COVID-19 (2019 novel coronavirus infectious diseases) IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.
|Product Name||COVID-19 IgG/IgM Rapid Test Cassette|
|Warranty||Room temperature 24 months|
• Materials Provided
1.Test Cassette 2.Pipette Dropper 3.Package Insert 4.Buffer
• Materials Required But Not Provided
1.Specimen collection containers 2.Lancets (for fingerstick whole blood only) 3.Centrifuge (for plasma only) 4.Timer 5.Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)
3.Individual package,Easy to use;
4.Home self-test,Protect privacy;
Allow test cassette, specimen, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1.Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2.Place the test device on a clean and level surface.
For Serum or Plasma Specimens:
With a 5 μL mini plastic dropper provided, draw serum/plasma specimen to exceed the specimen line as showed in the following image and then transfer drawn serum/plasma specimen into the sample well (S). Then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
For Whole Blood Specimen:
Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the specimen well(S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
3.Wait for the colored line(s) to appear. The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.
NEGATIVE: If only the C band is present, the absence of any burgundy color in the both T bands (IgG and IgM) indicates that no anti-COVID-19 antibodies are detected in the specimen. The result is negative.
IgM POSITIVE: In addition to the presence of C band, if only IgM band is developed, the test indicates for the presence of IgM anti-COVID-19 in the specimen. The result is IgM anti-COVID-19 positive.
IgG POSITIVE: In addition to the presence of C band, if only IgG band is developed, the test indicates for the presence of IgG anti-COVID-19 in the specimen. The result is IgG anti-COVID-19 positive.
IgG and IgM POSITIVE: In addition to the presence of C band, both IgG and IgM bands are developed, the test indicates for the presence of both IgG and IgM anti-COVID-19 in the specimen. The result is IgG and IgM anti-COVID-19 positive.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
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