Tuberculosis(TB) is a chronic disease with strong infectiousness caused by Mycobacterium tuberculosis. It can infect various organs and systems of the human body, regardless of age, gender, race, occupation and region. Among all, pulmonary tuberculosis is the most common. It is the deadliest bacterial infection, which can cause over 14 million death per year[1]. TB is the ninth leading cause of death worldwide and an important cause of death as an infectious disease.

The Key facts from WHO

· A total of 1.6 million people died from TB in 2021 (including 187 000 people with HIV). Worldwide, TB is the 13th leading cause of death and the second leading infectious killer after COVID-19 (above HIV/AIDS).

· In 2021, an estimated 10.6 million people fell ill with tuberculosis(TB) worldwide. Including 6 million men, 3.4 million women and 1.2 million children. TB is present in all countries and age groups. But TB is curable and preventable.

· In 2021, the 30 high TB burden countries accounted for 87% of new TB cases. 

· An estimated 66 million lives were saved through TB diagnosis and treatment between 2000 and 2020.

· Ending the TB epidemic by 2030 is among the health targets of the United Nations Sustainable Development Goals (SDGs).

At the just-concluded 2023 MedLab exhibition, TB related products received great attention from IVD reagent enterprises and clinical clients around the world.

Mycobacterium Tuberculosis

Mycobacterium tuberculosis also known as tubercle bacillus, is an asporous, atrichous obligate aerobic bacterium. Mycobacterium tuberculosis is extensively existing worldwide and has been the leading pathogen of lethal bacterial infection since it was discovered and proven as the cause of TB in 1882[2]. 

Infections caused by Mycobacterium tuberculosis are highly prevalent in the spring. Mycobacterium tuberculosis can infect organs throughout the body. 90% of symptoms are infections in the lungs while the rest of the symptoms spreading to other parts of the body through blood circulation, leading to extrapulmonary infections. With the ability of resistance to macrophages, Mycobacterium tuberculosis can massively re-product in large numbers after entering the alveoli [3], which would cause lung inflammation and primary infection. Even if cured, fibrosis or calcification can form in the lung. In addition, the pathogen can also cause secondary infection in the lung, which means a long-term chronic onset.

Main Methods of Diagnosis 

Regular Diagnosis: MTB and tuberculin diagnosis are routine methods for TB diagnosis. Sputum is used to detect tuberculosis bacteria by smearing the patient's sputum and observing MTB infection with a microscope [4]. Sputum tuberculosis diagnosis is convenient and feasible, but with low sensitivity.

Nowadays, tuberculosis culture is the “gold standard” of MTB detection whose results are highly reliable, and drug sensitivity tests on tuberculosis bacteria can be done together. However, it takes 6-8 weeks, which makes the application very limited.

TB-IGRA: Latent Tuberculosis Infection (LTBI) usually refers to the presence of Mycobacterium tuberculosis in the body with asymptomatic and the absence of TB bacteria in the sputum. As a new approach to LTBI, TB- IGRAs collects human blood and tests the amount of IFN-γ which is released from T cell stimulated by MTB antigens. There are two ways for this new diagnosis: ELISpot (which directly counts the number of IFN-γ-secreting T lymphocytes) and whole blood ELISA (the concentration of IFN-γ secreted by T lymphocytes).

TB-LAM: Lipoarabinomannan(LAM) is an important part of the cell wall of mycobacteria, widely present in the glycolipid structure of the surface of Mycobacterium tuberculosis. It is a specific antigen that controls the immunomodulation to Mycobacterium tuberculosis and stimulates the body to produce antibodies. It is a widely used antigen in tuberculosis serology diagnostics. Studies have shown that LAM protein has an inhibitory effect on macrophages and can inhibit its lethal effect on Mycobacterium tuberculosis. Besides, it’s a highly specific antigen.

TB antibody: There is a close connection between pulmonary tuberculosis and the immune mechanism of the human body. When Mycobacterium tuberculosis invades the body again, the B-lymphocytes can produce IgG and IgM immunoglobulins, while changing them. Immunoglobulins such as IgG and IgM will still be positive even one year after the patient's recovery. Another study has shown [5] that the patients who had the longer course or the more severe symptoms are more likely to have an immune response with notably increased IgG and IgM. Therefore, in the clinic, the detection of immunoglobulins can be used to understand the states of tuberculosis infection in patients.

What we offer

Cnpair has long indulged in the development and production of core raw materials of IVD reagents and won the trust of numerous well-known IVD manufacturers. Based on the scientific design and rigorous development, Cnpair has introduced a completely new series of Mycobacterium tuberculosis immunoassay raw materials. These materials are highly sensitive and highly potent, and have excellent performance for detection, fully satisfying the requirements of clinical assays and monitoring.

In addition, Cnpair also provides high-quality enzymes, antibodies, and premixes for TB molecular detection and TB drug-resistant mutant molecular detection, which have gained the trust and favorite of our customers. 

Cnpair offers you with a full range of support for TB product development: TB antibody assays, TB-IGRA assays(WHO gold standard), the most cutting-edge TB-LAM assays, as well as TB molecular detection. Cnpair work with you to prevent the TB epidemic!

Refenrences:

[1]Bouzeyen R, Javid B. Therapeutic Vaccines for Tuberculosis: An Overview. Front Immunol. 2022 Jun 24;13:878471. 

[2]S. Keshavjee, P. Farmer Tuberculosis, drug, resistance, and the history of modern medicine N Engl J Med, 367 (10) (2012), pp. 931-936

[3]Chackerian AA, Alt JM, Perera TV, Dascher CC, Behar SM. Dissemination of Mycobacterium tuberculosis is influenced by host factors and precedes the initiation of T cell immunity. Infect Immun. 2002;14:4501–4509.

[4]LUO Mingzhi;  CHEN Hesheng;  ZHOU Yuanqun;  GAO Haiyang;  JIN Yang;  LI Lin;  DENG Linhong.Global Tuberculosis Epidemic and New Diagnosis Technology, Journal of Changzhou University(Natural Science Edition),2016,(06):18-22.[doi:10.3969/j.issn.2095-0411.2016.06.004

[5]Han Wei, Cui Weijun, Huangjian,etc. Value of combined detection of anti-Mycobacterium tuberculosis IgG,IgM antibody and LAM-IgG in the diagnosis of active pulmonary tuberculosis[J].

Journal of Molecular Diagnostics and Therapy, 2022, 14(1):5.