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Fungal detection is attracting attention, how to choose the right reagent kit?

As companies accelerate their deployment and compete fiercely in the field of fungal detection, and molecular diagnostic technology becomes a clinical focus, a key issue emerges. How to ensure the reliability of each test result? The answer lies in the invisible "ruler" of "quality control products".

Ningpu Medical has been deeply involved in the field of in-vitro diagnostic quality control for many years. The core value of fungal detection quality control products lies in providing authoritative support for the reliability of test results.

 

 

Why do fungal tests need a reliable "ruler" even more?

Invasive fungal disease (IFD) is an infectious disease caused by fungi invading the human body, growing and reproducing in tissues, organs, or blood, and causing inflammation and tissue damage. IFD has a high mortality rate, but because of its atypical early manifestations and difficulty in diagnosis, it is easily misdiagnosed or missed. Molecular detection technology (such as PCR fluorescence probe method) has seized the market with its high sensitivity, but "high sensitivity" does not equal "high accuracy". ：

  • The nucleic acid extraction of fungi such as Pneumocystis jirovecii and Aspergillus is easily interfered with by sample impurities, and miscellaneous bacteria in sputum may lead to false positives;
  • differences in cell wall breakage efficiency and amplification systems of different reagent kits may cause significant deviations in the results of the same sample;
  • the clinical evaluation of "fungal detection using molecular diagnostic methods" varies greatly, largely due to the lack of a unified quality benchmark.

 

At this time, quality control products are like a calibrated ruler that can help the laboratory verify: Whether the reagent kit can truly detect high-sensitivity targets? Is the detection of different sample types accurate? Is the inter-batch difference within the acceptable range?

Ningpu Medical Natural pathogen quality control products ，construct a full-process quality control system ，empowering the entire process from sample pre-processing to result interpretation, and building a precise defense line for test results:

  • Using natural pathogens as raw materials, it has a relatively complete structure and complete genome;
  • A method for inactivating fungi has been developed, ensuring effective inactivation while maintaining extraction efficiency;
  • High compatibility with mainstream reagent kits;
  • Customize relevant inter-laboratory quality assessment materials for clinical testing centers, leading industry standards.

Referring to the requirements of the "Expert Consensus on the Diagnostic Pathway of Invasive Pulmonary Fungal Diseases (2024 Edition)", "Expert Consensus on the Clinical Application of Laboratory Diagnostic Methods for Invasive Fungal Diseases", and "EORTC/MSGERC Consensus", etc., Ningpu Medical quality control products can help laboratories:

  • Meet the requirements of various quality systems for "traceability of the detection process" ;
  • When launching new projects rapidly verify the performance of reagent kits , shortening the clinical application cycle;
  • Help laboratories establish standardized systems.

Choose the right ruler to make fungal detection "fast and accurate".

When leading companies compete on "who has higher sensitivity", smart laboratories have already built a foundation with quality control products:

  • For the inspection department: Regularly verify through Ningpu quality control products to avoid missed/misdiagnosis due to reagent kit problems;
  • For enterprises: When registering products or entering hospitals, use third-party quality control data to prove performance advantages and accelerate market access.

The battlefield of fungal detection is not only about the parameters of the reagent kit, but also the credibility of each result. Ningpu Medical is willing to be this "precise ruler", allowing molecular diagnostic technology to truly become the "sharp eyes" of the clinic.

 

References:

  1. World Federation of Chinese Medical Mycology Professionals. Expert Consensus on the Diagnostic Pathway of Invasive Pulmonary Fungal Diseases (2024 Edition)[J]. Chinese Journal of Laboratory Medicine, 2025, 48(04):459-468.
  2. Yang Qiwen, Ni Yuxing, Lin Likai, et al. Expert Consensus on Basic Requirements for the Construction of Fungal Detection Capacity in Clinical Microbiology Laboratories. Chinese Journal of Laboratory Medicine, 2019, 42(7):514-528.
  3. China National Accreditation Service for Conformity Assessment. Accreditation Guide for Molecular Diagnostics in Medical Laboratories: CNAS-GL050. Beijing: China Standard Press, 2021:2-8.
  4. China Pharmaceutical Education Association Mycology Professional Committee, National Clinical Medical Research Center for Skin and Immune Diseases (Peking University First Hospital), National Clinical Medical Research Center for Blood Diseases (Peking University People's Hospital). Expert Consensus on the Clinical Application of Laboratory Diagnostic Methods for Invasive Fungal Diseases. Chinese Journal of Internal Medicine, 2022, 61(2):8.
  5. Henan Provincial Society of Microbiology Clinical Microbiology Professional Committee, Henan Medical Association Microbiology and Immunology Branch, Li Yi, et al. Henan Expert Consensus on Rapid Detection of Invasive Fungal Infections[J]. Henan Medical Research, 2024, 33(16):2881-2887.
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