Use of serum biomarkers to differentiate benign breast lesions from invasive breast cancer in women with a BI-RADS 3 or 4.

2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 20-20
Author(s):  
Meredith C. Henderson ◽  
Michael Silver ◽  
Susan Yeh ◽  
Christa Corn ◽  
Sherri Borman ◽  
...  
Keyword(s):  
Breast Imaging ◽  
Clinical Decision Making ◽  
Serum Proteins ◽  
Clinical Performance ◽  
Imaging Techniques ◽  
High Sensitivity ◽  
Serum Biomarkers ◽  
Serum Samples ◽  
Meso Scale Discovery ◽  
Multiple Imaging

20 Background: The Provista Biomarker Assay (PBA) combines multiple serum biomarkers, measured at high sensitivity, in order to determine the likelihood of an invasive breast tumor at the time of testing. PBA, when paired with traditional breast imaging technologies, provides a biochemical tool that can help guide additional imaging or biopsy decisions. As part of our ongoing efforts to characterize clinical performance, we conducted a proof-of-concept study wherein PBA assay performance was tested in prospectively enrolled BI-RADS 3 and 4 patients. Methods: To maximize performance and sensitivity, we utilized the Meso Scale Discovery ELISA-based system to analyze a randomized cohort of 350 prebiopsy serum samples from women under the age of 50. Enrollment in the trial required a BI-RADS 3 or 4 radiologic assessment utilizing multiple imaging modalities. Serum proteins and autoantibodies were measured for each patient and applied to a proprietary statistical algorithm. Results: We were able to obtain statistically significant differentiation using the Provista Biomarker Assay in women under age 50 who were characterized as BI-RADS 3 or 4. The majority of patients in the study were diagnosed with a benign breast lesion, consistent with prior studies. However, the data indicate that PBA, when used in combination with imaging techniques, more accurately informs clinical decision-making. Conclusions: The Provista Biomarker Assay provides a powerful tool for physicians to more accurately assess patients with a BI-RADS 3 or 4 classification. With more clinical evidence, the assay may translate into changes in clinical treatment decisions for women under the age of 50 with a BI-RADS 3 or 4 classification. Clinical trial information: NCT01839045.

Proteomics: A panel of seven serum biomarkers as a promising diagnostic tool for breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e22019-e22019
Author(s):  
R. Lastra ◽  
A. Monasterio ◽  
I. Alvarez-Busto ◽  
J. Mayordomo ◽  
J. Algorta ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Serum Proteins ◽  
Simultaneous Detection ◽  
Serum Biomarkers ◽  
Protein Chip ◽  
Differentially Expressed ◽  
Clinical Validation ◽  
Serum Samples ◽  
Screening Programs ◽  
Healthy Women

e22019 Background: Conventionals serum biomarkets have a low sensibility in breast cancer diagnosis. Proteomic is a promising tool to identify new proteins profiles to be used in screening and early diagnosed. Methods: 1)Biomarker identification: Serum proteins from 114 women were separated and analysed by bidimensional gel electrophoresis; data from 72 patients (p) were compared with those from 42 control women to search for differentially expressed proteins. Several comparisons were performed between controls and p regarding clinical parameters such as histological type, tumour stage and lymph node affection (-/+). A total of 53 spots were found to be differentially expressed and identified by mass spectrometry (MS) as potential breast cancer biomarkers.2) Protein Chip development: A Protein Chip was developed with antibodies against six biomarkers and three control proteins (an antibody for the detection of a spiked control, for data normalization and two proteins as positive and negative controls). An antibody against CA15–3 antigen was also included as a reference breast tumour marker to be compared with our biomarker panel. 3) Clinical validation of the Protein Chip: A clinical validation study was carried out with 75 healthy women and 125 breast cancer p. After multivariate statistical analysis of the biomarker data, CA15–3 was discarded due to its low significance while a panel of 5 biomarkers was obtained as the best predictive model to discriminate p from healthy subjects. Results: 53 diferentially expressed proteins have been identified as potential breast cancer serum biomarkers after analysing 114 serum samples by 2DE Technology. A Protein Chip has been developed for the simultaneous detection of five serum biomarkers and three control proteins. After clinical validation with 200 p and healthy women, the sensitivity of the Protein Chip to detect breast cancer was 95% and its specificity was 27%. Conclusions: The high sensitivity of the Protein Chip suggests that it could be a valid tool to complement mammography (sensitivity < 80%) in breast cancer screening programs, specially when its sensitivity tends to decrease, as it happens in young women and dense breast cases. Larger clinical validation trials are being developed. This work is supported by INDAS BIOTECH. No significant financial relationships to disclose.

scholarly journals Multisite Comparison of High-Sensitivity Multiplex Cytokine Assays

2011 ◽  
Vol 18 (8) ◽  
pp. 1229-1242 ◽  
Author(s):  
Elizabeth Crabb Breen ◽  
Sandra M. Reynolds ◽  
Christopher Cox ◽  
Lisa P. Jacobson ◽  
Larry Magpantay ◽  
...  
Keyword(s):  
Plasma Concentrations ◽  
High Sensitivity ◽  
Small Sample ◽  
Great Promise ◽  
Serum Samples ◽  
Meso Scale Discovery ◽  
Necrosis Factor Alpha ◽  
Multiplex Assays ◽  
Long Term Study

ABSTRACTThe concentrations of cytokines in human serum and plasma can provide valuable information aboutin vivoimmune status, but low concentrations often require high-sensitivity assays to permit detection. The recent development of multiplex assays, which can measure multiple cytokines in one small sample, holds great promise, especially for studies in which limited volumes of stored serum or plasma are available. Four high-sensitivity cytokine multiplex assays on a Luminex (Bio-Rad, BioSource, Linco) or electrochemiluminescence (Meso Scale Discovery) platform were evaluated for their ability to detect circulating concentrations of 13 cytokines, as well as for laboratory and lot variability. Assays were performed in six different laboratories utilizing archived serum from HIV-uninfected and -infected subjects from the Multicenter AIDS Cohort Study (MACS) and the Women's Interagency HIV Study (WIHS) and commercial plasma samples spanning initial HIV viremia. In a majority of serum samples, interleukin-6 (IL-6), IL-8, IL-10, and tumor necrosis factor alpha were detectable with at least three kits, while IL-1β was clearly detected with only one kit. No single multiplex panel detected all cytokines, and there were highly significant differences (P< 0.001) between laboratories and/or lots with all kits. Nevertheless, the kits generally detected similar patterns of cytokine perturbation during primary HIV viremia. This multisite comparison suggests that current multiplex assays vary in their ability to measure serum and/or plasma concentrations of cytokines and may not be sufficiently reproducible for repeated determinations over a long-term study or in multiple laboratories but may be useful for longitudinal studies in which relative, rather than absolute, changes in cytokines are important.

scholarly journals A novel highly quantitative and reproducible assay for the detection of anti-SARS-CoV-2 IgG and IgM antibodies

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Kenta Noda ◽  
Kouki Matsuda ◽  
Shigehiro Yagishita ◽  
Kenji Maeda ◽  
Yutaro Akiyama ◽  
...  
Keyword(s):  
Clinical Performance ◽  
High Sensitivity ◽  
Clinical Severity ◽  
Detection Accuracy ◽  
Serum Samples ◽  
Serological Tests ◽  
Nucleocapsid Proteins ◽  
Assay Performance ◽  
Quantification Accuracy ◽  
Antibody Levels

AbstractThe quantitative range and reproducibility of current serological tests for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) are not optimized. Herein, we developed a diagnostic test that detects SARS-CoV-2 IgG and IgM with high quantitativeness and reproducibility and low interference. The system was based on the high-sensitivity chemiluminescence enzyme immunoassay (HISCL) platform and detects IgG and IgM specific to SARS-CoV-2 spike and nucleocapsid proteins. Quantification accuracy and reproducibility were evaluated using serially diluted samples from 60 SARS-CoV-2-infected patients. Assay performance was evaluated using serum samples from the SARS-CoV-2-infected patients and 500 SARS-CoV-2-negative serum samples collected before the emergence of SARS-CoV-2. The system showed high quantification accuracy (range, 102), high reproducibility (within 5%), and no cross-reaction between SARS1- and MERS-S proteins. Detection accuracy was 98.3% and 93.3% for IgG and IgM against spike proteins and 100% and 71.7% for IgG and IgM against nucleocapsid proteins, respectively. Mean antibody levels were > 10 times that in negative samples upon admission and > 100 times that at convalescent periods. Clinical severity upon admission was not correlated with IgG or IgM levels. This highly quantitative, reproducible assay system with high clinical performance may help analyze temporal serological/immunological profiles of SARS-CoV-2 infection and SARS-CoV-2 vaccine effectiveness.

scholarly journals Performance of the commercially available SERION ELISA classic Echinococcus IgG test for the detection of cystic echinococcosis in clinical practice

2018 ◽  
Vol 93 (05) ◽  
pp. 636-639 ◽  
Author(s):  
M.J. Sarink ◽  
R. Koelewijn ◽  
B.C.G.C. Slingerland ◽  
A.G.M. Tielens ◽  
P.J.J. van Genderen ◽  
...  
Keyword(s):  
Cystic Echinococcosis ◽  
Clinical Performance ◽  
Imaging Techniques ◽  
Healthy Controls ◽  
Imaging Studies ◽  
Serum Samples ◽  
Predictive Values ◽  
Complementary Role ◽  
Negative Controls ◽  
Positive Results

AbstractDiagnosis of cystic echinococcosis (CE) is at present mainly based on imaging techniques. Serology has a complementary role, partly due to the small number of standardized and commercially available assays. Therefore we examined the clinical performance of the SERION ELISA classic Echinococcus IgG test. Using 10 U/ml as a cut-off point, and serum samples from 50 CE patients and 105 healthy controls, the sensitivity and specificity were 98.0% and 96.2%, respectively. If patients with other infectious diseases were used as negative controls, the specificity decreased to 76.9%, which causes poor positive predictive values. However, if results between 10 and 15 U/ml are classified as indecisive, the specificity of positive results (≥15 U/ml) increased to 92.5% without greatly affecting the sensitivity (92.0%). Using this approach in combination with imaging studies, the SERION ELISA classic Echinococcosis IgG test can be a useful aid in the diagnosis of CE.

scholarly journals SARS-CoV-2 Antibody Testing in Healthcare Workers: a comparison of the clinical performance of three commercially available antibody assays

2021 ◽  
Author(s):  
Niamh Allen ◽  
Melissa Brady ◽  
Antonio Isidro Carrion Martin ◽  
Lisa Domegan ◽  
Cathal Walsh ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Natural Infection ◽  
Sample Selection ◽  
High Sensitivity ◽  
Population Based ◽  
Serological Response ◽  
Antibody Testing ◽  
Serum Samples ◽  
Entire Study ◽  
Asian Ethnicity

SARS-CoV-2 antibodies are an excellent indicator of past COVID-19 infection. As the COVID-19 pandemic progresses, retained sensitivity over time is an important quality in an antibody assay that is to be used for the purpose of population seroprevalence studies. We compared 5788 healthcare worker (HCW) serum samples on two serological assays (Abbott SARS-CoV-2 anti-nucleocapsid IgG and Roche Anti-SARS-CoV-2 anti-nucleocapsid Total Antibody) and a subset of samples (all Abbott assay positive or grayzone, n=485) on Wantai SARS-CoV-2 anti-spike Antibody ELISA. For 367 samples from HCW with previous PCR-confirmed SARS-CoV-2 infection we correlated the timing of infection with assay results. Overall seroprevalence was 4.2% on Abbott, 9.5% on Roche. Of those with previously confirmed infection, 41% (150/367) and 95% (348/367) tested positive on Abbott and Roche respectively. At 21 weeks (150 days) after confirmed infection, positivity on Abbott started to decline. Roche positivity was retained for the entire study period (33 weeks). Factors associated (P≤ 0.050) with Abbott seronegativity in those with previous PCR-confirmed infection included sex (male OR0.30;95%CI0.15-0.60), symptom severity (OR0.19 severe symptoms;95%CI0.05-0.61), ethnicity (OR0.28 Asian ethnicity;95%CI0.12-0.60) and time since PCR diagnosis (OR2.06 for infection 6 months previously;95%CI1.01-4.30. Wantai detected all previously confirmed infections. In our population, Roche detected antibodies up to at least seven months after natural infection with SARS-CoV-2. This may indicate that Roche is better suited than Abbott to population-based studies. Wantai demonstrated high sensitivity but sample selection was biased. The relationship between serological response and functional immunity to SARS-CoV-2 infection needs to be delineated.

An x-ray microprobe based upon a close-coupled focal-spot / glass capillary arrangement

1992 ◽  
Vol 50 (2) ◽  
pp. 1758-1759
Author(s):  
D. A. Carpenter ◽  
M. A. Taylor
Keyword(s):  
Imaging Techniques ◽  
Fluorescence Analysis ◽  
High Sensitivity ◽  
Specimen Preparation ◽  
X Rays ◽  
Glass Capillary ◽  
Close Coupling ◽  
X Ray ◽  
Point To Point ◽  
Beam Damage

The development of intense sources of x rays has led to renewed interest in the use of microbeams of x rays in x-ray fluorescence analysis. Sparks pointed out that the use of x rays as a probe offered the advantages of high sensitivity, low detection limits, low beam damage, and large penetration depths with minimal specimen preparation or perturbation. In addition, the option of air operation provided special advantages for examination of hydrated systems or for nondestructive microanalysis of large specimens.The disadvantages of synchrotron sources prompted the development of laboratory-based instrumentation with various schemes to maximize the beam flux while maintaining small point-to-point resolution. Nichols and Ryon developed a microprobe using a rotating anode source and a modified microdiffractometer. Cross and Wherry showed that by close-coupling the x-ray source, specimen, and detector, good intensities could be obtained for beam sizes between 30 and 100μm. More importantly, both groups combined specimen scanning with modern imaging techniques for rapid element mapping.

Digital imaging and quantitative image analysis of polymer blends

1996 ◽  
Vol 54 ◽  
pp. 170-171
Author(s):  
Xiao Zhang
Keyword(s):  
Digital Imaging ◽  
Imaging Techniques ◽  
Imaging Systems ◽  
Polymer Science ◽  
Key Factors ◽  
Multiple Imaging ◽  
Quantitative Image ◽  
Digital Imaging Systems ◽  
Multi Phase ◽  
Network Technologies

Polymer microscopy involves multiple imaging techniques. Speed, simplicity, and productivity are key factors in running an industrial polymer microscopy lab. In polymer science, the morphology of a multi-phase blend is often the link between process and properties. The extent to which the researcher can quantify the morphology determines the strength of the link. To aid the polymer microscopist in these tasks, digital imaging systems are becoming more prevalent. Advances in computers, digital imaging hardware and software, and network technologies have made it possible to implement digital imaging systems in industrial microscopy labs.

scholarly journals Computer-supported Detection of M-Components and Evaluation of Immunoglobulins after Capillary Electrophoresis

2001 ◽  
Vol 47 (1) ◽  
pp. 110-117 ◽  
Author(s):  
Magnus Jonsson ◽  
Joyce Carlson ◽  
Jan-Olof Jeppsson ◽  
Per Simonsson
Keyword(s):  
Capillary Electrophoresis ◽  
Decision Support ◽  
Protein Separation ◽  
Serum Proteins ◽  
Cost Effective ◽  
Clinical Samples ◽  
Serum Samples ◽  
Computerized Decision Support ◽  
Cost Effective Method ◽  
Mathematical Algorithms

Abstract Background: Electrophoresis of serum samples allows detection of monoclonal gammopathies indicative of multiple myeloma, Waldenström macroglobulinemia, monoclonal gammopathy of undetermined significance, and amyloidosis. Present methods of high-resolution agarose gel electrophoresis (HRAGE) and immunofixation electrophoresis (IFE) are manual and labor-intensive. Capillary zone electrophoresis (CZE) allows rapid automated protein separation and produces digital absorbance data, appropriate as input for a computerized decision support system. Methods: Using the Beckman Paragon CZE 2000 instrument, we analyzed 711 routine clinical samples, including 95 monoclonal components (MCs) and 9 cases of Bence Jones myeloma, in both the CZE and HRAGE systems. Mathematical algorithms developed for the detection of monoclonal immunoglobulins (MCs) in the γ- and β-regions of the electropherogram were tested on the entire material. Additional algorithms evaluating oligoclonality and polyclonal concentrations of immunoglobulins were also tested. Results: CZE electropherograms corresponded well with HRAGE. Only one IgG MC of 1 g/L, visible on HRAGE, was not visible after CZE. Algorithms detected 94 of 95 MCs (98.9%) and 100% of those visible after CZE. Of 607 samples lacking an MC on HRAGE, only 3 were identified by the algorithms (specificity, 99%). Algorithms evaluating total gammaglobulinemia and oligoclonality also identified several cases of Bence Jones myeloma. Conclusions: The use of capillary electrophoresis provides a modern, rapid, and cost-effective method of analyzing serum proteins. The additional option of computerized decision support, which provides rapid and standardized interpretations, should increase the clinical availability and usefulness of protein analyses in the future.

scholarly journals Laboratory predictors of death from coronavirus disease 2019 (COVID-19) in the area of Valcamonica, Italy

2020 ◽  
Vol 58 (7) ◽  
pp. 1100-1105 ◽  
Author(s):  
Graziella Bonetti ◽  
Filippo Manelli ◽  
Andrea Patroni ◽  
Alessandra Bettinardi ◽  
Gianluca Borrelli ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Clinical Decision Making ◽  
Troponin I ◽  
Laboratory Data ◽  
High Sensitivity ◽  
Clinical Decision ◽  
International Normalized Ratio ◽  
Serum Glucose ◽  
Hospital Death ◽  
Laboratory Findings

AbstractBackgroundComprehensive information has been published on laboratory tests which may predict worse outcome in Asian populations with coronavirus disease 2019 (COVID-19). The aim of this study is to describe laboratory findings in a group of Italian COVID-19 patients in the area of Valcamonica, and correlate abnormalities with disease severity.MethodsThe final study population consisted of 144 patients diagnosed with COVID-19 (70 who died during hospital stay and 74 who survived and could be discharged) between March 1 and 30, 2020, in Valcamonica Hospital. Demographical, clinical and laboratory data were collected upon hospital admission and were then correlated with outcome (i.e. in-hospital death vs. discharge).ResultsCompared to patients who could be finally discharged, those who died during hospital stay displayed significantly higher values of serum glucose, aspartate aminotransferase (AST), creatine kinase (CK), lactate dehydrogenase (LDH), urea, creatinine, high-sensitivity cardiac troponin I (hscTnI), prothrombin time/international normalized ratio (PT/INR), activated partial thromboplastin time (APTT), D-dimer, C reactive protein (CRP), ferritin and leukocytes (especially neutrophils), whilst values of albumin, hemoglobin and lymphocytes were significantly decreased. In multiple regression analysis, LDH, CRP, neutrophils, lymphocytes, albumin, APTT and age remained significant predictors of in-hospital death. A regression model incorporating these variables explained 80% of overall variance of in-hospital death.ConclusionsThe most important laboratory abnormalities described here in a subset of European COVID-19 patients residing in Valcamonica are highly predictive of in-hospital death and may be useful for guiding risk assessment and clinical decision-making.

scholarly journals An overlooked situation in the interpretation of serum thyroglobulin level in a papillary thyroid cancer patient

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Fevziye Burcu Sirin ◽  
Hakan Korkmaz
Keyword(s):  
Thyroid Cancer ◽  
Papillary Thyroid Cancer ◽  
Serum Sample ◽  
Imaging Techniques ◽  
Needle Aspiration ◽  
Papillary Thyroid ◽  
Serum Samples ◽  
Serum Thyroglobulin ◽  
Thyroid Cancer Patient ◽  
Serial Dilutions

AbstractIn the present study we report a case of thyroglobulin (TGB) measurement interference in a total thyroidectomized and radio-ablated 61-year old woman with papillary thyroid cancer. We investigated possible interference in the measurement of TGB due to discordant TGB in relation to clinical condition during the follow-up period. Serum TGB was measured with the chemiluminescence method using Beckman Coulter Unicel DxI 800 instrument. To investigate possible interference in TGB measurement serial dilutions, polyethylene glycol precipitation (PEG), treatment with heterophile blocking tube (HBT), rheumatoid factor level determination and retesting of TGB with an alternative method were performed. Serial dilutions of the serum sample revealed linearity but a remarkable decrease in TGB in the patient’s serum samples post PEG and post HBT treatments. Also, TGB results under functional sensitivity level obtained with a different method suggested that TGB interference developed due to heterophile antibody presence in the serum sample. The patient had unnecessarily undergone expensive imaging techniques, and invasive procedures such as lymph node fine needle aspiration biopsy, before the analytical interference was suspected by the clinician. This report illustrates the importance of early communication and close collaboration between clinicians and laboratorians in order to avoid unnecessary clinical intervention.

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