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• In this work, We used the pseudoviruses and euvirus neutralization assay to evaluate the value of anti-SARS-CoV-2 antibody tests in a population of 10776 close contacts in the Delta variant epidemic of Fujian. And the results showed that neutralizing antibodies detected by Wantai bio. or Yahuilong bio. can get the level of 0.93 or 0.82 in correlation with euvirus neutralization assay. The findings of this study demonstrate that the detections of antibodies have profound value in the diagnosis of COVID-19. Nucleic acid detection represents limitations due to its false-negative rate and technical complexity in the COVID-19 pandemic. Anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody tests are widely spread all over the world presently. However, there is no report on the effectiveness of anti-SARS-CoV-2 antibody testing methods in China. We gathered 10776 serum samples from close contacts of the SARS-CoV-2 infections in Fujian of China and used 2 chemiluminescence immunoassays (Wantai Bio., Yahuilong Bio.) and 2 lateral flow immunoassays (Lizhu Bio. and Dongfang Bio.) to perform the anti-SARS-CoV-2 antibody tests in China. The 4 antibody tests have great diagnostic value for infected or uninfected, especially in the neutralizing antibodies tests, the AUC can reach 0.939 (Wantai Bio.) and 0.916 (Yahuilong Bio.). Furthermore, we used pseudoviruses and euvirus neutralization assay to validate the effectiveness of these antibody test, the results of pseudoviruses neutralization assay or euvirus neutralization assay shows a considerable correlation with the 4 antibody detection respectively, particularly in euvirus neutralization assay, neutralizing antibodies detected by Wantai Bio. or Yahuilong Bio., the correlation can get the level of 0.93 or 0.82. The findings of this study demonstrate that the detections of antibodies have profound value in the diagnosis of COVID-19. [ABSTRACT FROM AUTHOR]

Inhibiting the nonspecific protein adsorption on the surface of magnetic microspheres has become a pressing challenge for immunoassays. In this paper, a novel dextran-modified sandwich-type magnetic polymer microsphere was developed and demonstrated to be a promising carrier for chemiluminescence immunoassay (CLIA). Dextran-modified sandwich-type magnetic polymer microspheres (PFS-PGDN) were synthesized by surface-initiated atom transfer radical polymerization (SI-ATRP) and ring-opening reaction of epoxy and aminodextran on the surface of magnetic P(GMA-MMA)-NH 2 @Fe 3 O 4 @SiO 2 (PFS) microspheres. Then, carboxylated dextran-modified sandwich-type magnetic polymer microspheres (PFS-PGDC) were prepared by the surface carboxylation of the microspheres, which allowed the prepared microspheres to better couple with nucleic acids or antibodies. It is found that after grafting dextran, magnetic PFS-PGDC microspheres could significantly reduce the nonspecific protein adsorption by over 90 %. The chemiluminescence immunoassay assay showed a reduction of the background value to a very low level, indicating that the magnetic spheres showed significant advantages in improving the sensitivity of the chemiluminescence assay. Moreover, the chemiluminescence sensitivity and signal values of the synthesized magnetic microspheres have reached high levels. Therefore, the magnetic microspheres synthesized here hold great promise for applications in the field of CLIA. [Display omitted] • A novel dextran-modified sandwich-type magnetic polymer microsphere was developed and demonstrated to be a promising carrier for chemiluminescence immunoassay. • The magnetic PFS-PGDC microspheres significantly reduced nonspecific protein adsorption by more than 90 % by chemically grafting dextran. • Chemiluminescent immunoassay tests for D-dimer indicated that the chemiluminescence sensitivity and signal values of the synthesized magnetic microspheres have reached high levels. [ABSTRACT FROM AUTHOR]

ABSTRACTThis multicenter, retrospective study included 346 serum samples from 74 patients with coronavirus disease 2019 (COVID-19) and 194 serum samples from non-COVID-19 patients to evaluate the performance of five anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody tests, i.e. two chemiluminescence immunoassays (CLIAs): Roche Elecsys® Anti-SARS-CoV-2 Test (Roche Test) and Abbott SARS-CoV-2 IgG (Abbott Test), and three lateral flow immunoassays (LFIAs): Wondfo SARS-CoV-2 Antibody Test (Wondfo Test), ASK COVID-19 IgG/IgM Rapid Test (ASK Test), and Dynamiker 2019-nCoV IgG/IgM Rapid Test (Dynamiker Test). We found high diagnostic sensitivities (%, 95% confidence interval [CI]) for the Roche Test (97.4%, 93.4–99.0%), Abbott Test (94.0%, 89.1–96.8%), Wondfo Test (91.4%, 85.8–94.9%), ASK Test (97.4%, 93.4–99.0%), and Dynamiker Test (90.1%, 84.3–94.0%) after >21 days of symptom onset. Meanwhile, the diagnostic specificity was 99.0% (95% CI, 96.3–99.7%) for the Roche Test, 97.9% (95% CI, 94.8–99.2%) for the Abbott Test, and 100.0% (95% CI, 98.1–100.0%) for the three LFIAs. Cross-reactivity was observed in sera containing anti-cytomegalovirus (CMV) IgG/IgM antibodies and autoantibodies. No difference was observed in the time to seroconversion detection of the five serological tests. Specimens from patients with COVID-19 pneumonia demonstrated a shorter seroconversion time and higher chemiluminescent signal than those without pneumonia. Our data suggested that understanding the dynamic antibody response after COVID-19 infection and performance characteristics of different serological test are crucial for the appropriate interpretation of serological test result for the diagnosis and risk assessment of patient with COVID-19 infection.

Coronavirus disease-19 (COVID19), the novel respiratory illness caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2), is associated with severe morbidity and mortality. The aim of our study was to compare different immunoassays. We evaluated three immunochromatographic test (The StrongStep®SARS-CoV-2 IgG/IgM kit, AllTest COV-19 IgG/IgM kit, and Wondfo® SARS-CoV-2 Antibody) and two chemiluminescence immunoassays (CMIA) (Covid-19 VIRCLIA® IgM+IgA/IgG monotest and the Abbott SARS-CoV-2 IgG assay) in COVID-19 patients. The assays were performed using serum samples of three group patients, i.e., healthy controls, patients with SARS-CoV-2 PCR positive, and patients with SARS-CoV-2 PCR negative clinically diagnosed of COVID-19 infection. The detection percentages of IgG with the StrongStep® SARS-CoV-2 IgG/IgM kit and AllTest COV-19 IgG/IgM kit were similar in both groups (83.3% and 80.6%, respectively in group 2, p = 0.766) and (42.9% and 50.0%, respectively in group 3, p = 0.706). There were some differences on IgM detection between StrongStep® SARS-CoV-2 IgG/IgM kit and AllTest COV-19 IgG/IgM kit (11.1% and 30.6%, respectively in group 2, p = 0.042 and 0.0% and 28.6%, respectively in group 3, p = 0.031). The positive rate of IgG in group 2 is higher compared to group 3 with the two immunoassays tested. We observe the same positive rates of IgG with the two CMIA. Our study shows excellent performance of CMIA compared to immunochromatographic test and confirms its potential use in the diagnosis of the new SARS-CoV-2. [ABSTRACT FROM AUTHOR]

Metal-organic frameworks (MOF) are promising candidates for the construction of artificial nanozymes and have found applications in many fields. However, the preparation of nanosized MOF materials with high performance and good dispersibility is still a big challenge and is in great demand as signal labels for immunoassays. In this work, hierarchically structured and highly dispersible MOF nanoparticles were facilely prepared in a one-pot method. Self-assembled micelles from PEGylated hematin were used as structured templates to mediate the formation of zeolitic imidazole framework-8 (ZIF-8) nanoparticles in aqueous solution. The encapsulation of micelles in ZIF-8 frameworks produces well-dispersed nanoparticles and generates dual-confinement effects for catalytic hematin. Owing to the hierarchical structures, the formed MOF nanozymes show enhanced peroxidase-like activity and enable persistent chemiluminescence behaviors for the luminol system. Sandwich-type chemiluminescence immunoassays for carcinoembryonic antigen (CEA) were proposed using MOF nanozymes as signal labels, and good analytical performances were achieved. The combination of self-assembly and biomineralization may open new avenues for the development of MOF nanomaterials.

An indirect competitive chemiluminescence (CL) immunoassay based on FeO@SiO@Au magnetic nanoparticles (Au-SCMPs) has been optimized and developed for the detection of aflatoxin B (AFB). To improve the detection sensitivity and efficiency, this method combines 2′,6′-dimethylcarbonylphenyl-10-sulfopropyl acridinium-9-carboxylate 4′-NHS ester (NSP-DMAE-NHS) as a new kind of high efficient luminescence reagent with a simplified separation procedure based on the optimized Au-SCMPs. Superparamagnetic nanoparticles were coated with different sizes of Au colloids (18, 30, and 50 nm), and their capacities in immobilization of bovine serum albumin (BSA) were investigated. The BSA-AFB conjugate (BSA-AFB) was immobilized on the optimized Au-SCMPs and competed with the free AFB for specially binding the NSP-DAME-NHS-labeled anti-AFB antibody (mAb-AFB). After the indirect competitive immunoreactions and magnetic separation, the CL of the nanoparticles was measured by a homemade luminescent measurement system. Under the optimum conditions, the IC value was 0.07 ng mL and the limit of detection (LOD) of AFB was 0.01 ng mL, respectively. The result shows a much lower IC and LOD than that typically achieved by ELISA. This proposed immunoassay method was rapid, low-cost, and suitable for the detection of AFB. [ABSTRACT FROM AUTHOR]

An enzyme and antibody dual labeled gold nanoparticles enhancing chemiluminescence strategy was developed for highly sensitive CE immunoassay (IA) of prostate-specific antigen (PSA). In this work, gold nanoparticles were labeled with horseradish peroxidase and antiprostate specific antigen-antibody, and used as the marker (Ab * ). After PSA (antigen, Ag) was added into the system, a noncompetitive immune reaction was happen between Ab * and Ag to form an immune complex (Ag-Ab * ). Subsequently, the obtained Ag-Ab * and unreacted Ab * were separated by CE, and the chemiluminescence intensity of Ag-Ab * was used to estimate PSA concentration. The calibration curve showed a good linearity in the range of 0.25-10 ng/mL. Based on a S/N of 3, the detection limit for PAS was estimated to be 0.092 ng/mL. Proposed CE method was applied for PSA quantification in human serum samples from healthy volunteers and patients with prostate cancer. The obtained results demonstrated that the proposed CE method may serve as an alternative tool for clinical analysis of PSA., (© 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)

Abstract not available. [ABSTRACT FROM AUTHOR]