BNCC Launches Biological Quality Control Materials for Drug-Resistant *Mycobacterium tuberculosis* Strains

Tuberculosis (TB) remains a major global infectious disease, and the emergence of drug-resistant TB poses significant challenges for both diagnosis and clinical treatment. Accurate detection of drug resistance is a prerequisite for the early identification and intervention of drug-resistant TB; the reliability of such test results depends on the use of stable, compliant quality control (QC) materials.

To address the need for quality control in testing for first- and second-line anti-TB drugs, BNCC has introduced biological QC materials based on *Mycobacterium tuberculosis* strains resistant to rifampicin, ofloxacin, and streptomycin. These materials are specifically designed for molecular drug-resistance testing and antimicrobial susceptibility testing (AST), ensuring the quality of laboratory diagnostic procedures.

Key Product Advantages

1. Well-Defined Drug-Resistance Genotypes and Stable Test Results

These QC strains feature clearly defined drug-resistance profiles and genotypes. They offer excellent batch-to-batch consistency and high reproducibility, enabling stable monitoring of the entire experimental process and the timely detection of any fluctuations within the testing system.

2. Enhanced Biosafety and Reduced Experimental Risk

By utilizing specific drug-resistant strains, these materials mitigate the biosafety risks associated with handling highly pathogenic live bacteria. This reduces the burden of laboratory biosafety management, allowing for safer and more secure experimental operations.

3. Multi-Platform Compatibility and Versatility

Compatible with mainstream experimental platforms—including molecular nucleic acid testing and antimicrobial susceptibility testing—these materials work with most commercially available TB drug-resistance detection kits. They require no significant changes to existing laboratory workflows, ensuring ease of implementation.

Applications

1. TB testing laboratories at all levels of Centers for Disease Control and Prevention (CDC);

2. Designated TB hospitals, clinical laboratories in general hospitals, and specialized TB laboratories;

3. Routine internal quality control and external quality assessment (EQA) for molecular TB drug-susceptibility testing;

4. Research and development, regulatory registration, and performance validation of *in vitro* diagnostic (IVD) kits for TB.