you on the day of the test. The test takes roughly 15 minutes to provide a result and you will be provided with a confirmation email and certificate of this result by the end of the day.

These tests are CE Marked and have been submitted to MHRA for approval inline with current Government guidelines. They are for trained medical professionals and in vitro diagnostic use only. In other words, you need to arrange for a Medical Professional to carry out these tests for you. We can arrange these if required, please contact us for a quote.

The test has a minimum Sensitivity of 97.3% and a Specificity of 99%.

Sensitivity concerns the false negative rate and is expressed as a percentage: out of 100 truly positive patients, how many are detected as positive by the test? The higher the sensitivity, the fewer the numbers of false negatives. In the USA, sensitivity is often called positive percent agreement (PPA).

Specificity concerns the false positive rate and is expressed as a percentage: out of 100 truly negative patients, how many are detected as negative by the test? The higher the specificity, the fewer the numbers of false positives. In the USA, specificity is often called negative percent agreement (NPA).

The extraction buffer includes components to dissociate viral proteins from their surfaces to be used as a target for the test. The method of the extraction buffer is used to prepare the test sample by dissolving the virus shell, which also deactivates the virus.

The test kit includes an extraction buffer that is used to prepare the specimen for testing purposes. The extraction buffer IS NOT transport media and should not be used to preserve or transport specimens.

The Rapid COVID-19 Antigen Test is for direct nasopharyngeal swab specimen only.
The test can only be used with the swab provided in the kit.

The specimen should be tested immediately after collection. The specimen can be retained up to 1 hour following collection if immediate testing of specimens is not possible. Dispose of the specimen and recollect if retained for more than 1 hour.

The device should never be frozen. If refrigerated, allow the test kit components to reach room temperature before use. Negative results do not rule out SARS-CoV-2 infection, particularly those who have been in contact with the virus. Follow up testing with a molecular diagnostic test should be considered to rule out infection in these individuals. Use of this test is limited to laboratories certified to perform high complexity testing, including testing at point-of-care when the site is covered by the laboratory's CLIA certificate of high-complexity testing.

Before taking the test, it is important to understand the following.

1. You should not use one of these tests if you have previously tested positive from a PCR test in the previous 90 days, as this can return a false result.
   
2. You should not use any nasal medication for 24 hours prior to testing as this can spoil the sample.
3. Please download the Product Brochure for further details