کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2777380 1567976 2015 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Analytical evaluation of a BNP assay on the new point-of-care platform respons®IQ
موضوعات مرتبط
علوم زیستی و بیوفناوری بیوشیمی، ژنتیک و زیست شناسی مولکولی بیوشیمی بالینی
پیش نمایش صفحه اول مقاله
Analytical evaluation of a BNP assay on the new point-of-care platform respons®IQ
چکیده انگلیسی


• New point-of-care platform with micro-fluidics and evanescence field technology.
• A B-type natriuretic peptide assay was validated on the system.
• Correlation with a POC and a laboratory system was high (r≥0.972).
• Sensitivity was in the performance range of lab analyzer tests.

a) Objectives: respons®IQ is a new point-of-care (POC) immunoassay platform utilizing evanescent field total internal reflection fluorescence (TIRF) detection and active microfluidics controlled by optical sensors. A B-type natriuretic peptide (BNP) assay was developed on this system. The objective was to show that the BNP test fulfils the basic requirements regarding analytical performance, storage stability of cartridges and correlation to reference systems to be used as a POC test.b) Design and methods: Analytical sensitivity and imprecision were determined in 10 separate experiments over a period of one year. Cartridge storage stability at 4–7 °C and 37 °C was tested. The correlation of responsIQ whole blood measurements to a POC reference device and a laboratory analyzer was determined using 100 patient samples.c) Results: Limit of detection (LOD) was 2.3±1.0 pg/ml BNP and within-run coefficient of variation (within-run CV) was 4.8±1.4% down to a concentration of <40 pg/ml BNP. Cartridge storage stability at 4–7 °C was greater than 50 weeks and at 37 °C, stability was three weeks. The correlation of responsIQ results with both reference methods was high (r≥0.972).d) Conclusions: The developed BNP test fulfils the basic requirements for the performance parameters defined above. The test׳s sensitivity was in the performance range of laboratory analyzer BNP tests. This is the first extensive proof of concept of the responsIQ system.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Practical Laboratory Medicine - Volume 2, 1 August 2015, Pages 15–21
نویسندگان
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