Report from the HarmoSter study: different LC-MS/MS androstenedione, DHEAS and testosterone methods compare well; however, unifying calibration is a double-edged sword.
Clin Chem Lab Med
; 62(6): 1080-1091, 2024 May 27.
Article
in En
| MEDLINE
| ID: mdl-38205643
ABSTRACT
OBJECTIVES:
Current liquid chromatography-tandem mass spectrometry (LC-MS/MS) applications for circulating androgen measurements are technically diverse. Previously, variable results have been reported for testosterone. Data are scarce for androstenedione and absent for dehydroepiandrosterone sulfate (DHEAS). We assessed the agreement of androstenedione, DHEAS and testosterone LC-MS/MS measurements among nine European centers and explored benefits of calibration system unification.METHODS:
Androgens were measured twice by laboratory-specific procedures in 78 patient samples and in EQA materials. Results were obtained by in-house and external calibration. Intra- and inter-laboratory performances were valued.RESULTS:
Intra-laboratory CVs ranged between 4.2-13.2â¯% for androstenedione, 1.6-10.8â¯% for DHEAS, and 4.3-8.7â¯% and 2.6-7.1â¯% for female and male testosterone, respectively. Bias and trueness in EQA materials were within ±20â¯%. Median inter-laboratory CV with in-house vs. external calibration were 12.0 vs. 9.6â¯% for androstenedione (p<0.001), 7.2 vs. 4.9â¯% for DHEAS (p<0.001), 6.4 vs. 7.6â¯% for female testosterone (p<0.001) and 6.8 and 7.4â¯% for male testosterone (p=0.111). Median bias vs. all laboratory median with in-house and external calibration were -13.3 to 20.5â¯% and -4.9 to 18.7â¯% for androstenedione, -10.9 to 4.8â¯% and -3.4 to 3.5â¯% for DHEAS, -2.7 to 6.5 % and -11.3 to 6.6â¯% for testosterone in females, and -7.0 to 8.5â¯% and -7.5 to 11.8â¯% for testosterone in males, respectively.CONCLUSIONS:
Methods showed high intra-laboratory precision but variable bias and trueness. Inter-laboratory agreement was remarkably good. Calibration system unification improved agreement in androstenedione and DHEAS, but not in testosterone measurements. Multiple components, such as commutability of calibrators and EQA materials and internal standard choices, likely contribute to inter-laboratory variability.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Testosterone
/
Dehydroepiandrosterone Sulfate
/
Androstenedione
Type of study:
Prognostic_studies
Limits:
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Clin Chem Lab Med
/
Clin. chem. lab. med
/
Clinical chemistry and laboratory medicine
Journal subject:
QUIMICA CLINICA
/
TECNICAS E PROCEDIMENTOS DE LABORATORIO
Year:
2024
Type:
Article
Affiliation country:
Italy