Clinical and Laboratory Evaluation of a New Specific Point-of-Care Test for Intact Proinsulin
| Autor: | Gunther Burgard, Andreas Pfützner, Peter H. Kann, Anke H. Pfützner |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male Oncology medicine.medical_specialty Endocrinology Diabetes and Metabolism Point-of-care testing Biomedical Engineering 030209 endocrinology & metabolism Bioengineering 030204 cardiovascular system & hematology Sensitivity and Specificity 03 medical and health sciences 0302 clinical medicine Internal medicine Internal Medicine medicine Humans Prospective cohort study Aged Proinsulin Immunoassay business.industry Original Articles Middle Aged Early Diagnosis Endocrinology Diabetes Mellitus Type 2 Point-of-Care Testing Biomarker (medicine) Female business Biomarkers |
| Zdroj: | Journal of Diabetes Science and Technology. 11:278-283 |
| ISSN: | 1932-2968 |
| DOI: | 10.1177/1932296816663745 |
| Popis: | Background:Intact proinsulin is a biomarker for pancreatic ß-cell dysfunction. In large prospective studies in nondiabetic subjects, elevated intact proinsulin predicted development of type 2 diabetes and/or macrovascular events up to 7 years in advance. This study was performed to evaluate a new semiquantitative lateral flow-based point-of-care rapid test (POCT) for elevated intact proinsulin (cutoff: 15 pmol/L). The test requires 10 µL of capillary whole blood, with visual readout after 5 minutes. It is best applied at 2 hours after a glucose challenge or a meal.Methods:POCT results were obtained by health care professionals from 60 patients and healthy subject (33 female, 27 male, 28 type 2 diabetes, age: 53.6 ± 12.3 years). An additional venous blood sample was obtained from all participants for measurement of intact proinsulin by means of a quantitative ELISA reference method (TecoMedical, Sissach, Switzerland).Results:Elevated intact proinsulin levels (>15 pmol/L) were determined by the reference method in 26 participants, of whom 22 were also positive with the POCT (sensitivity: 85%). All 34 subjects with low intact proinsulin levels were tested negative by the POCT (specificity: 100%).Conclusions:The test successfully detected elevated postprandial intact proinsulin levels in 85% of the tested subjects and no false positive test result occurred. This POCT can therefore serve as a simple screening tool for identification of patients with prevalent ß-cell dysfunction, who are at high risk for development of type 2 diabetes and/or macrovascular events within the next 5-7 years. |
| Databáze: | OpenAIRE |
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