PMID- 25591854
OWN - NLM
STAT- MEDLINE
DCOM- 20151230
LR  - 20221207
IS  - 1932-2968 (Electronic)
IS  - 1932-2968 (Linking)
VI  - 9
IP  - 2
DP  - 2015 Mar
TI  - Analytical evaluation of the Diazyme glycated serum protein assay on the siemens 
      ADVIA 1800: comparison of results against HbA1c for diagnosis and management of 
      diabetes.
PG  - 192-9
LID - 10.1177/1932296814567894 [doi]
AB  - Hemoglobin A1c (HbA1c) is considered the gold standard for assessment of glycemic 
      control in diabetic patients. HbA1c is inadequate in individuals homozygous or 
      compound heterozygous for hemoglobin variants or in conditions with an altered 
      red blood cell turnover. In these cases glycated albumin (GA) is proposed as an 
      alternative assay. We aimed to evaluate the analytical performance of the Diazyme 
      glycated serum protein (GSP) assay on an automated analyzer, to establish a 
      reference interval (RI), and to compare from a clinical perspective, GSP/GA with 
      glycated Hb (glyHb) results. Validation studies followed the CLSI guidelines and 
      included precision, linearity, interferences, concordance of results with glyHb, 
      and RI calculation. GSP was analyzed on representative samples with previously 
      ordered HbA1c and albumin from the Dyna LIFE : DX laboratory. Samples from 
      patients with bisalbuminemia, hemoglobinopathies, and multiple myeloma were also 
      included. Within-run and total imprecision was <3.0% at both levels of control, 
      analytical sensitivity was 5.31 mumol/L, and linearity was verified from 10 to 
      1150 mumol/L (total allowable error of 5%). Clinical concordance between %GA and 
      glyHb was substantial (n = 175, R2 = .91, kappa = .78, P = .167). GSP RI was 160 
      to 340 mumol/L or if expressed as %GA 10.5 to 17.5%. Analytical performance of the 
      Diazyme GSP assay on the Siemens ADVIA 1800 is acceptable for clinical use. The 
      RI obtained was higher than that suggested by the manufacturer.
CI  - (c) 2015 Diabetes Technology Society.
FAU - Rodriguez-Capote, Karina
AU  - Rodriguez-Capote K
AD  - Dyna LIFE DX Diagnostic Laboratory Services, Edmonton, AB, Canada Department of 
      Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada 
      karina.capote@dynalifedx.com.
FAU - Tovell, Kayla
AU  - Tovell K
AD  - Dyna LIFE DX Diagnostic Laboratory Services, Edmonton, AB, Canada.
FAU - Holmes, Deborah
AU  - Holmes D
AD  - Dyna LIFE DX Diagnostic Laboratory Services, Edmonton, AB, Canada.
FAU - Dayton, Janice
AU  - Dayton J
AD  - Dyna LIFE DX Diagnostic Laboratory Services, Edmonton, AB, Canada.
FAU - Higgins, Trefor N
AU  - Higgins TN
AD  - Dyna LIFE DX Diagnostic Laboratory Services, Edmonton, AB, Canada Department of 
      Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20150114
PL  - United States
TA  - J Diabetes Sci Technol
JT  - Journal of diabetes science and technology
JID - 101306166
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Glycation End Products, Advanced)
RN  - 0 (Serum Albumin)
RN  - 0 (Glycated Serum Albumin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Blood Chemical Analysis/*instrumentation/methods
MH  - Blood Glucose/*analysis
MH  - Diabetes Mellitus/*blood/diagnosis
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Glycation End Products, Advanced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Reference Values
MH  - Sensitivity and Specificity
MH  - Serum Albumin/*analysis
MH  - Young Adult
MH  - Glycated Serum Albumin
PMC - PMC4604597
OTO - NOTNLM
OT  - diabetes mellitus
OT  - glycated albumin
OT  - glycated hemoglobin
OT  - glycated protein
OT  - glycemic markers
OT  - hemoglobin A1c
COIS- Declaration of Conflicting Interests: The author(s) declared no potential 
      conflicts of interest with respect to the research, authorship, and/or 
      publication of this article.
EDAT- 2015/01/17 06:00
MHDA- 2015/12/31 06:00
PMCR- 2016/01/14
CRDT- 2015/01/17 06:00
PHST- 2015/01/17 06:00 [entrez]
PHST- 2015/01/17 06:00 [pubmed]
PHST- 2015/12/31 06:00 [medline]
PHST- 2016/01/14 00:00 [pmc-release]
AID - 1932296814567894 [pii]
AID - 10.1177_1932296814567894 [pii]
AID - 10.1177/1932296814567894 [doi]
PST - ppublish
SO  - J Diabetes Sci Technol. 2015 Mar;9(2):192-9. doi: 10.1177/1932296814567894. Epub 
      2015 Jan 14.