Detecting Total Serum Testosterone by Chemiluminescence Immunoassays, Radioactive Assays, and Liquid-Chromatography Tandem Mass Spectrometry: A Comparative Study

Aim: LC-MS/MS is still considered the gold standard for detecting steroid hormones in clinic. The aim of this study was to compare the analytical sensitivity of chemiluminescence immunoassays (CLIA) platforms, radioimmunoassay (RIA) platform, and high-performance liquid-chromatography tandem mass spectrometry (LC-MS/MS) platform for detecting total testosterone (tTES) in human samples (males and females). Method: Sixty-nine healthy male serum samples and 114 female serum samples were collected. The serum testosterone was detected by automatic immunoassay systems of Beckman and SIEMENS, radioimmunoassay, and LC-MS/MS. Pearson’s correlation coefficients were calculated to assess the agreement of other platforms with LC-MS/MS. Result: When evaluating TES in males, the results detected by SIEMENS2000 had a good correlation with LC-MS/MS (r=0.986), followed by Beckman DXI800, while RIA showed a weak correlation. There was no statistical difference between the results detected by SIEMENS2000 compared to those detected by DXI800 (p=0.87). When evaluating TES in females, DXI800 showed a good correlation with LC-MS/ MS (r=0.8784). SIEMENS2000 had most of the detected values below its low limit, and the SIEMENS2000 results with definite values were not statistically different compared to DXI800 results. Conclusion: The results detection platforms (SIEMENS2000 and DXI800) both had a better correlation with those of LC-MS/MS than RIA. Yet, Siemens 2000 had better consistency with LC-MS/MS in detecting the serums with low tTES value than DXI800. the samples with definite values; were above the lowest limit of Simense (0.69nmom/L). The samples’ values the RIA obviously The correlation coefficient between the two immunoassay platforms and the LC-MS/MS was higher than that between RIA and LC-MS/MS in males. We further analyzed the samples’ results below 0.69nmol/L when using two chemiluminescence platforms.