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On December 31, 2019, several cases of pneumonia in Wuhan City, Hubei Province of China were reported to the World Health Organization (WHO). The novel virus, now known as SARS-CoV-2 (previously known as 2019-nCoV), a RNA virus of the beta coronavirus family, has since spread across China and to other countries and territories. The WHO has named the disease caused by SARS-CoV-2 as coronavirus disease 2019 (abbreviated “COVID-19”).

INTENDED USE

COVID-19 Antibody Test (Lateral Flow Method) is an immunochromatographic assay for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG/IgM antibody in human whole blood, serum or plasma sample. The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.

The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decision.

For in vitro diagnostic use only. For professional use only.

PRINCIPLE

COVID-19 Antibody Test (Lateral Flow Method) is based on the principle of capture immunoassay for determination of SARS-CoV-2 IgG/IgM antibodies in human whole blood, serum and plasma. When the specimen is added into the test device, the specimen is absorbed into the device by capillary action, mixes with the SARS-CoV-2 antigen-dye conjugate and flows across the pre-coated membrane.

When the SARS-CoV-2 antibodies level in the specimen is at or above the target cutoff (the detection limit of the test), the antibodies bound to the antigen-dye conjugate are captured by anti-human IgG antibody and anti-human μ chain antibody immobilized in the Test Region (T) of the device, and this produces a colored test band that indicates a positive result. When the SARS-CoV-2 antibody level in the specimen is zero or below the target cutoff, there is not a visible colored band in the Test Region (T) of the device. This indicates a negative result.

To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly.

TEST PROCEDURE

Please read the instruction for use carefully before performing the test.

  1. Allow the device, buffer and specimen to equilibrate to room temperature (10ºC ~30ºC) prior to testing.
  2. Remove a test cassette from the foil pouch by tearing at the notch

and place it on a level surface.

  1. Transfer 10 μL of whole blood or serum or plasma specimen to the sample well (small well) and then add 2-3 drops (80 μL) of buffer solution to the buffer well (large well).
  2. As the test begins to work, you will see purple color move across the result window in the center of the test device.
  3. Wait for 15 minutes and read the results. Do not read results after 20 minutes.

Note: the rightmost window on the cassette shows the product abbreviation “nCoV” to identify this product.

RESULT INTERPRETATION

Positive Result

Colored bands appear at both test line (T) and control line (C). It indicates a positive result for the SARS-CoV-2 antibodies in the specimen.

Negative Result

Colored band appear at control line (C) only. It indicates that the concentration of the SARS-CoV-2 antibodies is zero or below the

detection limit of the test.

Invalid Result

No visible colored band appear at control line after performing the test. The directions may not have been followed correctly or the test may have deteriorated. It is recommended that the specimen be re-tested.

PRECAUTION

  1. This kit is for in vitro diagnostic use
  2. All specimens should be treated as capable of transmitting diseases. Use appropriate precautions in the collection, handling,storage and disposal of patient samples and used kit contents. And follow biosafety level 2 or higher guidelines.
  3. Wear appropriate personal protective equipment (e.g. gowns, gloves, eye protection) when handing the contents of this
  4. Proper specimen collection storage and transport are critical to the performance of this
  5. Discard after first use. The test cannot be used more than
  6. Do not touch the reaction area of test
  7. Do not use test kit beyond the expiration
  8. Do not use the kit if the pouch is punctured or not well
  9. Testing should be applied by professionally trained staff working in certified laboratories or clinics at which the sample(s) is taken by qualified medical
  10. The test result should be interpreted by the physician along with clinical findings and other laboratory test
  11. DISPOSAL OF THE DIAGNOSTIC: All specimens and the used-kit has the infectious risk. The process of disposing the diagnostic must follow the local infectious disposal law or laboratory

 

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3 Replies to “COVID-19 test kit made in China | COVID-19 Antibody Test| COVID-19 IgM antibodies”

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