PMID- 28467597
OWN - NLM
STAT- MEDLINE
DCOM- 20171129
LR  - 20171129
IS  - 1939-165X (Electronic)
IS  - 0275-6382 (Linking)
VI  - 46
IP  - 2
DP  - 2017 Jun
TI  - Objective evaluation of analyzer performance based on a retrospective 
      meta-analysis of instrument validation studies: point-of-care hematology 
      analyzers.
PG  - 248-261
LID - 10.1111/vcp.12492 [doi]
AB  - BACKGROUND: Information on quality requirements and objective evaluation of 
      performance of veterinary point-of-care analyzers (POCAs) is scarce. OBJECTIVES: 
      The study was aimed at assessing observed total errors (TE(obs) s) for veterinary 
      hematology POCAs via meta-analysis and comparing TE(obs) to allowable total error 
      (TE(a) ) specifications based on experts' opinions. METHODS: The TE(obs) for 
      POCAs (impedance and laser-based) was calculated based on data from instrument 
      validation studies published between 2006 and 2013 as follows: TE(obs) = 2 x CV 
      [%] + bias [%]. The CV was taken from published studies; the bias was estimated 
      from the regression equation at 2 different concentration levels of measurands. 
      To fulfill quality requirements, TE(obs) should be < TE(a) . Measurands were 
      considered as globally acceptable if > 60% of analyzers showed TE(obs) < TE(a) . 
      RESULTS: Six studies evaluating 11 analyzers and 5 studies evaluating 5 analyzers 
      were included for canine and feline hematology variables, respectively. For the 
      CBC, TE(obs) was < 15% for canine and < 13% for feline measurands, except for HGB 
      and platelet counts. Measurands of the CBC, excluding differential WBC and 
      platelet counts, and HGB concentration were considered globally acceptable. For 
      most of the cell types in the WBC differential count, TE(obs) was > TE(a) (data 
      from 3 analyzers). CONCLUSION: This meta-analysis is considered a pilot study. 
      Experts' requirements (TE(obs) < TE(a) ) were fulfilled for most measurands 
      except HGB (due to instrument-related bias for the ADVIA 2120) and platelet 
      counts. Available data on the WBC differential count suggest an analytic bias, so 
      nonstatistical quality control is recommended.
CI  - (c) 2017 American Society for Veterinary Clinical Pathology.
FAU - Cook, Andrea M
AU  - Cook AM
AD  - Department of Clinical Sciences, Clinical Pathophysiology and Clinical Pathology, 
      Faculty of Veterinary Medicine, Justus-Liebig-University Giessen, Giessen, Germany.
FAU - Moritz, Andreas
AU  - Moritz A
AD  - Department of Clinical Sciences, Clinical Pathophysiology and Clinical Pathology, 
      Faculty of Veterinary Medicine, Justus-Liebig-University Giessen, Giessen, Germany.
FAU - Freeman, Kathleen P
AU  - Freeman KP
AD  - IDEXX Laboratories, Ltd., Wetherby, UK.
FAU - Bauer, Natali
AU  - Bauer N
AD  - Department of Clinical Sciences, Clinical Pathophysiology and Clinical Pathology, 
      Faculty of Veterinary Medicine, Justus-Liebig-University Giessen, Giessen, Germany.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20170503
PL  - United States
TA  - Vet Clin Pathol
JT  - Veterinary clinical pathology
JID - 9880575
SB  - IM
MH  - Animals
MH  - Blood Cell Count/instrumentation/veterinary
MH  - Cat Diseases/blood
MH  - Cats/blood
MH  - Dog Diseases/blood
MH  - Dogs/blood
MH  - Hematology/*instrumentation/standards
MH  - Hemoglobinometry/instrumentation/veterinary
MH  - Leukocyte Count/instrumentation/veterinary
MH  - Pathology, Veterinary/*instrumentation/standards
MH  - Platelet Count/instrumentation/veterinary
MH  - *Point-of-Care Systems/standards
MH  - Retrospective Studies
OTO - NOTNLM
OT  - In-clinic hematology analyzers
OT  - quality goal index
OT  - six sigma metrics
OT  - total allowable error
OT  - total observed error
EDAT- 2017/05/04 06:00
MHDA- 2017/12/01 06:00
CRDT- 2017/05/04 06:00
PHST- 2017/05/04 06:00 [pubmed]
PHST- 2017/12/01 06:00 [medline]
PHST- 2017/05/04 06:00 [entrez]
AID - 10.1111/vcp.12492 [doi]
PST - ppublish
SO  - Vet Clin Pathol. 2017 Jun;46(2):248-261. doi: 10.1111/vcp.12492. Epub 2017 May 3.