Novel Coronavirus (2019-nCoV) Antibody IgG/IgM Rapid Test Cassette

Coronavirus Antibody IgG/IgM Colloidal Gold Screening Test 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



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.

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

Timer or stopwatch
Blood collection devices, for the testing of venipuncture whole blood, serum or plasma
Biohazard disposal container
Disposable gloves
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) .

Interpretation of Results



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.

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.

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.

Negative of lgG and IgM: Only one color line in the control zone(C) indicates IgG and IgM test result is negative.

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.

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.