Publications by authors named "Danna Pu"

Background: Element-tagged immunoassay coupled with inductively coupled plasma mass spectrometry (ICP-MS) detection has the potential to revolutionize immunoassay analysis for multiplex detection. However, a further study referring to the standard evaluation and clinical sample verification is needed to ensure its reliability for simultaneous analysis in clinical laboratories.

Methods: Carcinoembryonic antigen (CEA) and α-fetoprotein (AFP) were chosen for the duplex immunoassay.

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Background: The development of a combined immunoassay method, based on a stable isotope tagging strategy and inductively coupled plasma mass spectrometry (ICP-MS), has created options for quantitative bioanalysis. The aim of the study was to develop a combined immunoassay, featuring ICP-MS and a stable element labeling strategy, for the detection of human chorionic gonadotropin (HCG), and developed methodology applicable for clinical practice.

Methods: In accordance with guidelines published by the Clinical and Laboratory Standards Institute (CLSI), we developed our assay and then evaluated its analytical performance, including the limit of detection (LOD), the upper limit of quantification (ULoQ), linearity, precision, recovery, cross reactivity, and interference.

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Background: The second-generation electrochemiluminescence immunoassay (ECLIA) kit of vitamin B12 is widely used in clinical laboratories, and the establishment of a reference interval (RI) is essential to provide the basis for clinical monitoring. The purpose of this study was to establish a laboratory RI for vitamin B12 in China and at the same time verify the method performance of the second-generation kit.

Methods: The verification of the method performance was conducted according to the Clinical and Laboratory Standards Institute (CLSI) guidelines.

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Introduction Element-tagged immunoassay coupled with inductively coupled plasma-mass spectrometry (ICP-MS) detection has the potential to revolutionize immunoassay analysis in clinical detection; however, a systematic evaluation with the standard guidelines of the assay is needed to ensure its performance meets the requirements of the clinical laboratory. Methods Carcinoembryonic antigen (CEA) was chosen for analysis using the proposed method. A systematic evaluation of the proposed assay was carried out according to the Clinical and Laboratory Standards Institute (CLSI).

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