GC Labs, a leading South Korea clinical laboratory, today announced that it has recently obtained certification of standardization programs from the U.S. Centers for Disease Control and Prevention (CDC) for vitamin D and hormones (testosterone).

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% and 88% 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, 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."

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.