GENRUI SARS-CoV-2 Antigen Test Kit Instruction Manual

GENRUI SARS-CoV-2 Antigen Test Kit

For self-testing

• For use by people between 18 and 75 years of age. For child and adolescents ages 18 years or younger and for people over 75 years of age, use only under the supervision of authorized persons.

PRECAUTIONS

Please read all the information in this instruction before performing the test.

• This kit is only used for in vitro diagnosis.
• The test card is for one-time use only, and cannot be reused or used by more than one person at a time.
• Do not interchange components from different batches.
• Do not use expired products. If the product packaging bag is damaged, poorly sealed or the sample diluent leaks, the product should not be used.
• Avoid high temperatures (above 30°C) during the test. Cryogenically stored test cards, samples and sample diluents must be brought back to room temperature (18-28°C) prior to opening. Please do not perform the test in the following situations or scenarios: outdoors under the sunlight, temperatures above 30°C, in a moving vehicle or in places where stability cannot be guaranteed.
• Do not touch the reaction area of the test paper and keep the swab clean.
• For substances that contain or are suspected to contain sources of infection, appropriate biosafety assurance procedures should be followed. If the liquid splashes in your eyes or on your skin, rinse with plenty of water. If you feel unwell, go to a specialist for a checkup.

SAMPLE REQUIREMENTS

• Nasal swab can be used for testing.

INTENDED USE & BENEFITS

Genre SARS-CoV-2 antigen test kit (colloidal gold) is an immunochromatographic assay for rapid and qualitative test of N protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antigen detection in nasal swabs. This test is applicable to all individuals suspected of being infected by SARS- CoV-2. The test will be used to assist in the diagnosis of the coronavirus infectious disease (COVID-19) caused by SARS-CoV-2. The test kit is simple, safe, effective and intended for self-testing, which is suitable for individuals to use in non-laboratory settings like homes, offices, schools, sports stadiums airports, etc.

TEST PRINCIPLE

During the test, the processed samples to be tested are added to the sample holes. When the sample contains SARS-CoV-2 antigen, it first combines with the colloidal gold-labelled anti-SARS-CoV-2 antibody. Chroma-tography is then performed. When it binds to the anti-SARS-CoV-2 monoclonal antibody previously immobilized on another membrane, a purple-red band will appear in the test area (T). If there is no SARS-CoV-2 antigen in the sample, there will be no purple-red band in the test area (T). A purple-red band will appear in the quality control area (C) regardless of the presence of new coronavirus antigen in the sample, which is used as a criterion to determine whether there is sufficient sample or the chromatography is processed properly. It is also used as an internal control standard for the test kit.

MAIN COMPONENTS

• 1 test card, 1sample diluent (0.5 mL), 1 dripper, 1 swab, 1 biohazard sample bag and 1 Instruction for Use (IFU).
• The main components of the test card are foil pouch, desiccant, glass fiber membrane (colloidal gold labeled anti-novel coronavirus monoclonal antibody), nitrocellulose membrane (detection area coated with anti-novel coronavirus monoclonal antibody, quality control area coated with Goat anti Mouse IgG) and PVC plate.
• Sample diluent: the main component is phosphate buffer (PBS).
• Accessories required but not provided Timer.

STORAGE CONDITIONS

• The test kit can be stored at 2-30°C and the expiration date is 18 months. Once the foil pouch is opened, the validity period is 1 hour at a temperature of 18-28°C and humidity less than 65%.
• The sample solution is valid for 1 month from the date of opening. The production date is shown on the outer box.

USE CONDITIONS

• Please make sure that the ambient temperature is 18-28°C when using.
• When the humidity level is below 65%, please use the product within one hour after opening the bag. And when the humidity is higher than 65%, please make sure to use the product immediately after opening it.
• TRANSPORT CONDITIONS
  Transport at 2-30°C.

QUALITY CONTROL
Each test card has a built-in control. The purple-red band at the control line can be considered as an internal positive program control. If the procedure was performed correctly, the control line will appear. If no control line appears, then the test is invalid and a new test should be performed.

LIMITATIONS

• Test results cannot be used as a basis for diagnosis. Comprehensive judgments should be made based on clinical symptoms, epidemiological conditions and further clinical data.
• The accuracy of the test depends on the sample collection process. Improper sample collection will affect the test results.
• A positive test result does not rule out concurrent infection with other pathogens. The negative result may be caused by:
  1. Improper sample collection, improper sample transfer or handling so that the amount of virus in the sample is too low.
  2. The level of SARS-CoV-2 antigen is lower than the limit of detection.
  3. Variations in viral genes may lead to changes in antibody determinants.
• There may be other unlisted reasons that cause the detection to be abnormal.
• This product can only qualitatively detect the SARS-CoV-2 antigen in the sample, but cannot determine the concentration of the antigen in the sample.

PERFORMANCE CHARACTERISTICS
Clinical performance
207 nasal swab samples, which include 107 confirmed as COVID-19 positive and 100 confirmed as COVID-19 negative by RT-PCR assay, were obtained for testing, and then compared the test results of Genrui SARS-CoV-2 Antigen Test Kit (Colloidal Gold) with that of RT-PCR. The results are shown below:
Positive Percent Agreement:

Ct value| Number of Sample| Number of true positive Rapid Test Samples| Number of false negative Rapid Test Samples| Sensitivity of SARS-CoV-2

Antigen Rapid Test (Cl)

---|---|---|---|---
≤30| 80| 80| 0| 100%(96-100)
≤32| 91| 91| 0| 100%(96-100)
≤34| 101| 100| 1| 99%(94-99)
≤36| 107| 105| 2| 98.13%(93-99)

Negative Percent Agreement:

Number of Sample| Number of true

negative Rapid Test Samples

| Number of false

positive Rapid Test Samples

| Specificity of

SARS-CoV-2 Antigen Rapid Test (Cl)

---|---|---|---
100| 100| 0| 100%(96-100)

PREPARATION BEFORE THE TEST

Take out all kit components at room temperature, make sure the sample diluent and test card reach the room temperature. See illustration below (example of one-person use).

Preparation

Use the dripper tip to pierce the sealed foil of the tube containing sample diluent, pull out the dripper tip and place the sample diluent on the table for later use. (Note: pierce the sealed foil all the way through, but there should be a gap between the dripper and the tube.)

Nasal swab collection

1. Tear the swab packaging bag, keep the swab tip clean and make sure it does not touch any surface before use.
2. Insert the entire swab tip (usually 2 cm) into left nostril.
3. Firmly brush against insides of nostril in a circular motion 5 times or more for at least 15 seconds.
4. Remove swab and insert it into right nostril, firmly brush against insides of nostril in a circular motion 5 times or more for at least 15 seconds.
5. Remove the dripper, put the swab into the sample diluent and proceed to sample processing.
   Note: It is recommended that specimens are tested at the time of collection. If the specimens are not tested immediately, please follow the sample cleanup procedure.

SAMPLE PROCESSING

1. Pinch the tube wall with fingers as shown below, meanwhile rotate the swab against the tube wall 5-6 times to allow the swab to soak well. After the sample is completely dissolved, let it stand for 1 minute.
2. Pinch the tube wall to squeeze the swab gently to keep as much liquid in the tube as possible. Remove the swab and put it into a biohazard sample bag.
3. Press the dripper thoroughly onto the tube and shake it at least 10 times to mix it evenly.
4. Take out the test card from the package and lay it flat on a dry surface.
5. Remove the dripper cap at the top, drop 3 to 4 drops (about 0.1 mL) of evenly mixed solution from the tube vertically into the sample hole of the test card, close the dripper cap and put the used sample diluent tube into a biohazard sample bag. Wait for the test results from the test card.
   Note: Read and interpret the test result at 15 minutes, the test result should not be read and interpreted after 20 minutes.

TEST RESULTS INTERPRETATION AND ACTIONS

Positive Result: The appearance of both control line (C) and the test line (T) indicates that the SARS-CoV-2 antigen is positive. Look very closely! The T line can be very faint. Any pink/purple line visible here indicates a Positive Result.
A positive test result for COVID-19 indicates that antigens from SARS-CoV-2 were detected, and you are very likely to be infected with the virus and presumed to be contagious. Please follow your local self-isolation guidelines and contact your doctor/family doctor or local health authority immediately and have a COVID-19 nucleic acid PCR confirmatory test to confirm the infection.

Negative Result: The appearance of only the control line (C) and no test line (T) indicates a negative result.
A negative result does not rule out COVID-19 and should not be used as the sole basis for infection control decisions. Please continue to comply with all applicable rules and protective measures when in contact with others. There may be an infection, even if the test result is negative. If you suspect an infection (symptoms like headache, migraine, fever, loss of taste, etc.), then please repeat the test within 1-2 days, as the amount of virus at all stages of the infection may be too low to be reliably detected. Mutations in viral genes may lead to changes in antigenic determinants and result in negative results. Whilst variations in viral genes may lead to changes in antibody determinants and the new virus variants might cause false negative results.

Invalid Result: The control line (C) does not appear, it will be considered as invalid regardless of whether there is T line. The test should be repeated.
The control line may be faulty due to insufficient sample volume or improper operation. Please review the procedure and repeat the test with a new test kit. If the problem persists, please stop using the current batch immediately, contact with the vender and/or contact your doctor or COVID-19 test center for professional opinions.

SAMPLE CLEANUP

1. Put the test card into the biohazard sample bag. Make sure that test card, sample diluent and swab are in the biohazard sample bag, then have it sealed.
2. Dispose of the sealed biohazard sample bag in accordance with local government regulations and then use the hand sanitizer.

References

• Biography: Historical & Celebrity Profiles
• Genrui Biotech China IVD Company/Manufacturer, In Vitro Diagnostic Company

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