Abstract：
BACKGROUND:In recent years, a large number of studies have been published on the performance of glucose monitors. The quality of these reports is not known. METHODS:We searched the PubMed database for performance evaluations of handheld glucose monitors published from August 2002 to November 2006. Relevant articles were compared to 20 recommendations from the Standards for Reporting Diagnostic Accuracy (STARD) and 18 recommendations from the Clinical and Laboratory Standards Institute (CLSI). RESULTS:A total of 52 reports met our inclusion criteria and were reviewed. None (0%) of the reports conformed to all 38 STARD and CLSI recommendations. The range of compliance to these recommendations varied widely (median 53%; range 21%-84%). Only 1 study of the 52 reported following a CLSI recommendation for checking reference test results. Fewer than half (42%) of the reports contained STARD-recommended statements regarding how and when comparative measurements were performed. CONCLUSIONS:None of the glucose monitor reports from our review conformed to all STARD and CLSI recommendations. Our finding that the average rate of compliance to recommendations was low suggests that many of the researchers did not follow published recommendations for study design, methodology, and reporting and that study quality and conclusions may have been affected. Future studies evaluating the performance of glucose monitoring systems should be carefully designed and follow published recommendations for methodological and reporting quality.
journal_name
Clin Chemjournal_title
Clinical chemistryauthors
Mahoney J,Ellison Jdoi
10.1373/clinchem.2006.083493subject
Has Abstractpub_date
2007-06-01 00:00:00pages
1122-8issue
6eissn
0009-9147issn
1530-8561pii
clinchem.2006.083493journal_volume
53pub_type
杂志文章,评审abstract：BACKGROUND:The 2447 A > T pathogenic variation at codon 816 of exon 17 (D816V) in the KIT gene, occurring in systemic mastocytosis (SM), leads to constitutive activation of tyrosine kinase activity and confers resistance to the tyrosine kinase inhibitor imatinib mesylate. Thus detection of this variation in SM patients...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2006.068205
更新日期：2006-12-01 00:00:00
abstract：:An electrospray ionization-mass spectrometric procedure has been developed for determining glycohemoglobin. Whole-blood samples from 78 diabetic and 50 nondiabetic subjects (glycation range 3-15%, as determined by electrospray mass spectrometry) were diluted 500-fold in an acidic denaturing solvent and introduced dire...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1997-05-01 00:00:00
abstract：:We describe a rapid method for determining cholesterol sulfate in plasma and erythrocytes. After its single-step isolation by means of anion-exchange chromatography cholesterol sulfate is hydrolyzed, trimethylsilylated, and determined by gas chromatography with flame ionization detection. 5 beta-Cholestan-3 alpha-ol s...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1983-07-01 00:00:00
abstract：BACKGROUND:Emerging technologies for rapid identification of microbes demonstrate a shift from traditional biochemical and molecular testing algorithms toward methods using mass spectrometry (MS) for the semiquantitative analysis of microbial proteins and genetic elements. This study was performed to assess the diagnos...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2011.161968
更新日期：2011-07-01 00:00:00
abstract：:Abnormal creatine kinase (CK) isoenzyme patterns were observed in the serum of a 64-year-old woman with severe heart disease. Agarose electrophoresis revealed the presence of all the usual CK isoenzymes (MM, MB, and BB) plus an extra band between MM and MB. Total serum CK activity was within the normal range. Within 2...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1982-10-01 00:00:00
abstract：:We have separated serum proteins in only 15 min by high-performance liquid chromatography. The identification of several peaks in the chromatographic profile was greatly aided by the use of multiple-wavelength detection. We have found a good correlation between retention times and electrophoretic mobilities. Serum sam...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1980-09-01 00:00:00
abstract：:In this enzyme-linked immunoassay for human thyrotropin (TSH) in unextracted serum we use 96-well immunoenzymometric assay plates, first coated with polyclonal antibody to TSH, then incubated with the serum samples and reacted with mouse monoclonal antibody to human TSH. After incubation with alkaline phosphatase-labe...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1985-07-01 00:00:00
abstract：:The Axial Separation Module (ASM), which separates whole-blood specimens serially in Axial Process Containers (APC), was evaluated for clinical performance at the University of Virginia Health Sciences Center (UVA HSC) in a community-based outpatient laboratory (North Ridge Clinic). We hypothesized that moving the tas...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1997-02-01 00:00:00
abstract：:Creatine kinase (CK) isoenzymes MM, MB, and BB are located primarily in the cell cytosol, and increased CKMB in plasma is the hallmark of myocardial infarction. However, whether CK is released with reversible ischemic injury remains controversial. Here, we assessed plasma CK activity--cytosolic and mitochondrial CK--i...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1997-03-01 00:00:00
abstract：BACKGROUND:Cardiac troponins are specific biochemical markers of myocardial injury used in the diagnosis of acute myocardial disease and cardiac risk stratification. To avoid misclassification of patients, troponin assays must demonstrate precision at the low end of the measuring range. We report our evaluation of the ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2005.057216
更新日期：2006-02-01 00:00:00
abstract：:We modified the ISO-DALT two-dimensional gel electrophoresis system to allow the routine examination of serum specimens from patients with monoclonal gammopathies. This system, MC-Iso 1, is characterized by a broad pH gradient for resolving the basic immunoglobulin heavy and light chains. The increased resolution of b...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1982-04-01 00:00:00
abstract：:In the diagnosis of chronic (as opposed to acute) liver diseases, combinations of indicators are needed to improve specificity. Alanine aminopeptidase (AAP; microsomal aminopeptidase, EC 3.4.11.2) activity in serum reportedly is a very sensitive indicator of intrahepatic cholestasis and biliary obstruction; it is also...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1987-03-01 00:00:00
abstract：BACKGROUND:Cardiovascular mortality is markedly higher in Russia than in Western Europe and the US. Little is known about indicators of atherosclerotic risk in the Russian population. To our knowledge, this is the first study of apolipoprotein (apo) AI and B in Russia based on the WHO-IFCC standard. METHODS:We measure...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2003.023853
更新日期：2004-02-01 00:00:00
abstract：BACKGROUND:Institutions face increasing charges related to molecular genetic testing for neurological diseases. The literature contains little information on the utilization and performance of these tests. METHODS:A retrospective utilization review was performed to determine the diagnostic yield of neurogenetic tests ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2006.083360
更新日期：2007-06-01 00:00:00
abstract：:This HPLC/immunoassay procedure measures digoxin in serum with no interference from digoxin metabolites or digoxin-like factors. We used solid-phase (C18 and Diol) extraction, a C18 column with a tetrahydrofuran/water mobile phase, and final quantification by fluorescence polarization immunoassay. Deslanoside and gito...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1988-12-01 00:00:00
abstract：:Binary-system capillary electrophoresis (CE) with head-column field-amplified sample stacking permits determination of amiodarone and desethylamiodarone in 20-microL serum samples. The assay is characterized by a detection limit for both compounds of 80 nmol/L and by excellent linear response over the recommended ther...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1996-11-01 00:00:00
abstract：:We have modified an automated measurement system of urinary iodine (UI) and established a sensitive UI assay system by using ultraviolet (UV) digestion. The automated system is sensitive enough to detect concentrations of UI < 0.78 mumol/L (< 10 micrograms/dL) in a small volume of urine (500 microL). Sample throughput...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1995-04-01 00:00:00
abstract：:To establish optimum conditions for creatine kinase (EC 2.7.3.2) activity measurement with the creatine phosphate in equilibrium creatine reaction, we re-examined all kinetics factors relevant to an optimal and standardized enzyme assay at 30 and 25 degrees C. We determined the pH optimum in vaious buffers, considerin...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1976-05-01 00:00:00
abstract：BACKGROUND:Endothelin-1 (ET-1), a potent vasoconstrictor, is difficult to measure because of its instability and its binding to receptors and plasma proteins. We report a rapid, robust way to indirectly quantify ET-1 release by measuring the C-terminal ET-1 precursor fragment (CT-proET-1) without an extraction step. M...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2005.065581
更新日期：2006-06-01 00:00:00
abstract：:Like any other medical technology or intervention, diagnostic tests should be thoroughly evaluated before their introduction into daily practice. Increasingly, decision makers, physicians, and other users of diagnostic tests request more than simple measures of a test's analytical or technical performance and diagnost...
journal_title：Clinical chemistry
pub_type： 杂志文章,评审
doi：10.1373/clinchem.2012.182576
更新日期：2012-12-01 00:00:00
abstract：:We describe modifications to two cartridges, those for alkaline phosphatase and creatinine, on an 18-channel SMAC (Sequential Multichannel Analyzer Computerized), which allow all 18 tests to be run with a commonly prediluted sample. This decreases the required sample size and eliminates the problem of fibrin clots in ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1980-05-01 00:00:00
abstract：:We describe a sensitive method for the determination of vanadium in biological substances by atomic absorption spectroscopy. By using background correction and pyrolytically coated graphite tubes with flameless apparatus, this vanadium assay has a sensitivity of 65 pg and a detection limit of 30 pg, approximately sixf...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1982-01-01 00:00:00
abstract：:The serum pancreolauryl test has limited sensitivity for detecting mild pancreatic insufficiency. The aim of this study was to optimize the serum pancreolauryl test so as to increase the probability of positive results in patients with chronic pancreatitis. The study had three parts. First, the sampling time was optim...
journal_title：Clinical chemistry
pub_type： 临床试验,杂志文章
doi：
更新日期：1998-04-01 00:00:00
abstract：:The poly-T tract in intron 8 of the cystic fibrosis conductance transmembrane regulator (CFTR) gene exists in three variants, 5T, 7T, and 9T. The 7T and 9T variants generate a predominantly normal transcript, whereas the 5T variant engenders an anomalous product. The analysis of the poly-T tract is assuming increasing...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1998-05-01 00:00:00
abstract：:We have measured by reversed-phase HPLC concentrations of amino acids in plasma in groups of 80 normal appropriate-weight term babies fed from birth either a casein formula (WhiteCap SMA, n = 26), a whey formula (Gold Cap SMA, n = 26), or breast milk (n = 28). They were studied from day 11 to week 15 postpartum. The t...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1990-11-01 00:00:00
abstract：:We describe a procedure by which surfactant/albumin ratios in bronchoalveolar fluid (BALF) may be quantified with the Abbott Laboratories TDx fluorescence polarization analyzer and fetal lung maturity reagents. Adding albumin to BALF samples shifted the surfactant/albumin ratios to within the analytical range of the m...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1993-07-01 00:00:00
abstract：BACKGROUND:The European Atherosclerosis Society-European Federation of Clinical Chemistry and Laboratory Medicine Consensus Panel aims to provide recommendations to optimize atherogenic lipoprotein quantification for cardiovascular risk management. CONTENT:We critically examined LDL cholesterol, non-HDL cholesterol, a...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2018.287037
更新日期：2018-07-01 00:00:00
abstract：:We report the development and characterization of an IRMA for the direct measurement of nicked human chorionic gonadotropin (hCGn) in blood and urine. hCGn derived from a reference preparation of hCG used as an immunogen elicits monoclonal antibodies (mAbs) with enhanced recognition of human luteinizing hormone epitop...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1999-01-01 00:00:00
abstract：:This semi-automated colorimetric assay for the MB isoenzyme of creatine kinase (EC 2.7.3.2) is based on a monoclonal antibody ("Conan-MB") specific for this isoenzyme and is a modification of a previously published method (Vaidya et al., Clin Chem 1986;32:657-63). A 0.64-cm bead coated with 2 to 3 micrograms of antibo...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1988-03-01 00:00:00
abstract：:We compared results obtained with the Beckman Creatinine Analyzer (Beckman Instruments, Inc.) to those with the GEMSAEC Centrifugal Analyzer (Electro-Nucleonics, Inc.) and with a manual method for determination of creatinine in serum and urine. Linearity, stability, recovery, and precision were evaluated. Interference...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1979-06-01 00:00:00
