Test Kit for Tuberculosis Bacteria (Mycobacterium Tuberculosis) - MTB REAL TM

MTB Real-TM is a Real-time PCR test kit for detecting the tuberculosis bacteria group (M. tuberculosis, M. africanum, M. bovis, M. bovis BCG, M. microti) in sputum, urine, bronchial aspirates, tissue, and other biological materials.

OVERVIEW OF TUBERCULOSIS

A Brief Overview of Tuberculosis

According to the World Health Organization (WHO) ranking, tuberculosis is a dangerous infectious disease. According to WHO data, in 2021 there were 10.6 million people infected with tuberculosis and 1.6 million deaths, including as many as 1.2 million children [1].

People with tuberculosis easily transmit the disease to others when they cough, spit, or sneeze, spraying saliva droplets containing tuberculosis bacteria into the surrounding environment. It is estimated that a person with active tuberculosis can infect 10-15 other people through close contact within one year [9]. People suspected of having tuberculosis show symptoms such as a cough lasting more than 2 weeks, chest pain, shortness of breath, low-grade fever in the afternoon, weight loss, etc. [7].

Figure 1: Main transmission route of tuberculosis

Bacteria That Cause Tuberculosis

The tuberculosis bacterium was first isolated in 1882 by Dr. Robert Koch. To date, a total of 9 tuberculosis-causing Mycobacteria species have been identified (Mycobacterium tuberculosis complex), including species that infect humans, such as  Mycobacterium tuberculosis, M. africanum, M. bovis, M. bovis BCG, M. microti tuberculosis [2].

M. tuberculosis is a small, aerobic, non-motile Gram-negative bacillus. The bacterial cell wall is rich in peptidoglycan and lipid complexes such as mycolic acid and glycolipids, which is one of the factors that help the bacterium evade the immune system and persist in the body for a long time [3].        

Figure 2: Mycobacterium tuberculosis bacteria

How Tuberculosis Bacteria Act in the Body

Infection begins with the inhalation of airborne droplets containing M. tuberculosis bacteria released when a person with tuberculosis coughs or sneezes. The bacteria travel through the respiratory tract into the alveoli of the lungs. There, macrophages engulf them into phagosomes and transport them to lysosomes for degradation. In many cases, the bacteria can effectively block the acidification and maturation of the phagosome in order to survive. The human body responds by forming structures called granulomas - clusters of immune cells around macrophages that prevent spread and help kill the bacteria. However, some tuberculosis bacteria can still survive in the body in an inactive form (called latent tuberculosis)[4].

Although contained within granulomas, M. tuberculosis can cause tuberculosis to recur when a person's immunity is compromised and can cause chronic inflammation. An estimated ¼ of the world's population is infected with tuberculosis, and about 10% will progress to disease, with an especially high risk in immunocompromised individuals such as young children and people with HIV/AIDS, malnutrition, alcoholism, or diabetes [4].

Tuberculosis bacteria mainly cause disease in the lungs (80-85%). In addition, the bacteria can also cause disease in other organs such as the central nervous system, circulatory system, reproductive system, bones, joints, and even the skin [5].

Figure 3: The process of tuberculosis infection in the body

Early diagnosis of tuberculosis enables timely and effective treatment, improving clinical outcomes since anti-tuberculosis drug therapy is effective, and prevents spread to the community.

REAL-TIME PCR REAGENT KIT FOR DETECTING THE  MYCOBACTERIUM  TUBERCULOSIS GROUP OF BACTERIA THAT CAUSES TUBERCULOSIS - MTB REAL-TM

Intended Use:  

A nucleic acid amplification test for detecting the Mycobacterium tuberculosis group (M. tuberculosis, M. africanum, M. bovis, M. bovis BCG, M. microti) that causes tuberculosis, using Real-time PCR technology.

Sample Matrix / Sample Source: 

• Sputum, tracheal or bronchial lavage fluid, tissue samples, whole blood, cerebrospinal fluid, synovial fluid, urine, culture fluid...

Product Information:

KEY ADVANTAGES OF THE MTB REAL-TM KIT

1. Sensitivity:  5 CFU/sample
2. Certifications: CE-IVD, ISO 13485
3. Reagent/kit is open: compatible with many common Real-time PCR instruments such as SaCycler-96™ (Sacace), CFX96™/iQ5™ (BioRad); Applied Biosystems® 7300/7500 Real-time PCR, ...
4. Contains a dUTP/UDG system to prevent carryover contamination
5. Includes an internal control to monitor the extraction process and Real-Time PCR inhibition
6. Simple result analysis based on only 2 detection channels: FAM shows the DNA signal of the human tuberculosis-causing bacteria group, and HEX is the signal of the internal control (IC) that monitors the reaction. 

Figure 4: Illustrative run results of the MTB Real-TM kit on the Sacycler 96

REFERENCES:

[1]: Global Tuberculosis Report, (2022). WHO

[2]: R.D. Kanabalan et al., (2021). Human tuberculosis and Mycobacterium tuberculosis complex: A review on genetic diversity, pathogenesis and omics approaches in host biomarkers discovery. Microbiological Research 246 126674. Doi: 10.1016/j.micres.2020.126674

[3]: Kalscheuer R et al., (2019). The Mycobacterium tuberculosis capsule: a cell structure with key implications in pathogenesis. Biochem J, 476(14):1995-2016. doi: 10.1042/BCJ20190324.

[4]: Chai Q et al., (2018). Mycobacterium tuberculosis: An adaptable pathogen associated with multiple human diseases. Front. Cell. Infect. Microbiol. 8:158. doi: 10.3389/fcimb.2018.00158.

[5]: Heye T et al., (2011). Extrapulmonary tuberculosis: radiological imaging of an almost forgotten transformation artist. Rofo, 183(11):1019-29. German. doi: 10.1055/s-0031-1273429.

[6]: Huang, Y et al., (2022). Review and Updates on the Diagnosis of Tuberculosis. J. Clin. Med, 11, 5826. Doi: 10.3390/jcm11195826.

[7]: Decision 1314/QD-BYT dated Mar 24, 2020 of the Minister of Health on the Guidelines for the diagnosis, treatment, and prevention of tuberculosis [In Vietnamese].

[8]: Decision 4263/QD-BYT dated Oct 13, 2015 of the Minister of Health on the Guidelines for the diagnosis, treatment, and prevention of tuberculosis [In Vietnamese].

[9] WHO, (2022). Tuberculosis. https://www.who.int/westernpacific/health-topics/tuberculosis#tab=tab_1

[10] Ministry of Health Portal, (2023). Celebrating World Tuberculosis Day: "Vietnam defeats tuberculosis" [In Vietnamese]. https://moh.gov.vn/tin-noi-bat//asset_publisher/3Yst7YhbkA5j/content/ky-ngay-the-gioi-phong-chong-lao-viet-nam-chien-thang-benh-lao.