Hemoglobin assay for validation and quality control of medical device reprocessing
| Autor: | Zhenyu Li, Steven Turtil, Allan Guan, K. Scott Phillips, Justin Frey |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
Quality Control
Detection limit Analyte Chromatography Extraction (chemistry) Analytical chemistry Reproducibility of Results Sensitivity and Specificity Biochemistry Analytical Chemistry Microplate Reader Equipment Failure Analysis Hemoglobins chemistry.chemical_compound Equipment and Supplies Linear range chemistry Reagent Equipment Contamination Colorimetry Hemoglobin Sodium dodecyl sulfate |
| Zdroj: | Analytical and Bioanalytical Chemistry. 407:6885-6889 |
| ISSN: | 1618-2650 1618-2642 |
| Popis: | Hemoglobin (Hb) is an important analyte in medicine, forensics, and research. One area of crucial need for real-world Hb quantitation is the validation and quality control (QC) of reprocessed medical device cleaning. Here, we show how a microplate reader and colorimetric blood test strips can be used to quantitate nanogram (ng) quantities of Hb in a 1-min assay. The assay had a linear range of 0–50 ng (0–370 ng on a log scale) for Hb, with a limit of detection (LOD) of 3.3 ng, which was ∼500-fold more sensitive than the micro-BCA reagent (LOD = 1.6 μg) and on the same order of magnitude as detection of labeled Hb with fluorescence (LOD = 1.9 ng). For validation of medical device cleaning, the assay was specific for Hb in the presence of artificial test soil and was unaffected by interferences from common cleaning reagents at 10 ppm. Lubricant and sodium dodecyl sulfate did not significantly affect the assay at 10 ppm but affected the assay at 1 % g/g. The method showed 100 % recovery of hemoglobin in extracted soils, with extraction from silicone having the greatest variability in recovery, while Teflon and stainless steel had |
| Databáze: | OpenAIRE |
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