PMID- 28522444
OWN - NLM
STAT- MEDLINE
DCOM- 20170710
LR  - 20220408
IS  - 1530-8561 (Electronic)
IS  - 0009-9147 (Linking)
VI  - 63
IP  - 7
DP  - 2017 Jul
TI  - Harmonization of Serum Thyroid-Stimulating Hormone Measurements Paves the Way for 
      the Adoption of a More Uniform Reference Interval.
PG  - 1248-1260
LID - 10.1373/clinchem.2016.269456 [doi]
AB  - BACKGROUND: The IFCC Committee for Standardization of Thyroid Function Tests 
      developed a global harmonization approach for thyroid-stimulating hormone 
      measurements. It is based on a multiassay method comparison study with clinical 
      serum samples and target setting with a robust factor analysis method. Here we 
      describe the Phase IV method comparison and reference interval (RI) studies 
      conducted with the objective to recalibrate the participating assays and 
      demonstrate the proof-of-concept. METHODS: Fourteen manufacturers measured the 
      harmonization and RI panel; 4 of them quantified the harmonization and first 
      follow-up panel in parallel. All recalibrated their assays to the statistically 
      inferred targets. For validation, we used desirable specifications from the 
      biological variation for the bias and total error (TE). The RI measurements were 
      done with the assays' current calibrators, but data were also reported after 
      transformation to the new calibration status. We estimated the pre- and 
      postrecalibration RIs with a nonparametric bootstrap procedure. RESULTS: After 
      recalibration, 14 of 15 assays met the bias specification with 95% confidence; 8 
      assays complied with the TE specification. The CV of the assay means for the 
      harmonization panel was reduced from 9.5% to 4.2%. The RI study showed improved 
      uniformity after recalibration: the ranges (i.e., maximum differences) exhibited 
      by the assay-specific 2.5th, 50th, and 97.5th percentile estimates were reduced 
      from 0.27, 0.89, and 2.13 mIU/L to 0.12, 0.29, and 0.77 mIU/L. CONCLUSIONS: We 
      showed that harmonization increased the agreement of results from the 
      participating immunoassays, and may allow them to adopt a more uniform RI in the 
      future.
CI  - (c) 2017 American Association for Clinical Chemistry.
FAU - Thienpont, Linda M
AU  - Thienpont LM
AD  - Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent 
      University, Ghent, Belgium; linda.thienpont@ugent.be.
AD  - Current affiliation: Thienpont & Stockl Wissenschaftliches Consulting GbR, 
      Rennertshofen (OT Bertoldsheim), Germany.
FAU - Van Uytfanghe, Katleen
AU  - Van Uytfanghe K
AD  - Ref4U, Laboratory of Toxicology, Faculty of Pharmaceutical Sciences, Ghent 
      University, Ghent, Belgium.
FAU - De Grande, Linde A C
AU  - De Grande LAC
AD  - Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent 
      University, Ghent, Belgium.
FAU - Reynders, Dries
AU  - Reynders D
AD  - Department of Applied Mathematics, Computer Science, and Statistics, Faculty of 
      Sciences, Ghent University, Ghent, Belgium.
FAU - Das, Barnali
AU  - Das B
AD  - Biochemistry and Immunology Laboratory, Kokilaben Dhirubhai Ambani Hospital and 
      Medical Research Institute, Mumbai, India.
FAU - Faix, James D
AU  - Faix JD
AD  - Clinical Chemistry and Immunology, Montefiore Medical Center, and Department of 
      Pathology, Albert Einstein School of Medicine, New York, NY.
FAU - MacKenzie, Finlay
AU  - MacKenzie F
AD  - Birmingham Quality/UK NEQAS, University Hospitals Birmingham NHS Foundation 
      Trust, Birmingham, UK.
FAU - Decallonne, Brigitte
AU  - Decallonne B
AD  - Department of Endocrinology, University Hospitals Leuven, Leuven, Belgium.
FAU - Hishinuma, Akira
AU  - Hishinuma A
AD  - Department of Infection Control and Clinical Laboratory Medicine, Dokkyo Medical 
      University, Tochigi, Japan.
FAU - Lapauw, Bruno
AU  - Lapauw B
AD  - Department of Endocrinology, Ghent University Hospital, Ghent, Belgium.
FAU - Taelman, Paul
AU  - Taelman P
AD  - Laboratory of Endocrinology, Department of Laboratory Medicine, AZ 
      Maria-Middelares Sint-Jozef, Campus Maria-Middelares, Ghent, Belgium.
FAU - Van Crombrugge, Paul
AU  - Van Crombrugge P
AD  - Department of Endocrinology, OLV Ziekenhuis Aalst-Asse-Ninove, Aalst, Belgium.
FAU - Van den Bruel, Annick
AU  - Van den Bruel A
AD  - Department of Endocrinology, General Hospital Sint Jan, Bruges, Belgium.
FAU - Velkeniers, Brigitte
AU  - Velkeniers B
AD  - Department of Endocrinology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
FAU - Williams, Paul
AU  - Williams P
AD  - Department of Endocrinology, Royal Prince Alfred Hospital, Camperdown, Australia.
CN  - IFCC Committee for Standardization of Thyroid Function Tests (C-STFT)
LA  - eng
PT  - Journal Article
PT  - Validation Study
DEP - 20170518
PL  - England
TA  - Clin Chem
JT  - Clinical chemistry
JID - 9421549
RN  - 9002-71-5 (Thyrotropin)
SB  - IM
CIN - Clin Chem. 2017 Jul;63(7):1184-1186. PMID: 28522443
MH  - Calibration
MH  - Humans
MH  - *Immunoassay/standards
MH  - Reference Standards
MH  - Reference Values
MH  - Thyrotropin/*blood/standards
EDAT- 2017/05/20 06:00
MHDA- 2017/07/14 06:00
CRDT- 2017/05/20 06:00
PHST- 2016/11/17 00:00 [received]
PHST- 2017/04/04 00:00 [accepted]
PHST- 2017/05/20 06:00 [pubmed]
PHST- 2017/07/14 06:00 [medline]
PHST- 2017/05/20 06:00 [entrez]
AID - clinchem.2016.269456 [pii]
AID - 10.1373/clinchem.2016.269456 [doi]
PST - ppublish
SO  - Clin Chem. 2017 Jul;63(7):1248-1260. doi: 10.1373/clinchem.2016.269456. Epub 2017 
      May 18.