Evaluation of the Siemens Healthineers Atellica TSTII testosterone assay in the CDC HoSt-TT program
Authors' conclusion
The TSTII assay is CDC HoSt-TT certified, has strong alignment to LC-MS/MS, and shows good correlation of calculated FT with equilibrium dialysis/LC-MS/MS. Although LC-MS/MS remains the reference method for testosterone quantification, particularly at low concentrations, CDC HoSt certification of the TSTII assay supports its potential suitability for measuring testosterone concentrations in women and children within defined analytical and clinical contexts.
Study context
- Population
- HoSt-TT certification samples and remnant patient samples
- Comparison
- Atellica IM TSTII assay vs ID-LC-MS/MS
- Outcome
- Compliance of Atellica IM TSTII assay with HoSt-TT criteria and correlation with LC-MS/MS
Methodological detailsmethod comparison, stratified by sex
- Method comparison
- Stratified by sex
Main finding
As reported in the abstract
Average bias
within ±6.4%
OLS regression slopes
1.02-1.06
Correlation
r ≥ 0.98
Further findings
TSTII analytical performance
- Repeatability
- 2.18% CV
- Within-lab precision
- 3.46% CV
- Overall total analytical error
- 18.3% (IQR 11.6-31.6%)
TT on TSTII vs LC-MS/MS (LDT), native patient samples
- Slope
- 0.9798
- Correlation
- r = 0.991
Calculated free testosterone (FT) (Vermeulen, ISSAM) vs equilibrium dialysis/LC-MS/MS
- Slope
- 0.9530
- Correlation
- r = 0.965
Original publication
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