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LOT OF 20 SARS-CoV-2 Antibody Test (Lateral Flow Method)


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LOT OF 20 SARS-CoV-2 Antibody Test (Lateral Flow Method)

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LOT OF 20 SARS-CoV-2 Antibody Test (Lateral Flow Method)


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.
3. Transfer 1 drop (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).
4. As the test begins to work, you will see purple color move across the result window in the center of the test device.
5. Wait for 15 minutes and read the results. Do not read results after 20 minutes.


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.


Sensitivity and Specificity
596 clinical case samples which include 361 confirmed case samples* and 235 confirmed excluded case samples*, were obtained for testing, and then compared the test results between SARS-CoV- 2 Antibody Test (Lateral Flow Method) and the confirmed case samples. The results of sensitivity and specificity between the two method are show below.

* Confirmed cases were the patients diagnosed according to the treatment plan.
* Confirmed excluded cares were identified by negative PCR results.
Results analysis:
Sensitivity: 86.43% (95%CI: 82.51%~89.58%) Specificity: 99.57% (95%CI: 97.63%~99.92%)
Total consistent: 91.61% (95%CI: 89.10%~93.58%)

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