PMID- 28398583
OWN - NLM
STAT- MEDLINE
DCOM- 20171220
LR  - 20220316
IS  - 1943-7730 (Electronic)
IS  - 0007-5027 (Linking)
VI  - 48
IP  - 2
DP  - 2017 May 1
TI  - CLSI-Based Validation of Manufacturer-Derived Reference Intervals on the Cobas 
      8000 Platform.
PG  - e30-e35
LID - 10.1093/labmed/lmx020 [doi]
AB  - BACKGROUND: Reference intervals provided by diagnostic test manufacturers should 
      be transferred to clinical laboratories after validation. Although protocols 
      exist, laboratories rarely perform and report on results of validation studies. 
      METHODS: We validated reference intervals (RIs) of 87 analytes on a Cobas 8000 
      platform according to standards published by the Clinical and Laboratory 
      Standards Institute (CLSI). RESULTS: For 8 analytes, decision limits were 
      provided in the package inserts. Among the 79 RIs subjected to transference 
      validation, 8 were found not valid for transference, including lactate 
      dehydrogenase (LDH) among women, and the following among both sexes: potassium, 
      homocysteine, immunoglobulin E (IgE), free lambda light chain (FLC lambda), C3 
      complement (C3c), folate, and 25-hydroxy vitamin D (25[(OH]D). For LDH, 
      potassium, homocysteine, C3c, folate, and 25(OH)D, RIs or thresholds suitable for 
      transference were available in the literature; however, this was not the case for 
      IgE and FLC lambda. CONCLUSION: The present study demonstrates that validation of RIs 
      provided in the manufacturer provided package inserts is indispensable.
CI  - (c) American Society for Clinical Pathology, 2017. All rights reserved. For 
      permissions, please e-mail: journals.permissions@oup.com
FAU - Leitner-Ferenc, Veronika
AU  - Leitner-Ferenc V
AD  - Institute of Laboratory Diagnostics, Kaiser Franz Josef Hospital, Vienna, 
      Austria.
FAU - Atamaniuk, Johanna
AU  - Atamaniuk J
AD  - Institute of Laboratory Diagnostics, Kaiser Franz Josef Hospital, Vienna, 
      Austria.
FAU - Jansen-Skoupy, Sonja
AU  - Jansen-Skoupy S
AD  - Institute of Laboratory Diagnostics, Kaiser Franz Josef Hospital, Vienna, 
      Austria.
FAU - Stockelmeier, Brigitta
AU  - Stockelmeier B
AD  - Institute of Laboratory Diagnostics, Kaiser Franz Josef Hospital, Vienna, 
      Austria.
FAU - Grohs, Katharina
AU  - Grohs K
AD  - Institute of Laboratory Diagnostics, Kaiser Franz Josef Hospital, Vienna, 
      Austria.
FAU - Fodinger, Manuela
AU  - Fodinger M
AD  - Institute of Laboratory Diagnostics, Kaiser Franz Josef Hospital, Vienna, 
      Austria.
AD  - Sigmund Freud Private University, Vienna, Austria.
LA  - eng
PT  - Journal Article
PL  - England
TA  - Lab Med
JT  - Laboratory medicine
JID - 0250641
SB  - IM
MH  - *Blood Chemical Analysis/instrumentation/methods/standards
MH  - Humans
MH  - Laboratories/*standards
MH  - Limit of Detection
MH  - Reference Values
MH  - Reproducibility of Results
OTO - NOTNLM
OT  - analytical system
OT  - decision limit
OT  - guideline
OT  - reference values
OT  - test provider
OT  - transference
EDAT- 2017/04/12 06:00
MHDA- 2017/12/21 06:00
CRDT- 2017/04/12 06:00
PHST- 2017/04/12 06:00 [pubmed]
PHST- 2017/12/21 06:00 [medline]
PHST- 2017/04/12 06:00 [entrez]
AID - 3192380 [pii]
AID - 10.1093/labmed/lmx020 [doi]
PST - ppublish
SO  - Lab Med. 2017 May 1;48(2):e30-e35. doi: 10.1093/labmed/lmx020.