Healgen Rapid Covid Test Kit - Single

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  • Healgen Rapid Covid Test Kit - Single

Features

  •  Rapid testing for COVID-19
  •  Results in 15 minutes
  •  98% effective
  •  High sensitivity and specificity
  •  Dual band results for simple interpretation
  •  All necessary reagents and equipment provided
  •  Includes full instructions for use
  •  No instrumentation required
  •  Simple, time-saving procedure

Pack Contents

  • 1 x Test cassettes
  • 1 x Sterile swabs
  • 1 x Extraction tubes and tips
  • 2 x Extraction buffer vials
  • 1 x Workstation
  • 1 x Package insert

FAQs

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.


Description

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

Clinical Evaluation

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. Covid-19 Rapid Antigen Test results


How to Test using Healgen Covid-19 Rapid Antigen Test


Rapid COVID-19 Antigen Self-Test

TEST PROCEDURE

IMPORTANT This test can be used within the first ten days that symptoms appear for COVID-19.

The test will take approximately 5 minutes to setup and the test results must be read at 15 minutes. It is important that you carefully follow the instructions to achieve the correct result.

The test device and the buffer solution must be at room temperature (15-30°C) before starting the test.

Step 1.

Insert the tube into the workstation. Remove the lid from the top of the tube.

Step 2.

Open the swab package where indicated. Pull the swab out by grasping the plastic end. Do not touch the absorbent swab tip.

Step 3.

Carefully insert the absorbent tip of the swab into your left nostril. Ensure that the entire swab tip is inside your nostril (2-4 cm deep). Do not insert the swab further after you feel resistance.

Step 4.

Roll the swab at least 5 times against the insides of your nostril. Ensure good contact between the swab and the insides of your nostril.

Step 5.

Remove the swab and insert into your right nostril. Repeat Steps 3 and 4.

Step 6.

Remove the swab from your nostril and insert the swab into the prepared tube in the workstation.

Step 7.

Mix well by rolling the swab at least 6 times while pressing the head of the swab against the bottom and sides of the tube.

Step 8.

Start timer. Leave the swab in the tube for 1 minute.

Step 9.

Squeeze the tube several times from the outside. Try to dissolve as much solution from the swab as possible.

Step 10.

Remove the swab and discard in a plastic bag.

Step 11.

Push the tip provided in the kit into the tube and ensure it fits tightly.

Step 12.

Remove the test device from the pouch and lay it on a fiat clean surface.

Step 13.

Add 4 drops of the solution into the sample well of the test device by gently squeezing the tube.

Step 14.

Start timer and read results at 15 minutes. It is important to read the results at 15 minutes.

Step 15.

Read your results. There are three possible types of results.

Positive Test Result

If the test device looks like either of the positive result above, you have a current Covid-19 infection. Please call your doctor or your local health department and make sure you adhere to local guidelines for self-isolation. Re-testing with other test methods such as a PCR test may be required.

Negative Test Result

If the test device looks like the negative result above, no Covid-19 infection could be detected. In a suspected case, repeat the test after 1-2 days since the virus cannot be accurately detected in all phases of an infection. Despite a negative test result, you still have to comply with all applicable rules regarding contact with others and protective measures.

Invalid Test Result

If your test result looks different, meaning there is no line visible or only one line at T, the result is invalid. This may be a result of the test execution, and the test should be repeated. If invalid test results continue, please contact your doctor or a COVID test center.