The COVID IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to SARS-CoV-2 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 SARS-CoV-2 antigen-coated particles in the test. 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 SARS-CoV-2. 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 SARS-CoV-2, 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 SARS-CoV-2 IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains SARS-CoV-2 IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain SARS-CoV-2 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.
DIRECTIONS FOR USE
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Exact QR Code from the QR code card for specific information of the test. Use only QR code card provided inside the test kits.
2. 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.
3. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
Use a dropper: Hold the dropper vertically, draw the specimen to the fill line (approximately 10uL), and transfer the specimen to the specimen well (S), then add 2 drops of buffer (approximately 80uL) to Buffer well(B) , and start the timer.
Use a pipette: Transfer 10 uL of specimen to the specimen well(S), then add 2 drops of buffer (approximately 80 uL) to Buffer well(B), and start the timer
For Venipuncture Whole Blood specimen:
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) to Buffer well (B) and start the timer.
Use a pipette: Transfer 20 uL of whole blood to the specimen well(S), then add 2 drops of buffer (approximately 80 uL) to Buffer well(B), and start the timer
For Fingerstick Whole Blood specimen:
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) to Buffer well (B) and start the timer.
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 80uL) to Buffer well (B) and start the timer. See illustration below.
4. Wait for the colored line(s) to appear. Read results should be read with the Citest LF Reader at 10 minutes.
5. Do not interpret test results visually.
