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Hepatitis E virus antigen, antigen composition thereof and kit comprising antigen or antigen composition and application thereof

A technology of hepatitis E virus and its composition, which is applied in the field of hepatitis virus antigen, can solve the problems of no commercial reagents, etc., and achieve the effects of high sensitivity, strong antigenicity and strong specificity

Active Publication Date: 2013-08-07
NAT INST FOR FOOD & DRUG CONTROL +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the current RT-PCR diagnostic method for detecting HEV RNA is only used in laboratory research, and there is no commercial reagent widely used in clinical practice.

Method used

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  • Hepatitis E virus antigen, antigen composition thereof and kit comprising antigen or antigen composition and application thereof
  • Hepatitis E virus antigen, antigen composition thereof and kit comprising antigen or antigen composition and application thereof
  • Hepatitis E virus antigen, antigen composition thereof and kit comprising antigen or antigen composition and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080] This embodiment relates to the C-terminal and N-terminal antigenic sites of two genotype HEV ORF2 antigens, which are:

[0081] The pS1-6 is the C-terminal antigen of HEV ORF2 type 1, and its site is 351-391 to 640-660aa;

[0082] The pS4-6 is the C-terminal antigen of HEV ORF2 type 4, and its site is 365-405 to 654-674 aa;

[0083] The pS1-1 is the N-terminal antigen of HEV ORF2 type 1, and its site is 1-20 to 90-130aa;

[0084] The pS4-1 is the N-terminal antigen of type 4 HEV ORF2, and its site ranges from 1-20 to 104-144aa.

[0085] The specific implementation scheme of this embodiment is:

[0086]First, the genes were fished out from the stool samples of clinical patients, and they belonged to type 1 and type 4 after sequencing analysis. Its isoelectric point and hydrophilicity were analyzed by Biosun biological software (developed by the Academy of Military Medical Sciences), and according to the literature (Panda SK, Thakral D, Rehman S.2007.Hepatitis E Virus....

Embodiment 2

[0096] This embodiment relates to an antigen composition, a combination of both ends of the ORF2 antigens of hepatitis E type 1 and type 4, that is, the combination of the N-terminal and the C-terminal of the corresponding subtype. Specifically, the C-terminal of pS1-6 is combined with the N-terminal of pS1-1, or the C-terminal of pS4-6 is combined with the N-terminal of pS4-1.

[0097] In the experiment of Example 1, the inventors found that the N-terminal and C-terminal antigens of the ORF2 protein were complementary when detecting anti-HEVIgM antibodies, and pS1-1 and pS1-6, pS4-1 and pS4-6 were combined and packaged respectively. The serial sera of the above ten monkeys were detected, and the results showed that ( Figure 4-A —J), the detection time of the combined antigen is almost the same as that of a single antigen, but the sensitivity of the reagent coated with the combined antigen is enhanced, and the positive detection rate is the sum of the detection rates of the t...

Embodiment 3

[0099] This embodiment relates to a kit for detecting HEV IgM antibody using the aforementioned antigen composition and any one of the antigens in an indirect ELISA method.

[0100] The test adopts the indirect ELISA method, using 96-well polystyrene plates for coating, and using carbonate buffer solution of pH 9.6 to dilute the antigen to 0.5 mg / ml. Use the gradient dilution method to select the optimal coating concentration, that is, to coat the antigen to be coated by gradient dilution, and select confirmed positive and negative samples as positive and negative controls, respectively. With the decrease of the antigen coating concentration, the P / N value It will gradually become larger and reach a plateau, and the inventors choose the antigen concentration at this time as the antigen coating concentration of ELISA. The optimal coating concentrations of the selected antigens pS1-1, pS1-6, pS4-1, pS4-6, pS1-1+pS1-6 and pS4-1+pS4-6 are: 0.5, 2.0, 0.5, 2.0 , 0.5+2.0 and 0.5+2.0...

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Abstract

The invention relates to a Hepatitis E virus antigen. The antigen has the following antigen fragments of: pS1-6, pS4-6, pS1-1 or pS4-1, wherein pS1-6 is a C tail end antigen of type 1 HEV ORF2 with a locus of 351-391 to 640-660aa; pS4-6 is the C tail end antigen of type 4 HEV ORF2 with a locus of 365-405 to 654-674aa; pS1-1 is an N tail end antigen of type 1 HEV ORF2 with a locus of 1-20 to 90-130aa; and pS4-1 is the N tail end antigen of type 4 HEV ORF2 with a locus of 1-20 to 104-144aa. The invention also relates to a composition comprising the antigen and a kit comprising the antigen or the antigen composition and application in detecting the Hepatitis E virus antigen. The Hepatitis E virus antigen provided by the invention has the advantages of strong antigen city and strong specificity. The kit provided by the invention and the application can detect an anti-HEV IgM antibody appearing in a sample as soon as possible so as to realize correct detection and diagnosis in the early period of HEV infection.

Description

technical field [0001] The present invention relates to a hepatitis virus antigen, in particular to a hepatitis E virus antigen, its antigen composition, and a kit and application containing the antigen or antigen composition. Background technique [0002] HEV is a non-enveloped single-stranded positive-sense RNA virus with a genome length of about 7.2kb and three open reading frames (ORFs), which are non-coding regions (NCR), ORF1, ORF2, ORF3 and 3' UTR and PolyA tail. Among them, ORF3 overlaps with an amino acid at the C-terminus of ORF1 and part of the N-terminal amino acids of ORF2. ORF1 encodes 1690 amino acids, mainly non-structural proteins related to viral replication. ORF2 encodes 660 amino acids and is a structural protein of the virus. ORF3 encodes 123 amino acids, and its function is not yet clear. At present, the International Committee on Taxonomy of Viruses (ICTV) has not yet classified it accurately. Lu (Lu L, Li CH, Hagedorn.2006.Phylogenetic analysis o...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K14/08G01N33/53
Inventor 王佑春马红霞张贺秋宋晓国
Owner NAT INST FOR FOOD & DRUG CONTROL
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