Highly Sensitive and Novel Point-of-Care System, aQcare Chlamydia TRF Kit for Detecting Chlamydia trachomatis by Using Europium (Eu) (III) Chelated Nanoparticles
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Korean J Lab Med 2009; 29(5): 430-438
Published online October 1, 2009 https://doi.org/10.3343/kjlm.2009.29.5.430
Copyright © Korean Journal of Laboratory Medicine.
Hyunwoong Park, M.D.1,2, Dae-Hyun Ko, M.D.1,2, Jin Q Kim, M.D.1,3, and Sang Hoon Song, M.D.1,2
Department of Laboratory Medicine1, Seoul National University College of Medicine, Seoul; Department of Laboratory Medicine2, Seoul National University Bundang Hospital, Seongnam; Department of Laboratory Medicine3, Seoul National University Hospital, Seoul, Korea
Correspondence to: Sang Hoon Song, M.D.
Department of Laboratory Medicine, Seoul National University Bundang Hospital, 300 Gumi-dong, Bundang-gu, Seongnam 463-707, Korea
Tel : +82-31-787-7693, Fax : +82-31-787-4015
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Background : Point-of-care (POC) tests are used increasingly due to fast results and simple test procedures, which enables rapid diagnosis and therapeutic monitoring. We evaluated the performance of the Piccolo xpress Chemistry Analyzer (Abaxis, USA) a POC chemistry analyzer.
Methods : Fourteen analytes, Na+, K+, Cl-, Ca2+, total carbon dioxide, AST, ALT, total bilirubin, alkaline phosphatase, blood urea nitrogen, creatinine, albumin, total protein, and glucose; were measured simultaneously with a 100 μL of whole blood sample using a Comprehensive Metabolic Reagent disk. Within-run and total precision and linearity were evaluated according to CLSI EP15-A and EP6-A guidelines, respectively. Comparison with a central laboratory chemistry analyzer was performed using 144 patient samples.
Results : The coefficients of variations of within-run and total precision were all within 5% for three levels except for total carbon dioxide, ALT, alkaline phosphatase, total bilirubin, and creatinine in low level, and creatinine in middle level. The results of 14 analytes were linear within a commonly encountered range in clinical samples (r2≥0.98). More than 10% of samples in Na+, AST, ALT, glucose, BUN did not satisfy CLIA analytical quality requirement.
Conclusions : The Piccolo xpress Chemistry Analyzer can analyze multiple analytes with a minimal amount of whole blood in a short time. It showed an acceptable performance for precision, linearity and comparison with central laboratory analyzer. It can be useful as a screening tests modality in mobile clinics, ambulances, and field clinics for military use, and for pediatric patients from whom enough sample volume is difficult to obtain.
Keywords: Point-of-care systems, Analytical chemistry, Evaluation studies