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.

 
WeChat 圖片_20200605101537.png

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.

bf80d2768e53d5f664498a40252b42d_edited_edited_edited.jpg

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%.

ddc1e9011ba288b51034d73443b43a2_edited.jpg

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

a5fff48a254314bec66c4097b1b2677.png
7e69f304becaf89cb04f8b6fb5ca9f5.png
adf59cdc85b9bea82e97f621bcd2b51_edited.jpg

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

 
f0150f7150eb59eb97f7f9e8fadc667.png
c9d83ccce11470a255f329724b5b108.png
b36cd70b1bf925d0defa7952970a763.png

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.

 
fda_edited.jpg
ce_edited.jpg
 

©2020 by Genelogic Research Limited.

fda_edited.jpg