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

Main Features:

Intended Use

The kit is used to detect the lgM and lgG antibodies to severe acute respiratory Syndrome corona virus 2 (SARS CoV-2) in human serum, plasma or whole blood sample qualitatively. Itis to be used as an aid in the diagnosis of coronavirus infection disease (COVID- 19), which is caused bySARS-COV-2. The test provides preliminary test results. Negative results don't preclude SARSCOV-2 infection and they cannot be used as the sole basis for treatment or similar decision.

Sample Collection and Test Preparation

Finger stick Specimens (Whole Blood)

1. Clean the area to be lanced with an alcohol pad

2. Squeeze the end of the fingertip and pierce it with a sterile lancet.

3. Wipe away the first drop of blood with sterile gauze or cotton； collect the sample from the second drop

4. 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

1. Collect whole blood into a collection tube (containing EDTA, Na-citrate or heparin) by venipuncture

2. Separate the plasma by centrifugation.

Serum

1. Collect whole blood into a collection tube (containing no anticoagulants) by venipuncture.

2. Allow the blood to clot.

3. 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 3days at 2-8℃

Interpretation of Results

1. 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.

2. Positive of lgM: if two lines respectively appears in the line of Zone C and M, It indicates IgM test result is positive.

3. Positive of IgG: if two lines respectively appears in the line of Zone C and G, It indicates lgG test result is positive.

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

5. 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% (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%)

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.

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.