PMID- 19563791
OWN - NLM
STAT- MEDLINE
DCOM- 20091222
LR  - 20180813
IS  - 1873-3492 (Electronic)
IS  - 0009-8981 (Linking)
VI  - 408
IP  - 1-2
DP  - 2009 Oct
TI  - Specifications for trueness and precision of a reference measurement system for 
      serum/plasma 25-hydroxyvitamin D analysis.
PG  - 8-13
LID - 10.1016/j.cca.2009.06.027 [doi]
AB  - BACKGROUND: The divergence in analytical quality of serum/plasma 
      25-hydroxy-vitamin D analysis calls for defining specifications for a reference 
      measurement system. METHODS: Fundamentally, in a reference measurement system, 
      there should be a relationship between the analytical specifications for higher- 
      (reference) and lower-order (routine) measurements. Therefore, when setting 
      specifications, we started with limits for routine imprecision (CV(rou)) and bias 
      (B(rou)) using 4 models: (1) the misclassifications in diagnosis, (2) biological 
      variation data (reference interval (RI) and monitoring), (3) expert 
      recommendations, and (4) state-of-the-art performance. Then, we used the derived 
      goals to tailor those for reference measurements and certified reference 
      materials (CRMs) for calibration by setting the limits for CV(ref) at 0.5 
      CV(rou), B(ref) at 0.33 B(rou)(,) max. uncertainty (U(max)) at 0.33 B(ref). 
      RESULTS: The established specifications ranged between CV(rou)<or=22%, 
      B(rou)<or=10%, CV(ref)<or=11%, B(ref)<or=3.3%, U(max) 1.1% (model 3) and 
      CV(rou)<or=4%, B(rou)<or=2.6%, CV(ref)<or=2%, B(ref)<or=0.9%, U(max) 0.3% (model 
      2, monitoring). CONCLUSIONS: Model 2 (monitoring) gave the most stringent goals, 
      model 3, the most liberal ones. Accounting for state-of-the-art performance and 
      certification capabilities, we used model 2 (RI) to recommend achievable goals: 
      for routine testing, CV(rou)<or=10%, B(rou)<or=5%, for reference measurements, 
      CV(ref)<or=5%, B(ref)<or=1.7%, and for CRMs, U(max) 0.6%.
FAU - Stockl, Dietmar
AU  - Stockl D
AD  - Laboratory for Analytical Chemistry, Faculty of Pharmaceutical Sciences, Ghent 
      University, Harelbekestraat 72, B-9000 Ghent, Belgium.
FAU - Sluss, Patrick M
AU  - Sluss PM
FAU - Thienpont, Linda M
AU  - Thienpont LM
LA  - eng
PT  - Journal Article
DEP - 20090627
PL  - Netherlands
TA  - Clin Chim Acta
JT  - Clinica chimica acta; international journal of clinical chemistry
JID - 1302422
RN  - 1406-16-2 (Vitamin D)
RN  - A288AR3C9H (25-hydroxyvitamin D)
SB  - IM
MH  - Adolescent
MH  - Aged
MH  - Blood Chemical Analysis/*methods/*standards
MH  - Child
MH  - Female
MH  - Humans
MH  - Laboratories
MH  - Male
MH  - Reference Standards
MH  - Sensitivity and Specificity
MH  - Vitamin D/*analogs & derivatives/blood
EDAT- 2009/07/01 09:00
MHDA- 2009/12/23 06:00
CRDT- 2009/07/01 09:00
PHST- 2009/03/25 00:00 [received]
PHST- 2009/06/22 00:00 [revised]
PHST- 2009/06/22 00:00 [accepted]
PHST- 2009/07/01 09:00 [entrez]
PHST- 2009/07/01 09:00 [pubmed]
PHST- 2009/12/23 06:00 [medline]
AID - S0009-8981(09)00337-4 [pii]
AID - 10.1016/j.cca.2009.06.027 [doi]
PST - ppublish
SO  - Clin Chim Acta. 2009 Oct;408(1-2):8-13. doi: 10.1016/j.cca.2009.06.027. Epub 2009 
      Jun 27.