ACQUITY UPLC I-Class/Xevo TQ-S micro IVD System: Analytical Performance for Progestogens and Androgens
For in vitro diagnostic use. Not available in all countries.
Introduction
The Waters ACQUITY UPLC I-Class/Xevo TQ-S micro IVD System enables the quantification of organic compounds in human biological liquid matrices.
This document describes a test of the analytical performance of the ACQUITY I-Class/Xevo TQ-S micro IVD System for the analysis of dihydrotestosterone (DHT), dehydroepiandrosterone (DHEA), testosterone, androstenedione, 17-hydroxyprogesterone, and progesterone in serum.
Experimental
The ACQUITY UPLC I-Class/Xevo TQ-S micro IVD System was controlled by MassLynx IVD Software (v4.1) and the data processed using the TargetLynx Application Manager. Calibrators and Quality Controls were prepared by spiking commercially available reference material in stripped serum and the samples were processed using the following conditions:
Sample Description
Sample preparation conditions 100 μL sample was processed with methanol, diluted with water, and centrifuged. Samples were loaded on Oasis MAX μElution plates, washed, and eluted prior to analysis.
LC Conditions
|
Column: |
CORTECS UPLC C18 1.6 μm, 2.1 mm × 50 mm |
|
Mobile phase A: |
0.05 mM Ammonium fluoride in water |
|
Mobile phase B: |
Methanol |
|
Flow Rate: |
0.25 mL/min |
|
Gradient: |
40% B over 0.5 minutes, 40–70% B over 3.5 minutes, 95% B for 0.5 minutes |
MS Conditions
|
Resolution: |
MS1 (0.75 FWHM), MS2 (0.5 FWHM) |
|
Acquisition mode: |
MRM |
|
Polarity: |
ESI+ |
Results and Discussion
Performance characteristics of the steroid hormones on the ACQUITY UPLC I-Class/Xevo TQ-S micro IVD System are shown in Table 1. Analytical sensitivity of the system for analysing extracted steroid hormone samples is illustrated in Figure 1.
Table 1. Performance characteristics of the analytes evaluated. Range defined by linear fit where r2 >0.99. LLOQ defined by S/N (PtP) >10 and %RSD ≤20%. %RSD at LLOQ determined through analytical sensitivity experiments performed over five occasions (n=40). Total precision and repeatability of QCs performed over five occasions (n=25). Mean bias determined through Bland-Altman comparison of calculated concentrations to RCPA QAP target values for DHT and EQA mass spectrometry mean values for testosterone, androstenedione, and 17-OHP.
Note: To convert SI units to conventional mass units divide by 3.45 for DHT (nmol/L to ng/mL), 3.47 for DHEA (nmol/L to ng/mL), 3.47 for testosterone (nmol/L to ng/mL), 3.49 for androstenedione (nmol/L to ng/mL), 3.03 for 17-OHP (nmol/L to ng/mL), and 3.18 for progesterone (nmol/L to ng/mL).
Conclusion
The ACQUITY UPLC I-Class/Xevo TQ-S micro IVD System has demonstrated the capability to deliver analytically sensitive and selective performance with excellent precision and accuracy for DHT, DHEA, testosterone, androstenedione, 17-hydroxyprogesterone, and progesterone in serum.
Disclaimer
The analytical performance data presented here is for illustrative purposes only. Waters does not recommend or suggest analysis of the analytes described herein. These data are intended solely to demonstrate the performance capabilities of the system for analytes representative of those commonly analyzed using liquid chromatography and tandem mass spectrometry. Performance in an individual laboratory may differ due to a number of factors, including laboratory methods, materials used, intra-operator technique, and system conditions. This document does not constitute a warranty of merchantability or fitness for any particular purpose, express or implied, including for the testing of the analytes in this analysis.
720006324, August 2021
