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

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.

Atomic spectrometry update: review of advances in the analysis of clinical and biological materials, foods and beverages

“…[178][179][180][181] An AuNP-CA19-9 antibody probe ICP-MS based immunoassay demonstrated good correlation with electrochemiluminescence (R 2 0.999) for CA19-9 analysis in 21 serum samples. 178 Following on from previous work on CEA, Jiang et al 179 reported a duplex assay for determination of CEA and AFP using Eu and Sm tags with ICP-MS detection. This group applied the same methodology for hCG quantitation and both hCG and the duplex CEA/ AFP immunoassays were validated to CLSI standards.…”

“…This review period was no different with proposed assays for CA19-9, CEA, AFP and hCG. [178][179][180][181] An AuNP-CA19-9 antibody probe ICP-MS based immunoassay demonstrated good correlation with electrochemiluminescence (R 2 0.999) for CA19-9 analysis in 21 serum samples. 178 Following on from previous work on CEA, Jiang et al 179 reported a duplex assay for determination of CEA and AFP using Eu and Sm tags with ICP-MS detection.…”

“…Using rolling circular amplication, protein quantitation was achieved with higher sensitivity but smaller dynamic range than with Eu/Sm tagging. 11,179,181 Yin et al 182 used Mucin 1 (MUC1) from the human breast cancer cell line MCF-7 to model a multifunctional platform based on capture and release for non-destructive enumeration of circulating tumour cells (CTCs), thus allowing for subsequent molecular and functional readouts. Capture of MUC1 by capture probes (MUC1 specic aptamer hybridized to partially complementary strand (initiator) and immobilised on magnetic beads) caused release of initiator strands that were then hybridised to Tb labelled complementary strands (substrates) immobilised on detection probes.…”

“…This group applied the same methodology for hCG quantitation and both hCG and the duplex CEA/AFP immunoassays were validated to CLSI standards. 179,180 Zhang et al 181 described an alternative duplex assay for CEA and AFP based on DNA-conjugated AuNPs and rolling circular amplification with ICP-MS. Consistent with ELISA, analysis of human serum gave higher concentrations of CEA and AFP in liver cancer patients ( n = 10) compared to healthy controls ( n = 10).…”

Study of Long-Term Determination Accuracy for REEs in Geological Samples by Inductively Coupled Plasma Quadrupole Mass Spectrometry

“…ICP-OES is more convenient for rapid REEs determination, but the detection limits are not low enough, making complicated separation and preconcentration necessary [ 8 ]. ICP-MS is a well-established analytical method, which is characterized by small sample volume and low detection limits, extremely high sensitivity, wide dynamic range, simple spectra and multi-element analytical capability [ 21 , 22 ]. Currently, ICP-MS is the most attractive technique for REEs determination [ 23 ].…”