Igm Detection Is Simple And Quick.

The colloidal gold kit stood on the spotlight stage again.

In February 27th, the Information Office of the Guangzhou municipal government held a special press conference on epidemic prevention and control at Guangzhou Medical University. Zhong Nanshan, director of the high level expert group of the Chinese Academy of engineering and head of the national health and Health Committee, and director of the National Center for respiratory diseases clinical medical research, pointed out that workers must undergo double tests before going to work: one is nucleic acid detection, the other is IgM (immunoglobulin) detection, and the two tests prove that it is all right. In addition, all factories, including tap water and toilet sewer, must be kept unobstructed.

Prior to the announcement by the State Administration of food and Drug Administration in the evening of February 22nd, emergency examination and approval passed 3 new coronavirus products from 3 enterprises, including 2 colloidal gold antibody detection reagents and 1 isothermal amplification chip nucleic acid detection reagents. The 3 companies are Wanfu biological coronavirus (2019-nCoV) antibody detection kit (colloidal gold method), the new 2019- coronavirus IgM/IgG joint detection kit (colloidal gold method), Boao biological new coronavirus (2019-nCoV) isothermal amplification chip nucleic acid reagents.

With the approval of the first batch of IgM kits, a number of agencies claimed to have developed colloidal gold kits for re manufacturing and resuming production. Antibody detection is used for primary screening to ensure that no leakage is detected; nucleic acid detection is used for differential diagnosis of pathogens and to ensure good market positioning remains to be clarifying.

Stir up frequently without being approved.

In addition to Weifang, Shandong, Hong Wah, Tangshan, Tangshan, Guangzhou, Wanfu biology, and other companies, Zhongshan Hospital Affiliated to Fudan University, academician Ge Jun wave team also announced the joint development of the same technology IgM antibody and IgG antibody detection reagent. The two reagents can be used to determine whether the patient is infected with the new crown virus within 10 minutes and distinguish early or late infection.

The number of companies entering the IgM kit is increasing. In the two enterprises currently approved, Wanfu has revealed that the capacity of the new crown product will soon reach 300 thousand per person per day, and the production capacity will climb to 500 thousand people per day or even more with the gradual resumption of production workers and the maturity of production technology. Many other unapproved enterprises are also eager to try.

"At the present stage, the research and development of IgM kit is very hot. Many related enterprises and institutions are pouring in. Even some unapproved enterprises have begun to stir up the fry. Although the kit has been developed successfully, it still takes a while to go through the examination and approval of medical devices and the wide application in clinical practice. Nucleic acid detection is still the gold standard for the diagnosis of new crown pneumonia, and the efficacy of antibody detection still needs large-scale clinical verification. An in vitro detection researcher from Southern China told the twenty-first Century economic news reporter.

The first batch of newly approved coronavirus antibodies tested in the colloidal gold kit is a Guangzhou Wanfu biotech Limited by Share Ltd. In terms of biology, the kit uses colloidal gold method to detect the new crown virus IgM/IgG antibody in human serum, plasma and whole blood samples. It is easy to operate and can be read in 15 minutes.

Although the IgM kit has obvious characteristics, it is still a supplement to the "gold standard" for nucleic acid detection, and has not yet been included in the diagnostic criteria of the health care committee.

Wang Peng, director of the laboratory center of Beijing Ditan Hospital, believes that it is possible to incorporate antibody tests into new diagnostic protocols after having reliable kit. But there is still a long way to go from developing the kit to the extensive clinical application. The most difficult process is to obtain the registration process of medical devices. Although the state has opened a fast track for emergency response, it will take weeks to complete clinical trials and approval. Before, the average daily detection ability of nucleic acid detection in Wuhan was less than 1000 cases, which could not meet the most basic diagnostic needs, let alone screening. Nucleic acid detection is like fishing rod fishing in the tributary of the reservoir. The specificity is good. IgM and IgG detection is to use nets to catch fish in the reservoir, with high sensitivity and high efficiency.

Easy operation and fast screening efficiency

The advantages of IgM kit are obvious, and the main advantage is fast.

IgM refers to the immunoglobulin M in serum. It is the first immunoglobulin produced by the human body after exposure to the virus. It is an important indicator of acute or short-term infection of the virus. It can be detected in patients with infection for seventh days or third days. IgG refers to the immunoglobulin G in serum, which may eventually be carried, suggesting that the virus has been infected.

Compared with nucleic acid detection, simple sampling and high detection efficiency are the most prominent features of antibody detection. Unlike nucleic acid tests, throat swabs are needed for sampling. The sampling procedure for antibody detection is simpler. IgM and IgG test using immune chromatography or colloidal gold method, by collecting finger tip blood, only need 0.5 milliliters of blood (20~50 micro rise serum) can be completed detection, so that bedside detection or entry detection can be achieved.

In addition to simple sampling operations, the results of detection of antibodies are shorter, which can greatly improve the detection efficiency.

Dr Pan Liqiang, a researcher at Zhejiang University, said that compared with nucleic acid detection, the test strip technology based on IgM can be detected instantly and the detection time can be reduced to 15 minutes. Academician Ge Junbo also said in a media interview that the combination of the two reagents could determine whether the patient was infected with the new crown virus within 10 minutes.

Antibody testing also helps to reduce the manpower and material resources of patients' isolation consumption. The biggest role is to liberate a number of suspected cases and a large number of close contacts. If the result is negative, it means that the patient is not in the early and middle stages of viral infection, and can greatly shorten the time of returning to normal life.

Wang Jihua, Wanfu biological director, told reporters on twenty-first Century economic report that nucleic acid detection is a diagnostic method for new crown virus infection and has great value for the prevention and control of the epidemic. IgM and IgG are the key components of the body's immune response to the virus. For a long time, the detection of serum IgM and IgG antibodies is a very necessary and routine laboratory examination method for virus infection, such as HIV, hepatitis C virus and so on.

IgM antibody positive usually indicates recent infection. IgG antibody positive indicates longer infection time or previous infection. The new crown virus antibody reagent used colloidal gold immunochromatographic assay for the detection of new crown virus antibody IgM and IgG. It can be used to cover the different stages of the disease development process of new crown pneumonia patients and complement each other with nucleic acid detection. The new crown virus antibody test reagent does not require special testing equipment and reagents to store and transport at room temperature from 2 to 30 degrees. The detection of antibody against new crown virus can make up for the limitation of nucleic acid detection to some extent. For epidemic prevention and control, it provides an important complementary and cooperative means for nucleic acid detection.

?