Drug intelligence / Profile preview

recombinant mycobacterium tuberculosis 11-kDa allergen

Development stage
Unknown
Lead developer
Beijing Sanroad Biological Products
Modality
Recombinant Proteins and Enzymes
Administration
Intradermal
01

Overview

Recombinant Mycobacterium tuberculosis 11-kDa allergen (also known as rCFP-10) is a diagnostic skin test reagent developed by Beijing Xiangrui Bioproducts for the detection of *Mycobacterium tuberculosis* infection. The product contains the recombinant 10-kDa culture filtrate protein (CFP-10), an antigen encoded by the RD1 genomic region of *M. tuberculosis*, which is absent in the *Bacillus Calmette-Guérin* (BCG) vaccine strain and most non-tuberculous mycobacteria. This absence allows the test to differentiate between true TB infection and prior BCG vaccination, addressing a major limitation of the traditional tuberculin purified protein derivative (PPD) test. Upon intradermal administration, the allergen induces a delayed-type hypersensitivity (DTH) response in individuals with T-cell memory of *M. tuberculosis*, which is then measured by the diameter of skin induration.

Brand names
YikaEkai
Other names
Recombinant Mycobacterium tuberculosis 11kDa proteinrCFP10rCFP-10rCFP 10重组结核杆菌11kDa蛋白
02

Targets

Culture filtrate protein 10-specific CD4+ T-cell receptor

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