Correlation of PMN elastase and PMN elastase-to-neutrophil ratio with disease activity in patients with myositis

Abstract Background Polymorphonuclear (PMN) elastase plays an important role in a variety of inflammatory disorders. Our aim was to analyse PMN elastase in idiopathic inflammatory myopathies (IIMs) and its association with disease activity. Methods PMN elastase levels were measured using enzyme-linked immunosorbent assay in serum samples obtained from 74 patients with myositis (58 with dermatomyositis [DM] and 16 with polymyositis [PM]) and 22 healthy controls. Receiver operating characteristic (ROC) curve analysis was performed to evaluate the discriminant capacity of PMN elastase level and PMN elastase-to-neutrophil ratio (ENR) in patients with active and remission myositis. The association of serum PMN elastase level and ENR with disease variables was evaluated in patients with IIMs. The disease specificity of PMN elastase level and ENR was further examined in 60 patients with other systemic autoimmune diseases. Results PMN elastase level and ENR were significantly higher in patients with active IIMs, DM, and PM than in patients with remission. ROC curve analysis revealed that PMN elastase level and ENR both outperformed creatine kinase (CK), the currently used laboratory marker, and strongly discriminated patients with active disease and those with remission of IIMs, DM, and PM (area under the ROC curve [AUC] 0.9, 0.9, and 0.88 for PMN elastase; AUC 0.96, 0.96, and 1.0 for ENR; AUC 0.72, 0.70, and 0.80 for CK, respectively). PMN elastase level and ENR were positively correlated with myositis disease activity assessment, CK, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, C-reactive protein, and erythrocyte sedimentation rate. PMN elastase level and ENR were higher in the anti-PM-Scl positive myositis group than those in the anti-PM-Scl negative myositis group. Nevertheless, PMN elastase was not a specific disease marker for IIMs when compared with other autoimmune diseases. Conclusions PMN elastase, particularly ENR, were significantly correlated with disease activity and could serve as useful biochemical markers for evaluating the disease activity of patients with IIMs. Thus, they are potentially helpful in monitoring disease progression and guiding treatment.

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Soluble cytotoxic T-lymphocyte–associated antigen 4 (sCTLA-4) as a potential biomarker for diagnosis and evaluation of the prognosis in Glioma

BMC Immunology ◽

10.1186/s12865-021-00422-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Jiajia Liu ◽

Xiaoyi Tian ◽

Yan Wang ◽

Xixiong Kang ◽

Wenqi Song

Keyword(s):

T Lymphocyte ◽

Roc Curve ◽

Cytotoxic T Lymphocyte ◽

Tumor Grade ◽

Curve Analysis ◽

Enzyme Linked Immunosorbent Assay ◽

Low Grade ◽

High Grade ◽

Healthy Individuals ◽

Roc Curve Analysis

Abstract Background The cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) is widely considered as a pivotal immune checkpoint molecule to suppress antitumor immunity. However, the significance of soluble CTLA-4 (sCTLA-4) remains unclear in the patients with brain glioma. Here we aimed to investigate the significance of serum sCTLA-4 levels as a noninvasive biomarker for diagnosis and evaluation of the prognosis in glioma patients. Methods In this study, the levels of sCTLA-4 in serum from 50 patients diagnosed with different grade gliomas including preoperative and postoperative, and 50 healthy individuals were measured by an enzyme-linked immunosorbent assay (ELISA). And then ROC curve analysis and survival analyses were performed to explore the clinical significance of sCTLA-4. Results Serum sCTLA-4 levels were significantly increased in patients with glioma compared to that of healthy individuals, and which was also positively correlated with the tumor grade. ROC curve analysis showed that the best cutoff value for sCTLA-4 for glioma is 112.1 pg/ml, as well as the sensitivity and specificity with 82.0 and 78.0%, respectively, and a cut-off value of 220.43 pg/ml was best distinguished in patients between low-grade glioma group and high-grade glioma group with sensitivity 73.1% and specificity 79.2%. Survival analysis revealed that the patients with high sCTLA-4 levels (> 189.64 pg/ml) had shorter progression-free survival (PFS) compared to those with low sCTLA-4 levels (≤189.64 pg/ml). In the univariate analysis, elder, high-grade tumor, high sCTLA-4 levels and high Ki-67 index were significantly associated with shorter PFS. In the multivariate analysis, sCTLA-4 levels and tumor grade remained an independent prognostic factor. Conclusion These findings indicated that serum sCTLA-4 levels play a critical role in the pathogenesis and development of glioma, which might become a valuable predictive biomarker for supplementary diagnosis and evaluation of the progress and prognosis in glioma.

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Availability of Circulating microRNAs As a Biomarker for the Early Diagnosis of Diffuse Large B-Cell Lymphoma

Blood ◽

10.1182/blood.v124.21.2988.2988 ◽

2014 ◽

Vol 124 (21) ◽

pp. 2988-2988 ◽

Cited By ~ 2

Author(s):

Katsushige Inada ◽

Yasushi Okoshi ◽

Yukiko Cho ◽

Hitoaki Saito ◽

Tatsuo Iijima ◽

...

Keyword(s):

Lymph Nodes ◽

Healthy Volunteers ◽

Roc Curve ◽

B Cell Lymphoma ◽

Curve Analysis ◽

Serum Samples ◽

Roc Curve Analysis ◽

Expression Levels ◽

Circulating Mirna ◽

Large B Cell Lymphoma

Abstract Introduction: MicroRNA (miRNA) is a class of non-coding small RNA (~22 nucleotides), which regulates post-transcriptional gene expression through binding to complementary sites of target messenger RNA. Recent studies have revealed that miRNA plays important roles in oncogenesis mainly by regulating oncogenes or tumor suppressor genes. As miRNA exists not only within cells but also in peripheral blood, circulating miRNA can be an easily obtainable cancer biomarker. Furthermore, circulating miRNA, which exists within exosomes or as a complex with particular proteins such as argonaute2, is a suitable and convenient sample for handling because of its stability. Based on these findings, this study planned to pursue the possibility that circulating miRNA could be used for the early diagnosis of diffuse large B-cell lymphoma (DLBCL). Materials and Methods: This study was performed with the permission of our IRB. Expression levels of mature miRNA (both the 5p and 3p strands) were evaluated using different types of materials, namely serum, exosome-enriched serum, and formalin-fixed paraffin-embedded (FFPE) tissue. Serum samples were obtained from patients with newly diagnosed DLBCL (n=33) or healthy volunteers (n=22) at our institution between 2012 and 2014. The exosome-enriched samples were obtained from serum using a total exosome isolation reagent (Invitrogen, CA). The FFPE biopsy samples were obtained from DLBCL lesions, mainly from lymph nodes (n=22), or from reactive hyperplastic lymph nodes (n=6). Based on the results of previous reports, ten miRNAs (the 5p and 3p strands of miR-15a, miR-21, miR-155, miR-181a, and miR-210) were selected as candidate biomarkers. Expression levels of miRNA were analyzed by the quantitative Real-Time PCR method, and were normalized to hsa-miR-24-3p. Diagnostic accuracy was evaluated using receiver operating characteristics (ROC) curve analysis. Results and Discussion: In serum samples, the expression levels of hsa-miR-15a-3p, hsa-miR-21-5p, hsa-miR-181a-5p, and hsa-miR-210-5p were significantly different between DLBCL patients and healthy volunteers (p<0.05). ROC curve analysis revealed that hsa-miR-15a-3p and hsa-miR-21-5p were valuable biomarkers for differentiating patients with DLBCL from healthy volunteers with an area under the ROC curve (AUC) of 0.676 (p=0.029) and 0.711 (p=0.009), respectively. However, substantial percentages of false-positive and false-negative samples were also observed. To improve diagnostic accuracy, we next analyzed the expression levels of miRNAs in exosome-enriched serum samples. Among the candidate miRNAs, expression levels of hsa-miR-15a-3p, hsa-miR-21-5p, and hsa-miR-181a-5p were significantly different between DLBCL and healthy volunteer in exosome-enriched serum samples (p<0.05). ROC curve analysis revealed that hsa-miR-15a-3p, hsa-miR-21-5p, and hsa-miR-181a-5p were valuable biomarkers with AUCs of 0.714 (p=0.033), 0.779 (p=0.001), and 0.672 (p=0.047), respectively. Contrary to these results, expression levels of these miRNAs in FFPE were not significantly different between DLBCL and reactive lymph nodes. We thus consider that some miRNAs in serum or exosome-enriched serum might be useful in the differential diagnosis of DLBCL. These miRNAs seem to be produced outside of the lymphoma tissue. To use miRNAs as an accurate and sensitive diagnostic biomarker, it is necessary to first identify lymphoma cell-derived miRNA in blood. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

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411. Application of a SARS-CoV-2-specific serologic assay for translational research and surveillance

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.605 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S273-S273

Author(s):

Amy C Sherman ◽

Teresa C Smith ◽

Daniel Espinoza ◽

Yerun Zhu ◽

Jessica Howard-Anderson ◽

...

Keyword(s):

Sensitivity And Specificity ◽

Roc Curve ◽

Research Training ◽

Natural Infection ◽

Curve Analysis ◽

Antibody Responses ◽

Enzyme Linked Immunosorbent Assay ◽

Rt Pcr ◽

Research Support ◽

Roc Curve Analysis

Abstract Background Sensitive and specific SARS-CoV-2 antibody diagnostics are urgently needed to estimate the seroprevalence of SARS-CoV-2 infection in both the general population and special risk groups. Moreover, validated serologic assays are critical to understanding immunity to SARS-CoV-2 infection over time and identifying correlates of protection. Methods An enzyme-linked immunosorbent assay (ELISA) protocol to detect antibodies (IgG) that bind the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein was validated and ROC curve analysis performed by testing a large panel of pre-pandemic sera (n=162) and convalescent sera from RT-PCR-confirmed COVID-19 cases (n=60). We then applied this test in two cohorts: 1) Healthcare personnel (HCP) that were enrolled in a longitudinal surveillance cohort just after peak local transmission and 2) Mildly ill patients being tested for SARS-CoV-2 infection by RT-PCR from NP swabs in an ambulatory testing clinic. Demographics of mildly symptomatic patients tested for SARS-CoV-2 with RT-PCR Results ROC curve analysis yielded an AUC of 0.9953, with a sensitivity and specificity at 91.67% and 99.38% at the optimal OD normalization threshold of 0.20. In 240 HCP surveilled at enrollment, 5.83% had positive IgG results. Of 19 symptomatic patients who presented to the ambulatory clinic, 5/19 had a positive PCR. In convalescence (13–74 days post symptom onset), 3 of those 5 were positive for IgG. Validation of the SARS-CoV-2 RBD ELISA ROC Curve Analysis Conclusion We demonstrated high sensitivity and specificity of the SARS-CoV-2 RBD ELISA. This simple assay is an efficient way to track seroconversion and duration of antibody responses to SARS-CoV-2 for different populations, particularly since RBD-binding antibodies have been shown to correlate with neutralization activity and may be useful to determine protective immunity following natural infection or vaccination. Ongoing work will assess variation in magnitude, character and duration of antibody responses in key populations and seek to maximize deployability of large-scale SARS-CoV-2 serology. Disclosures Jessica Howard-Anderson, MD, MSc, Antibacterial Resistance Leadership Group (ARLG) (Other Financial or Material Support, The ARLG fellowship provides salary support for ID fellowship and mentored research training) Nadine Rouphael, MD, Lilly (Grant/Research Support)Merck (Grant/Research Support)Pfizer (Grant/Research Support)Quidel (Grant/Research Support)Sanofi Pasteur (Grant/Research Support)

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P723 Therapeutic thresholds for golimumab serum concentrations during induction and maintenance: Results from the GO-LEVEL study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.851 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S582-S583

Author(s):

M Samaan ◽

G Cunningham ◽

G Tamilarasan ◽

K Rawstron ◽

K Hawash ◽

...

Keyword(s):

Maintenance Therapy ◽

Disease Activity ◽

Induction Therapy ◽

Roc Curve ◽

Curve Analysis ◽

Therapeutic Drug ◽

Response Relationship ◽

Roc Curve Analysis ◽

Exposure Response ◽

Therapeutic Threshold

Abstract Background The exposure–response relationship associated with the use of golimumab for UC has been previously demonstrated in the PURSUIT trial programme. A significant association between serum golimumab concentrations (SGC) and favourable outcomes was observed during both induction and maintenance therapy. However, data regarding the optimal therapeutic SGC threshold is limited. Methods GO-LEVEL was an open-label, phase IV, investigator initiated study (NCT03124121) which included a prospective cohort of UC patients commencing golimumab induction therapy, as well as a cross-sectional cohort receiving maintenance treatment (>18 weeks from initiation). Patients commencing induction therapy all had disease activity objectively confirmed and were evaluated at weeks 6, 10 and 14. Patients receiving maintenance therapy were recruited either at the point of flare, or during stable remission. Clinical disease activity was evaluated using SCCAI and PRO2, and biochemical activity using FC and CRP. Combined clinical-biochemical remission was defined as SCCAI<3 as well as FC<250ug/g. SGC and anti-golimumab antibodies (AGA) were measured using a drug-sensitive ELISA (LISATRACKER, Theradiag). Fishers exact or Mann–Whitney U were used to compare groups, ROC analysis to identify therapeutic thresholds and Spearman’s rank coefficient (rs) for correlations. Results Thirty-nine patients were included in the induction cohort, of whom 15 (38%) achieved combined remission at week 6. The median SGC of those in combined remission was significantly higher than those who were not (5.0 vs. 3.1 μg/ml, respectively, p = 0.03). ROC curve analysis demonstrates 3.8 μg/ml as the optimal therapeutic threshold to achieve combined remission at week 6 (sensitivity 0.71, specificity 0.65, AUC 0.72). Significant, inverse correlations were also observed between week 6 SGC and PRO2, CRP and FC (rs −0.41 (p = 0.01), −0.47 (p = 0.004) and −0.40 (p = 0.02), respectively). However, week 6 SGC did not predict outcomes at week 10 or 14. Sixty-four patients were included in the maintenance cohort; 32 (50%) were in combined remission, 32 were not. The median SGC of those in combined remission was significantly higher (3.0 vs. 2.1 μg/ml, respectively, p = 0.003). ROC curve analysis demonstrates 2.4 μg/ml as the optimal therapeutic threshold to achieve combined remission (sensitivity 0.73, specificity 0.66, AUC 0.71). No AGA were detected in either cohort. Conclusion GO-LEVEL offers further evidence of the exposure-response relationship with golimumab. Clinicians may consider using therapeutic drug monitoring to optimise golimumab dosing aiming to achieve our suggested SGC therapeutic thresholds of 3.8 μg/ml at week 6 and 2.4 μg/ml during maintenance.

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The correlation of JKAP with risk, severity, inflammation and in-hospital mortality of severe acute pancreatitis

10.21203/rs.2.12782/v1 ◽

2019 ◽

Author(s):

Jing Li ◽

Min Ming ◽

Yonghong Han

Keyword(s):

Acute Pancreatitis ◽

Hospital Mortality ◽

Severe Acute Pancreatitis ◽

Roc Curve ◽

Sofa Score ◽

Curve Analysis ◽

Enzyme Linked Immunosorbent Assay ◽

Healthy Controls ◽

Roc Curve Analysis ◽

Ranson Score

Abstract Background This study aimed to investigate the predictive value of JNK pathway-associated phosphatase (JKAP) level for severe acute pancreatitis (SAP) risk, and its association with disease severity, inflammation and in-hospital mortality in SAP patients. Methods Our study recruited 50 SAP patients, 50 moderate-severe acute pancreatitis (MSAP) patients, 50 mild acute pancreatitis (MAP) patients and 50 healthy controls. And the serum samples were obtained from all acute pancreatitis patients within 24 hours after admission and from health controls at their enrollment to detect JKAP level by enzyme-linked immunosorbent assay. Results JKAP level was decreased in SAP patients compared with healthy controls, MSAP and MAP patients. And receiver operating characteristics (ROC) curve analysis revealed that JKAP could not only distinguish SAP patients from healthy controls (AUC: 0.914, 95%CI: 0.857-0.971), but also differentiate SAP patients from MAP patients (AUC: 0.869, 95%CI: 0.802-0.937) and MSAP patients (AUC: 0.712, 95%CI: 0.610-0.813). In SAP patients, JKAP was negatively correlated with Ranson score, acute physiology and chronic health care evaluation II (APACEH II) score, sequential organ failure assessment (SOFA) score and C-reactive protein (CRP). And lower JKAP level, higher CRP level, Ranson score, APACEH II score and SOFA score were associated with increased in-hospital mortality in SAP patients. Additionally, ROC curve analysis showed that JKAP could predict decreased in-hospital mortality in SAP patients (AUC: 0.720, 95%CI: 0.526-0.914). Conclusions JKAP might serve as a biomarker for disease risk and management for SAP.

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Correlation between C-Reactive Protein to Albumin Ratio and Disease Activity in Patients with Axial Spondyloarthritis

Disease Markers ◽

10.1155/2021/6642486 ◽

2021 ◽

Vol 2021 ◽

pp. 1-8

Author(s):

Zheng Zhong ◽

Yukai Huang ◽

Yuqi Liu ◽

Junming Chen ◽

Meng Liu ◽

...

Keyword(s):

Ankylosing Spondylitis ◽

Disease Activity ◽

Roc Curve ◽

Axial Spondyloarthritis ◽

Curve Analysis ◽

Active Group ◽

C Reactive Protein ◽

Roc Curve Analysis ◽

Reactive Protein ◽

Inactive Group

Background. The C-reactive protein (CRP) to albumin (ALB) ratio (CAR) has emerged as a novel inflammatory biomarker. This study was designed to investigate the role of CAR in the disease activity of axial spondyloarthritis (axSpA). Methods. A total of 241 patients and 61 healthy controls were retrospectively enrolled in this study. AxSpA patients were further divided into the inactive group ( n = 176 ) and active group ( n = 65 ) according to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) cutoff value of 4. Laboratory data and clinical assessment indices were recorded. Spearman’s correlation analysis, receiver operation characteristic (ROC) curve analysis, and binary logistic regression analysis were performed. Results. In axSpA patients, CAR was significantly higher than the healthy group ( P < 0.001 ). Similarly, axSpA patients in the active group had higher CAR than the inactive group ( P < 0.001 ). Besides, CAR was positively correlated with erythrocyte sedimentation rate (ESR) ( r = 0.704 , P < 0.001 ), CRP ( r = 0.996 , P < 0.001 ), BASDAI ( r = 0.329 , P < 0.001 ), and Bath Ankylosing Spondylitis Functional Index (BASFI) ( r = 0.330 , P < 0.001 ). ROC curve analysis suggested that the area under the curve (AUC) of CAR for axSpA of the active group was 0.701, which was higher than that of CRP and ESR. The optimal cutoff point of CAR for axSpA of the active group was 0.3644, with a sensitivity and specificity of 58.5% and 79.0%. Binary logistic analysis results revealed that CAR was an independent predictive factor for axSpA disease activity ( odds ratio = 4.673 , 95% CI: 1.423-15.348, P = 0.011 ). Conclusions. CAR was increased in axSpA and axSpA of the active group. CAR may be a novel and reliable indicator for axSpA disease activity.

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Utility of Alpha-Fetoprotein-L3 and Golgi Protein 73 for Diagnosis of Hepatocellular Carcinoma

10.51429/ejmm29402 ◽

2020 ◽

Vol EJMM29 (4) ◽

pp. 9-15

Author(s):

Rania A. El-Kady ◽

Mohammed M. El-Naggar ◽

ehab A. Abd El-Shakour ◽

Monir H. Bahgat

Keyword(s):

Hepatocellular Carcinoma ◽

Roc Curve ◽

Malignant Tumors ◽

Curve Analysis ◽

Alpha Fetoprotein ◽

Enzyme Linked Immunosorbent Assay ◽

Roc Curve Analysis ◽

Median Serum ◽

Significant Difference ◽

Golgi Protein

Background: Hepatocellular carcinoma (HCC) is amongst the most common malignant tumors that carries a poor prognosis. Clinically, alpha-fetoprotein (AFP) is the most extensively used serum biomarker for diagnosing HCC. Objectives: The current study was conducted to explore the diagnostic value of serum levels of alpha-fetoprotein-L3 (AFP-L3) and Golgi protein 73 (GP73) regarding HCC, and to determine the diagnostic accuracy of these biomarkers when used individually as well as in combination with AFP. Methodology: Blood samples were collected from 50 patients with HCV-related cirrhosis (25 subjects with HCC and 25 without HCC) recruited from the outpatient clinics of the Specialized Internal Medicine Hospital, Mansoura University, Egypt. Serum concentrations of AFP-L3 and GP73 were evaluated using enzyme-linked immunosorbent assay (ELISA). Diagnostic performance of AFP-L3 and GP73 was determined by receiver operating characteristic (ROC) curve analysis. Results: Overall, the median serum level of AFP-L3 was higher in the HCC group compared to the cirrhotic group (p=0.05). Moreover, a statistically-significant difference was observed between the median serum value of GP73 in HCC patients compared to those with cirrhosis (p < 0.001). The ROC curve analysis showed that the area under the ROC curve (AUROC) values for AFP, AFP-L3 and GP73 were 0.88, 0.67 and 0.83, respectively. Of the 3 biomarkers, GP73 demonstrated the highest sensitivity (88%). The AUROC for AFP and AFP-L3 combination was 0.85, whereas that for AFP and GP73 was 0.90. Conclusion: Our findings indicate that GP73 is more sensitive than AFP and AFP-L3 in diagnosing HCC. Furthermore, the combined determination of GP73 and AFP could improve the diagnostic ability of HCC.

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Diagnostic and Prognostic Value of IL-6 and sTREM-1 in SIRS and Sepsis in Children

Mediators of Inflammation ◽

10.1155/2020/8201585 ◽

2020 ◽

Vol 2020 ◽

pp. 1-8

Author(s):

Beata Smok ◽

Krzysztof Domagalski ◽

Małgorzata Pawłowska

Keyword(s):

Roc Curve ◽

Prognostic Value ◽

Curve Analysis ◽

Assay Method ◽

Enzyme Linked Immunosorbent Assay ◽

Control Group ◽

Serum Concentrations ◽

Roc Curve Analysis ◽

Baseline Serum ◽

Diagnostic And Prognostic Value

Purpose. The aim of this study was to evaluate the diagnostic and prognostic value of IL-6 and sTREM-1 in the course of SIRS and sepsis in children with reference to routinely used CRP and PCT. Methods. A prospective study included 180 patients at the ages from 2 months to 18 years hospitalized due to fever from November 2015 to January 2017. Forty-nine children without fever hospitalized due to noninfectious causes formed the control group. IL-6 and sTREM-1 serum concentrations were assessed with the enzyme-linked immunosorbent assay method. Results. The mean serum concentrations of all the analyzed biomarkers were statistically significantly higher in the study group compared to the control group. Mean IL-6, sTREM-1, and PCT serum concentrations were statistically significantly higher in the group of patients with SIRS/sepsis compared to the group of feverish patients without diagnosed SIRS (N-SIRS). Based on the ROC curve analysis, it was shown that of all the biomarkers tested, only two—IL-6 and procalcitonin—had potential usefulness in the diagnosis of SIRS/sepsis in children with fever. Conclusion. Elevated levels of IL-6 and PCT are important risk factors for the development of SIRS/sepsis in children with fever. It seems that elevated IL-6 baseline serum level may predict a more severe course of febrile illness in children, because based on the ROC curve analysis, it was found that IL-6 is a statistically significant prognostic marker of prolonged fever≥3 days and prolonged hospitalization>10 days. The assessment of the usefulness of sTREM-1 in the diagnosis of SIRS/sepsis in feverish children requires further research.

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Specific Serodiagnosis of Animal Brucellosis Based on A Recombinant Multiepitope Protein Antigen

10.21203/rs.3.rs-55889/v2 ◽

2021 ◽

Author(s):

Linlin Xu ◽

Qiongqiong Bai ◽

Jinpeng Zhang ◽

Yang Jiao ◽

Dehui Yin

Keyword(s):

Roc Curve ◽

Bovine Serum ◽

Animal Husbandry ◽

Diagnostic Value ◽

Agglutination Test ◽

Protein Antigen ◽

Enzyme Linked Immunosorbent Assay ◽

Serum Samples ◽

Roc Curve Analysis ◽

Personal Property

Abstract Background: Brucellosis is a zoonotic infectious disease that causes substantial public health problems and endangers the development of animal husbandry in endemic areas, causing huge losses of personal property. Early diagnosis of sick animals is a crucial step in reducing the incidence of brucellosis.Objective: In this study, we designed a recombinant multiepitope protein (rMEP) as a serum diagnostic antigen for brucellosis and evaluated its diagnostic value in cattle and goats.Methods: An indirect enzyme-linked immunosorbent assay (iELISA) was used to assess the new rMEP, and 159 goat and 153 bovine serum samples were measured, including brucellosis and nonbrucellosis samples. To better observe the effectiveness of rMEP, we performed receiver operating characteristic (ROC) curve analysis.Results: Evaluation of the 159 goat serum samples showed that the area under the ROC curve (AUC) was 0.9976, and compared with serum tube agglutination test (SAT) and the Rose Bengal plate agglutination test (RBPT), the positive and negative diagnostic accuracies of ELISA were 98.92% (92/93) and 96.97% (64/66), respectively. Evaluation of the 153 bovine serum samples showed that the AUC was 0.9974, and compared with those of SAT and RBPT, the positive and negative diagnostic accuracies of ELISA were 98.65% (73/74) and 96.20% (76/79), respectively.Conclusion: The results indicated that rMEP, as a protein antigen, can be used to diagnose brucellosis with high accuracy in both goats and bovines.

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Comparison of two multimarker serum tests for the prediction of ovarian cancer in women with a pelvic mass.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.5555 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 5555-5555

Author(s):

David G. Grenache ◽

Zivjena Vucetic

Keyword(s):

Ovarian Cancer ◽

Roc Curve ◽

Pelvic Mass ◽

Benign Disease ◽

Curve Analysis ◽

Cancer Risk Assessment ◽

Risk Scores ◽

Ca 125 ◽

Serum Samples ◽

Roc Curve Analysis

5555 Background: Distinguishing between benign and malignant disease in women with a pelvic mass is difficult. OVA1 and ROMA are two multi-marker serum tests that are FDA-cleared to assess risk of malignancy in individuals with a pelvic mass. This study compared the accuracy of these tests for the prediction of ovarian cancer (OCa) in women with a pelvic mass. Methods: OVA1 and ROMA risk scores were determined in a subset of 146 serum samples obtained prospectively from pelvic mass patients. Patients were categorized by an initial cancer risk assessment (ICRA) performed by a physician and true cancer status determined surgically. 31 patients with malignancy (6 with a benign ICRA) and 115 patients with benign disease (25 with a malignant ICRA) were evaluated. Quest Diagnostics performed the OVA1 tests (CA-125, prealbumin, apolipoprotein A-1, β2-microglobulin, transferrin) and calculated and interpreted the risk score. ROMA tests (CA-125 and HE-4) were determined by automated immunoassay using an Abbott Architect analyzer. ROMA risk scores were calculated using published formulas and interpreted against cutpoints previously established for automated CA-125 and HE-4 performed by manual ELISA. Results: There were 70 pre- and 76 post-menopausal subjects. Of the 31 with malignancy, 26 had OCa (54% >stage II), 5 with an ICRA of benign. ROC curve analysis of the entire cohort produced an AUC of 0.88 (95% CI 0.80-0.95) and 0.93 (95% CI 0.87-0.99) for OVA1 and ROMA, respectively. OVA1 had a sensitivity of 0.97 and a specificity of 0.55. ROMA had a sensitivity of 0.84 and a specificity of 0.83. The sensitivity of OVA1 for OCa in the ICRA benign cohort (N = 5) was 0.80 and for ROMA was 0.40. The respective specificity for benign disease in this cohort (N=90) was 0.64 and 0.90. The sensitivity of ROMA for OCa increased to 0.60 with a slight decrease in specificity (0.87) when a cutpoint determined by ROC curve analysis was used. Conclusions: Overall, OVA1 and ROMA have similar performance characteristics. In women with an ICRA of benign, OVA1 was more sensitive among those who had OCa but ROMA was more specific among those who did not. The use of a ROMA cutpoint specific for the combination of automated CA-125 and HE-4 tests improved sensitivity.

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