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

COVID-19 Rapid Teste Kit Novel Coronavirus Colloidal Gold Antibody IgG/IgM Test Cassette

Main Features

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.

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

Cassette and Materials Provided

► Test cassette(individually pouched)

► Each pouch contains one cassette with one desiccant bag

► Diluent buffer

► Instruction for use

► Plastic dropper(optional)

Interpretation of Results

► 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.

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:

Positive Coincidence Rate

Positive Coincidence Rate: A/(A+C)%=90.85% (Credibility Interval: 84.85% ～95.04%)

Negative Coincidence Rate: D/(B+D)%=100.00% (Credibility Interval: 99.04%～100.00%)

Total Coincidence Rate: (A+D)/( A+B+ C+D)% = 97.51% (Credibility interval: 95.79%～98.67%)

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.

Storage

COVID-19 IgG/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.