COVID-19 ANTIBODY RAPID TEST
High Sensitivity 94.8% & Specificity 91.7%, Results in 10-15mins
The COVID-19 IgG/IgM Rapid Test is a lateral flow immunoassay intended for the qualitative detection of IgM and IgG antibodies respectively to SARS-CoV-2 in serum, plasma (EDTA, citrate) or venipuncture whole blood specimens from patients suspected of COVID-19 infection.
THE APPLICATION OF SEROLOGIC TEST
The importance of antibody test
A diagnostic technique called polymerase chain reaction (PCR) is to detect the virus’ genetic material in oral or nasal swabs. It’s highly effective, but it only returns a positive result when the virus is still present in the body.
Antibody testing will tell us how many people had been infected with the virus weeks or even months ago – sometimes without knowing. And it helps to detect infection with few or no symptoms as well.
One clinical study showed that 72.73% of those PCR negative patients was antibody positive.
IgM is the first antibody to be immediately developed to defense. Afterward IgG will be generated substantially to serve long term protection from virus attack. So whenever IgM was detected, probably it is in acute infection status, while if only IgG being detected, the infection might be past already.
HOW IT WORKS
Lateral Flow Immunoassay
The blood diffuses across the strip. If it contained the COVID-19 IgM and/or IgG, it will bind to the COVID-19 antigen (colloidal gold labelled) in the conjugation pad (Pink). The IgM and IgG will be captured in the T1 and T2 respectively. The color of colloidal gold (darken) will be shown. C line is the control to show that the strip is properly functioning. If no C line appears, the test is invalid.
CLINICAL EVALUATION
Sensitivity 94.8%, Specificity 91.7%
A clinical test conducted in a local hospital sampling from 82 patients. Among which 58 patients was clinically confirmed positive, the results showed that 13 patients showed IgM positive, 40 patients showed both IgM/IgG positive, and 2 patients showed IgG positive. The sensitivity is 94.8%. The 24 patients who was clinically confirmed negative, the results showed that 22 patients were negative and 2 patients were IgG positive. The specificity is 91.7%.
EXTENSIVE CLINICAL ASSESSMENT
Over thousands patients being tested with about 90% sensitivity.
The assessment was conducted by clinical doctor in a country of western Europe. Over two thousands patients blood sample were tested. The sensitivity was about 90%. In addition, a monitoring test was carried out. The same positive patient was tested daily for 10 days and proven the consistence of the test kit.
HOW TO READ THE RESULT IF
C LINE DIDNT APPEAR
All results was invalid because it indicated that the test kit was faulty.
Suggest to run another test where the result will only be valid if C line shown.
I HAVE A NEGATIVE RESULT
You might probably not infected. However, it might also be a false negative because antibody need time to develop. Suggest you to run another test after 7 days. If negative again, probably no infection.
I HAVE T2 POSITIVE (IGM)
Either you have T2 alone or both T1/T2 positive, it suggested you are at the acute infection status.
Even you don't have any fever symptom, you should avoid close contact with anyone and seek for PCR test in a hospital to confirm.
I HAVE T1 POSITIVE ONLY (IGG)
If only T1 positive, it suggested you probably past infection. You could seek for PCR test in a hospital to confirm.
OPERATION INSTRUCTION
Step 1
Clean your finger tip with sanitizer/disinfectant
Step 2
Acupuncture your finger tip with a sterile needle
Step 3
Wipe off the first blood and use micro pipette to collect blood sample 20μl
Step 4
Put the blood sample inside the circle which is sample area
Step 5
Add 4 drops of diluent buffer into the sample area
Step 6
Wait for 10-15 mins to diffuse to mark “C” and see the result
GET A QUOTE
For Importer of minimum order of 5000 kits, please kindly send us your quote request below.
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