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Testosterone Replacement, Low T, HCG, & Beyond
Blood Test Discussion
Direct Measurements of Free Hormones Using Mass Spectrometry-Based Methods
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<blockquote data-quote="madman" data-source="post: 260324" data-attributes="member: 13851"><p><strong><em>*Well-developed and validated mass spectrometry-based methods are typically more specific, compared to other techniques. Because of this, reference intervals should be established for each FH method before they are introduced in routine clinical use. <u>Thorough method validation, standardization, and harmonization of mass spectrometry-based methods for FHs among different laboratories should facilitate the implementation of uniform reference intervals for LC–MS/MSbased methods for FHs</u> (113).</em></strong></p><p><strong><em></em></strong></p><p><strong><em>*Nonharmonized FH reference methods and unique patient demographics require that each laboratory establishes pertinent reference intervals. <u>Patient care could be improved, however, if methods for FHs would be harmonized across laboratories, allowing for adoption of reference intervals among laboratories</u>. In addition to method-related differences, there are among population and -ethnicity differences in the distributions of the FH concentrations characteristic of health, which necessitate development of population- and ethnicity-specific reference intervals for FHs.</em></strong></p><p><strong><em></em></strong></p><p><strong><em>*Last, <u>lot-to-lot variability in consumables (ED, UF, or SES devices) used for isolation of FHs, and among-method or among-procedure differences for FH separation from biological samples</u>, may contribute to the greater assay variability compared to methods for measurement of TH concentration.</em></strong></p><p></p><p><em><strong>*Direct methods that isolate FH, followed by LC–MS/MS analysis, are available at many clinical reference laboratories for measurements of FTe, FE2, FT4, FT3, and free plasma cortisol. <u>As shown in many studies, these methods provide specific analytical advantage over commercial immunoassays and indirect (e.g., calculation-based) methods</u>. High-throughput methods for physiologically important FHs have been developed and used for routine patient sample testing, providing adequate turnaround time and cost efficiency. <u>Mass spectrometry-based methods are considered a gold standard method (provide higher analytical sensitivity and specificity compared to other available techniques) for measurement of FH concentrations</u>. Multiple barriers currently prevent more widespread use of direct reference methods for measurement of FHs, including technical complexities that are best suited for clinical reference laboratories. Furthermore, sample preparation for direct measurement of FHs is time-consuming, with ED methods often requiring overnight incubation, thereby increasing assay turnaround time. <u>Emerging techniques such as SES, as well as current efforts to harmonize and standardize FH assays to make them more reliable, may alleviate the challenges of assay reliability and allow for reduced turnaround time</u>. <u>Laboratories with experience in high-complexity workflows and quality programs in place may be best suited for implementing methods for direct measurement of FH using LC–MS/MS</u>. <u>Laboratories should provide adequate information in directories to appropriately highlight the clinical conditions, advantages, and limitations of FH assays to promote clinical education and guidance regarding the appropriate use of FH measurements</u>. As research continues to reveal clinical associations between binding protein abnormalities and hormone physiology, it is likely that mass spectrometry-based methods for direct measurement of FH concentrations will be more widely used in future clinical practice.</strong></em></p></blockquote><p></p>
[QUOTE="madman, post: 260324, member: 13851"] [B][I]*Well-developed and validated mass spectrometry-based methods are typically more specific, compared to other techniques. Because of this, reference intervals should be established for each FH method before they are introduced in routine clinical use. [U]Thorough method validation, standardization, and harmonization of mass spectrometry-based methods for FHs among different laboratories should facilitate the implementation of uniform reference intervals for LC–MS/MSbased methods for FHs[/U] (113). *Nonharmonized FH reference methods and unique patient demographics require that each laboratory establishes pertinent reference intervals. [U]Patient care could be improved, however, if methods for FHs would be harmonized across laboratories, allowing for adoption of reference intervals among laboratories[/U]. In addition to method-related differences, there are among population and -ethnicity differences in the distributions of the FH concentrations characteristic of health, which necessitate development of population- and ethnicity-specific reference intervals for FHs. *Last, [U]lot-to-lot variability in consumables (ED, UF, or SES devices) used for isolation of FHs, and among-method or among-procedure differences for FH separation from biological samples[/U], may contribute to the greater assay variability compared to methods for measurement of TH concentration.[/I][/B] [I][B]*Direct methods that isolate FH, followed by LC–MS/MS analysis, are available at many clinical reference laboratories for measurements of FTe, FE2, FT4, FT3, and free plasma cortisol. [U]As shown in many studies, these methods provide specific analytical advantage over commercial immunoassays and indirect (e.g., calculation-based) methods[/U]. High-throughput methods for physiologically important FHs have been developed and used for routine patient sample testing, providing adequate turnaround time and cost efficiency. [U]Mass spectrometry-based methods are considered a gold standard method (provide higher analytical sensitivity and specificity compared to other available techniques) for measurement of FH concentrations[/U]. Multiple barriers currently prevent more widespread use of direct reference methods for measurement of FHs, including technical complexities that are best suited for clinical reference laboratories. Furthermore, sample preparation for direct measurement of FHs is time-consuming, with ED methods often requiring overnight incubation, thereby increasing assay turnaround time. [U]Emerging techniques such as SES, as well as current efforts to harmonize and standardize FH assays to make them more reliable, may alleviate the challenges of assay reliability and allow for reduced turnaround time[/U]. [U]Laboratories with experience in high-complexity workflows and quality programs in place may be best suited for implementing methods for direct measurement of FH using LC–MS/MS[/U]. [U]Laboratories should provide adequate information in directories to appropriately highlight the clinical conditions, advantages, and limitations of FH assays to promote clinical education and guidance regarding the appropriate use of FH measurements[/U]. As research continues to reveal clinical associations between binding protein abnormalities and hormone physiology, it is likely that mass spectrometry-based methods for direct measurement of FH concentrations will be more widely used in future clinical practice.[/B][/I] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Blood Test Discussion
Direct Measurements of Free Hormones Using Mass Spectrometry-Based Methods
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