Novel Coronavirus (2019-nCoV) Antibody IgG/IgM Rapid Test Cassette
COVID-19 (2019-nCoV) SARS-CoV-2 Colloidal Gold Antibody IgG/IgM
Fast Test Kit For In Vitro Diagnostic use
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
Intended Use
COVID-19IgG/lgM Fast Diagnostic Cassette is for the detection of
lgG/lgM in human serum, plasma or whole blood. It is used as a
supplementary test indicator for suspected cases of Novel
Coronavirus negative nucleic acid detection or used combine with
nucleic acid detection in the diagnosis of suspected cased, It
cannot be used as the evidence for the diagnosis and exclusion of
COVID-19.
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 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.
Positive of lgM: if two lines respectively appears in the line of Zone C and M, It
indicates IgM test result is positive.
Positive of IgG: if two lines respectively appears in the line of Zone C and G, It
indicates lgG test result is positive.
Negative of lgG and IgM: if Only one color line in the control zone C it indicates IgG and
IgM test result is negative.
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.
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.
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
Cassette 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)
Warning
For in vitro diagnostic use ONLY
Read the instruction carefully before use. It is very important
that the correct operation procedure is followed. Fail to add the
patient specimen may cause false negative result (i.e.a missed
positive) .
Storage
COVID-19IgG/IgM Rapid Diagnostic Kit should be placed in dark place
at 2-30°C for 12 months from the date of manufacture. Keep the test
kit in sealed pouch until use. Once you have taken the test
cassette out of the pouch, use it immediately. Do not use the test
kit once it exceeds the indicated expiration date.
