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A new quality control method for lateral flow assay

A new quality control method for lateral flow assay
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摘要 Precision and repeatability are challenging issues in point of care testing(POCT) analysis. Herein, we proposed a lateral flow assay(LFA) based on internal quality control microspheres to realize the accurate diagnosis of HbAlc in human body. Fluorescein cy5 decorated microspheres are used as labels for HbAlc detection, and BSA-fluorescein isothiocyanate(FITC) decorated microspheres are used as internal quality control labels. One test line was employed in the strip for the detection of glycosylated hemoglobin(HbAlc). This method can eliminate the interference of environmental factors(temperature, humidity,etc.) to LFA in the process of chromatography, and improve the precision and accuracy of HbAlc detection.The CV for detection of low concentration HbAlc was 1.05%, and the CV for detection of high concentration HbAlc was 0.69%. We envision the method to have great prospect in in vitro diagnosis(IVD). Precision and repeatability are challenging issues in point of care testing(POCT) analysis. Herein, we proposed a lateral flow assay(LFA) based on internal quality control microspheres to realize the accurate diagnosis of HbAlc in human body. Fluorescein cy5 decorated microspheres are used as labels for HbAlc detection, and BSA-fluorescein isothiocyanate(FITC) decorated microspheres are used as internal quality control labels. One test line was employed in the strip for the detection of glycosylated hemoglobin(HbAlc). This method can eliminate the interference of environmental factors(temperature, humidity,etc.) to LFA in the process of chromatography, and improve the precision and accuracy of HbAlc detection.The CV for detection of low concentration HbAlc was 1.05%, and the CV for detection of high concentration HbAlc was 0.69%. We envision the method to have great prospect in in vitro diagnosis(IVD).
出处 《Chinese Chemical Letters》 SCIE CAS CSCD 2018年第12期1853-1856,共4页 中国化学快报(英文版)
基金 supported by the State key Basic Research Program of the PRC(No.2014CB744501) the National Key Research and Development Program of China(No.2017YFA0205301) the National Natural Science Foundation of China(Nos.61527806,61471168 and 61871180) open Funding of State Key Laboratory of Oral Diseases(No.SKLOD20180F02)
关键词 Point of care testing Lateral flow assay HBA1C Fluorescein isothiocyanate PRECISION Point of care testing Lateral flow assay HbA1c Fluorescein isothiocyanate Precision
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