[YONGIN, South Korea] GC Labs, the leading clinical laboratory from South Korea, has recently obtained certification of standardization programs for vitamin D and hormones (testosterone) organized by the Centers for Disease Control and Prevention (CDC).
CDC operates international standardization programs aimed at manufacturers and laboratories to improve the detection and diagnosis of disease by ensuring that laboratory tests are accurate and reliable. The goal of the program is to contribute to improving the health of mankind by ensuring correct diagnoses and treatment of patients and reducing confusion and re-examination due to inaccurate data.
The program has a high level of difficulty for assessment procedures, where participants measure the true value of samples in multiple concentrations for a year and report the results, which would be assessed against the strict criterion. To be certified, participants should meet each performance criterion of ± 6.4 percent mean bias when compared to the true value provided by CDC for testosterone and of ± 5.0 percent mean bias with overall imprecision under 10 percent when compared to the true value provided by CDC for vitamin D during four consecutive quarters.
GC Labs becomes the first Korean clinical laboratory to participate in Vitamin D Standardization Certification Program (VDSCP) and the Hormone Standardization Program (HoSt) from the third quarter of 2021, and to be finally certified on July 14, 2022. In particular, the individual samples passing rate of VDSCP and HoSt was 68 percent and 88 percent respectively, which are much higher than those of the global top-tier manufacturers and laboratories.
“Special chemistry department in GC Labs is researching and developing various hormones and vitamin D measurements based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) to provide more accurate and precise test results than conventional immunological methods,” said Dr. Eun Hee Lee, M.D., Ph.D., President of GC Labs.
“The acquisition of global standardization certification proves that GC Lab’s test accuracy and reliability are very high and leads to strengthen its global competitiveness. Through continuous study, GC Labs will be reborn as a leading diagnostic laboratory contributing to the improvement of human health and welfare by expanding the clinical application of tandem mass spectrometry methods and producing accurate test results,” she said.
About GC Labs
GC Labs is South Korea’s leading clinical laboratory that also specializes in infectious diseases and serves as part of the Global Diagnostics Network. GC Labs has enabled patients to receive an accurate diagnosis and the right treatment with unrivalled quality of routine and specialized clinical tests. Around 800 employees at GC Labs offer more than 5,000 tests and test combinations, ranging from routine tests to highly esoteric molecular and genetic assays.
With more than 40 years of accumulated know-how, GC Labs values the principles of providing the best treatment for patients even in unpredictable medical environments through passionate and ceaseless efforts. Not only domestically, but also GC Labs has managed to expand overseas by entering a Lab Service Agreement with 20 institutions across 15 countries worldwide. GC Labs is qualified with world-class medical standards of medical manpower, level and infrastructure.
For further information, please visit our official website www.gclabs.co.kr/eng.