Abstract
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.
Highlights
Biomarker quantification is of great importance in the diagnosis of cancer and other diseases, since it can reflect the occurrence and development of diseases and monitor the response to treatment [1,2,3].Currently, antibody and antigen specific binding based immunoassays are commonly used tools for the target quantification of biomarkers [4]
As for the carryover of the analyzer for Sm3+, the results (Supplemental Table S2) implied that the carryover of the inductively coupled plasma mass spectrometry (ICP-MS) instrument was less than 0.5%
Many studies have been reported for the ICP-MS-based immunoassay, these was no report of multiplex detection involve in standard evaluation and clinical sample detection with the guidance of Clinical and Laboratory Standards Institute (CLSI) documents [23]
Summary
Biomarker quantification is of great importance in the diagnosis of cancer and other diseases, since it can reflect the occurrence and development of diseases and monitor the response to treatment [1,2,3].Currently, antibody and antigen specific binding based immunoassays are commonly used tools for the target quantification of biomarkers [4]. A variety of sophisticated non-radioactive immunoassays had gradually been proposed, including enzyme linked immunosorbent assay (ELISA), fluorescence immunoassay (FIA), time resolved fluorescence immunoassay (TAFIA), chemiluminescent immunoassay (CLIA), and electrochemiluminescent immunoassay (ECLIA) [4,7,8,9,10,11,12]. These conventional immunoassay methods are often significantly limited for simultaneous multianalyte quantification. A further study referring to the standard evaluation and clinical sample verification is needed to ensure its reliability for simultaneous analysis in clinical laboratories
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