Each kit contains
- 1 Test cassette
- 1 Sterile swab
- 1 Extraction tube with buffer and tip
- 1 Package insert
Healgen Covid-19 Antigen Test is one of only three rapid antigen tests listed by the Department of Health & Social Care on the UK Government website. It is widely used by local authorities, education settings and businesses and used by the UK Government for mass testing in Liverpool and other locations.
The Healgen Covid-19 testing kit is a high sensitivity lateral flow antigen test. It is understood that as many as one in three people who have coronavirus do not show symptoms but are infectious. Lateral flow tests help to quickly identify and reduce spread from those who appear healthy.
Lateral tests take a sample from the nose using a swab, which is then mixed with a buffer solution, with drops being added to a lateral flow device. Then the virus fragments pass along the strip within the lateral flow device where they can bind to labelled antibodies, which then shows up as a test line if the virus is detected, unlabelled antibodies provide a control line to show the test has worked. Healgen’s test screens for the SARS-CoV-2 antibodies, in the first one to three weeks of infection.
- The Healgen Covid-19 Antigen Test (Swab) does not differentiate between SARS-CoV and SARS-CoV-2
MHRA Assessment Results
- The Healgen Covid-19 Antigen Test (Swab) has been evaluated with specimens obtained from patients.
- A commercialised molecular assay was used as the reference method.
- The results show that the Healgen Covid-19 Antigen Test (Swab) has a high overall relative accuracy.
The Rapid COVID-19 Antigen 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 novel coronaviruses belong to the ß genus. COVID-19 is an acute respiratory infectious disease. Currently, individuals infected by SARS-CoV-2 are the main source of transmission; asymptomatic carriers are also known as a source of transmission. Based on the current epidemiological information, the incubation period can last from 1 to 14 days, where the average time before symptoms occur is about 5 days. Symptoms include fever or chills, cough, shortness of breath, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, runny nose, nausea or vomiting and diarrhoea.
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.
- Qualitative, visually read results in 15 minutes
- No instrument required
- Room temperature storage or refrigerated (2-30°C / 36-86°F)
- Procedural internal control included
- Sterile Swab, Extraction Buffer and Extraction Tube included
- Clinical Evaluation
- Positive Percent Agreement (PPA): 95.7%
- Negative Percent Agreement (NPA): 99.6%
- Overall Percent Agreement (OPA): 98.9%
- Specimen: Nasopharyngeal (NP) Swab
- Time to Results: 15 minutes
- Shelf Life: 24 months from the date of manufacture
Frequently asked questions
What is antigen testing?
Antigen tests detect proteins specific to a virus that appears in infected individuals, which indicates active infection. Rapid antigen testing is beneficial because of their portability, ease-of-use, and swift time to result.
What is the extraction buffer?
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.
Does the test kit include transport media?
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.
Can the test be used with alternative specimen types such as nasal swabs or any specimen contained in viral transport media?
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.
Can I collect the specimen and test at a later time?
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.
Can I freeze the device for long-term storage?
The device should never be frozen. If refrigerated, allow the test kit components to reach room temperature before use.Please note that this test is not intended for home use.
Emerging SARS-CoV-2 Variant - Omicron (B.1.1.529)
Healgen Scientific, as part of its continuous COVID-19 variant monitoring plan, is actively monitoring the newly identified SARS-CoV-2 strain, named Omicron. As you may be aware, several SARS-CoV-2 variants have emerged globally during this pandemic.
The scientific community has determined that Omicron (B.1.1.529) is located in the spike protein of the virus. Healgen's Rapid COVID-19 antigen test detects the nucleocapsid protein which is contained within the cell wall (envelope).
We are confident that our test should be able to detect the Omicron variant, due to the location of where the mutation occurs (1,2).
The scientific community is working diligently and expeditiously to understand this new variant's behaviour. Healgen Scientific will continue to closely follow any developments.
1. Classification of Omicron (B.1.1.529): Variant of Concern (26th November 2021) - W.H.O
2. Update on Omicron (28th November 2021) - W.H.O