Comparison of point of care and laboratory HbA1c analysis: a MetroNet study.
BACKGROUND
Evaluating new technology in clinical practice is an important component of translating research into practice. We considered the feasibility of using a Clinical Laboratory Improvement Amendments (CLIA)-waived point of care (POC) glycohemoglobin (HbA1c) methodology in busy family medicine centers by comparing the results of POC HbA1c and laboratory analysis results.


METHODS
Recruited from 5 MetroNet practices, the participants were adult diabetic patients having blood samples drawn for laboratory analysis of HbA1c. Each agreed to provide a capillary blood sample for POC testing.


RESULTS
With data on 99 paired samples, the POC method yielded a mean HbA1c of 7.38%, which was equivalent to the mean of 7.53% produced with all combined standard laboratory analyses. The Pearson correlation between POC and the laboratory analysis test results was 0.884 (P < .001). POC test sensitivity was 81.8% and specificity was 93.2%. Eighteen percent of patients with an HbA1c > = 7% by laboratory analysis were not identified as such by the POC test.


CONCLUSIONS
Before adopting a POC methodology, practices are encouraged to review its feasibility in the context of the office routine, and also to conduct periodic comparisons of the accuracy of POC test results compared with those from laboratory analysis.
Schwartz
Kendra L
KL
Monsur
Joseph
J
Hammad
Adnan
A
Bartoces
Monina G
MG
Neale
Anne Victoria
AV
D000293:Adolescent; D000328:Adult; D003430:Cross-Sectional Studies; D003920:Diabetes Mellitus / Q000097:blood; D003955:Diagnostic Tests, Routine / Q000592:standards*; D005194:Family Practice; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D008824:Michigan; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity; D055815:Young Adult
D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human