NOVABIOS乙腦IGM抗體檢測試劑盒用于暴露于日本腦炎病毒（JEV）是用于檢測人血清中的IgE抗體對JEV衍生的重組抗原（JERA）（1-4）的ELISA測定系統。這個測試是為了幫助診斷人類暴露于日本腦炎病毒（JEV）。它不是為了篩選血液或血液成分，僅用于專業的體外診斷用途。該試劑盒尚未針對疫苗誘導的血清學轉換研究進行優化。

            NOVABIOS乙腦IGM抗體檢測試劑盒

JE Detect^TM IgM ANTIBODY

CAPTURE ELISA (MAC-ELISA)

 

 

INTENDED USE

 

The JE Detect MAC-ELISA test for exposure to Japanese Encephalitis Virus (JEV) is an ELISA assay system for the detection of IgM antibodies in human serum to JEV derived recombinant antigen (JERA) (1-4). This test is to aid in the diagnosis of human exposure to the Japanese Encephalitis Virus (JEV). It is not intended to screen blood or blood components, and is for professional in vitro diagnostic use only. 

 

SUMMARY AND EXPLANATION OF THE TEST

 

Exposure to JEV causes a disease with a number of symptoms including encephalitis (5-8). The JE Detect MAC-ELISA employs a recombinant antigen called JERA, which can be used as a rapid serological marker for JEV infection. The JERA protein is a recombinant antigen, which consists of a stretch of peptides from different parts of the JEV antigens.

NOVABIOS乙腦IGM抗體檢測試劑盒 

 

PRINCIPLE OF THE TEST

 

 

The JE Detect MAC-ELISA consists of one enzymatically amplified "two-step" sandwich-type immunoassay.

 

In this assay, JE Detect Negative Control (Represents non-reactive serum), JE Detect IgM Positive Control (Represents reactive serum), and unknown serum samples are incubated in microtitration wells which have been coated with anti-human IgM antibodies, followed by incubation with both JEV derived recombinant JERA and Normal Cell Antigen (NCA) separay. The serum samples may be diluted with Sample Dilution Buffer for JE Detect IgM. After incubation and washing, the wells are treated with a JERA-specific antibody labeled with the enzyme horseradish peroxidase (HRP). After a second incubation and washing step, the wells are incubated with the tetramethylbenzidine (TMB) substrate.

An acidic stopping solution is then added and the degree of enzymatic turnover of the substrate is determined by absorbance measurement at 450 nanometers. Above a certain threshold, the ratio of the absorbencies of the JERA and the control wells accuray determines whether antibodies to JEV are present.

更具體的說明請根據以下信息

 

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