SARS-CoV-2(2019-nCOV) IgM/IgG Antibody Coronavirus Rapid Test Cassette

The 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to 2019-nCoV in whole blood, serum or plasma specimen. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with 2019-nCoV antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen contains IgG antibodies to 2019-nCoV. A colored line will appear in IgG test line region as a result of this. Similarly, anti-human IgM is coated in IgM test line region and if specimen contains IgM antibodies to 2019-nCoV, the conjugate-specimen complex reacts with anti-human IgM. A colored line appears in IgM test line region as a result. Therefore, if the specimen contains 2019-nCoV IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains 2019-nCoV IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain 2019-nCoV antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
Storage condition:  Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
Material:
Materials provided:
l   Test cassettes
l   Droppers
l   Buffer
l   Package insert
Materials required but not provided:
l   Specimen collection containers
l   Lancets (for fingerstick whole blood only)
l   Capillary tubes
l   Centrifuge (for plasma only)
l   Timer
l   Pipette
Test procedure: 
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
• To use a dropper: Hold the dropper vertically, draw the specimen to the fill line (approximately 20uL), and transfer the specimen to the specimen well (S), then add 2 drops of buffer (approximately 80 uL), and start the timer.
• To use a pipette: To transfer 20 uL of specimen to the specimen well(S), then add 2 drops of buffer (approximately 80 uL), and start the timer
For Venipuncture Whole Blood specimen:
• To use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill line and transfer 1 full drop (approx. 20μL) of specimen to the sample well(S). Then add 2 drops of buffer (approximately 80 uL) and start the timer.
• To use a pipette: To transfer 20 uL of whole blood to the specimen well(S), then add 2 drops of buffer (approximately 80 uL), and start the timer
For Fingerstick Whole Blood specimen:
• To use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill line and transfer 1 full drop (approx. 20μL) of specimen to the sample well(S). Then add 2 drops of buffer (approximately 80 uL) and start the timer.
• To use a capillary tube: Fill the capillary tube and transfer approximately 20uL of fingerstick whole blood specimen to the specimen well (S) of test cassette, then add 2 drops of buffer (approximately 80 uL) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.

  2019-nCoV(Sars-COV-2) IgM/IgG Antibody Coronavirus Rapid Test Cassette
  Handbook of COVID-19 Prevention and Treatment
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