Disease: CRISPR-based Mycobacterium tuberculosis Diagnostic Test for Pulmonary Tuberculosis

Disease info:

Tuberculosis (TB) is caused by a bacterium called Mycobacterium tuberculosis. The bacteria usually attack the lungs, but TB bacteria can attack any part of the body such as the kidney, spine, and brain. Not everyone infected with TB bacteria becomes sick. As a result, two TB-related conditions exist: latent TB infection (LTBI) and TB disease. If not treated properly, TB disease can be fatal.

TB bacteria are spread through the air from one person to another. The TB bacteria are put into the air when a person with TB disease of the lungs or throat coughs, speaks, or sings. People nearby may breathe in these bacteria and become infected.

TB is NOT spread by

  • shaking someone’s hand
  • sharing food or drink
  • touching bed linens or toilet seats
  • sharing toothbrushes
  • kissing

When a person breathes in TB bacteria, the bacteria can settle in the lungs and begin to grow. From there, they can move through the blood to other parts of the body, such as the kidney, spine, and brain.

TB disease in the lungs or throat can be infectious. This means that the bacteria can be spread to other people. TB in other parts of the body, such as the kidney or spine, is usually not infectious.

People with TB disease are most likely to spread it to people they spend time with every day. This includes family members, friends, and coworkers or schoolmates.

There are two kinds of tests that are used to detect TB bacteria in the body: the TB skin test (TST) and TB blood tests.  A positive TB skin test or TB blood test only tells that a person has been infected with TB bacteria. It does not tell whether the person has latent TB infection (LTBI) or has progressed to TB disease. Other tests, such as a chest x-ray and a sample of sputum, are needed to see whether the person has TB disease.

8,920: number of provisionally reported TB cases in the United States in 2019 (a rate of 2.7 per 100,000 persons). Up to 13 million: estimated number of people in the United States living with latent TB infection.
Official title:
Evaluation of CRISPR-based Test for the Rapid Identification of Mycobacterium Tuberculosis Complex in Pulmonary Tuberculosis Suspects

Wenhong Zhang Huashan Hospital

Jingwen Ai Huashan Hospital


China, Shanghai

Study start:
May. 1, 2019
800 participants
CRISPR-based Test performed on sputum or BALF in Tuberculosis suspects.
Pulmonary Tuberculosis
Safety updates:

No information 

Status: Active recruiting


This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a prospective study of pulmonary TB suspects who are undergoing sputum or bronchoalveolar lavage fluid (BALF) evaluation for pulmonary TB. The sensitivity and specificity of the CRISPR-based assay will be compared to clinical diagnosis, conventional culture methods and Xpert MTB/RIF assay on same batch specimens.

Last updated: Oct. 28, 2021
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