Evaluation of an Element-Tagged Duplex Immunoassay Coupled with Inductively Coupled Plasma Mass Spectrometry Detection: A Further Study for the Application of the New Assay in Clinical Laboratory
Wencan Jiang,
Gongwei Sun,
Wenbin Cui,
Shasha Men,
Miao Jing,
Danna Pu,
Sichun Zhang,
Xiaozhou Yuan,
Xinrong Zhang,
Chengbin Wang
Affiliations
Wencan Jiang
Department of Clinical Laboratory Medicine, Chinese People’s Liberation Army General Hospital & Postgraduate Medical School, Beijing 100853, China
Gongwei Sun
Beijing Key Laboratory for Microanalytical Methods and Instrumentation, Department of Chemistry, Tsinghua University, Beijing 100084, China
Wenbin Cui
Chromatography & Mass Spectrometry Thermo Fisher Scientific, China Commercial, Beijing 100853, China
Shasha Men
Department of Clinical Laboratory Medicine, Chinese People’s Liberation Army General Hospital & Postgraduate Medical School, Beijing 100853, China
Miao Jing
Chromatography & Mass Spectrometry Thermo Fisher Scientific, China Commercial, Beijing 100853, China
Danna Pu
Department of Clinical Laboratory Medicine, Chinese People’s Liberation Army General Hospital & Postgraduate Medical School, Beijing 100853, China
Sichun Zhang
Beijing Key Laboratory for Microanalytical Methods and Instrumentation, Department of Chemistry, Tsinghua University, Beijing 100084, China
Xiaozhou Yuan
Department of Clinical Laboratory Medicine, Chinese People’s Liberation Army General Hospital & Postgraduate Medical School, Beijing 100853, China
Xinrong Zhang
Beijing Key Laboratory for Microanalytical Methods and Instrumentation, Department of Chemistry, Tsinghua University, Beijing 100084, China
Chengbin Wang
Department of Clinical Laboratory Medicine, Chinese People’s Liberation Army General Hospital & Postgraduate Medical School, Beijing 100853, China
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. The performance of the assay was evaluated according to guidelines from the Clinical and Laboratory Standards Institute (CLSI). Moreover, reference intervals (RIs) of CEA and AFP were established. At last, 329 clinical samples were analyzed by the proposed method and results were compared with those obtained with electrochemiluminescent immunoassay (ECLIA) method. Results: The measurement range of the assay was 2–940 ng/mL for CEA and 1.5–1000 ng/mL for AFP, with a detection limit of 0.94 ng/mL and 0.34 ng/mL, respectively. The inter-assay and intra-assay imprecision were all less than 6.58% and 10.62%, respectively. The RI of CEA and AFP was 0–3.84 ng/mL and 0–9.94 ng/mL, respectively. Regarding to clinical sample detection, no significant difference was observed between the proposed duplex assay and the ECLIA method. Conclusions: The ICP-MS-based duplex immunoassay was successfully developed and the analytical performance fully proved clinical applicability. Well, this could be different with other analytes.
