A kit for improving the sensitivity of T-cell test for tuberculosis infection

A kit and a sensitivity technology are applied in the field of kits for improving the sensitivity of T-cell test for tuberculosis infection, which can solve the problems of reducing the sensitivity of the test, and the sensitivity needs to be further improved, so as to achieve the effect of improving the sensitivity and accuracy.

CN111735969BActive Publication Date: 2020-11-13南昌大学第一附属医院
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Publication Date
2020-11-13

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Abstract

The invention relates to a kit for improving tuberculosis infection T cell test sensitivity. The kit comprises a standard T-SPOT.TB test material and an alpha-PD-L1 antibody, the standard T-SPOT.TB test material comprises a microporous plate coated with an IFN-gamma antibody, a tuberculosis specific antigen early secretion targeting antigen, a culture filtered protein antigen, a positive quality control solution, a negative control cell culture solution, a concentrated biotin labeled secondary antibody reagent and a substrate developing solution. According to the invention, a PD-L1 antibody (alpha-PD-L1) is used to block the PD-1 / PD-L1 pathway; the sensitivity of T-SPOT.TB is protected from being influenced by inhibition of lDGs (low-density neutrophils) in PBMCs of tuberculosis patients on secretion of IFN-gamma by T cells, so that the sensitivity of T-SPOT and the accuracy of tuberculosis infection T cell tests are improved.
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Description

technical field

[0001] The invention relates to the technical field of early screening of tuberculosis infection, in particular to a kit for improving the sensitivity of tuberculosis infection T cell test. Background technique

[0002] Tuberculosis is a chronic infectious disease caused by Mycobacterium tuberculosis infection. The World Health Organization reported that there were 10 million new tuberculosis cases in 2018, but this is only the tip of the iceberg; there is also a huge number of latently infected people, about 1.7 billion people. This part of the latently infected population has no clinical symptoms, CT scans are normal, and there is no antibody response, making it difficult to diagnose the presence of Mycobacterium tuberculosis. The active tuberculosis cases all come from latent infection populations, and latent infection populations may turn into active tuberculosis when they have low immunity, such as comorbid underlying diseases such as diabetes, rheumati...

Examples

Embodiment

[0057] (1) Test subjects (source of venous blood collection): In actual clinical trials, tuberculosis patients in the First Affiliated Hospital of Nanchang University and Jiangxi Provincial Chest Hospital were used as clinical subjects. Inclusion criteria: in line with the 2005 release of the Chinese Medical Association According to the standards of the "Clinical Diagnosis and Treatment Guidelines. Tuberculosis Volume", patients with pulmonary tuberculosis can be clearly diagnosed. Exclusion criteria: pregnant women, HIV-infected patients, diabetes, chronic liver and kidney diseases, autoimmune diseases, and cancer. The control group was healthy adult volunteers from the Physical Examination Center of the First Affiliated Hospital of Nanchang University. Inclusion criteria: Chest X-ray showed no abnormalities, HIV and PPD tests were negative, and there was no recent infectious disease.

[0058] (2) T-SPOT.TB test process

[0059] (1) Separation of PBMCs, the process is as fo...