ISO CE 15 Min SARS-CoV-2 Fast Coronavirus Test Kit

Product Specification

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.