Tuberculosis (TB) is a disease caused by a bacterium known as Mycobacterium tuberculosis. Compared to the bacteria that attack the lungs, TB bacteria can afflict any part of the body, including the kidneys, spine, and brain. Not all people who have contracted TB bacteria suffer from the disease. Therefore, TB is associated with two conditions: latent tuberculosis infection (LTBI) and TB disease. Without appropriate treatments, TB can be fatal.
In 2022, WHO issued recommendations on the application of the tuberculosis antigen (or allergen) skin test (TBST), a new test, and approved it as an alternative method of tuberculin skin test (TST) and the Interferon-Gamma Release Assays (IGRAs) for the diagnosis of TB infection. TBST class refers to skin tests to detect TB infection that apply Mycobacterium tuberculosis-specific antigens (ESAT6 and CFP10). Tuberculosis antigens/allergens induce a hypersensitivity reaction in TB-infected individuals, which is considered to be a diagnostic marker.
WHO has assessed the following technologies:
- Cy-Tb (Serum Institute of India, India);
- Diaskintest (Generium, Russian Federation);
- C-TST (formerly known as ESAT6-CFP10 test, Anhui Zhifei Longcom, China)
Cy-Tb (C-Tb test), India
Produced by Statens Serum Institute (SSI) Denmark, Cy-Tb (formerly called C-Tb test) is a solution of two recombinant proteins, ESAT-6 and CFP-10 (1:1 ratio), manufactured by genetically modified Lactobacillus lactis. SSI partnered with the Serum Institute of India in 2019, which has a license to produce and commercialize Cy-Tb.
Diaskintest, Russian
Diaskintest is a recombinant CFP and ESAT protein derived from engineered Escherichia coli (E. coli) BL21 (DE3). It was approved by the Russian National Medicines Regulatory Authority.
C-TST (ESAT6-CFP10), China
Differing from Cy-Tb and Diaskintest, the active ingredient of C-TST is a recombinant fusion protein of ESAT-6 and CFP-10. The fusion protein of the two antigens (ESAT-6 and CFP-10) is expressed in genetically modified E. coli. For its utilization and marketing, C-TST is produced and commercialized by Anhui Zhifei Longcom Biopharmaceutical Co. Ltd and approved by the China National Medicines Regulatory Authority (NMPA).
Yaohai Bio-Pharma Offers One-Stop CDMO Solution for TB Antigen
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