PMID- 28164511
OWN - NLM
STAT- MEDLINE
DCOM- 20171212
LR  - 20221207
IS  - 1433-6510 (Print)
IS  - 1433-6510 (Linking)
VI  - 63
IP  - 1
DP  - 2017 Jan 1
TI  - Application of Six Sigma Model to Evaluate the Analytical Quality of Four HbA1c 
      Analyzers.
PG  - 79-83
LID - 10.7754/Clin.Lab.2016.160608 [doi]
AB  - BACKGROUND: The Six Sigma Model is a global quality management system applicable 
      to the determination of glycated hemoglobin (HbA1c). In addition, this model can 
      ensure the three characteristics influencing the patient risk: the correct 
      performance of the analytical method with low inaccuracy and bias, the quality 
      control strategy used by the laboratory, and the necessary quality of the 
      analyte. The aim of this study is to use the Six Sigma Model for evaluating 
      quality criteria in the determination of glycated hemoglobin HbA1c and its 
      application to assess four different HbA1c analyzers. METHODS: Four HbA1c 
      analyzers were evaluated: HA-8180V(R), D-100(R), G8(R), and Variant II Turbo(R). For 20 
      consecutive days, two levels of quality control (high and low) provided by the 
      manufacturers were measured in each of the instruments. Imprecision (CV), bias, 
      and Sigma values (sigma) were calculated with the data obtained and a method decision 
      chart was developed considering a range of quality requirements (allowable total 
      error, TEa). RESULTS: For a TEa = 3%, HA-8180V = 1.54 sigma, D-100 = 1.63 sigma, G8 = 
      2.20 sigma, and Variant II Turbo = -0.08 sigma. For a TEa = 4%, HA-8180V = 2.34 sigma, D-100 
      = 2.32 sigma, G8 = 3.74 sigma, and Variant II Turbo = 0.16 sigma. For a TEa = 10%, HA8180V = 
      7.12 sigma, D-100 = 6.46 sigma, G8 = 13.0 sigma, and Variant II Turbo = 1.56 sigma. CONCLUSIONS: 
      Applying the Stockholm consensus and its subsequent Milan review to the results: 
      the maximum level in quality requirements for HbA1c is an allowable total error 
      (TEa) = 3%, G8 is located in region 2 sigma (2.20), which is a poor result, and 
      HA-8180V and D-100 are both in region 1 sigma (1.54 and 1.63, respectively), which is 
      an unacceptable analytical performance.
FAU - Maesa, Jos Eacute M
AU  - Maesa JE
FAU - Fern Aacute Ndez-Riejos, Patricia
AU  - Fern Aacute Ndez-Riejos P
FAU - S Aacute Nchez-Mora, Catalina
AU  - S Aacute Nchez-Mora C
FAU - Toro-Crespo, Mar Iacute A De
AU  - Toro-Crespo MI
FAU - Gonz Aacute Lez-Rodriguez, Concepci Oacute N
AU  - Gonz Aacute Lez-Rodriguez CO
LA  - eng
PT  - Comparative Study
PT  - Evaluation Study
PT  - Journal Article
PL  - Germany
TA  - Clin Lab
JT  - Clinical laboratory
JID - 9705611
RN  - 0 (Biomarkers)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (hemoglobin A1c protein, human)
SB  - IM
MH  - Automation, Laboratory
MH  - Biomarkers/blood
MH  - Chromatography, High Pressure Liquid/*instrumentation/standards
MH  - Equipment Design
MH  - Glycated Hemoglobin/*analysis
MH  - Humans
MH  - Predictive Value of Tests
MH  - Quality Control
MH  - Reproducibility of Results
MH  - *Total Quality Management
EDAT- 2017/02/07 06:00
MHDA- 2017/12/13 06:00
CRDT- 2017/02/07 06:00
PHST- 2017/02/07 06:00 [entrez]
PHST- 2017/02/07 06:00 [pubmed]
PHST- 2017/12/13 06:00 [medline]
AID - 10.7754/Clin.Lab.2016.160608 [doi]
PST - ppublish
SO  - Clin Lab. 2017 Jan 1;63(1):79-83. doi: 10.7754/Clin.Lab.2016.160608.