CUOMO SARS-CoV-2 IgM/IgG Rapid Test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19) which is caused by SARS-CoV-2.
The test provides preliminary test results. Negative results don't preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decision.
There are no returns, exchanges and refunds for this product.
Each test box contains two sealed bags. One contains a box of blood test cards, a disposable dropper and a pack of desiccant; the other contains a needle device, diluent, and sterile alcohol paper. And an instruction for use.
Manufactured by: CUOMO BIOTECH LIMITED
Made in Hong Kong
Specimen Collection and Storage
The Test can be stored at any temperature between 2-30°C. Do not freeze. The stability of the kit under these storage conditions is 24 months. The test card should be used within 1 hour after opening the inner package to prevent the failure of detection due to moisture absorption.
Interpretation of result
(Please refer to the above illustration)
Negative: One pink line appears in control line C, and no G and M line in test region. Which showing that no SARS-CoV2 IgG/IgM was detected and the result was negative
1. If C line and apparent M line appear in the test region, it means that SARS-CoV2 IgM antibody was detected and the result was positive for IgM antibody.
2. If C line and apparent G line appear in the test region, it means that SARS-CoV2 IgG antibody was detected and the result was positive for IgG antibody.
3. If C line, apparent M line and G line appear in the test region, it means that SARS-CoV2 IgG and IgM antibody was detected and the result was positive for IgG and IgM antibody.
Allow all reagents and samples to equilibrate to room temperature before proceeding with the test.
Write the specimen number on the cassette and sample preparation device.
1. Remove the test device from its protective pouch, lay it on a dry and clean flat surface, and label the device with patient or specimen number.
2. Use a micropipette or a dropper to take 10 μl of serum, plasma and whole blood sample, directly into the well, and then add the 1-2 drops (about 30-70ul) assay buffer into the well. Start the timer.
3. Leave the test at room temperature and read the results within 15 minutes. Don't read result after 30 minutes.