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Syphilis helicoid antibody chemiluminescence immune assay determination kit and method for preparing same

A technology of chemiluminescent immunity and Treponema pallidum, which is applied in the field of immunoanalysis medical diagnosis, can solve the problems of inability to widely apply clinical diagnosis and scientific research work, and limit popularization and use, and achieve a shortened detection window period, non-infectious, and high sensitivity Effect

Inactive Publication Date: 2009-02-11
北京科美东雅生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The chemiluminescence immunoassay kit in the prior art is a closed fully automatic chemiluminescence measurement system, which requires an expensive fully automatic chemiluminescence measuring instrument, thus limiting its popularization and use, and cannot be widely used in clinical diagnosis and scientific research

Method used

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  • Syphilis helicoid antibody chemiluminescence immune assay determination kit and method for preparing same
  • Syphilis helicoid antibody chemiluminescence immune assay determination kit and method for preparing same

Examples

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Embodiment 1

[0038] Example 1 Preparation of Treponema pallidum antibody chemiluminescence immunoassay assay kit of the present invention

[0039] 1. Preparation of enzyme-labeled antigen

[0040] Three Treponema pallidum specific proteins 15 (TpN15), 17 (TpN17) and 47 (TpN47) were labeled with sodium periodate oxidation labeling method and coupled with horseradish peroxidase. After adding 50% glycerol, it was aliquoted and stored at -20°C.

[0041] 2. Preparation of TP negative and positive control substances

[0042] Positive control serum: the high-titer positive human serum determined by the exact method is mixed into positive plasma (PositivePool, the number of plasma parts is greater than 5), heated and inactivated at 56°C for 1 hour, properly diluted with newborn bovine serum, and added with biological preservation Add 1 / 10000th (W / V) of food red to make it red, sterilize and filter, and store at 2-8°C.

[0043] Negative control serum: use human serum that is negative for syphili...

Embodiment 2～3

[0089] Embodiment 2~3 preparation TP assay kit of the present invention

[0090] Except that the TP-specific recombinant antigen was labeled with alkaline phosphatase, AMPPD was used as the chemiluminescent substrate, plastic beads were used as the carrier, the pH value of the coating solution was 8.4, and the pH value of the blocking solution was 7.5. The same method as Example 1 was used to prepare the TP assay kit.

Embodiment 4

[0091] Example 4 Preparation of TP assay kit of the present invention

[0092] The TP assay kit was prepared in the same manner as in Example 1 except that magnetic particles were used as the carrier.

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Abstract

The invention discloses a kit of chemiluminescent immunological analysis measurement of a Treponema pallidum antibody, and preparation method thereof, which belongs to the technical field of immunological analysis medical diagnosis. The kit comprises (1) a carrier coated with a treponema pallidum specific recombination protein antigen; (2) treponema pallidum antibody negative and positive reference substances; (3) an enzyme labeled treponema pallidum specific recombination protein antigen; and (4) an enzyme acted chemiluminescent primer. Furthermore, the preparation method of the kit based on the invention comprises the following steps of (1) preparing TP antibody negative and positive reference substances; (2) labeling the TP specific recombination protein antigen with an enzyme; (3) coating with the carrier; (4) sub-packaging; and (5) assembling. The kit of the detection of the Treponema pallidum antibody has the advantages of easy and simple operation, easy popularization, high sensitivity, strong specificity, good repeatability, safety, non toxicity, and no pollution.

Description

technical field [0001] The invention belongs to the technical field of immunoanalysis medical diagnosis. Specifically, the invention provides a treponema pallidum antibody chemiluminescence immunoassay assay kit and a preparation method thereof. Background technique [0002] Syphilis (syphilis) is a common sexually transmitted disease caused by Treponema pallidum (also known as Treponema pallidum). It invades the skin and mucous membranes, and invades internal organs in the late stage. In severe cases, it can cause serious damage to the cardiovascular system and nervous system, causing disability or even life-threatening, which is extremely harmful. Syphilis is mainly transmitted to others through sexual behavior, and can also be transmitted to the fetus through the placenta, and congenital syphilis occurs; a very small number of patients can be transmitted through kissing, breastfeeding, blood transfusion, and contact with daily necessities that have infectious damage to pa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/571G01N33/569G01N33/543G01N21/76
Inventor 张黎詹先发应希堂胡国茂
Owner 北京科美东雅生物技术有限公司
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