New Product Launch | BNCC Biological Quality Control Material for Mpox Virus (Clade IIb)

The global Mpox (monkeypox) situation remains complex and fluid. The Clade IIb lineage—the primary strain responsible for the initial outbreak—is characterized by significant human-to-human transmission. It has been identified in both domestic and imported cases in my country, making it a key target for molecular diagnostics and ongoing public health surveillance and control efforts.

To support global and domestic public health surveillance networks and enhance the accuracy and specificity of Mpox nucleic acid testing, BNCC has launched a new biological quality control material for the Mpox virus (Clade IIb). This product is designed to meet the molecular diagnostic needs of public health agencies (CDCs), clinical laboratories, and third-party testing facilities, providing a robust and reliable standardized reference for the screening, identification, and control of the Mpox virus.

Precision Targeting for Key Surveillance Priorities

This newly released Clade IIb biological quality control material is specifically engineered for current primary surveillance targets. The target sequences are derived from the characteristic genetic regions of the Clade IIb sub-lineage, offering exceptional sequence specificity and the ability to account for subtle genetic mutations across different sub-lineages. The product is primarily intended for:

Assay Specificity Evaluation: Precisely verifying the detection capability of kits—such as those based on quantitative real-time PCR (qPCR) or digital PCR (dPCR)—for the Clade IIb lineage, helping to mitigate the risk of false-negative results.

Method Development and Optimization: Serving as a highly stable positive control for laboratories developing in-house diagnostic methods or optimizing testing workflows.

Routine Laboratory Quality Control: Acting as a core benchmark for internal and external quality control, ensuring the stability and consistency of results across different testing batches and platforms.

Proficiency Testing and Assessment: Meeting the requirements for annual proficiency testing and performance assessments for specific viral lineages in public health and clinical laboratories.

Strict Quality Control for Consistent and Reliable Testing Results

BNCC remains committed to monitoring pathogen mutation trends and continuously expanding its portfolio of molecular diagnostic quality controls and reference materials. We provide robust testing support to centers for disease control, clinical laboratories, third-party testing facilities, and organizations engaged in the R&D of in vitro diagnostic (IVD) reagents. BNCC—empowering precise molecular diagnostics and ensuring greater credibility for experimental data!