Gaps in the Traceability Chain of Human Growth Hormone Measurements

Boulo, Sébastien; Hanisch, Katja; Bidlingmaier, Martin; Arsene, Cristian; Panteghini, Mauro; Auclair, Guy; Sturgeon, Catharine M.; Schimmel, Heinz; Zegers, Ingrid

doi:10.1373/clinchem.2012.199489

Cited by 17 publications

(12 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although a reference measurement procedure existed for free thyroxine, we considered this option for TSH unlikely and developed a pragmatic approach to harmonization rather than standardization (17,18). To circumvent the often encountered commutability issues in establishing calibration traceability of IVD assays, it was a premise for C-STFT that harmonization should be done from a multi-assay method comparison study with a panel of native and clinically relevant samples (19)(20)(21). We developed a robust factor analysis method for estimation of the harmonization targets and demonstrated the equivalence of the approach to standardization to a reference measurement procedure (22,23).…”

Section: Introductionmentioning

confidence: 99%

Harmonization of Serum Thyroid-Stimulating Hormone Measurements Paves the Way for the Adoption of a More Uniform Reference Interval

et al. 2017

View full text Add to dashboard Cite

show abstract

Section: Introductionmentioning

confidence: 99%

Harmonization of Serum Thyroid-Stimulating Hormone Measurements Paves the Way for the Adoption of a More Uniform Reference Interval

et al. 2017

View full text Add to dashboard Cite

show abstract

“…A definitive statement as to this, however, would require a separate study, preferably with a further higher number of sera included. In general, the comparison of ID-MS data with the results from GH immunochemical assays is an option to detect the gaps in the traceability chain, which is frequently encountered in practice (32).…”

Section: Comparison Of Immunoassay Results With Id-msmentioning

confidence: 99%

Clinical evidence-based cutoff limits for GH stimulation tests in children with a backup of results with reference to mass spectrometry

Wagner¹,

Paetzold²,

Gausche³

et al. 2014

European Journal of Endocrinology

View full text Add to dashboard Cite

Context: Cutoff limits of GH stimulation tests to diagnose GH deficiency (GHD) in children and adolescents are not sufficiently validated by clinical studies due to discrepancies in the performance of GH immunoassays and lack of available study populations. Objective: We aimed to establish new cutoff limits for GH stimulation tests based on clinical evidence and compared these immunoassay-based values with an antibody-independent mass spectrometric method. Design and setting: In a retrospective study, GH cutoff limits for eight different immunoassays and isotope dilution mass spectrometry (ID-MS) were calculated from hGH peak concentrations of short-statured children with and without GHD. Patients: We compared the serum GH peak concentrations at GH stimulation test of 52 short-statured children and adolescents, who have normal GH secretion at initial workup and normal growth in the follow-up, with the serum GH peak concentrations of 44 GHD patients in the same age range, in order to optimize the cutoff limit calculation. Results: Discriminant analysis of re-measured GH led to a new cutoff limit of 7.09 mg/l using the iSYS assay (IDS) and the limits for the other seven hGH assays varied between 4.32 and 7.77 mg/l. For ID-MS, cutoffs of 5.48 mg/l (22k GH) and 7.43 mg/l (total GH) were ascertained. Conclusion: The establishment of method-specific clinical evidence-based GH cutoff limits is of importance to ensure adequate clinical diagnosis and treatment of children and adolescents with GHD. ID-MS may become an important tool for providing both reliable and sustainable SI traceability of GH measurements in the future.

show abstract

“…For instance, it could be shown for human growth hormone (hGH) that despite the good correlation between data from end user measurement procedures (all immunoassays) neither the international standard for hGH (WHO 98/574) nor dilutions of the standard were commutable which led to a breach in the traceability chain and explained the persistent discrepancies between results from end user measurement procedures [13]. It was also shown that a mass spectrometry based candidate RMP targeting peptides originating from digested hGH did not correlate well on clinical samples with the end user measurement procedures.…”

Section: General Requirements For Establishing An Efficient Calibratimentioning

confidence: 99%

Performance criteria for reference measurement procedures and reference materials

Schimmel

Zegers

2015

Clinical Chemistry and Laboratory Medicine (CCLM)

Self Cite

View full text Add to dashboard Cite

Abstract:The concept of metrological traceability of measurement results to property values assigned to measurement standards of higher metrological order or to the International System of Units (SI) through sequential calibrations, using reference materials and reference measurement procedures, plays a key role in ensuring that end user measurement procedures perform at an acceptable level in the clinical context. The aim is that measurement results produced over time or by different end users or with different end user measurement procedures for the same measurand will be equivalent within their corresponding uncertainties. These goals can only be reached under certain conditions and if requirements laid down in international standards on calibration concepts, reference measurement procedures and reference materials are fulfilled. Calibration hierarchies have to be implemented correctly and parameters contributing to measurement uncertainty and systematic bias need to be controlled and eliminated, respectively, by technically improving methods and reference materials and intermediate calibrators used for effectively achieving equivalence of measurement results and for meeting analytical performance requirements for in vitro diagnostic devices.

show abstract

Gaps in the Traceability Chain of Human Growth Hormone Measurements

Cited by 17 publications

References 18 publications

Harmonization of Serum Thyroid-Stimulating Hormone Measurements Paves the Way for the Adoption of a More Uniform Reference Interval

Harmonization of Serum Thyroid-Stimulating Hormone Measurements Paves the Way for the Adoption of a More Uniform Reference Interval

Clinical evidence-based cutoff limits for GH stimulation tests in children with a backup of results with reference to mass spectrometry

Performance criteria for reference measurement procedures and reference materials

Contact Info

Product

Resources

About