Analytical and Clinical Evaluation of a Chemiluminescent Immunoassay to Detect Serum Chitinase-3-like Protein 1 in HBV-Related Liver Diseases
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SUBMITTER: Liao Y
PROVIDER: S-EPMC10830935 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:Objectives Cancer antigen (CA) 72–4 assay is widely used for monitoring gastric and ovarian cancers. The antigen is a mucin-like, tumor-associated glycoprotein known as TAG-72. It has been identified and characterized using two different monoclonal antibodies, CC49 and B72.3, which recognize its glycochain epitopes, Galβ(1–3) sialyl-Tn and sialyl-Tn antigens, respectively. This study describes the quantitative analytical performance of a newly developed CA 72–4 assay, ARCHITECT CA 72–4. Design and Methods: The ARCHITECT CA 72–4 assay was developed using the ARCHITECT i2000SRs and three ARCHITECT i1000SRs. The assay performance was evaluated based on guidance from CLSI (Clinical and Laboratory Standards Institute) and correlation against Elecsys CA 72–4. Results In the total precision study, the minimum coefficient of variation (CV) for Control/Panel samples over 4 U/mL was 1.1%. The measuring interval was from 0.95 to 200 U/mL with good linearity; and limits of blank (LoB), detection (LoD), and quantitation (LoQ) were 0.09, 0.18, and 0.95 U/mL, respectively. High dose hook effect; differences among specimen tube types; and interference of common drugs, potential cross-reactants, and endogenous substances were not observed. Significantly, this assay has high biotin tolerance at 4875 mg/mL and correlates well with the Elecys CA 72–4 assay (correlation coefficient: 0.95). Conclusions ARCHITECT CA 72–4 is a highly sensitive and precise assay for CA 72-4 measurement in human sera and plasma. Highlights • CA 72–4 assay is widely used for monitoring gastric cancer and ovarian cancer.• The performance of a novel CA 72–4 assay, ARCHITECT CA 72–4 is described.• ARCHITECT CA 72-4 has high tolerance to biotin interference.• It can be used to test samples collected in available various sample tube types.• Our results indicate ARCHITECT CA 72–4 to be a sensitive and precise assay.
| S-EPMC9879778 | biostudies-literature
Project description:IntroductionMonitoring circulating progesterone concentration ([P4]) is an important component of basic and applied reproduction research and clinical settings. IMMULITE® 2000 XPi (Siemens Healthineers, Cary, NC) is a newly upgraded fully automated immunoassay system marketed for human use to measure concentrations of different measurands including P4.ObjectivesOur objective was therefore to characterize the analytical performance of the IMMULITE® 2000 XPi P4 immunoassay (IPI) across the reportable range in serum and plasma of cattle.MethodsThe IPI validation protocols included characterization of the method linearity, within-run, and between-run precision through calculation of the coefficient of variation (CV). The method accuracy was assessed through the calculation of the spiking-recovery (SR) bias across the reportable range (0.2-40.0 ng/mL). Passing-Bablok regression and Bland-Altman plots were used to determine the interlaboratory bias for two laboratories. Three types of observed total error (TEo) were calculated based on the considered type of bias, TEoSR (spiking-recovery), TEoRB (range-based bias), and TEoAB (average-based bias).ResultsThe IPI was linearly related to the true value (R 2 = 0.997) across the reportable range. The within-run and between-run precision (CV%) of the IPI for both serum and plasma [P4] of clinical relevance (1, 2, 5, and 10 ng/mL) were <5 and <10%, respectively. The TEo reported here for serum and plasma at [P4] of 1 and 5 ng/mL was ~20 and 25%, respectively. Of interest, the three types of TEo were relatively similar regardless of the considered bias.ConclusionsWe concluded that the automated IPI provides a precise, accurate, reliable, and safe method for measuring [P4] in both serum and plasma of cattle. Consistent with the manufacturer's recommendations, the serum matrix is more accurate than plasma.
| S-EPMC9868466 | biostudies-literature
Project description:BackgroundEnzyme-linked immunosorbent assay (ELISA) has traditionally been used to detect myeloperoxidase (MPO) and proteinase 3 (PR3) antibodies, although it is time-consuming and physically demanding. As a novel and highly effective immunoassay, we compared chemiluminescent immunoassay (CIA) with ELISA to verify the application value of CIA in MPO and PR3 antibodies detection.MethodsBy ELISA and CIA, serum levels of anti-MPO and anti-PR3 antibodies were measured in 63 anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) patients (AAV group), including 47 microscopic polyangiitis (MPA) patients and 16 granulomatosis with polyangiitis (GPA) patients, in addition, 68 patients in interference control group (IC group), 19 healthy subjects in healthy control group (HC group). We compared MPO and PR3 antibodies levels and positive rates measured by these two methods among groups. Relationship and coincidence rate between ELISA and CIA were investigated. Diagnostic values for clinical outcomes for MPO and PR3 antibodies were assessed by receiver operator characteristic (ROC) curve.ResultsIn AAV patients, when detecting anti-MPO (r = .90) and anti-PR3 (r = .81), CIA was highly correlated with ELISA, companying with highly total (88.89%, 92.06%, respectively) and positive coincidence rates (84.78%, 77.27%, respectively). In HC group, anti-PR3 positive rate detected by both immunoassay were 0, anti-MPO almost were 0, which without statistically significant difference (P = .32). In IC group, the total (76.47%, 58.82, respectively) and positive coincidence rates (48.38%, 30.00%, respectively) of anti-MPO and anti-PR3 were the lowest, but the negative coincidence rates reached 100%. By CIA, similar to ELISA, the levels of anti-MPO were significantly higher both in AAV patients (56.00; [4.40-235.30]) and MPA patients (98.00; [27.90-324.70]) compared with either IC group (3.20; [3.20-18.55) (P < .0001) or HC group (3.20; [3.20-3.20]) (P < .0001), yielded an area under curve (AUC) of 0.76 for AAV and 0.89 for MPA, the concentration of anti-PR3 in GPA group (66.65; [24.43-150.00]) was significantly higher than that in IC group (2.3; [2.3-10.95]) (P < .0001) and HC group (2.3; [2.3-2.3]) (P < .0001), with an AUC of 0.92.ConclusionSimilar to ELISA, CIA was competent to detect MPO and PR3 antibodies in AAV patients and healthy population, thus distinguish AAV patients from IC group and HC group and effectively diagnose MPA and GPA.
| S-EPMC7891508 | biostudies-literature
Project description:BackgroundCyclosporine A (CsA) is used as a posttransplantation immunosuppressant drug, and careful monitoring of CsA concentration in whole blood is essential. A new automated electrochemiluminescence immunoassay (ECLIA) for CsA measurement has been assessed in a multicenter evaluation.MethodsResidual EDTA whole blood samples from patients undergoing CsA therapy after organ transplant were used in assay evaluation at 5 clinical laboratories in Europe. Experiments included imprecision according to CLSI EP5-A2 (within-run and intermediate), lower limit of quantification, linearity according to CLSI EP6-A, and recovery of commercial external quality control samples. In addition, comparisons to liquid chromatography-tandem mass spectrometry methods in routine use at each investigational site and to commercial chemiluminescent microparticle immunoassay and antibody-conjugated magnetic immunoassay methods were performed.ResultsImprecision testing gave coefficients of variation of less than 9% in the 30-2000 mcg/L range for both within-run and intermediate imprecision. Lower limit of quantification of 6.8 mcg/L at one investigational site and 1.8 mcg/L at a second site at 20% coefficient of variation were observed. Linearity was measured over the concentration range 0-2000 mcg/L, yielding a deviation of less than ±12%. External quality control sample recovery by ECLIA was 93%-114% of LC-MS/MS sample recovery. Deming regression analysis of ECLIA method comparison to combined LC-MS/MS results yielded a slope of 1.04 [95% confidence interval (CI), 1.03-1.06] and intercept of 2.8 mcg/L (95% CI, 1.5-4.1 mcg/L). Comparison to chemiluminescent microparticle immunoassay yielded a slope of 0.87 (95% CI, 0.85-0.89) and intercept of 1.4 mcg/L (95% CI, -0.89 to 3.7 mcg/L); comparison to antibody-conjugated magnetic immunoassay yielded a slope of 0.96 (95% CI, 0.93-0.98) and intercept of -4.2 mcg/L (95% CI, -7.1 to -1.2 mcg/L).ConclusionsThe data from this multicenter evaluation indicate that the new ECLIA-based cyclosporine assay is fit for its purpose, the therapeutic monitoring of CsA.
| S-EPMC4218761 | biostudies-literature
Project description:BACKGROUND:Ongoing efforts in the development of HBsAg detection kits are focused on improving sensitivity and specificity. The purpose of this study was to evaluate an improved, highly sensitive quantitative assay, "Lumipulse HBsAg-HQ", a chemiluminescent enzyme immunoassay designed for a fully automated instrument, the "Lumipulse G1200". METHODS:Serum samples for reproducibility, dilution, correlation, sensitivity, and specificity studies were obtained from patients at the Osaka University Hospital. Seroconversion and sensitivity panels were purchased from a commercial vender. Subtype, sensitivity panels, and HBsAg recombinant proteins with one or two amino acid substitutions were prepared in-house. RESULTS:The coefficients of variation for the low, medium, and high concentration samples ranged from 1.93 to 2.55%. The HBsAg-HQ reagent for dilution testing showed good linearity in the 0.005-150 HBsAg IU/mL range and no prozone phenomenon. All 102 HBV carrier samples were positive by HBsAg-HQ, while other commercial reagents showed one or more to be negative. In the seroconversion panel, the 14-day blood sample was positive. The sensitivity against HBsAg-HQ "ad" and "ay" subtypes was 0.025 ng/mL. Comparisons among the HBsAg-HQ, HISCL, and Architect HBsAg reagents were performed using the Bland-Altman plot. Specificity for 1000 seronegative individuals was 99.7%. HBsAg-HQ detected 29 positive serum among 12 231 routinely obtained serum samples, which showed concentrations of 0.005-0.05 HBsAg IU/mL. CONCLUSIONS:According to these results, the Lumipulse HBsAg-HQ assay, with a highly sensitive limit of detection of 0.005 IU/mL, may facilitate the development of a better management strategy for a considerable proportion of infected patients.
| S-EPMC6817178 | biostudies-literature
Project description:Cancer antigen 125 (CA125) is a widely used biomarker in monitoring of epithelial ovarian cancer (EOC). Due to insufficient cancer specificity of CA125, its diagnostic use is severely compromised. Abnormal glycosylation of CA125 is a unique feature of ovarian cancer cells and could improve differential diagnosis of the disease. Here we describe the development of a quantitative lateral flow immunoassay (LFIA) of aberrantly glycosylated CA125 which is widely superior to the conventional CA125 immunoassay (CA125IA). With a 30 min read-out time, the LFIA showed 72% sensitivity, at 98% specificity using diagnostically challenging samples with marginally elevated CA125 (35-200 U/mL), in comparison to 16% sensitivity with the CA125IA. We envision the clinical use of the developed LFIA to be based on the substantially enhanced disease specificity against the many benign conditions confounding the diagnostic evaluation and against other cancers.
| S-EPMC7442799 | biostudies-literature
Project description:Background and Objectives: This study aimed to evaluate the performance of a new chemiluminescent immunoassay-based tuberculosis (TB) interferon-gamma release assay (IGRA), AdvanSureI3 TB-IGRA (LG Chem Ltd., Seoul, Republic of Korea), for detecting latent tuberculosis infection in comparison with T-SPOT.TB (Oxford Immunotec, Oxford, UK). Materials and Methods: Between June 2021 and December 2021, 125 non-duplicate blood specimens were collected from adult volunteers; each subject received both tests concurrently. Total agreement and Cohen's kappa coefficient (κ) were used to calculate concordance. The Jonckheere-Terpstra test was used to examine the correlation between interferon-gamma (IFN-γ) levels in AdvanSureI3 TB-IGRA and spot counts in T-SPOT.TB. Results: The IGRA findings of the two assays revealed 90.8% (95% confidence interval [CI] = 84.2-94.8) total agreement with κ of 0.740 (95% CI = 0.595-0.885), showing substantial agreement between the two tests. Additionally, the amount of IFN-γ in AdvanSureI3 TB-IGRA increased with the spot counts in T-SPOT.TB (p < 0.001). Conclusions: Our research revealed that the results of the AdvanSureI3 TB-IGRA were comparable to those of T-SPOT.TB.
| S-EPMC10608617 | biostudies-literature
Project description:Measurement of plasma aldosterone and renin concentration, or activity, is useful for selecting antihypertensive agents and detecting hyperaldosteronism in hypertensive patients. However, it takes several days to get results when measured by radioimmunoassay and development of more rapid assays has been long expected. We have developed chemiluminescent enzyme immunoassays enabling the simultaneous measurement of both aldosterone and renin concentrations in 10 minutes by a fully automated assay using antibody-immobilized magnetic particles with quick aggregation and dispersion. We performed clinical validation of diagnostic ability of this newly developed assay-based screening of 125 patients with primary aldosteronism from 97 patients with essential hypertension. Results of this novel assay significantly correlated with the results of radioimmunoassay (aldosterone, active renin concentration, and renin activity) and liquid chromatography-tandem mass spectrometry (aldosterone). The analytic sensitivity of this particularly novel active renin assay was 0.1 pg/mL, which was better than that of radioimmunoassay (2.0 pg/mL). The ratio of aldosterone-to-renin concentrations of 6.0 (ng/dL per pg/mL) provided 92.0% sensitivity and 76.3% specificity as a cutoff for differentiating primary aldosteronism from essential hypertension. This novel measurement is expected to be a clinically reliable alternative for conventional radioimmunoassay and to provide better throughput and cost effectiveness in diagnosis of hyperaldosteronism from larger numbers of hypertensive patients in clinical settings.
| S-EPMC5613948 | biostudies-literature
Project description:BackgroundMycoplasma pneumoniae is considered an important etiologic agent of community-acquired pneumonia (CAP) in outpatients. We aimed to evaluate the diagnostic accuracy of a quick automated chemiluminescent immunoassay (CLIA) for M. pneumoniae in a population-based prospective study of CAP.MethodsA total of 137 outpatients diagnosed with CAP were included in the study. Acute- and convalescent phase sera were analyzed for IgG and IgM to M. pneumoniae with both CLIA (VirClia® ) and ELISA immunoassays. Conventional serological criteria by quantitative ELISA were considered as reference standard. Sensitivity and specificity of the assay were assessed with the construction of receiver operating characteristic (ROC) curves, and the kappa index was used to evaluate the accuracy of the IgG and IgM determinations in the acute phase.ResultsThirty-eight patients were diagnosed with pneumonia by M. pneumoniae. ROC curves for IgG and IgM of convalescent and acute phase (C/A) quotients by the CLIA and ELISA assays were comparable. Specifically, for the CLIA, the best C/A quotient for IgG was 2.617 (sensitivity, 94.9%; specificity, 99.9%), and for IgM 1.400 (sensitivity, 65.8%; specificity, 100%). Regarding the acute phase, the best diagnostic accuracy for the CLIA was obtained with an IgG index of 1.120 (sensitivity, 89.5%; specificity, 73.7%). The CLIA was very simple to execute and required a minimum sample handling.ConclusionThe accuracy of the Virclia® assay for the diagnosis of M. pneumoniae infection in outpatients with CAP was equivalent to the quantitative ELISA. The CLIA was quicker to perform and displayed better analytic workability than conventional ELISA.
| S-EPMC6816995 | biostudies-literature
Project description:BackgroundCoccidioidomycosis is often diagnosed with a collection of tests that rely on the patient's ability to mount an immune response to the fungus (antibody-based diagnostics), making diagnosis of this infection challenging. Here we present an antigen-based assay that detects and quantifies coccidioidal chitinase-1 (CTS1) in human serum.MethodsAn inhibition-based enzyme-linked immunoassay (ELISA) was developed that utilizes a monoclonal antibody specific for coccidioidal CTS1. CTS1 was quantified in commercial antigen preparations using recombinant CTS1 as a standard. Sera from 192 individuals from an endemic area were tested, which included 78 patients (40.6%) with proven or probable coccidioidomycosis.ResultsThe quantity of CTS1 in diagnostic commercial antigen preparations from different suppliers varied. CTS1 antigenemia was detected in 87.2% of patients with proven or probable coccidioidomycosis. Specificity was determined to be 96.94% using serum from individuals who reside in the Phoenix, Arizona area who did not have coccidioidomycosis. Levels of CTS1 correlated with low- and high-titer serology from patients with a coccidioidomycosis diagnosis.ConclusionsSince the CTS1 inhibition ELISA described in this report does not depend on the host immune response, it is a promising diagnostic tool to aid in diagnosis and disease monitoring of coccidioidomycosis.
| S-EPMC8320284 | biostudies-literature