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.
The device should never be frozen. If refrigerated, allow the test kit components to reach room temperature before use.
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.
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.
It's recommended that used tests are disposed of in medical waste bins.
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.
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.
It is recommended that tests be carried out by clinical professionals such as doctors, practice nurses, employer occupational health departments or trusted carers or colleagues.
The Healgen COVID-19 Rapid 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 specimens directly from individuals within the first 10 days of COVID-19 infection. It is intended to aid in the rapid diagnosis of SARS-CoV02 infections.
Antigen tests detect proteins specific to a virus that appears in infected individuals, which indicates active infection. Rapid antigen testing is beneficial due to portability, ease-of-use, and swift time to result.
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
The Healgen COVID-19 Rapid Antigen Test makes viewing test results easy, with a positive test showing two coloured lines and a negative test showing only one. The quick return of easy to read results allows Health Care Professionals to take the best course of action based on the latest science and advice.
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.
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 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.
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.