REFERENCE INTERVAL

 

POSTIVE (+):
COVID-2019 IgG Postive:
One red line appears in the region G and the other line appears in the region C.
COVID-2019 IgM Postive:
One red line appears in the region M and the other line appears in the region C.
COVID-2019IgG& IgM Postive:
One red line appears in the region G , One red line appears in the region M, and the other line appears in the region C.
The positive results showed that the COVID-2019 antibody was present in the samples.
NEGATIVE (-):
The display window only shows the quality control line (C line). The negative results showed that the samples did not contain COVID-2019 antibody, or the content was lower than the detection level of this product.
Nucleic acid testing is recommended for samples with negative results.
INVALID:
The display window does not show the quality control line (C line), indicating incorrect operation process or deterioration of reagent. In this case, read the instructions carefully again and retest with new reagents. If the problem persists, discontinue use of the batch immediately and contact your local supplier.

 

【Interpretation Of Test Results】
1. The test results of this reagent are only for clinical reference. The clinical diagnosis and treatment of patients should be considered in combination with their symptoms, signs, medical history, other laboratory tests and treatment response.
2. Clinicians need confirmation tests when they have doubts about the test results or when the test results are obviously abnormal.
3. Operation errors, sample factors, environment, etc, may affect the test results.
【Limitations Of Test Methods】
1. Try to use fresh samples within 2 days for the kit.
2. The accuracy of the test depends on the sample collection process. Improper sample collection, improper storage of samples, unfresh samples, or repeated freeze-thaw cycles of samples will affect the test results.
3. The test cassette only provides qualitative detection of the COVID-19 antibody in the sample. If you need to detect the specific content of an indicator, please use the relevant professional instruments.
4. The test result of this kit is for clinical reference only and should not be used as the sole basis for clinical diagnosis and treatment. The clinical management of patients should be considered in combination with their symptoms/signs, medical history, other laboratory tests, and treatment responses.
5. Due to the limitation of the methodology of immunological detection reagents, its analytical sensitivity is generally lower than that of nucleic acid reagents. Therefore, the experimenters should pay more attention to the negative results and need to make a comprehensive judgment in combination with other test results. It is recommended to review the suspicious negative results by using nucleic acid detection or virus culture identification methods.
6. Analysis of the possibility of false negative results:
①Unreasonable sample collection, transportation and processing may lead to false negative results.
②Genetic variations of virus can cause changes in antibody determinants, which can lead to false negative results.
③The optimal sample type and sampling time after infection have not been verified, so collecting samples at different times on the same patient may avoid false negative results.

 
  • This test has not been reviewed by the FDA.

  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

  •  Not for the screening of donated blood

 

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