COVID-19 Antigen Rapid Test Kit (1pcs): Saliva Test

Saliva-based tests are especially convenient compared to nasal or oropharyngeal swabs making it easier for people to self-test.

Description of COVID-19 Antigen Rapid Test Kit

According to the EU IVDD (98/79/EC) In Vitro Diagnostic Devices Directive, Huachenayng’s COVID-19 Antigen Rapid Test Kit has provided a Self-Declaration (Doc) for the product.

The COVID-19 Antigen Test is an in vitro immunochromatographic method for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from the saliva of individuals suspected of COVID-19.

The test is to identify the SARS-CoV-2 nucleocapsid antigen that is generally detectable in upper respiratory samples during the acute phase of infection. A positive test result indicates the presence of viral antigens, but the correlation of clinical, medical history, and other diagnostic information is necessary to determine infection status. However, bacterial infection or co-infection with other viruses can also cause a positive test result.

If the sample does not contain the 2019-nCoV antigen, a red reaction line cannot be formed in the T zone.

Instructions for Use COVID-19 Ag Rapid Test Kit

NOTE:

1. Clean your hands before touching the tool.
2. Do not eat for 30 minutes before collection.
3. Take the sample buffer and test cassette to equilibrate to room temperature.
4. Rinse your mouth with water 30 minutes before saliva collection to clean up the residue.
5. Pressing your tongue against the bases of your upper and lower teeth will help you spit out a sufficient amount of saliva in a short amount of time.
6. The amount of saliva collected must reach the calibration line.
7. Used collection tools should be disposed of in the dedicated clinical waste bin.

Interpretation of the Test Results

Positive Result:

If both C and T lines are visible within 15 minutes, the test result is positive and valid.

Negative Result:

If the test area (T line) has no color and the control area displays a colored line, the result is negative and valid.

Invalid Result:

The test result is invalid if a colored line does not form in the control region. The sample must be re-tested, using a new test cassette.

NOTE:

• Read the result after 15 minutes.
• The interpretation is invalid for more than 30 minutes.
• Specimens containing very low levels of target antibodies may develop two colored lines over 15 minutes.
• When invalid results are presented, you should re-test with a new tool.

Cautions of COVID-19 Antigen Rapid Test Kit

• This test kit is a qualitative assay, not a quantitative assay.
• The accuracy of the test depends on the sample collection process. Improper sample collection, improper sample storage will affect the test result.
• It cannot be used as the only basis for treatment, patient management, and infection control. Negative test results should be considered based on the patient’s recent exposure history, medical history, and clinical signs and symptoms consistent with COVID-19.
• This kit is only used for in vitro auxiliary diagnosis and should be used strictly by the Instructions For Use.
• Please check the kit’s effective date and package integrity before use. The test equipment cannot be used if its packaging is damaged or the product is outdated.
• The time for testing and results reading must be followed.
• After the pouch of the test cassette is opened, the test should be performed within 60 min. The test cassette can only be used once.
• Due to the limitations of antigen detection test kits, it is recommended to use nucleic acid amplification or virus culture identification methods to review and confirm negative test results.
• The kit is stored at 2℃~30℃. Keep away from moist, sunlight, heat, or freezing conditions.
• The test results of this kit are only for clinical reference, and the clinical diagnosis of the disease should be considered in combination with the patient’s symptoms, signs, medical history, other laboratory tests, and treatment response.