Healgen COVID-19 Lateral Flow Rapid Antigen Test (Box of 20 tests)
The Healgen Lateral Flow Rapid Antigen test kit facilitates the detection of COVID-19 with rapid return of results.
- Healgen Covid-19 Antigen Test is one of only three UK Government approved Rapid Antigen Test. Click Here for details.
- This antigen test is intended for use by clinical professionals.
- 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), click here for details.
The Rapid COVID-19 Healgen 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.
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.
- Qualitative, visually read results in 15 minutes
- No instrument required
- Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
- Procedural internal control included
- Sterile Swabs, Extraction Buffer and Extraction Tubes included
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
- Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
- 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
Approved by Public Health England & validated by the UK government
- Rapid diagnosis of SARS-CoV-2 infections
- Evaluated and Validated by the UK’s MHRA/DHSC: 1 of only 3 approved tests for use by schools, hospitals, and the army. Used by the NHS in the UK. More details HERE.
- 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 (test 3 on the list).
- French Government Validation: Full compliance with the Ministry of Solidarity and Health requirements for Covid-19 testing.
- German Government Validation: Full compliance with the Federal Institute for Drugs and Medical Devices Covid-19 testing requirements.
- CE Marked: For professional use
- Home Use: 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), click here for details.
- ISO13485: Healgen manufacture in accordance with their ISO13485 Quality
This item line is exempt from our usual returns policy. This item is non-returnable or exchangeable.
1. Specimen Collection
- Use the nasopharyngeal swab supplied in the kit
- Carefully insert the swab into the nostril of the patient, reaching the surface of posterior nasopharynx that presents the most secretion under visual inspection.
- Swab over the surface of the posterior nasopharynx.
- Rotate the swab several times. Withdraw the swab from the nasal cavity.
2. Sample preparation
- Insert the test extraction tube into the workstation
- Make sure that the tube is standing firm and reaches the bottom of the workstation
- Add 0.3 mL (about 10 drops) of the sample extraction buffer into the extraction tube.
- 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. Leave the swab in the extraction tube for 1 minute.
- Squeeze the tube several times with fingers from outside of the to immerse the swab
- Fit the dropper tip with filter on top the extraction tube tightly
- Remove the swab. The extracted solution will be used as test sample.
3. Interpretation of Results
- Allow the test device, test sample and buffer to equilibrate to room temperature prior to testing
- Remove test device from the sealed pouch just prior to the testing and lay flat on work bench.
- Ensure the nozzle with filter is fitted on to the sample extraction tube tightly.
- Reverse the sample extraction tube, and add 4 drops (about 100 μL) of test sample by squeezing the extracted
- solution tube into the sample window.
- Wait for the colored band(s) to appear. The result should be read in 15 minutes.
- Do not interpret the result after 20 minutes.
- 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 color in the test line region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color 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.)
In-vitro use only. Please note, each box includes 1 x work station and 2x buffer solutions, therefore it can only be split in 2 packs of 10 test kits each.
For further information please refer to FAQ tab of this product page.