bluuebunny/crossref_metadata_2025_split huggingface dataset:
Exhaled human breath measurement method for assessing exposure to halogenated volatile organic compounds
Authors: Pleil Joachim D , Lindstrom Andrew B 
Published: January 2020

AbstractThe organic constituents of exhaled human breath are representative of blood-borne concentrations through gas exchange in the blood/breath interface in the lungs. The presence of specific compounds can be an indicator of recent exposure or represent a biological response of the subject. For volatile organic compounds (VOCs), sampling and analysis of breath is preferred to direct measurement from blood samples because breath collection is noninvasive, potentially infectious waste is avoided, and the measurement of gas-phase analytes is much simpler in a gas matrix rather than in a complex biological tissue such as blood. To exploit these advantages, we have developed the “single breath canister” (SBC) technique, a simple direct collection method for individual alveolar breath samples, and adapted conventional gas chromatography–mass spectrometry analytical methods for trace-concentration VOC analysis. The focus of this paper is to describe briefly the techniques for making VOC measurements in breath, to present some specific applications for which these methods are relevant, and to demonstrate how to estimate exposure to example VOCs on the basis of breath elimination. We present data from three different exposure scenarios: (a) vinyl chloride and cis-1,2-dichloroethene from showering with contaminated water from a private well, (b) chloroform and bromodichloromethane from high-intensity swimming in chlorinated pool water, and (c) trichloroethene from a controlled exposure chamber experiment. In all cases, for all subjects, the experiment is the same: preexposure breath measurement, exposure to halogenated VOC, and a postexposure time-dependent series of breath measurements. Data are presented only to demonstrate the use of the method and how to interpret the analytical results.
Diagnosis of Duchenne/Becker muscular dystrophy and quantitative identification of carrier status by use of entangled solution capillary electrophoresis
Authors: Fortina Paolo , Cheng Jing , Shoffner Mann A , Surrey Saul , Hitchcock Wendy M , Kricka Larry J , Wilding Peter 
Published: January 2020

Abstract
Use of capillary electrophoresis, a new and useful analytical tool, offers a variety of advantages for nucleic acid analyses, including rapid analysis, automation, high resolution, qualitative and quantitative results, and low consumption of both sample and reagents. We report the first example of the use of entangled solution capillary electrophoresis (ESCE) and laser-induced fluorescence detection (LIF) for separation-based diagnostics in the quantitative analysis of multiplex PCR products for determination of carrier status of Duchenne/Becker muscular dystrophy (DMD/BMD). This ap-proach greatly improved the speed, resolution, and sensitivity of information needed for the diagnosis of DMD/BMD compared with that from conventional diagnostic methods, and is of general utility for diagnosis of genetic diseases.
Measurement of antibodies against glutamic acid decarboxylase 65 (GADA): two new 125I assays compared with [35S]GAD 65-ligand binding assay
Authors: Borg Henrik , Fernlund Per , Sundkvist Göran 
Published: January 2020

AbstractRecently, 65-kDa glutamic acid decarboxylase (GAD 65) antibodies (GADA) have been introduced as autoimmune markers in blood to confirm the diagnosis of insulin-dependent diabetes mellitus (IDDM). In this study, to evaluate two new assays that use 125I-labeled GAD 65, we assayed samples from 100 children with recent onset of diabetes and 100 control children; the results were compared with those of a [35S]GADA assay and with results for islet cell antibodies (ICA), the conventional autoimmune marker. Receiver operating characteristic (ROC) curve analysis showed one of the new assays (from RSR) to be more sensitive (P = 0.01) than the comparison ([35S]GADA) assay, whereas the second new assay (from Elias) was less sensitive (P &lt;0.001). The GADA frequency at 97.5% specificity was greatest in the comparison assay: 63 of 100 vs 41 of 100 (P &lt; 0.01) and 53 of 100 (P = 0.16) in the RSR and Elias assays, respectively. Almost all GADA-positive patients had ICA, but one-third of the ICA-positive patients was GADA-negative. Accordingly, adding GADA analysis results to ICA testing increased the frequency of detection of autoimmune markers only slightly (from 81% to 85%). In conclusion, at 97.5% specificity the [35S]GADA assay seemed to be more efficient than the 125I assays, although the difference was significant only for the Elias 125I assay. Antigen-specific antibodies other than GADA may explain the difference in GADA and ICA frequencies.
Calculation of LDL-cholesterol by using apolipoprotein B for classification of nonchylomicronemic dyslipemia
Authors: Planella Teresa , Cortés Mariano , Martínez-Brú Cecília , González-Sastre Francesc , Ordóñez-Llanos Jordi 
Published: January 2020

Abstract
In this paper we propose a calculation of LDL-cholesterol (LDL-C) not affected by hypertriglyceridemia by using lipid quantities directly measured in total serum. We also propose an algorithm for the classification of nonchylomicronemic dyslipemias. Plasma apolipoproteins (apo) A-I, B, total cholesterol (TC), triglycerides (TG), and cholesterol of lipoproteins were measured in a group of 38 normolipemic and 120 dyslipemic patients (42 phenotype IIa, 38 IIb, and 40 IV) classified according to TG and LDL-C values. Discriminant analysis was applied to obtain the best classification with the lowest number of quantities directly measured from total serum (TC, TG, and apo B), and multiple regression analysis was performed to find an equation to calculate LDL-C from these quantities. Apo B seems to be a useful discriminator between normolipemic and phenotype IIa patients, by using a cutoff value of 1.35 g/L obtained by ROC curve analysis. The proposed algorithm, based on lipid quantities measured by easily automated methods, is shown to be a good alternative for the classification of nonhyperchylomicronemic dyslipemia. LDL-C calculated from TC, TG, and apo B proved a better estimate of true LDL-C than the estimate obtained with Friedewald’s formula.
Evaluation of a rapid, new method for detecting serum IgG antibodies to Helicobacter pylori
Authors: Sharma Tarun K , Young Eugene L , Miller Sherry , Cutler Alan F 
Published: January 2020

Abstract
There is an increased need for rapid, inexpensive tests to diagnose Helicobacter pylori infection. Our objective was to determine the performance characteristics of an immunochromatographic test (ICT) for detection of anti-H. pylori IgG antibodies. A commercially available ICT kit (FlexSure® HP) was tested with a well-characterized cohort of banked sera as well as with fresh serum from randomly selected symptomatic patients. The ICT was evaluated with 107 stored sera and 96 prospective patients. The test correctly identified 65 of 68 H. pylori-infected and 37 of 39 noninfected stored sera and 54 of 57 infected and 30 of 39 noninfected patients. Sensitivity, specificity, and positive and negative predictive values were 96%, 95%, 97%, and 93% in stored serum and 95%, 77%, 86%, and 91% in fresh serum, respectively. We concluded that the ICT, reported at 4 min, is highly sensitive for detecting anti-H. pylori IgG antibodies in human serum. With a high negative predictive value, the test may be used to exclude H. pylori infection in symptomatic patients.
Designing in quality through design control: a manufacturer’s perspective
Authors: Lasky Fred D , Boser Robert B 
Published: January 2020

Abstract
Quality by design is a comprehensive program that begins with understanding user needs and continues through (but does not end with) monitoring customer acceptance. Management tools and processes such as ISO 9000 standards and the Food and Drug Administration Quality System Regulations exist to guide medical device manufacturers in quality practices. The goal is to deliver products acceptable for their intended use. Quality control begins with defining attributes ranging from color to accuracy and precision. Failure mode and effects analysis and risk analysis consider both probability and severity of potential malfunctions and their effects on patients or operators. Tools used to implement design and production practices include Program Evaluation and Review Technique (PERT) charts and industry-conceived concepts, such as Six Sigma techniques. Their use varies with manufacturer, depending on product and customer needs and the manufacturer’s specific quality practices. Verification confirms that input goals are met. Then, validation assures that intended clinical needs are continually satisfied by establishing adequate production specifications. Conformance is monitored to verify that stable, consistent processes are in place, and precise user instructions enable the device to satisfy its intended use. Finally, complaint tracking can help assess whether needs have been met. Modifications in service, hardware, or instructions (including quality control) might be required. Therefore, both manufacturers and users work in partnership for continual improvement. The manufacturer’s knowledge of design, production, and service needs of its devices enable it to recommend appropriate quality-control protocols for clinical testing.
Quality systems for unit-use testing devices
Authors: Phillips David L 
Published: January 2020

Abstract
Unit-use testing or single-test-system analysis has existed for many years. Quality-control and quality-assurance procedures have generally used conventional methods and lyophilized or aqueous control materials. Because these materials were readily available and generally accepted, they became part of the quality-assurance program for many early unit-use test systems such as the DuPont aca®. Over the years, these control products became standard and are now required as part of good laboratory practice. Technically speaking, however, conventional quality-control methods and materials cannot completely control the test system when used in a unit-use or single-test-system device. When conventional control material is run on a unit-use single-test system, only that testing unit is checked. One cannot test every unit with control material because by definition these are single-test systems: Once the control has been run, the patient’s sample cannot be run. Conventional quality-assurance and quality-control methods do not, of themselves, assure quality. A one-size-fits-all, or “two levels per day of use” as outlined in the CLIA ’88 regulations, is not appropriate. The divergence between HCFA-approved practices and those of the deemed agencies, coupled with the financial aspects of this quality-control method, led to the formation of the Subcommittee on Unit Use Testing of the National Committee on Clinical Laboratory Standards to develop guidelines for manufacturers, users, and regulators to use in developing new quality systems.
Decision-making laboratory computer systems as essential tools for achievement of total quality
Authors: Blick Kenneth E 
Published: January 2020

Abstract
Areas other than the analytical process should be the focus of concern about quality issues in the laboratory because nearly 95% of errors occur at the nonanalytical front and back ends of the testing process. Until now, computer systems have been designed to handle the more predictable aspects of laboratory testing, necessitating that the infrequent and unpredictable data events be handled by manual systems. The manual systems are termed “workarounds” and indeed, because they occur sporadically, they are frequently not handled predictably. Here, I describe and give examples of an expert laboratory computer system that can be designed to handle both predictable and unpredictable data events without the use of manual workarounds. This expert system works in concert with a dynamic database allowing such data events to be detected in real time and handled predictably, thus providing a tool to address quality assurance issues throughout the testing process. The system performs up to 31 separate actions or tasks based on data events that in the past were handled by human workarounds.
Simultaneous identification and quantitation of codeine, morphine, hydrocodone, and hydromorphone in urine as trimethylsilyl and oxime derivatives by gas chromatography–mass spectrometry
Authors: Broussard Larry A , Presley Lance C , Pittman Thomas , Clouette Randy , Wimbish Gary H 
Published: January 2020

Abstract
Following enzymatic hydrolysis of urine, a gas chromatography–mass spectrometry method for the simultaneous determination of codeine, morphine, hydrocodone, and hydromorphone uses hydroxylamine to form oxime derivatives of the keto-opiates (i.e., hydrocodone, hydromorphone, oxycodone, and oxymorphone). These trimethylsilyl-derivatized forms no longer interfere with the detection and quantitation of codeine and morphine. Samples are extracted on solid-phase columns and quantitated by deuterated internal calibrations of each analyte with selected ion monitoring. Codeine, morphine, hydrocodone, and hydromorphone are completely separated, allowing simultaneous quantitation without interference and a chromatographic analysis time &lt;9 min.
Evaluation of selected-ion storage ion-trap mass spectrometry for detecting urinary anabolic agents
Authors: Bowers Larry D , Borts David J 
Published: January 2020

Abstract
Limits of detection are important issues for GC/MS screening for anabolic agents and for confirmation of various drugs of abuse. We compared a quadrupole ion trap (QIT) operated in two different selected-ion storage modes and a quadrupole mass filter (QMF) operated in the selected-ion monitoring mode. Results with the model compound tetrachlorobenzene indicate that, for simultaneous monitoring of more than four ions, the QIT operated in a frequency-modulated selected-ion storage mode has better limits of detection than the QMF. Use of a single-ion storage technique gave results similar to those of the QMF. We also evaluated both QIT selected-ion storage approaches for the limits of detection of the trimethylsilyl derivatives of four anabolic steroid metabolites and the β-agonist clenbuterol. We found no improvement in detection limits over that of a similar method with selected-ion monitoring and a QMF when four anabolic steroid metabolites and clenbuterol were extracted from a urine matrix. The lack of improvement in the limit of detection resulted from matrix background signals at masses similar to those of the steroids.
Semiautomated procedures for evaluation of carbohydrate-deficient transferrin in the diagnosis of alcohol abuse
Authors: Bean Pamela , Liegmann Karsten , Løvli Trond , Westby Christina , Sundrehagen Erling 
Published: January 2020

AbstractCarbohydrate-deficient transferrin (CDT) may now be the most valuable biological marker for diagnosis of alcohol abuse. We compared the diagnostic performance of two new CDT tests, Axis %CDT turbidimetric immunoassay (TIA) and Axis %CDT HPLC, against Specialty Laboratories’ isoelectric focusing/immunoblotting/laser densitometry (IEF/IB/LD). Both Axis tests include one-half the concentration of trisialotransferrin isoforms in their CDT quantitation schemes. Considering an alcohol abuse prevalence of 7%, Axis %CDT TIA shows a sensitivity of 87% at 98% specificity and a positive predictive value (PPV) of 0.75; %CDT HPLC shows a sensitivity of 87% at 100% specificity for a PPV of 1, and the IEF/IB/LD shows 81% sensitivity at 94% specificity for a PPV of 0.5. All three CDT tests show the same negative predictive value (0.98). Both Axis procedures perform better than IEF/IB/LD in the diagnosis of alcohol abuse; %CDT TIA is available in several semiautomated, cost-effective formats.
Apolipoprotein E genotyping by capillary electrophoretic analysis of restriction fragments
Authors: De Bellis Gianluca , Salani Giuliana , Panigone Silvia , Betti Ferruccio , Invernizzi Luigia , Luzzana Massimo 
Published: January 2020

AbstractWe present the genotyping of apolipoprotein (apo) E by means of restriction fragment analysis of amplified genomic DNA by high-performance capillary electrophoresis and a replaceable non-gel-sieving matrix. This procedure streamlines the genotyping of apo E in large-scale population studies because of the automation and speed of capillary electrophoresis.
Measurement of serum iohexol by determination of iodine with inductively coupled plasma–atomic emission spectroscopy
Authors: Braselton W Emmett , Stuart Kirk J , Kruger John M 
Published: January 2020

AbstractWe used inductively coupled plasma–atomic emission spectroscopy to measure serum iodine to determine plasma clearance of iohexol, an iodinated radiographic contrast agent. We determined I at 178.276 nm on the phosphorus 178.287 nm channel of the polychromator by utilization of spectrum shifter offset software, while correcting for P with the sequential P 214.914 nm emission line. Determination of I on the polychromator provided excellent precision in the measurement of serum I, even though the interelement correction of P was done with a sequential P line. Total imprecision (CV) (n = 13) was 16% (at 13.7 mg/L I), 8.6% (28.7 mg/L), 3.6% (59.0 mg/L), 2.6% (120.5 mg/L), 1.7% (237.8 mg/L), 1.2% (478.7 mg/L), and 1.8% (597 mg/L). The linear range was 15 to 600 mg/L. Iohexol added to serum (mg/L I) and recoveries (%) were 15 (91.3%), 30 (95.7%), 60 (98.3%), 120 (100.4%), 240 (99.1%), 480 (99.7%), and 600 (99.5%). Studies on dogs and cats administered a single intravenous injection of iohexol indicated that a dose of 300 mg I/kg body weight was sufficient for measurement of glomerular filtration rate by using a single compartment model for plasma clearance with three samples drawn 3 to 7 h after treatment. With this protocol, correlation coefficients were &gt;0.99 on the β phase of the plasma disappearance curve.
Prostate-specific antigen expression in a case of intracystic carcinoma of the breast: characterization of immunoreactive protein and literature surveys
Authors: Mannello Ferdinando , Sebastiani Maurizio , Amati Silvana , Gazzanelli Giancarlo 
Published: January 2020

Abstract
A case is presented of female breast intracystic carcinoma with prostate-specific antigen (PSA) expressed in high amounts in aspirated cystic fluid (55 μg/L). Tumor extract analysis revealed the presence of both estrogen and progesterone receptors (0.38 and 1.87 nmol/L, respectively) and high quantities of PSA too (19.52 μg/L). Chromatographic analysis of cystic fluid revealed two peaks of PSA, at the expected positions for free and bound serine protease. A major proportion of 33-kDa free form was also confirmed by Western blotting analysis. Free PSA was heat-stable at 56 °C and displayed no change after freezing–thawing. These findings are discussed in the context of a detailed literature survey. Our data support the contention that PSA immunoreactivity in intracystic fluid of breast carcinoma is partly the result of secretory activity by the neoplastic cells and that the steroid receptors can also modulate its expression.
Molecular biological xxxmethods in diagnosis and treatment of liver diseases
Authors: Worman Howard J 
Published: January 2020

AbstractMolecular biology is making a tremendous impact on the diagnosis and treatment of liver diseases. Methods such as the polymerase chain reaction are changing the way physicians diagnose and monitor patients with viral hepatitis. Assays based on recombinant protein antigens allow for detection of specific autoantibodies in diseases such as primary biliary cirrhosis. The diagnosis of inherited metabolic diseases, such as hemochromatosis and Wilson disease, is being revolutionized by discovery of the defective genes involved and the development of methods to rapidly sequence DNA and identify mutations. Treatments and preventive measures are now possible with use of drugs and vaccines produced by recombinant DNA technology. Gene therapy and nucleic acid-based therapeutics are also realistic future treatment options for individuals with liver diseases.
History of posttransfusion hepatitis
Authors: Tobler Leslie H , Busch Michael P 
Published: January 2020

AbstractThe risk of hepatitis virus transmission from transfusions has declined dramatically from that of the 1940s when posttransfusion hepatitis (PTH) was first appreciated. Introduction of hepatitis B surface antigen screening and conversion to volunteer donors for whole-blood donations in the late 1960s and early 1970s led to substantial reduction in PTH cases. However, up to 10% of the recipients continued to develop PTH, most cases of which were attributed to an unknown non-A, non-B viral agent. Implementation of surrogate marker testing (i.e., alanine aminotransferase and anti-hepatitis B virus core antigen) for residual non-A, non-B hepatitis in the late 1980s reduced the per unit risk of PTH from 1 in 200 to about 1 in 400. Hepatitis C virus was discovered in 1989 and quickly was established as the causative agent of &gt;90% of non-A, non-B PTH. Introduction of progressively improved antibody assays in the early 1990s reduced the risk of PTH due to hepatitis C virus to about 1 in 100 000. Although additional hepatitis viruses exist (e.g., hepatitis G virus), these appear to be minor contributors to clinical PTH, which has been virtually eradicated.
Hepatitis C—diagnosis and monitoring
Authors: Urdea Mickey S , Wuestehube Linda J , Laurenson Patricia M , Wilber Judith C 
Published: January 2020

Abstract
Cloning of the hepatitis C virus (HCV) genome was a tremendous advance in the development of tests for diagnosis and monitoring of HCV-infected patients. Serological tests, including enzyme-linked immunoassays and RIBATM strip immunoblot assays, are primarily used to screen blood donations and to diagnose and confirm HCV infection. Tests for HCV RNA, including polymerase chain reaction (PCR)-based assays and the branched-DNA (bDNA) assay, are used for therapeutic monitoring and prognostics. Here, we present the development and future potential of these diagnostic tests. We also provide examples of how these tests are used to follow the progression of disease, select and adjust treatment protocols, and evaluate the efficacy of therapeutic regimens.
International collaborative study to evaluate a recombinant L ferritin preparation as an International Standard
Authors: Thorpe Susan J , Walker Dawn , Arosio Paolo , Heath Alan , Cook James D , Worwood Mark 
Published: January 2020

AbstractA recombinant L ferritin preparation, lyophilized in ampoules and designated 94/572, was evaluated by 18 laboratories in 9 countries for its suitability as an International Standard (IS). The preparation was assayed in a wide range of in-house and commercial immunoassays against the 2nd IS for ferritin (of spleen origin; 80/578). The immunological reactivity of the recombinant material was similar to that of the 2nd IS for ferritin in the majority of assays and demonstrated adequate stability in accelerated degradation studies. On the basis of the results presented here, the WHO Expert Committee on Biological Standardization established 94/572 as the 3rd IS for ferritin, recombinant.