Sun. Sep 25th, 2022

1. Intended Use

The COVID-19 Saliva Antigen Test Kit is an in vitro immunoassay that detects SARS-CoV-2 variant alpha, beta, gamma, kappa and delta. The team is for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from human saliva samples collected from people suspected of having COVID-19 within the first 7 days of symptom onset.

The COVID-19 antigen Saliva test kit is designed to be used by non-professionals and allows self-assessment in House. The test identifies the SARS-CoV-2 viral nucleoprotein antigen. The antigen is usually detectable in saliva samples during the acute phase of infection.

2. Principle

COVID-19 Antigen Saliva Test Kit Detects SARS-CoV-2 Viral Antigens through visual interpretation of colour development. Anti-SARS-CoV-2 the antibodies are immobilized on the test region of the nitrocellulose membrane. Anti-SARS-CoV-2 antibodies conjugated with coloured particles are immobilized on the conjugate pad. A sample is added to the extraction buffer in the base, which is optimized to release SARS-CoV-2 antigens from the sample.

During the test, the target antigens will be released, if they are present in the saliva samples in the extraction buffer individually packaged in the kit. The extracted antigens will bind to anti-SARS-CoV-2 antibodies conjugated to coloured particles. As the sample migrates along the strip by capillary action and interacts with the reagents on the membrane, the complex will be captured by the anti-SARS-CoV-2 antibodies in the test region.

Excess coloured particles are captured inside the control zone. The presence of a coloured band in the test region indicates a positive result for SARS-CoV-2 viral antigens, while their absence indicates a negative result. TO coloured band in the control region serves as a procedural control, usually indicating that the proper volume of sample and membrane has been added absorption is working.

3. Materials

3.1. Materials Provided

Pack of 2: 2 individually packaged tests  1 package insert  2 disposal bags
Pack of 5: 5 individually packaged tests  1 insert  5 waste bags

3.2. Materials Required But Not Provided

Clock, timer, or timer

4. Precautions

  • For in vitro diagnostic use only
  • Each device is for single use only and cannot be reused
  • DO NOT eat, drink, smoke, brush your teeth, or chew gum for 30 minutes before collecting saliva. Don’t swallow it. Avoid choking by being careful when inserting the sponge into the mouth.
  • Keep out of the reach of children. Children between the ages of 2 and 15 must be tested by an adult. Children over 15 years of age must be assisted by an adult. Do not use this test on children under 2 years of age.
  • Use a separate test for each person
  • This test is for human use only.
  • Read the package insert before use. The instructions must be read and followed carefully.
  • Do not use the kit or components beyond the expiration date.
  • Do not use it if the bag is damaged or open.
  • Test devices are packaged in foil bags that exclude moisture during storage. Inspect each foil bag before opening it. Do not use devices with holes in the foil or bag not completely sealed. An erroneous result may occur if the test reagents or components are stored incorrectly.
  • Do not use the kit when any component, including test device, shield, stand, the prospectus is missing.
  • Do not bring samples and reagents to room temperature before testing may decrease the sensitivity of the assay or may lead to false-positive results. Inaccurate or inappropriate specimen collection, storage, and transportation can also return false test results.
  • Buffer components in the base include salts, surfactants, preservatives sodium azide and water as the solvent. Avoid skin or eye contact with the tampon.
  • Keep the collector clean. Do not touch the manifold and make sure you do not touch any surface before use. Place the swab on the base immediately after collecting the sample.
  • The COVID-19 antigen saliva test kit could detect the alpha variant of SARS-CoV-2, beta, gamma, kappa and delta.

5. Storage And Stability

Please store the COVID-19 Antigen Saliva Test Kit at 2~30℃ when not in use.
DO NOT FREEZE.
Do not use the kit or components beyond the expiration date.

6. Quality Control

Internal Procedural Controls

The COVID-19 Antigen Saliva Test Kit has built-in (procedural) controls. Each test device has an internal standard zone to ensure proper sample flow. The user You must confirm that the colour band located in the “C” region is present before reading the result.

7. Limitations Of The Test/Warnings

1. The COVID-19 Antigen Saliva Test Kit is for in vitro diagnostic use and should only be used once for the qualitative detection of SARS-CoV-2 antigen. The brightness of a positive band should not be evaluated as “quantitative or semi-quantitative”.
2. Children under 15 years old need adult supervision.
3. Failure to comply with the TEST PROCEDURE and RESULT INTERPRETATION may adversely affect test performance and/or invalidate the test result.
4. If the result is positive, the results should still be confirmed immediately by a laboratory PCR test and seek follow-up clinical care.
5. Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be the definitive cause of the disease.
6. A positive result does not necessarily mean that the patient is infected
7. Negative results do not exclude SARS-CoV-2 infection and the person does not being infectious. Therefore, the results must be confirmed through a laboratory. Test PCR especially if the person has symptoms and should seek follow-up clinical care.
8. Even if the result is negative, you must still observe all protective measures and hygienic measures.
9. If there is a continuing suspicion of infection or a high rate of infection in the area, it is recommended to repeat the test within 1 to 3 days.
10. The tests are less reliable in the last phase of the infection and in asymptomatic patients individuals
11. False-negative results may occur if the test is not performed within the first 7 days from the onset of symptoms.
12. There may be false negatives due to unknown new variants of SARS-Cov-2 before the validation of available data
13. A negative result does not rule out infection with another type of respiratory virus.

8. Performance

8.1. Cross-reactivity:

Cross-reactivity has been studied with the following organisms. positive samples of the following organisms are not cross-reactive with the COVID-19 antigen Saliva test kit. Adenoviruses, Epstein-Barr virus, enteroviruses, Echovirus 6, HCoV virus, Bordetellas, Candida albicans, Chlamydia pneumonia, Group C Streptococcus, Haemophilus influenzae, Legionella pneumophila, MERScoronovirus, SARS-coronavirus, Human Metapneumovirus, Influenza A (H1N1)pdm09, Influenza Virus, Novavirus, Parainfluenza Virus, Respiratory syncytial virus, rhinovirus B52, Mycoplasma pneumonia, Mycobacterium tuberculosis, staphylococcus, streptococcus. COVID-19 antigen saliva test kit could have cross-reactivity with the human coronavirus HKU1 and SARS-CoV because they have high homology to SARS-CoV-2

8.2. Interfering Substances:

The following substances, which are naturally present in respiratory samples or which may be artificially introduced into the respiratory tract, were evaluated. None of them was found to affect the performance of the COVID-19 antigen saliva test Team. 3 over-the-counter nasal sprays, 3 over-the-counter types of mouthwash, 3 over-the-counter throat drops, 4- acetamidophenol adamantanamine, acetylsalicylic acid, albuterol, chlorpheniramine, dexamethasone, dextromethorphan, diphenhydramine, Doxylamine succinate, flunisolide, guaiacol glyceryl ether, mucin, mupirocin, Oxymetazoline Phenylephrine, phenylpropanolamine, oseltamivir phosphate, Tobramycin, Triamcinolone, Whole Blood, Zanamivir