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.
