Unique Approach to Derivation of Random Error in Laboratory Assays: Application to Glycohemoglobin Testing Demonstrates Poor Clinical Performance for Immunochemistry Assay

Diabetes Technology and Therapeutics

Volumn 5, Issue 6, 2003, Pages 975-978

  Tran, David V ^a   Hofer, Tammy L ^a   Lee, Terrence ^a   Cembrowski, George S ^a,b  

^a UNIVERSITY OF ALBERTA HOSPITAL   (Canada)

^b Capital Health Edmonton   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; GLYCOSYLATED HEMOGLOBIN;

ANALYTICAL ERROR; ARTICLE; BIOASSAY; COEFFICIENT OF VARIATION; FEEDBACK SYSTEM; HEMOGLOBIN DETERMINATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; IMMUNOASSAY; IMMUNOCHEMISTRY; LABORATORY ASSAY; LABORATORY TEST; MOTIVATION; NATIONAL GLYCOHEMOGLOBIN STANDARDIZATION PROGRAM; PATIENT COUNSELING; PATIENT EDUCATION; PERFORMANCE; PRIORITY JOURNAL; REGRESSION ANALYSIS; STANDARD; VARIANCE;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; IMMUNOHISTOCHEMISTRY; LABORATORIES; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 0347506753     PISSN: 15209156     EISSN: None     Source Type: Journal    
DOI: 10.1089/152091503322641015     Document Type: Article

References (10)

1. Kolatkar NS, Cembrowski GS, Callahan PL, Etzwiler DD: Intensive diabetes management requires very precise testing of glycohemoglobin. Clin Chem 1994;40:1608-1609.
2. Little RR, Rohlfing CL, Wiedmeyer H-M, Myers GL, Sacks DB, Goldstein DE, for the NGSP Steering Committee: The National Glycohemoglobin Standardization Program: a five-year progress report. Clin Chem 2001;47:1985-1992.
3. Nowatzke WL, Parvin CA, Scott MG, Hock K, Cole TG: Correction of positive bias of the Roche Tinaquant II hemoglobin A1c (HbA1c) assay at low HbA1c percentages. Clin Chem 2001;47:976-978.
4. Higgins TN, Blakney GB, Dayton J: Analytical evaluation of the Bio-Rad variant II automated HbA(1C) analyzer. Clin Biochem 2001;34:361-365.
5. Otto E, Higgins T, Toth E, Attrill J, Winchester T, Cembrowski G: Non-optimal utilization of glycohemoglobin testing in Northcentral Alberta [abstract]. Can J Diabetes Care 1999;23:87.
6. Cembrowski GS, Carey RN: Laboratory Quality Management. Chicago: American Society of Clinical Pathologists, 1989:14.
7. Tiran A, Pieber T, Tiran B, Halwachs-Baumann G, Dobnig H, Grubelnig H, Wilders-Truschnig MM: Automated determination of glycated hemoglobin: comparative evaluation of five assay systems. J Clin Lab Anal 1994;8:128-134.
8. Eckfeldt JH, Copeland KR: Accuracy verification and identification of matrix effects. The College of American Pathologists' protocol. Arch Pathol Lab Med 1993;117:381-386.
9. Valenstein P, Leiken A, Lehmann C: Test-ordering by multiple physicians increases unnecessary laboratory examinations. Arch Pathol Lab Med 1988;112:238-241.
10. Maguire GA, Edwards OM: Seasonal variation in glycated hemoglobin in diabetics. Ann Clin Biochem 2001;38:59-60.