FDA Venipuncture IgG IgM Rapid Coronavirus Test Kit

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

For the Qualitative Detection of IgG/IgM Antibodies in serum and plasma and Whole Blood

Main Features

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

Sample Collection and Test Preparation

Finger stick Specimens (Whole Blood)

☀ Clean the area to be lanced with an alcohol pad

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

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

☀ 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

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

☀ Separate the plasma by centrifugation.

Serum

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

☀ Allow the blood to clot.

☀ 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 3 days at 2-8℃

Built-In Control

COVID-19 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 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.

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) .