IVD Cassette CoV-19 IgG IgM Antibody Test Kit 2C To 30C Storage Temp

Rapid Test Kit Antibody Rapid Test CoV-19 IgG/IgM Antibody Rapid Test Kit High Accuracy Rapid Antibody Test Kit

Intended Use
COVID-19 IgG/IgM Antibody Rapid Test Kit is a rapid test intended for the qualitative detection of the IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma or whole blood sample from patients suspected of COVID-19 infection. The test Kit for professional use only. It is an aid in the diagnosis of the patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and results of other laboratory tests. But to be attention the test Results from this test kit should not be used as the sole basis for diagnosis. The test provides preliminary test results.
Specification

Main Components

• Test Cassettes
• Disposable Pipettes
• Sample Buffer
• Instruction Manual

Product Feature

• Get result within 10-15 minutes.
• High accuracy
• Easy to operate, Suitable for any scene, no professional, no tedious operation
• Facilitates patient treatment decisions quickly
• Little specimens is enough

Advantage

• ​Fast results as soon as 10-15 minutes
• Facilitates patient treatment decisions quickly
• Simple, time-saving procedure
• All necessary reagents provided & no equipment needed
• High sensitivity and specificity

SAMPLE REQUIREMENT

• The reagent can be used for the serum, plasma and whole blood samples.
•  A serum / plasma / whole blood sample must be collected in a clean and dry container. EDTA, sodium citrate, heparin can be used as anticoagulants in plasma / whole blood samples. Detect immediately after collecting blood.

• Serum and plasma samples may be stored at 2-8℃ for 3 days prior to assay. If testing is delayed more than 3 days, the sample should be frozen (-20℃ or colder). Repeat freeze and thaw for no more than 3 times. Whole blood samples with anticoagulant can be stored at 2-8℃ for 3 days, and should not be frozen; whole blood samples without anticoagulant should be used immediately (if the sample has agglutination, it can be detected by serum) .

Use Step

For Serum/Plasma

1. Remove the test device from the sealed pouch, place it on a clean and level surface with the sample well up.

2. Add serum or plasma (10µl) vertically into the sample well .

3. Add two (2) drops (80-100µl) of sample buffer into the sample well .

4. Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

For Whole Blood

1. Remove the test cassette from the sealed pouch, place it on a clean and level surface with the sample well up.

2. Add whole blood (20µl) vertically into the sample well .

3. Add two (2) drops (80-100µl) of sample buffer into the sample well .

4. Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

 
Interpretation of result

• POSITIVE: Two or three distinct red lines appear. One line should be in the control region (C) and the other line would be in the test region (IgG line, IgM line or both).
• NEGATIVE: One red line appears in the control region(C). No red or pink line appears in the test region (IgG line, IgM line).
• INVALID: No red lines appear or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

Other Information

• This reagent is designed for the qualitative screening test. Concentration of SARS-CoV-2 IgM/IgG antibody cannot be determined by this qualitative test. The depth of the T-line(IgG/IgM) color is not necessarily related to the concentration of the antibody in the sample.
• The results of the reagent are only for clinical reference, which is not the only basis for clinical diagnosis and treatment. A confirmed diagnosis and treatment should only be made by a physician after all clinical and laboratory findings have been evaluated.

FAQ

• How about the MOQ?

MOQ is more than 10000 pcs, but our sales team will advise you how much to order based on the products you need, national market conditions, international logistics costs and other factors

• Which certificate you have?

CE, ISO13485

• Do you manufacturer or trading company?

We are factory, all product we supply is R&D and produce by ourself.