Novel Coronavirus (2019-nCoV) Antibody detection Kit
The 2019-nCoV antibody detection kit for novel coronaviruses is used to quickly and accurately identify novel coronavirus IgM/IgG antibodies in human whole blood, serum, and plasma. Within 15 minutes, at the most, visual inspection can provide the test findings.
The 2019-nCoV Antibody Detection Kit for New Coronaviruses is
a Category III Medical Device.
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 benefits does antibody detection offer?
1. To increase the detection rate, along with nucleic acid detection.
2. The issue of sampling may result in false negatives in the detection of nucleic acids, but the sampling used in the detection of antibodies is often uniform.
3. Antibody detection can significantly increase the accuracy of suspected cases' diagnoses.
4. Because the laboratory requirements are modest, hospitals of all levels can use them widely.
5. Epidemiological research offers supportive evidence.
What classifications does an antibody test fall under?
It is classified into the following 4 groups in accordance with the detecting principle:
1. A new IgM/IgG antibody detection kit for coronavirus (colloidal gold method)
2. A novel IgM/IgG antibody detection kit for coronavirus (fluorescence immunochromatography
3. A new IgM/IgG antibody detection kit for coronavirus (enzyme-linked immunosorbent assay)
4. A novel IgM/IgG antibody detection kit for coronavirus
(chemiluminescence method)
Detection-based broadcast editing
(Use the IgM antibody as an illustration)
Method #1: Colloidal gold (taking indirect method as an example)
The novel coronavirus (2019-nCoV) IgM antibody detection kit (colloidal gold technique) works on the idea of labelling mouse anti-human IgM.
Indirectly using colloidal gold immunochromatography, the novel coronavirus antigen is also deposited on the nitrocellulose membrane at the same time.
The method's basic idea succeeds in finding the novel
coronavirus IgM antibody in human serum.
3. Fluorescent Immunochromatography
The novel coronavirus IgM antibody detection kit's methodology (fluorescence immunochromatography) is based on dry fluorescent labelling and immunochromatography technologies, and it supports an automatic fluorescence immunoassay quantitative analyzer with samples of whole blood, serum, or plasma.
To achieve "sample in, result out," automatically
puncture and inject samples are used. This minimises the creation of aerosols
and the risk of operator and environmental pollution.
3. ELISA (take capture method as an example)
The anti-human IgM monoclonal antibody is coated on the reaction plate using the new coronavirus IgM antibody detection kit's (enzyme-linked immunosorbent assay) basic operating concept is to use the capture enzyme-linked immunosorbent assay method, add calibrators or diluted samples.
An anti-human IgM antibody-IgM antibody complex is created when the viral IgM antibody binds with the coated monoclonal antibody.
After washing, an anti-human IgM antibody is created by mixing in the HRP-labeled 2019-nCoV N protein antigen (or E protein antigen or S protein antigen). 2019 nCoV N protein antigen-IgM antibody-HRP complex.
The TMB substrate was added to the plate after it had been washed, and the HRP-catalyzed substrate on the complex created a blue substance. This substance turned yellow when the stop solution was added, and it had a distinct absorption peak at 450 nm. The qualitative peak level detection of 2019-nCoV IgM antibodies in human serum.
4. The use of chemiluminescence (taking indirect method as an
example)
The recombinant protein of the virus, which is used to bind the virus antibody IgM in the blood sample, is marked by the high-tech material magnetic beads in the innovative coronavirus antibody detection kit (chemiluminescence method). The secondary antibody is then used to identify the antibody.
The secondary antibody is linked to alkaline phosphatase. A light indication will be produced after the substrate has been added.
The chemiluminescence apparatus achieves high sensitivity
detection at the pg (picogram) level by detecting photons through an extremely
sensitive PMT (photomultiplier tube).
What distinguishes the several COVID antibody detection
techniques?
The immunofluorescence chromatography method is as convenient as the colloidal gold method and the detection is quick, but it requires instrument interpretation. The colloidal gold method is simple to use, can be immediately visually interpreted, and the detection can be finished in approximately 15 minutes.
Conventional enzymes can be used in the enzyme-linked immunosorbent assay. In general, the typical instrument's sensitivity is quite high, but the detection time is lengthy (approximately 1.5 hours) and there are numerous operation steps.
During the procedure, precautions should be followed
to prevent infection.
The fully automatic chemiluminescence immunoassay can be
utilised to complete the detection without requiring a lot of manual labour,
and the detection time is typically around 30 minutes. The chemiluminescence
approach is typically more sensitive.
What is the COVID antibody detection's range of use?
For the in vitro qualitative detection of human serum, plasma, and venous whole blood samples containing novel coronavirus (2019-nCoV) IgM/IgG antibodies.
Only suspected cases with negative nucleic acid tests for new
coronaviruses or suspected cases diagnosed in conjunction with nucleic acid
detection are utilised for this index. only for usage in medical institutions.
What are the operational stages for running an anti-corona virus test?
(As an illustration, consider the National Machinery Note 20203400240.)
(1) Remove the kit and let it acclimate for 20–30 minutes at room temperature.
(2) Pour 20 mL of whole blood and 10 l of serum or plasma into the reaction well, and then wait for the liquid to be completely inhaled.
(3) To the reaction well, add 2 drops of the sample diluent. Then, wait until the liquid has been completely inhaled.
(4) 1–15 minutes to analyse the findings.
Positive outcome: The C-line and T-line of the test card have
bands 1 to 15 minutes into the test.
Negative outcome: The T line of the test card has no band,
and only the C line does within 15 minutes.
Invalid result: either only at the position of the T line and
no strip at the position of the C line on the test card within a 15-minute time
frame.
Specimen Transport
1. In-hospital transportation
Packaging: After the sample is obtained, use 1000 mg/L of
1000 mg/L chlorine-containing disinfectant to wipe or spray the exterior of the
sample container. Then, place the sample in a special specimen ziplock bag and
attach a biosafety warning label to the outside of the ziplock bag.
L of disinfection that contains chlorine is cleaned, cleaned
inside and out, and then put inside a specific closed transfer box. The
transfer box's exterior is then cleaned with 1000 mg/L of disinfectant that
contains chlorine.
Transport: It will be brought to the lab by employees who
have undergone biosafety training and are properly trained in doing so. The
transportation staff should dress in isolation gowns, disposable medical masks,
caps, and gloves. Keep the transfer box steady and steer clear of abrupt bumps
and shocks during transferring.
2. Transportation to and from hospitals
The "Regulations on the Management of the Transportation
of Highly Pathogenic Pathogenic Microorganisms (Virus) Species or Samples that
Can Infect Humans" should be followed when implementing it (Order No. 45 of
the Ministry of Health).
The transportation packaging of novel coronavirus strains and
other potentially infectious goods is categorised as Class A according to the
national standard "Technical Guidelines for Laboratory Testing of
Pneumonia Infected by Novel Coronavirus." The packing materials should
adhere to the PI602 categorization and packaging requirements, and the related
UN number is UN2814.
1. Don't consume food or smoke while collecting specimens from the body. Put on disposable gloves, then wash your hands.
2. Because the antibody detection kit is so sensitive to humidity, keep an eye out for any functional deterioration.
3. When removing the reagent, keep your hands and any foreign items away from the test line.
4. Keep in mind that repeated freezing and thawing could produce falsely negative or falsely positive results when evaluating the data.
What clinical significance does a kit for testing for the corona virus have?
1. After being exposed to the novel coronavirus, the human
body produces immune response proteins called IgM and IgG antibodies. IgM
antibodies are created early, and once infected, they are created swiftly, last
for a brief period of time, and then dissipate.
A positive blood test can be used to diagnose infections
early and as a sign of illness in the early stages.
2. IgG antibodies develop late, last for a long time, and
fade away gradually. Blood tests that are positive can be used to detect
current and past infections.
The serological basis for confirmed cases is that "3.
Serum 2019-nCoV-specific IgM and IgG antibodies 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."
The 2019-nCoV antibody detection kit for novel coronaviruses
is used to quickly and accurately identify novel coronavirus IgM/IgG antibodies
in human whole blood, serum, and plasma. Within 15 minutes, at the most, visual
inspection can provide the test findings.
 |
| Dr. Shawna Reason |
Education: MBBS, MD
Occupation: Medical Doctor / Virologist
Specialization: Medical Science, Micro Biology / Virology, Natural Treatment
Experience: 15 Years as a Medical Practitioner
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