Mass spectrometry (MS)-based 17-hydroxyprogesterone (17OHP) methods show considerable variation in results in external quality assurance (EQA) programs. An understanding of the current status of MS-based serum/plasma 17OHP quantification is important to facilitate harmonization.
A 50-item e-survey related to (1) laboratory characteristics, (2) pre-analytical considerations and (3) analysis of 17OHP was developed and circulated to clinical MS laboratories via professional associations in Asia Pacific, Europe and North America.
Forty-four laboratories from 17 countries completed the survey. Sample preparation varied between laboratories with protein precipitation and liquid-liquid extraction being the most common processes. Analyte separation was most commonly achieved by liquid chromatography (LC) using a C18 column and mobile phases of water, methanol and formic acid. The ions selected for quantification were 331>97 m/z or 331>109 m/z. Alternative transition ions were used as qualifiers. Twenty-seven of 44 respondents reported preparing their calibrators in-house and variations in material purity and matrix were evident. Nine of 44 laboratories did not participate in an EQA program, and half did not know if their method separated out isobars. The reference intervals, and also their partitioning, reported by the laboratories were highly discrepant, in some cases, by multiple folds.
Although MS-based methods are similar in many facets, they are highly disparate. Five recommendations have been developed as an outcome of this survey to support the continued improvement of analysis of serum/plasma 17OHP by MS.
We wish to thank Professors Leslie Lai, Loralie Langman, Patti Jones, Rachana Santiyanont and all colleagues for assisting in the dissemination of this survey. Thank you to all the participants of this survey for their motivation and enthusiasm in completing this detailed survey. Our thanks are also extended to Drs Lindsey Mackay and Stephen Davies from the National Measurement Institute of Australia for supporting the development of the CRM for 17OHP. Stefan A. Wudy (chair), Michaela Hartmann (member), Yolanda de Rijke (member) and Ronda Greaves (international member) of working group 3 “Harmonisation of Laboratory Assessment” appreciate support from European Cooperation in Science and Technology (COST) Action BM1303 “DSDnet”. Ronda Greaves (chair), Chung Shun Ho (member), Tze Ping Loh (member), Peter Graham (member) and Lisa Jolly (past member) of the Mass Spectrometry Harmonisation Working Group acknowledge the support of the APFCB and the AACB. Finally, we wish to acknowledge the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) for in-kind support to continue this work through the Emerging Technologies Division of the IFCC.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2017-1039).
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