Novel Coronavirus (2019-nCoV) Antibody IgG/IgM Rapid Test Cassette
For the Qualitative Detection of IgG/IgM Antibodies in serum and
plasma and Whole Blood
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 EN13641:2002 |
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
Sample Collection and Test Preparation
Finger stick Specimens (Whole Blood)
☀ Clean the area to be lanced with an alcohol pad
☀ Squeeze the end of the fingertip and pierce it with a sterile
lancet.
☀ Wipe away the first drop of blood with sterile gauze or cotton；
collect the sample from the second drop
☀ 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
☀ Collect whole blood into a collection tube (containing EDTA,
Na-citrate or heparin) by venipuncture
☀ Separate the plasma by centrifugation.
Serum
☀ Collect whole blood into a collection tube (containing no
anticoagulants) by venipuncture.
☀ Allow the blood to clot.
☀ 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 3 days at 2-8℃
Built-In Control
COVID-19 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.
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.
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)
.
