TY - JOUR
T1 - Selected performance characteristics of the Roche Elecsys® testosterone II assay on the Modular analytics E 170 analyzer
AU - Owen, William E.
AU - Rawlins, Mindy L.
AU - Roberts, William L.
N1 - Generated from Scopus record by KAUST IRTS on 2023-09-20
PY - 2010/8/1
Y1 - 2010/8/1
N2 - Background: Serum testosterone measurements have utility in diagnosis of clinical conditions characterized by both increased and decreased testosterone concentrations. Studies have indicated that testosterone immunoassays may give inaccurate results for women and children. We evaluated the performance of a second generation testosterone immunoassay from Roche Diagnostics. Methods: Testo II performed on a Modular Analytics E 170 analyzer is an automated random access electrochemiluminometric assay. We evaluated limit of blank (LoB), imprecision, linearity, interference, and method comparison with liquid chromatography-tandem mass spectrometry assay (LC-MS/MS). Method comparison included the current generation Roche testosterone assay (Testo I) and the Access 2 testosterone chemiluminometric assay (Beckman Coulter). Results for men and women were analyzed for analytic concordance. The relative % differences of immunoassay compared to LC-MS/MS results were evaluated. Results: The LoB was 0.07. nmol/l. Total imprecision was 22.5. g/l. Analytic concordance showed improved specificity for women. Comparison of results to LC-MS/MS indicated comparable performance with other immunoassays for men and improved performance for women, boys, and girls with mean differences of 0.5%, -. 0.7%, and 24.4%, respectively. Conclusions: The Roche Testo II assay demonstrated excellent precision. Comparison to 2 other automated immunoassays showed comparable performance for men and improved performance for women and children. However, challenges still exist for quantifying testosterone concentrations
AB - Background: Serum testosterone measurements have utility in diagnosis of clinical conditions characterized by both increased and decreased testosterone concentrations. Studies have indicated that testosterone immunoassays may give inaccurate results for women and children. We evaluated the performance of a second generation testosterone immunoassay from Roche Diagnostics. Methods: Testo II performed on a Modular Analytics E 170 analyzer is an automated random access electrochemiluminometric assay. We evaluated limit of blank (LoB), imprecision, linearity, interference, and method comparison with liquid chromatography-tandem mass spectrometry assay (LC-MS/MS). Method comparison included the current generation Roche testosterone assay (Testo I) and the Access 2 testosterone chemiluminometric assay (Beckman Coulter). Results for men and women were analyzed for analytic concordance. The relative % differences of immunoassay compared to LC-MS/MS results were evaluated. Results: The LoB was 0.07. nmol/l. Total imprecision was 22.5. g/l. Analytic concordance showed improved specificity for women. Comparison of results to LC-MS/MS indicated comparable performance with other immunoassays for men and improved performance for women, boys, and girls with mean differences of 0.5%, -. 0.7%, and 24.4%, respectively. Conclusions: The Roche Testo II assay demonstrated excellent precision. Comparison to 2 other automated immunoassays showed comparable performance for men and improved performance for women and children. However, challenges still exist for quantifying testosterone concentrations
UR - https://linkinghub.elsevier.com/retrieve/pii/S0009898110002305
UR - http://www.scopus.com/inward/record.url?scp=77953290645&partnerID=8YFLogxK
U2 - 10.1016/j.cca.2010.03.041
DO - 10.1016/j.cca.2010.03.041
M3 - Article
SN - 0009-8981
VL - 411
SP - 1073
EP - 1079
JO - Clinica Chimica Acta
JF - Clinica Chimica Acta
IS - 1-16
ER -