Healgen COVID-19 Lateral Flow Rapid Antigen Test (Box of 20 Tests)

Key Details

• 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.

• Stock purchased from authorised Healgen distributor

• Results in 15 minutes

• Each kit includes clear instructions and is easy to use.

• Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)

• Each kit contains everything required to carry out the tests- no additional equipment is needed: Sterile Swabs, Extraction Buffer and Extraction Tubes included

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

Instructions for Use

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.
2. Lay device on flat surface and add specimen.
3. With the plastic dropper provided, draw specimen to exceed the specimen line, as shown in the diagram below.
4. Hold the dropper vertically and transfer drawn specimen into the sample well. Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well, ensuring that buffer vial tip does not touch the sample.
5. Avoid air bubbles. Wait for the control line to change from blue to a red colour.
6. If, after 2 minutes, the sample has not moved across the test window, add 1 additional drop of sample buffer to the buffer well.
7. The results should be read in 10 minutes. Do not interpret the result after 15 minutes.

Test Procedure:   

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. 

Sample Preperation

• 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.

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 coloured band(s) to appear.
• The result should be read in 15 minutes. Do not interpret the result after 20 minutes.

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.

IMPORTANT INFORMATION