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Human immunodeficiency virus antigen and antibody combined detection kit, use and detection method thereof

A technology of human immunodeficiency and detection kit, which is applied in the field of human immunodeficiency virus detection to achieve the effects of reliable detection results, improved early detection rate and high detection sensitivity

Inactive Publication Date: 2017-03-29
SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Unfortunately, such requirements pose great challenges to the sensitivity and specificity of the kit

Method used

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  • Human immunodeficiency virus antigen and antibody combined detection kit, use and detection method thereof
  • Human immunodeficiency virus antigen and antibody combined detection kit, use and detection method thereof
  • Human immunodeficiency virus antigen and antibody combined detection kit, use and detection method thereof

Examples

Experimental program
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Effect test

Embodiment approach

[0029] According to one embodiment of the present invention, the detection kit comprises the following components:

[0030] (a) Magnetic particle coating: HIV-1 / M specific antigen, HIV-1 / O specific antigen, HIV-2gp36 antigen and HIV p24 antibody are coated on the magnetic particle, present in the magnetic particle diluent ;

[0031] (b) Enzyme markers: labeled enzyme-labeled HIV-1 / M-specific antigens, HIV-1 / O-specific antigens, HIV-2gp36 antigens and HIV p24 antibodies, present in enzyme marker diluents;

[0032] (c) Sample Treatment Fluid: Contains a non-ionic surfactant; and

[0033] (d) Test diluent: buffer used to dilute the sample to be tested.

[0034] The above four components are described in detail below. It should be noted that, unless otherwise specified, the content percentage (%) in the present invention refers to weight volume percentage (W / V%), for example, 1.0% refers to 1.0W / V%, wherein weight ( The units of W) and volume (V) may be grams (g) and millilite...

Embodiment 1

[0079] The HIV antigen and antibody combined detection kit of this embodiment contains the following components: magnetic particle coating working solution (Ra), enzyme marker working solution (Rb), sample processing solution (Rc) and test diluent (Rd). The process of kit preparation is as follows:

[0080] 1. Preparation of magnetic particle coating

[0081] The process of linking specific antibodies or antigens to magnetic beads by covalent coupling is called magnetic particle coating; the prepared magnetic particle and antibody or antigen conjugate is called magnetic particle coating.

[0082] In the preparation of the HIV kit in this example, the antigens or antibodies used to coat the magnetic particles include HIV-1 / M specific gp41 antigen, HIV-1 / O specific gp41 antigen, HIV-2 gp36 antigen and HIV p24 antibody IV Among them, the HIV p24 antibody is a monoclonal antibody of two sources (respectively, a mouse-derived antibody and a human-derived antibody). The basic prin...

Embodiment 2

[0125] The magnetic particle coating and the enzyme label were prepared in the same manner as in Example 1. The components of magnetic particle coating working solution (Ra), enzyme marker working solution (Rb) and test diluent (Rd) are the same as in Example 1.

[0126] Prepare the sample treatment solution (Rc) according to the composition in the table below

[0127]

[0128] Use the kit of this embodiment to detect HIV-1 / 2 antibody national reference substance and HIV p24 antigen national reference substance, negative and positive reference substance coincidence rate, precision, sensitivity and other index results are shown in Table 3 and Table 4. In addition, 10 HIV-1 / O antibody-positive samples were tested, and all 10 were positive.

[0129] Table 3 HIV-1 / 2 antibody national reference product test results

[0130]

[0131] Table 4 HIV p24 antigen national reference product test results

[0132]

[0133] In order to illustrate the influence of the pH value of t...

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Abstract

The invention discloses a human immunodeficiency virus antigen and antibody combined detection kit, use and a detection method thereof. The detection kit comprises the following components: (a) magnetic particle coating matter, which includes an HIV-1 / M specific antigen, an HIV-1 / O specific antigen, an HIV-2gp36 antigen, and an HIV p24 antibody that coat the magnetic particles and exist in a magnetic particle diluent; (b) an enzyme marker, which inlcudes marker enzyme marked HIV-1 / M specific antigen, HIV-1 / O specific antigen, HIV-2gp36 antigen, and HIV p24 antibody in an enzyme marker diluent; (c) a sample treatment solution, which contains a nonionic surfactant; and (d) a test diluent, which is a buffer solution for diluting a to-be-tested sample. The kit can realize combined detection of human immunodeficiency virus antigens and antibodies, and has good specificity and high sensitivity.

Description

technical field [0001] The invention relates to the technical field of human immunodeficiency virus detection, in particular to a combined detection kit for human immunodeficiency virus antigen and antibody and its use and detection method. Background technique [0002] Human Immunodeficiency Virus (Human Immunodeficiency Virus, HIV), the pathogen of acquired immunodeficiency syndrome (AIDS), belongs to the family Retroviridae, the genus Lentivirus, and the subgenus Primate Immunodeficiency. HIV transmission mainly includes blood and contaminated blood products, sexual contact and mother-to-child transmission before, during and after pregnancy. [0003] There are currently two types of human immunodeficiency virus, namely HIV-1 and HIV-2, and they have their own subtypes. Different subtypes are prevalent in different regions, and the same subtype also has certain differences in different regions. HIV-1 can be divided into three distant groups: M group (main group), O group...

Claims

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Application Information

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IPC IPC(8): G01N33/569G01N33/543G01N33/535
CPCG01N33/535G01N33/54326G01N33/56988G01N2333/161
Inventor 吴令嘉余枝广姜德华王頔张强杨薇
Owner SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD
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