Novel Coronavirus (2019-nCoV) Antibody IgG/IgM Rapid Test Cassette
Main Features:
1. Fast to get the result in 15～20 mins.
2. High sensitivity and specificity.
3. Simple to use.
4. High Accurate (97.51%) and Reliable (Credibility Interval:
95.79%～98.67%)
5. Ambient storage.
6. Certified by Authoritative Certification
7. Unique 3-line Patented Design
8. Meet Multiple Criteria as follows:
EN ISO 13485:2016 EN 13612:2002
EN ISO 14971:2012 EN ISO 23640:2015
EN ISO 18113-1:2011 EN ISO 18113-2:2011
EN ISO 15223-1:2016 EN 13641:2002
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:
Intended Use
This kit is used for the qualitative detection of Novel Coronavirus
antibodies in human serum, plasma and whole blood samples in vitro.
It is only used as a supplementary detection indicator for
suspected cases of Covid-19 negative nucleic acid detection or used
in conjunction with nucleic acid detection in the diagnosis of
suspected cased. It cannot be used as a basis for the diagnosis and
exclusion of pneumonitis caused by Covid-19 infection
Principle
This kit uses Colloidal Gold Immunochromatography and indirect
immune capture principle of comprehensive detection technology to
detect IgG/lgM of Severe Acute Respiratory Syndrome Coronavirus 2
(SARS-CoV-2) in human serum, plasma and whole blood. During
detection, the colloidal gold labeled recombinant antigens bind to
the SARS-CoV-2 antibodies in the sample to form immune complexes.
The immune complexes move forward along the cassette by
chromatography. The IgM in the immune complexes will be captured by
the pre-coated anti-human IgM on the test zone, condense the color
to form the reaction line M. The IgG in the immune complexes will
be captured by the pre-coated anti-human IgG on the test zone,
condense the color to form the reaction line G. The colloidal
gold-labeled chicken IgY antibodies are combined with the
pre-coated goat anti-chicken IgY antibodies on the quality control
line to form the quality control line C.
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%)
Assay Procedure
Sample preparation: Fresh serum, plasma or whole blood samples, no
pretreatment is required. lf the samples are stored in2~8℃, the
samples should be restored at room temperature for15~30 minutes
before use, returned to room temperature, and thoroughly mixed
before testing.
Reagent preparation: Open the package, the pouch should be sealed
well. lf the test reagent stores in the refrigerator, it should be
restored to room temperature. Then open the package pouch and take
out the test reagent, place it on the platform.
Detection and interpretation: Add10µL serum/plasma or 20µL whole
blood sample into S well, after the sample has permeated
completely, add 2 drops diluent buffer. Read the result in15-20
minutes, interpret the test result after 20 minutes may cause false
result.
Interpretation of Results
1. Positive of lgG and IgM: One color line in the control zone(C),
one color line in the test zone(G) and one color line in the test
zone(M) .Indicates IgG and IgM test result is positive.
2. Positive of IgG: One color line in the control zone(C) and one
color line in the test zone(G), indicates lgG test result is
positive.
3. Positive of lgM: One color line in the control zone(C) and one
color line in the test zone(M), indicates IgM test result is
positive.
4. Negative of lgG and IgM: Only one color line in the control
zone(C) indicates IgG and IgM test result is negative.
5. Invalid: If no color line appears in the control zone(C), the
test is invalid.Discard the test cassette and perform with new
cassette.
Built-In Control
COVID-19IgG/lgM Rapid Test Cassette has a built-in procedural
control that demonstrates assay validity. A color line appeared on
the control zone(C) indicates that the test runs correctly.
Reagents and Materials Provided
1. Test cassette(individually pouched)
2. Each pouch contains one cassette with one desiccant bag
3. Diluent buffer
4. Instruction for use
5. Plastic dropper(optional)
Materials Required But Not Provided
1. Timer or stopwatch
2. Blood collection devices, for the testing of venipuncture whole
blood, serum or plasma
3. Biohazard disposal container
4. Disposable gloves
5. Pipette and pipette tip
For fingerstick samples, the following materials are required:
Alcohol pad
Sterile lancet
Sterile gauze or cotton
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.
