Novel coronavirus detection kit and detection method

Abstract

The invention discloses a detection kit for detecting a novel coronavirus. The kit comprises an anti-2019-nCoV IgM reaction conjugate, an anti-2019-nCoV IgG reaction conjugate, a 2019-nCoV IGRAs reaction conjugate, an anti-2019-nCoV IgM marker, an anti-2019-nCoV IgG marker, a 2019-nCoV IGRAs marker and the like. The kit disclosed by the invention has the advantages that the detection results of the anti-2019-nCoV IgM, the anti-2019-nCoV IgG and the 2019-nCoV IGRAs are combined; the kit is helpful for early auxiliary diagnosis of the 2019-nCoV in the acute infection period and the recurrence period, judgment of recent infection and long-term infection of the 2019-nCoV, and auxiliary diagnosis of dominant infectors and recessive infectors when antibodies of the 2019-nCoV infectors do not appear. Positive infected people can be detected and confirmed more simply, conveniently, rapidly and accurately, the detection rate of novel coronavirus nucleic acid negative suspected patients is increased, and light or asymptomatic novel coronavirus pneumonia restorers are tracked.

Description

technical field [0001] The invention relates to the technical field of biomedical detection, in particular to a detection kit and detection method for a novel coronavirus. Background technique [0002] Novel coronavirus (2019-nCoV), coronaviruses are a large family of viruses known to cause colds as well as more serious diseases such as Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS). The novel coronavirus is a new strain of coronavirus that has never been found in humans before. Common signs after a person is infected with a coronavirus include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, infection can lead to pneumonia, severe acute respiratory syndrome, kidney failure, and even death. Currently, there is no specific treatment for the disease caused by the novel coronavirus. At present, suspected cases can be diagnosed with one of the following etiological evidences: 1. Real-time fluores...

AI Technical Summary

Problems solved by technology

At present, nucleic acid and virus gene sequencing detection is difficult, and the detection rate of nucleic acid is not high. At present, the detection rate of nucleic acid for real cases is only 30% to 50%. The operation is cumbersome, and the clinical diagnosis of new coronary pneumonia is slow. A common problem, related to many experimental factors, such as: different raw material suppliers, production processes, R&D personnel capabilities, technical means used, patient virus infection cycle, sample type selection, sampling quality, sampling process, transportation process, nucleic acid extraction The purity and yield and experimental operation factors will affect the accuracy of nucleic acid detection reagents

Specimens for virus antigen detection are generally upper respiratory tract specimens, which are generally sampled by oropharyngeal swabs or nasopharyngeal swabs, which have a good detection effect in the early stage of the disease, but the positive rate of detection decreases with the development of the disease and treatment. Antigen detection The sensitivity of reagents is greatly affected by the performance of antibody raw materials and markers, and is also affected by factors such as the patient’s virus infection cycle, sample type selection, sampling quality, and sampling process. Between 20% and 70%, and the target virus cannot be detected when the viral load is low, and a negative test cannot be used as a diagnostic criterion for excluding infection, and the nucleic acid test will only be positive when the virus still exists

Tests do not identify people who have experienced infection, recovered, and cleared the virus from their bodies

In addition, it has also been reported that 2019-nCoV IgM / IgG antibodies can be used as supplementary detection indicators for suspected cases with negative nucleic acid tests of the new coronavirus or used in conjunction with nucleic acid detection in the diagnosis of suspected cases. IgM antibodies are the earliest antibodies in the initial humoral immune response, and IgG Antibody is the antibody with the highest content in serum and body fluid, accounting for 75% to 80% of the total serum Ig. It has high affinity and is widely distributed in the body. The IgG antibody level in the recovery period is 4 times or more higher than that in the acute period. Only retrospectively Diagnostic significance, generally produced in large quantities during the recovery period of patients, with poor timeliness, IgG antibody cannot be used as an early diagnosis of viral infection, and is meaningless for the diagnosis and prevention and control of the highly infectious new coronavirus 2019-nCoV

However, the current 2019-nCoV IgM antibody detection on the market uses an indirect method, which is greatly affected by the high IgG antibody content, resulting in low sensitivity, low detection rate, and is susceptible to cross-reaction of interfering factors in blood samples. prone to false positives

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