The test is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. With the Healgen Covid-19 Antigen Test (Swab), you can find out if you are currently infectious with COVID-19 in just 15 minutes with this simple and accurate swab test.
With 99% accuracy, this test is currently being used by governments globally, as well as professional sports teams, film productions, and other organisations who need to know there and then if their people are infectious.
The Antigen Rapid Test that we provide is a simple swab test that detects specific proteins (antigens) on the surface of the COVID-19 virus and has a 98.2% sensitivity in detecting viral levels that are currently considered to be infectious. No need to send it away to a laboratory and no time delay!
We would encourage you to CONTACT US if you are purchasing single units of more than 25.
- Prices above exclude delivery.
- Orders placed before 2pm Monday to Friday will be posted the same day for next day delivery.
- Orders placed before 11am on Saturday will be posted the same day, and will be delivered the following Monday.
- Orders placed after 11am on Saturday, or on Sunday, will not be posted until the following Monday.
APPROVAL AND CERTIFICATIONS
Approved by the UK government and Public Health England, these rapid lateral flow tests are designed to detect large numbers of SARS-CoV-2 infectious cases in a short space of time to prevent further onward transmission. The rapid test is performed using nasopharyngeal swabs and is proven to give excellent accuracy (99%) with a sensitivity of 96.72% and a specificity of 99.22%. The Healgen Rapid Swab Test is CE certified and MHRA registered. CLICK HERE to view the certification.
- Rapid testing for SARS-CoV-2 antigen within 15 minutes
- Facilitates patient treatment decisions quickly
- Simple, time-saving procedure
- All necessary items provided & no equipment needed
- High sensitivity and specificity
- 99.4 % Accuracy
- 99.22% Relative Specificity
- 96.72% Relative Sensitivity
- Specimen: Nasal (NP) Swab
- Result in 15 minutes
- Shelf Life: usually 24 months from the date of manufacture
- Store in the original container at 2-30 degrees.
- No machine or lab required to process the test.
- No cold storage required. Store between 2 and 30 degrees Centigrade.
- Please read and comply with the instructions for use (IFU)
- CE certified and MHRA registered
- We recommend tests be conducted only by those medically qualified to do so, using the same PPE worn when conducting a PCR test.
- Dispose of used test components according to the IFU.
With our innovative app and test pack, you can test yourself and get the result of that test on your smart device within 15 minutes. CLICK HERE for further information on the COVID-19 Passport App.
HOW TO CARRY OUT A TEST
- Using the sterile nasopharyngeal swab provided in the kit, carefully insert the swab in the patient’s nostril.
- Swab over the surface of the posterior nasopharynx and rotate the swab several times.
- Withdraw the swab from the nasal.
SAMPLE PREPARATION PROCEDURE
- lnsert the test extraction tube into the workstation provided in the kit. Make sure that the tube is standing upright and reaches the bottom of the workstation.
- Add 0.3 ml (approximately 10 drops) of the sample extraction buffer into the extraction tube.
- lnsert 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 from the outside to immerse the swab. Remove the swab.
SPECIMEN TRANSPORT AND STORAGE
Do not return the nasopharyngeal swab to the original paper packaging. Specimen should be tested immediately after collection. If immediate testing of specimen is not possible, insert the swab into an unused general-purpose plastic tube. Ensure the breakpoint swab is level with the tube opening. Bend the swab shaft at a 180 degrees angle to break it off at the breaking point. You may need to gently rotate the swab shaft to complete the breakage. Ensure the swab fits within the plastic tube and secure a tight seal. The specimen should be disposed and recollected for retesting if untested for longer than 1 hour.
Allow the test device, test sample and buffer to equilibrate to room temperature (15-30°C) prior to testing.
- Just prior to testing remove the test device from the sealed pouch and lit it on a flat surface.
- Push the nozzle which contains the filter onto the extraction tube. Ensure the nozzle has a tight fit.
- Hold the extraction tube vertically and add 4 drops (approximately 100 µL) of test sample solution tube into the sample well.
- Start the timer.
- Read the results at 15 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
The presence of only control line (C) within the result window indicates a negative result.
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 analyses present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive. 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.
View the following instructional video for more information.
A procedural control is included in the test. A red line appearing in the control line region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this test. However, it is recommended that positive and negative controls are sourced from a local competent authority and tested as a good laboratory practice, to confirm the test procedure and verify the test performance.
The following first aid measures are only relevant in the event of serious misuse, whereby the whole device is disassembled and there is exposure to the chemicals in the test strip.
- After Skin Contact, wash with soap and water and rinse thoroughly.
- After Eye Contact, rinse opened eye for several minutes under running water.
- After Ingestion, if desiccant or other components are swallowed seek medical attention.
- Keep out of reach of children.
- Store in the original container at 2-30 degrees.
- The Device is an article containing solid components.
- The product is not self-igniting.
** WARNING **
Healgen Covid-19 Antigen Test has ONLY been designed to act as a supplementary test for suspected cases of negative coronavirus nucleic acid detection or in conjunction with nucleic acid detection in the diagnosis of suspected cases. Results from nucleocapsid protein antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status.