97.51% Accuracy COVID 19 IgG IgM Rapid Test Cassette

 

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.