Clinical utility and validation of emerging biochemical markers for mammary adenocarcinoma.

Abstract:

:The clinical utilities of the emerging biochemical markers for mammary adenocarcinoma CA 15-3, CA 549, CA M26, CA M29, and MCA (mucin-like carcinoma-associated antigen) were assessed by a formal rating according to six desirable marker characteristics. All five indicators similarly have good specificities but limited sensitivities. As a consequence, these markers mainly meet just two desirable criteria: their frequency and degree of expression reflect tumor burden and prognosis, and they may correlate with therapeutic results. The validation of these assay properties by clinical trials was evaluated by another rating system, designed to assess proband sample selection, restrictions on allowable observations, and choice of statistical descriptors. By these benchmarks, the estimates of the prior probabilities of test outcome (sensitivity and specificity) are reasonably definitive, but conclusive judgments about the posterior probabilities of test outcome ("predictive values") and about values and costs associated with testing are not possible. Three approaches to enhance the limited clinical utility of biochemical breast cancer markers are considered: shifts of the diagnostic decision threshold, marker panels, and sequential testing. However, none of these strategies improves the described performance characteristics.

journal_name

Clin Chem

journal_title

Clinical chemistry

authors

Werner M,Faser C,Silverberg M

subject

Has Abstract

pub_date

1993-11-01 00:00:00

pages

2386-96

issue

11 Pt 2

eissn

0009-9147

issn

1530-8561

journal_volume

39

pub_type

杂志文章,评审
  • RNA extraction from archival formalin-fixed paraffin-embedded tissue: a comparison of manual, semiautomated, and fully automated purification methods.

    abstract:BACKGROUND:Formalin-fixed paraffin-embedded (FFPE) tumor material represents a valuable resource for the analysis of RNA-based biomarkers, both in research laboratories and in routine clinical testing. A robust and automated RNA-extraction method with a high sample throughput is required. METHODS:We evaluated extracti...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2008.122572

    authors: Bohmann K,Hennig G,Rogel U,Poremba C,Mueller BM,Fritz P,Stoerkel S,Schaefer KL

    更新日期:2009-09-01 00:00:00

  • Improved interassay correlation of digoxin results in patients with and without renal failure by elimination of digoxin-like immunoreactive factors.

    abstract::Use of immunoassays that do not detect endogenous digoxin-like immunoreactive factors (DLIF) in serum significantly improves the between-assay correlation of digoxin results for patients. We investigated five different immunoassay methods (Abbott, Clinical Assays, Corning, Du Pont, and Syva), measuring digoxin by all ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Skogen WF,Rea MR,Valdes R Jr

    更新日期:1987-06-01 00:00:00

  • Production and certification of an enzyme reference material for gamma-glutamyltransferase (CRM 319). Part 2: Certification campaign.

    abstract::We describe the process of certification for a gamma-glutamyltransferase reference material (CRM no. 319). Fifteen laboratories participated to this interlaboratory evaluation. All steps of the measurements were controlled in an effort to locate potential sources of variations. In particular, the exclusion of some dat...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Schiele F,Muller J,Colinet E,Siest G

    更新日期:1987-11-01 00:00:00

  • Serum thyrotropin as measured with a one-step monoclonal-antibody radioimmunometric assay compared with two commercial radioimmunoassay kits.

    abstract::We compared results obtained with a commercial immunoradiometric assay kit for human thyrotropin in which monoclonal antibodies are used (Tandem -R TSH (ONE STEP) ImmunoRadioMetricAssay; Hybritech Inc.) with those obtained with two commercial radioimmunoassay methods: GAMMA-DAB [125I]HS-hTSH RIA (Clinical Assays) and ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Pekary AE,Hershman JM

    更新日期:1986-06-01 00:00:00

  • Quality-control (QC) performance measures and the QC planning process.

    abstract::Numerous outcome measures can be used to characterize and compare the performance of alternative quality-control (QC) strategies. The performance measure traditionally used in the QC planning process is the probability of rejecting an analytical run when a critical out-of-control error condition exists. Another perfor...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Parvin CA

    更新日期:1997-04-01 00:00:00

  • Role of serotonin in the pathophysiology of depression: focus on the serotonin transporter.

    abstract::Considerable evidence has accrued in the last two decades to support the hypothesis that alterations in serotonergic neuronal function in the central nervous system occur in patients with major depression. These findings include the following: (a) reduced cerebrospinal fluid (CSF) concentrations of 5-hydroxyindoleacet...

    journal_title:Clinical chemistry

    pub_type: 杂志文章,评审

    doi:

    authors: Owens MJ,Nemeroff CB

    更新日期:1994-02-01 00:00:00

  • Direct solid-phase time-resolved immunofluorometric assay of cortisol in serum.

    abstract::A dissociation-enhanced lanthanide fluoroimmunoassay of serum cortisol based on time-resolved fluorescence is described. The assay is a direct assay, where cortisol immobilized on the wall of a microtiter-strip well competes with cortisol in the sample for the europium-labeled polyclonal antibody. The amount of bound ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Eskola JU,Näntö V,Meurling L,Lövgren TN

    更新日期:1985-10-01 00:00:00

  • Plasma fibrinogen, cholinesterase activity, and anemia: utility of fibrinogen in multiphasic screening and in assessing the activity of diseases.

    abstract::I present the general pattern relationship between (a) plasma fibrinogen and cholinesterase activity and (b) plasma fibrinogen and hemoglobin, in 250 and 310 hospitalized adults, respectively. Although responses of cholinesterase were often unrelated to fibrinogen, when its activity in plasma was depressed, above-norm...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Rice EW

    更新日期:1977-01-01 00:00:00

  • High urinary concentrations of activin A in asphyxiated full-term newborns with moderate or severe hypoxic ischemic encephalopathy.

    abstract:BACKGROUND:Hypoxic ischemic encephalopathy (HIE) is a major cause of permanent neurological disabilities in full-term newborns. We measured activin A in urine collected immediately after birth in asphyxiated full-term newborns, and assessed the ability of the measurements to predict the occurrence of perinatal encephal...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2005.062604

    authors: Florio P,Luisi S,Moataza B,Torricelli M,Iman I,Hala M,Hanna A,Petraglia F,Gazzolo D

    更新日期:2007-03-01 00:00:00

  • Computerized multicuvette system for single substance and group analysis and for the chromatographic isolation and quantitation of compounds in complex mixtures.

    abstract::A new computer-interfaced system of general applicability in the clinical laboratory has been built. The system is constructed around a new type multicuvette. Quantitation is currently by spectrophotometry and is on-line, with use of a mini-computer with output going to an electrostatic printer/plotter. The system can...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Vestergaard P,Bachman A

    更新日期:1975-08-01 00:00:00

  • Gas-chromatographic determination of mephenytoin and desmethylmephenytoin, after off-column alkylation.

    abstract::We describe a gas-liquid chromatographic method for determining mephenytoin and its active metabolite, desmethylmephenytoin, in human serum. 5-Methyl-5-phenylhydantoin is used as the internal standard. The method involves extraction of the drugs by adsorption onto charcoal and off-column derivatization to their pentyl...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Raisys VA,Zebelman AM,MacMillan SF

    更新日期:1979-01-01 00:00:00

  • Abnormal composition of apoproteins C-I, C-II, and C-III in plasma and very-low-density lipoproteins of non-insulin-dependent diabetic Chinese.

    abstract::Apoprotein (apo) C-I, C-II, and C-III were measured in plasma from 35 white American non-diabetic subjects. The mean concentrations (mg/L) in plasma from normolipidemic and hypertriglyceridemic subjects, respectively, were apo C-I, 78 and 311; apo C-II, 37 and 200; and apo C-III, 98 and 529. These concentrations were ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Pan XR,Cheung MC,Walden CE,Hu SX,Bierman EL,Albers JJ

    更新日期:1986-10-01 00:00:00

  • Evaluation of clinical assays for measuring high-dose methotrexate in plasma.

    abstract::Four routine assays commonly used for monitoring plasma methotrexate (MTX) during high-dose therapy were validated by HPLC as the comparison method. MTX and its main metabolite, 7-hydroxymethotrexate (7-OHMTX), were analyzed by HPLC with postcolumn derivatization and fluorometric detection. About 200 clinical plasma s...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Albertioni F,Rask C,Eksborg S,Poulsen JH,Pettersson B,Beck O,Schroeder H,Peterson C

    更新日期:1996-01-01 00:00:00

  • Laboratory computing--process and information management supporting high-quality, cost-effective healthcare.

    abstract::One currently observes many healthcare institutions rushing to reengineer and install information systems with the expectation of achieving enhanced efficiency, competitiveness, and, it is hoped, higher patient satisfaction resulting from timely, high-quality care. Unfortunately, information system concepts, design, a...

    journal_title:Clinical chemistry

    pub_type: 杂志文章,评审

    doi:

    authors: Buffone GJ,Moreau DR

    更新日期:1995-09-01 00:00:00

  • Adjusted ionized calcium (at pH 7.4) and actual ionized calcium (at actual pH) in capillary blood compared for clinical evaluation of patients with disorders of calcium metabolism.

    abstract::We report results for adjusted ionized calcium (at pH 7.4) and actual ionized calcium (at actual pH) in capillary blood from 183 patients with disorders of calcium metabolism (primary hyperparathyroidism, secondary hyperparathyroidism of malabsorption, primary hypoparathyroidism, Paget's disease, acromegaly, hypercalc...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Thode J,Holmegaard SN,Transbøl I,Fogh-Andersen N,Siggaard-Andersen O

    更新日期:1990-03-01 00:00:00

  • Chromosomal instability in cell-free DNA is a serum biomarker for prostate cancer.

    abstract:BACKGROUND:Genomic instability resulting in copy number variation is a hallmark of malignant transformation and may be identified through massive parallel sequencing. Tumor-specific cell free DNA (cfDNA) present in serum and plasma provides a real-time, easily accessible surrogate. METHODS:DNA was extracted from serum...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2014.226571

    authors: Schütz E,Akbari MR,Beck J,Urnovitz H,Zhang WW,Bornemann-Kolatzki K,Mitchell WM,Nam RK,Narod SA

    更新日期:2015-01-01 00:00:00

  • Microassay for nuclear binding of steroid receptors with use of intact cells from small samples of avian and human tissue.

    abstract::A micro version of a nuclear binding assay to assess the biological activity of receptors for steroid hormones was developed for application to small (needle) biopsies of human tumors for the purpose of predicting responses to steroid therapy. This easier assay requires 10-fold less tissue than the original nuclear bi...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Colvard DS,Jankus WR,Berg NJ,Graham ML 2nd,Jiang NS,Ingle JN,Spelsberg TC

    更新日期:1988-02-01 00:00:00

  • Diagnosis and monitoring of hepatic injury. II. Recommendations for use of laboratory tests in screening, diagnosis, and monitoring.

    abstract:PURPOSE:To review information on the use of laboratory tests in screening, diagnosis, and monitoring of acute and chronic hepatic injury. DATA SOURCES AND STUDY SELECTION:A MEDLINE search was performed for key words related to hepatic diseases, including acute hepatitis, chronic hepatitis, alcoholic hepatitis, cirrhos...

    journal_title:Clinical chemistry

    pub_type: 杂志文章,评审

    doi:

    authors: Dufour DR,Lott JA,Nolte FS,Gretch DR,Koff RS,Seeff LB

    更新日期:2000-12-01 00:00:00

  • Type A viral hepatitis: epidemiology, diagnosis, and prevention.

    abstract::Hepatitis A virus (HAV) infection occurs worldwide and is an important cause of acute viral hepatitis in the US. In this review, I cover the epidemiology, course of infection, clinical manifestations, serological responses, and prevention of this infection. Although most patients completely recover from this disease, ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章,评审

    doi:

    authors: Lemon SM

    更新日期:1997-08-01 00:00:00

  • Quantification of urinary porphyrins by liquid chromatography after oxidation of porphyrinogens.

    abstract::A quantitative "high-performance" liquid-chromatographic method is described for determining porphyrins in human urine. Porphyrinogens in urine are first converted to the corresponding porphyrins by oxidation with iodine. Uroporphyrin, hepatacarboxylic acid porphyrin, hexacarboxylic acid porphyrin, pentacarboxylic aci...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Abe K,Konaka R

    更新日期:1989-08-01 00:00:00

  • Effect of serum-clot contact time on clinical chemistry laboratory results.

    abstract::The effect of serum-clot contact time on laboratory results was studied by dividing each blood specimen into four blood collection tubes. The control sera were separated from the clot within 30 min of the collection. The other tubes were incubated at 32 degrees C, and the sera were separated at 3, 6, and 24 h. The ser...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Zhang DJ,Elswick RK,Miller WG,Bailey JL

    更新日期:1998-06-01 00:00:00

  • Radioimmunometric assay for a monoclonal antibody-defined tumor marker, CA 19-9.

    abstract::We describe a solid-phase radioimmunometric sandwich assay for a new tumor marker defined by a monoclonal antibody (19-9). This antibody reacts with a carbohydrate antigenic determinant (CA 19-9) found at low concentrations in sera from healthy individuals but frequently increased in sera from patients with adenocarci...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Del Villano BC,Brennan S,Brock P,Bucher C,Liu V,McClure M,Rake B,Space S,Westrick B,Schoemaker H,Zurawski VR Jr

    更新日期:1983-03-01 00:00:00

  • Use of the laboratory in prediction of outcome in the high-risk newborn.

    abstract::This paper reviews our ability to predict survival and neurodevelopmental outcome in the newborn period. Traditionally, prognosis is based on individual risk factors or disease states. The laboratory plays an important role in diagnosing some of these. For example, prenatal and newborn screening are important in the d...

    journal_title:Clinical chemistry

    pub_type: 杂志文章,评审

    doi:

    authors: Synnes AR

    更新日期:1997-01-01 00:00:00

  • Multilayer fluorescent immunoassay technique.

    abstract::We describe a new multilayer immunoassay element for the determination of haptens in undiluted serum and plasma. Polysaccharide layers are coated onto a plastic base. The signal layer contains an immobilized antibody and a fluorescent-labeled hapten. A second layer, containing a pigment, acts as an optical screen. Sam...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Grenner G,Inbar S,Meneghini FA,Long EW,Yamartino EJ Jr,Bowen MS,Blackwood JJ,Padilla AJ,Maretsky D,Staedter M

    更新日期:1989-09-01 00:00:00

  • Modifying an enzyme immunoassay of immunoreactive trypsinogen to use time-resolved fluorescence.

    abstract::A coated microtiter-well, enzyme-linked immunometric assay for quantifying immunoreactive trypsinogen in dried blood spots was modified to use time-resolved fluorescence of europium in place of end-point enzymatic color development as the quantification step. The streptavidin-horseradish peroxidase and color developme...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Ryall RG,Gjerde EM,Gerace RL,Ranieri E

    更新日期:1993-02-01 00:00:00

  • Noninvasive Detection of Cocaine and Heroin Use with Single Fingerprints: Determination of an Environmental Cutoff.

    abstract:BACKGROUND:Recent publications have explored the possibility of using fingerprints to confirm drug use, but none has yet dealt with environmental contamination from fingertips. Here we explored the possibility of establishing an environmental cutoff for drug testing from a single fingerprint. METHODS:Fingerprint sampl...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2017.281469

    authors: Ismail M,Stevenson D,Costa C,Webb R,de Puit M,Bailey M

    更新日期:2018-06-01 00:00:00

  • Global sequencing approach for characterizing the molecular background of hereditary iron disorders.

    abstract:BACKGROUND:New genetic forms of hereditary hemochromatosis (HH) or hereditary hyperferritinemia (HF) have been identified over the last few years, and abnormalities of various genes may interact in a single patient. This study aimed to develop a rapid automated method for sequencing the main genes involved. METHODS:We...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2007.090605

    authors: Cunat S,Giansily-Blaizot M,Bismuth M,Blanc F,Dereure O,Larrey D,Quellec AL,Pouderoux P,Rose C,Raingeard I,Renard E,Schved JF,Aguilar-Martinez P,CHU Montpellier AOI 2004 Working Group.

    更新日期:2007-12-01 00:00:00

  • Improved HPLC method for carbohydrate-deficient transferrin in serum.

    abstract:BACKGROUND:There is need for a reference method for transferrin glycoforms in serum to which routine immunologic methods for the alcohol marker carbohydrate-deficient transferrin (CDT) can be traceable. We describe an improved HPLC method for transferrin glycoforms. METHODS:Transferrin was iron-saturated by mixing the...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2003.023341

    authors: Helander A,Husa A,Jeppsson JO

    更新日期:2003-11-01 00:00:00

  • Detection of alpha 1-antitrypsin Z and S mutations by polymerase chain reaction-mediated site-directed mutagenesis.

    abstract::alpha 1-Antitrypsin (A1AT) deficiency is a relatively common autosomal recessive disease, resulting most often from a single base pair (1 bp) substitution called the Z mutation. Previous genetic tests for carriers and affected patients have relied on quantitative binding of radioactive probes to an amplified gene prod...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Tazelaar JP,Friedman KJ,Kline RS,Guthrie ML,Farber RA

    更新日期:1992-08-01 00:00:00

  • Endotoxin binding to platelets in blood from patients with a sepsis syndrome.

    abstract::Endotoxin, the lipopolysaccharide cell wall constituent of Gram-negative bacteria, produces symptoms of the Gram-negative sepsis syndrome. By measuring endotoxin in blood from septic patients it may be possible to select a subpopulation of patients in which mortality can be prevented by treatment with anti-endotoxin a...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Salden HJ,Bas BM

    更新日期:1994-08-01 00:00:00