Novel Coronavirus (2019-nCoV) Antibody IgG/IgM Rapid Test Cassette
Main Features:
Intended Use
The kit is used to detect the lgM and lgG antibodies to severe
acute respiratory Syndrome corona virus 2 (SARS CoV-2) in human
serum, plasma or whole blood sample qualitatively. Itis to be used
as an aid in the diagnosis of coronavirus infection disease (COVID-
19), which is caused bySARS-COV-2. The test provides preliminary
test results. Negative results don't preclude SARSCOV-2 infection
and they cannot be used as the sole basis for treatment or similar
decision.
Sample Collection and Test Preparation
Finger stick Specimens (Whole Blood)
1. Clean the area to be lanced with an alcohol pad
2. Squeeze the end of the fingertip and pierce it with a sterile
lancet.
3. Wipe away the first drop of blood with sterile gauze or cotton；
collect the sample from the second drop
4. Use dropper to draw the fresh blood to 1/ 2 of the tube wall and
dispense into the sample well
Fingerstsick whole blood should be used immediately after can be
used.
Serum/Plasma specimens:fresh serum or plasma specimen can be used.
Plasma
1. Collect whole blood into a collection tube (containing EDTA,
Na-citrate or heparin) by venipuncture
2. Separate the plasma by centrifugation.
Serum
1. Collect whole blood into a collection tube (containing no
anticoagulants) by venipuncture.
2. Allow the blood to clot.
3. Separate the serum by centrifugation.
Avoid the use of hemolytic, turbid, microorganism contaminated
specimens. Specimen should be stored at 2-8℃for up to3 days or
frozen at -20℃for up to 9 days. Avoid specimen deterioration by
multiple freeze-thaw cycles
Venipuncture Whole Blood
Venipuncture whole blood can be used immediately after collection
or stored up to 3days at 2-8℃
Interpretation of Results
1. Positive of lgG and IgM: if three lines appear in their
respective zone C, G, M, then it Indicates IgG and IgM test result
is positive.
2. Positive of lgM: if two lines respectively appears in the line
of Zone C and M, It indicates IgM test result is positive.
3. Positive of IgG: if two lines respectively appears in the line
of Zone C and G, It indicates lgG test result is positive.
4. Negative of lgG and IgM: if Only one color line in the control
zone C it indicates IgG and IgM test result is negative.
5. Invalid: If no color line appears in the control zone C, then
the test is invalid. Discard the test cassette and resume the
performance with new cassette through correct procedures.
Sensitivity and Specificity
A total of 523 clinical samples were tested for validation, of
which 142 were positive and 381 were negative. The test results are
as follows:
Positive Coincidence Rate:
Positive Coincidence Rate: A/(A+C)%=90.85% (95% Credibility
Interval: 84.85% ～95.04%)
Negative Coincidence Rate: D/(B+D)%=100.00% (95% Credibility
Interval: 99.04%～100.00%)
Total Coincidence Rate: (A+D)/( A+B+ C+D)% = 97.51% (95%
Credibility interval: 95.79%～98.67%)
Built-In Control
IgG/lgM Rapid Test Cassette has a built-in procedural control to
see whether or not the operation is correct or effective, if one
color line appeared on the control zone C, it indicates that the
test operation is Correct.
Warning
For in vitro diagnostic use ONLY
Read the package insert completely before use.It is very important
that the correct procedure is followed. Fail to add the patient
sample may lead to a false negative result (i.e.a missed positive)
.
Storage
COVID-19 IgG/IgM Rapid Test Cassette should be stored in dark place
at 2-30°C for 12 months from the date of manufacture. Keep the test
cassette in sealed pouch until use. Once you have taken the test
cassette out of the pouch, use it immediately. Do not use the test
beyond the indicated expiration date.
