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 of concern, including Omicron (B.1.1.529), Delta (B.1.617.2), UK (B.1.1.7), South Africa (B.1.351) and Brazil (P.1).

The Healgen Rapid COVID-19 Antigen Self-Test will be able to detect the Omicron Variant as a result of where the mutation is located. The nucleocapsid protein found in the cell wall (envelope) can be detected by the test.

Pack Contents:   

• 1 Test Cassette
• 1 Extraction Tube with Buffer and Tip
• 1 Sterile Swab
• 1 Package Insert 

Meets requirements for Pre-Departure Testing

The Healgen test meets the standards for pre-departure testing of ≥97% specificity, ≥80% sensitivity at viral loads above 100,000 copies/ml, when this test is provided by a Government approved test site.  https://www.gov.uk/guidance/travel-abroad-from-england-during-coronavirus-covid-19

Healgen Covid-19 Antigen Test is a UK Government approved Rapid Antigen Test.

An application for exceptional use of a COVID-19 rapid test, to be used by members of the public for home use, was approved on the 23rd December 2020 by the Medicines and Healthcare products Regulatory Agency (MHRA).

• 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 Swabs, Extraction Buffer and Extraction Tubes included
• Shelf Life: 24 months from the date of manufacture

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 by their healthcare provider. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.

Test results:

• POSITIVE – The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.

• NEGATIVE* – The presence of only control line (C) within the result window indicates a negative result.

• INVALID – If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.

Note: The intensity of colour in the test line region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of colour in the test line region (T) should be considered positive. Please note that this is a qualitative test only and cannot determine the concentration of analytes in the specimen. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

(*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.)

The novel coronaviruses belong to the β 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 diarrhea.

This item line is exempt from our usual returns policy. This item is non-returnable or exchangeable.

Technical Specification

Detailed Technical Information

• 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

Performance Characteristics

• 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.

Validation and Approval

• Rapid diagnosis of SARS-CoV-2 infections
• Approved by Public Health England & validated by the UK government
• This test is being rolled out by the UK government to mass test the population in Liverpool and other cities, See www.gov.uk for more information