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Abstract Background The CDC Hormone Standardization (CDC HoST) Certification Program, is traceable to the primary testosterone Standard National Measurement Institute (NMI) M914. The Atellica® IM, ADVIA Centaur® Testosterone II (TSTII) and Dimension Vista® LOCI Total Testosterone (TTST) assays are enrolled in the program. Certification is a yearlong process of 40 blinded samples from the CDC, 10 for testing each quarter. If 4 consecutive quarters meet bias acceptance criteria of ± 6.4%, CDC certification is achieved. Methods Initially, to standardize the assay approximately 120 samples were obtained from CDC with CDC HoST ID-LC-MS dose values to value assign master curve standards. Multiple ADVIA Centaur TSTII reagent lots were tested with CDC patient samples. Internal master curve standards were assayed as unknowns and dose values assigned using the RLU (system generated units-Relative Light Units) to CDC ID-LC-MS dose relationship. For TSTII (2019- 2023), after standard value assignment, at least 179 CDC blinded samples were tested across all platforms. Each quarter, 10 blinded samples were tested in duplicate over 2 days. Similar procedures were followed for TTST. Results were analyzed by the CDC. Results Correlation between the CDC assigned values and Atellica IM, ADVIA Centaur, and ADVIA Centaur CP TSTII assay results was strong across all quarters from 2019 to 2023 combined. TTST results were strong for 2023. Mean bias between TSTII and TTST results and CDC reference values was consistently 6.4%. This enabled the TSTII assays to be CDC certified for a fourth consecutive year, and TTST for 2023. The table presents TSTII (2019-2023) and TTST (2014-2023) results. Conclusions The TSTII assay consistently achieved CDC certification from 2019 to 2023, while the TTST assay was initially certified in 2014. Siemens Healthineers is the only testosterone immunoassay manufacturer to be currently certified, the TSTII assay has achieved certification for four consecutive years.
Abou‐Diwan et al. (Tue,) studied this question.