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What is Coronavirus Antibody Detection Kit?

 

Novel Coronavirus (2019-nCoV) Antibody detection Kit

The novel coronavirus (2019-nCoV) antibody detection kit is used for rapid qualitative detection of novel coronavirus IgM/IgG antibodies in human whole blood, serum and plasma. The test results can be obtained by visual observation within 15 minutes at the fastest.

 

New Coronavirus (2019-nCoV) Antibody Detection Kit is in Category III Medical Devices.

 

Table of Content

1. Advantages of antibody detection

2. categories

3. Detection principle

4. Characteristics of various detection methods

5. Scope of application

6. Operation steps

7. Specimen Transport

8. Notes

9. Clinical significance

 

What are the advantages of antibody detection?

1. Combined with nucleic acid detection to improve the detection rate.

2. The problem of sampling may lead to false negatives in nucleic acid detection, and the sampling of antibody detection is relatively uniform.

3. Antibody detection can effectively help improve the diagnosis rate of suspected cases.

4. The laboratory requirements are low, which is conducive to widespread deployment in hospitals at all levels.

5. Epidemiological studies provide supporting data.

Testing kit infographics for COVID19



What categories is antibody test divided into?

According to the detection principle, it is divided into the following 4 categories:

1. Novel coronavirus IgM/IgG antibody detection kit (colloidal gold method)

2. Novel coronavirus IgM/IgG antibody detection kit (fluorescence immunochromatography)

3. Novel coronavirus IgM/IgG antibody detection kit (enzyme-linked immunosorbent assay)

4. Novel coronavirus IgM/IgG antibody detection kit (chemiluminescence method)

Detection principle editing broadcast

(Take IgM antibody as an example)

1. Colloidal gold method (taking indirect method as an example)

The detection principle of the new coronavirus (2019-nCoV) IgM antibody detection kit (colloidal gold method) is to label mouse anti-human IgM with colloidal gold. 

Also at the same time, the new coronavirus antigen is coated on the nitrocellulose membrane, and the colloidal gold immunochromatography is used to indirectly.

The principle of the method achieves the purpose of detecting the novel coronavirus IgM antibody in human serum.


2. Fluorescence Immunochromatography

The principle of the new coronavirus IgM antibody detection kit (fluorescence immunochromatography) is based on dry fluorescent labeling technology and immunochromatography technology, using whole blood, serum or plasma as samples, and supporting an automatic fluorescence immunoassay quantitative analyzer. 

Automatic puncture and sample injection to achieve "sample in, result out", avoiding the generation of aerosols to the greatest extent, and reducing the risk of pollution to operators and the environment.


3. ELISA (take capture method as an example)

The principle of the new coronavirus IgM antibody detection kit (enzyme-linked immunosorbent assay) is to apply the capture enzyme-linked immunosorbent assay method, coat the reaction plate with anti-human IgM monoclonal antibody, add calibrators or diluted samples.

The viral IgM antibody combines with the coated monoclonal antibody to form an anti-human IgM antibody-IgM antibody complex. 

After washing, the HRP-labeled 2019-nCoV N protein antigen (E protein antigen or S protein antigen) is added to form an anti-human IgM antibody. -IgM antibody-2019-nCoV N protein antigen-HRP complex. 

After washing the plate, the TMB substrate was added, and the HRP catalyzed substrate on the complex formed a blue substance, which turned yellow after adding the stop solution, and had a specific absorption peak at 450nm wavelength. Qualitative detection of 2019-nCoV IgM antibodies in human serum by peak level.


4. Chemiluminescence method (taking indirect method as an example)

The principle of the novel coronavirus antibody detection kit (chemiluminescence method) is that the high-tech material magnetic beads mark the recombinant protein of the virus, which is used to bind the virus antibody IgM in the blood sample, and then use the secondary antibody to identify the antibody.

Alkaline phosphatase is coupled to the secondary antibody. After adding the substrate, a light signal will be generated.

The chemiluminescence instrument detects photons through a highly sensitive PMT (photomultiplier tube), thereby achieving high sensitivity detection at the pg (picogram) level.


What are the features of various COVID antibody detection methods?

The colloidal gold method is easy to operate and can be directly visually interpreted, and the detection can be completed in about 15 minutes; the immunofluorescence chromatography method is as convenient as the colloidal gold method, and the detection is rapid, but requires instrument interpretation.

The enzyme-linked immunosorbent assay can use conventional enzymes Generally speaking, the sensitivity of the standard instrument is relatively high, but the detection time is long (about 1.5 hours), and there are many operation steps. Measures should be taken to avoid infection during the operation.

The chemiluminescence method is generally more sensitive, and the fully automatic chemiluminescence immunoassay can be used to complete the detection without too much manual operation, and the detection time is generally about half an hour.

 

What is the scope of application of COVID antibody detection?

For the qualitative detection of novel coronavirus (2019-nCoV) IgM/IgG antibodies in human serum, plasma and venous whole blood samples in vitro. 

It is only used as a supplementary test index for suspected cases with negative nucleic acid test for novel coronavirus or used in conjunction with nucleic acid detection in the diagnosis of suspected cases. For medical institution use only.

 

What are the Operation steps of conducting Corona virus antibody test?

(Take the National Machinery Note 20203400240 as an example)

(1) Take out the kit and equilibrate at room temperature for 20~30 minutes.

(2) Drop 10 μL of serum or plasma sample, and 20 μL of whole blood sample into the reaction well, and wait for the liquid to be fully inhaled.

(3) Add 2 drops of sample diluent to the reaction well, and wait until the liquid is fully inhaled.

(4) 1-15 minutes to interpret the results.

Positive result: 1-15 minutes after the start of the test, there are bands on the C-line and T-line of the test card.

Negative result: Only the C line of the test card has a band within 15 minutes, and there is no band at the T line.

Invalid result: within 15 minutes, there is no strip at the position of C line and T line of the test card or only at the position of T line and no strip at the position of C line.

Corona virus testing

 


Specimen Transport 

1. In-hospital transportation

Packaging: After the specimen is collected, wipe or spray the outer surface of the specimen container with 1000mg/L chlorine-containing disinfectant, and then put it in a special specimen ziplock bag with a biosafety warning label for packaging, and use 1000mg/L of 1000mg/L chlorine-containing disinfectant on the outer surface of the ziplock bag.

L chlorine-containing disinfectant is disinfected, and then placed in a special closed transfer box, and the outer surface of the transfer box is disinfected with 1000mg/L chlorine-containing disinfectant.

Transportation: It will be transported to the laboratory by specially trained personnel who have undergone biosafety training. The transportation personnel should wear hats, disposable surgical masks, gloves, and isolation gowns. During the transfer, keep the transfer box stable and avoid violent shocks and bumps.

 

2. Out-of-hospital transportation

It should be implemented in accordance with the requirements of the "Regulations on the Management of the Transportation of Highly Pathogenic Pathogenic Microorganisms (Virus) Species or Samples that Can Infect Humans" (Order No. 45 of the Ministry of Health).

According to the national standard of "Technical Guidelines for Laboratory Testing of Pneumonia Infected by Novel Coronavirus", the transportation packaging of new coronavirus strains and other potentially infectious materials is classified as Class A. The corresponding UN number is UN2814, and the packaging materials should meet the PI602 classification and packaging Require.

 

Coronavirus Test Kit Notes 

1. Do not ingest food or smoke when collecting specimens. Wear disposable gloves and wash your hands afterwards.

2. The antibody detection kit is very sensitive to humidity, so pay attention to the function decline caused by humidity.

3. When taking out the reagent, avoid touching the test line with hands or other foreign objects.

4. When judging the results, be aware that repeated freezing or thawing may lead to false negative or false positive results.

 

What is the clinical significance of Corona virus testing with the aid of kit?

1. IgM and IgG antibodies are immune defense proteins produced by the human body after infection with the new coronavirus. IgM antibodies are produced early, and once infected, they are produced rapidly, last for a short time, and disappear quickly. 

A positive test in blood can be used as an indicator of early infection and can be used for Early diagnosis of infection.

2. IgG antibodies are produced late, last for a long time, and disappear slowly. A positive test in blood can be used as an indicator of infection and previous infection.

3. The serum 2019-nCoV-specific IgM antibody and IgG antibody are positive; the serum 2019-nCoV-specific IgG antibody changes from negative to positive, or the recovery period is 4 times or more higher than that in the acute period" is the serological basis for confirmed cases.

 

The novel coronavirus (2019-nCoV) antibody detection kit is used for rapid qualitative detection of novel coronavirus IgM/IgG antibodies in human whole blood, serum and plasma. The test results can be obtained by visual observation within 15 minutes at the fastest.


 


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