Stability That Matters – How QYM Substrates Ensure Consistent IVD Test Results

In innovative diagnostic tools, substrate stability is often underrated yet critical for high-precision assays.For IVD substrates, stable performance directly determines test accuracy and reliability. An unstable substrate leads to inconsistent results, compromising the entire diagnostic process.To ensure precision, substrates must maintain integrity against temperature changes, solvents, and other environmental stresses. Only a stable substrate delivers consistent, dependable performance, laying a solid foundation for accurate and repeatable in vitro diagnostic results.

At QYM, we recognize the critical role of substrate stability in diagnostic assays. We have established a management organization adapted to the production of IVD raw materials, covering the Quality Department, Production Department, Materials Department, etc., staffed by qualified personnel. Key quality control and production positions are held by master’s degree holders who are familiar with critical control points of the products. Meanwhile, we have formulated strict quality management documents and a comprehensive quality assurance system, clarifying the responsibilities of each department, improving the documentation system, validation and records, and developing quality system procedures including deviation management and change control.

QYM Quality Control Center is equipped with advanced analytical instruments such as high-performance liquid chromatography (HPLC) and UV-Vis spectrophotometer, enabling full-process quality control of substrate raw materials including Glupa-C and pNPP. We conduct comprehensive analysis and control over product purity, individual impurity content and other indicators to ensure each batch meets international quality standards for the IVD industry.

A laboratory control system has been established in accordance with Good Manufacturing Practices (GMP) for pharmaceuticals. We have developed quality standards and testing procedures for starting materials, intermediates and finished products. Printed chromatograms with digital signal processing systems are provided for key testing items, ensuring full traceability of critical information.

In conclusion, the stability of the substrate plays a crucial role in the success of high precision diagnostic assays. By choosing an IVD substrate that guarantees stable performance, you can enhance the accuracy and reliability of your diagnostic tests. QYM are committed to supplying high-quality substrates to ensure the stability of in vitro diagnostic reactions and reduce detection errors, providing reliable raw material support for diagnostic reagent manufacturers worldwide.

Visit us today at www.qymbiomaterial.com to explore our full range of IVD reagent substrate solutions. Keep your brand trustworthy with stable, cost-effective substrates.