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 Chemjournal_title
Clinical chemistryauthors
Werner M,Faser C,Silverberg Msubject
Has Abstractpub_date
1993-11-01 00:00:00pages
2386-96issue
11 Pt 2eissn
0009-9147issn
1530-8561journal_volume
39pub_type
杂志文章,评审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
更新日期:2009-09-01 00:00:00
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:
更新日期:1987-06-01 00:00:00
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:
更新日期:1987-11-01 00:00:00
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:
更新日期:1986-06-01 00:00:00
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:
更新日期:1997-04-01 00:00:00
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:
更新日期:1994-02-01 00:00:00
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:
更新日期:1985-10-01 00:00:00
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:
更新日期:1977-01-01 00:00:00
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
更新日期:2007-03-01 00:00:00
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:
更新日期:1975-08-01 00:00:00
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:
更新日期:1979-01-01 00:00:00
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:
更新日期:1986-10-01 00:00:00
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:
更新日期:1996-01-01 00:00:00
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:
更新日期:1995-09-01 00:00:00
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:
更新日期:1990-03-01 00:00:00
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
更新日期:2015-01-01 00:00:00
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:
更新日期:1988-02-01 00:00:00
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:
更新日期:2000-12-01 00:00:00
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:
更新日期:1997-08-01 00:00:00
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:
更新日期:1989-08-01 00:00:00
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:
更新日期:1998-06-01 00:00:00
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:
更新日期:1983-03-01 00:00:00
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:
更新日期:1997-01-01 00:00:00
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:
更新日期:1989-09-01 00:00:00
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:
更新日期:1993-02-01 00:00:00
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
更新日期:2018-06-01 00:00:00
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
更新日期:2007-12-01 00:00:00
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
更新日期:2003-11-01 00:00:00
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:
更新日期:1992-08-01 00:00:00
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:
更新日期:1994-08-01 00:00:00