PMID- 28447411
OWN - NLM
STAT- MEDLINE
DCOM- 20170612
LR  - 20190320
IS  - 1751-553X (Electronic)
IS  - 1751-5521 (Linking)
VI  - 39 Suppl 1
DP  - 2017 May
TI  - Establishing reference intervals in the coagulation laboratory.
PG  - 121-127
LID - 10.1111/ijlh.12661 [doi]
AB  - INTRODUCTION: Obtaining a reference interval (RI) is a challenge for any 
      laboratory and becomes more complicated in the coagulation laboratory due to 
      testing on samples with limited stability on reagents that are poorly 
      standardized. Reference intervals are required to be able to evaluate results in 
      relation to a patients' hemostatic disorder. This becomes one of the most 
      important tasks conducted in the coagulation laboratory. However, many 
      laboratories lack the time, finances and in many cases the expertise to conduct 
      this study. METHODS: Many RI are obtained from package inserts, or from 
      publications written by experts in lieu of laboratories conducting their own 
      studies. An overview of validating reference intervals and options for verifying 
      or transference of reference intervals is discussed. RESULTS: Based on the 
      confidence interval and the acceptability of risk laboratories are willing to 
      accept, coagulation laboratories have options to conduct robust studies for their 
      RI. Data mining or global reference studies may help to provide data for age 
      specific ranges. CONCLUSIONS: Pre-analytical variables and selection of healthy 
      subjects have the largest impact on coagulation testing outcomes and need to be 
      well controlled during the establishment of reference intervals. Laboratories 
      have options in lieu of conducting a full validation on how to verify RI based on 
      smaller RI studies or transference of RI after determining compatibility of the 
      original RI study.
CI  - (c) 2017 John Wiley & Sons Ltd.
FAU - Castellone, D D
AU  - Castellone DD
AD  - Department of Clinical Laboratories, Special Coagulation and Special Hematology, 
      New York Presbyterian Hospital- Columbia Medical Center, New York, NY, USA.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - England
TA  - Int J Lab Hematol
JT  - International journal of laboratory hematology
JID - 101300213
SB  - IM
MH  - Blood Coagulation Tests/methods/standards
MH  - Hemostatic Disorders/*blood/*diagnosis
MH  - Humans
MH  - Reference Standards
OTO - NOTNLM
OT  - coagulation
OT  - reference interval
OT  - validation
OT  - verification
EDAT- 2017/04/28 06:00
MHDA- 2019/03/21 06:00
CRDT- 2017/04/28 06:00
PHST- 2017/01/05 00:00 [received]
PHST- 2017/01/23 00:00 [accepted]
PHST- 2017/04/28 06:00 [entrez]
PHST- 2017/04/28 06:00 [pubmed]
PHST- 2019/03/21 06:00 [medline]
AID - 10.1111/ijlh.12661 [doi]
PST - ppublish
SO  - Int J Lab Hematol. 2017 May;39 Suppl 1:121-127. doi: 10.1111/ijlh.12661.