Abstract：
:To secure a successful product in today's era of cost containment, manufacturers and developers of new in vitro diagnostic technologies must consider payment issues--coverage and reimbursement by healthcare insurers--as critical market forces that must be addressed in the business plan. Similar to the regulatory hurdles involving 510(k)s and premarket applications, the requirements for payment are related to the unique features of the technology, its costs, and its effect on clinical outcomes. Because cost containment continues to be a driving force for change in healthcare, the business plan must not only include strategies for optimal payment at the product's introduction, but also contain provisions for continuous monitoring of the payment environment throughout the product's life cycle.
journal_name
Clin Chemjournal_title
Clinical chemistryauthors
Ivor LPsubject
Has Abstractpub_date
1996-09-01 00:00:00pages
1558-60issue
9eissn
0009-9147issn
1530-8561journal_volume
42pub_type
杂志文章abstract：:We present an improved fructosamine assay for use with the Technicon RA-1000 analyzer. Features of this assay include: specimen throughput of 100 per hour, within-batch CV of 1.5%, between-batch CV of 2.4%, standard curve linear up to 24.9 mmol of fructosamine per liter, and good correlation (r = 0.82) with hemoglobin...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1985-12-01 00:00:00
abstract：BACKGROUND:Pompe disease (PD) is the first lysosomal storage disorder to be added to the Recommended Uniform Screening Panel for newborn screening. This condition has a broad phenotypic spectrum, ranging from an infantile form (IOPD), with severe morbidity and mortality in infancy, to a late-onset form (LOPD) with vari...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2016.259036
更新日期：2017-04-01 00:00:00
abstract：:Single-strand conformation polymorphism (SSCP) analysis is widely used to prescreen mutations in p53 gene. However, standardization of SSCP to detect p53 mutations has rarely been pursued so far. We have developed complete conditions for a temperature-controlled nonradioactive SSCP for mutation detection in amplified ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1997-12-01 00:00:00
abstract：:We describe a new and specific method for measurement of lecithin palmitic acid in amniotic fluid. Dipalmitoyl lecithin, the major alveolar surfactant, has previously been estimated by measuring the lecithin-sphingomyelin ratio, total lecithin, total phospholipid phosphorus, and (or) total palmitic acid. Our method is...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1977-01-01 00:00:00
abstract：:Investigating the feasibility and validity of determining plasma ferritin concentration in blood obtained by finger prick, we studied 29 adults (ages 21-49 years) and 35 children (ages 14-66 months). Blood was sampled simultaneously in the same subject from both the antecubital vein (venous blood) and by finger pricki...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1983-05-01 00:00:00
abstract：:Patients' urines gave an unexpectedly high percentage of false-negative results for erythrocytes on a reagent strip, even when the test field for ascorbic acid indicated that none of this substance was present to inhibit the test reaction. By adding known amounts of erythrocytes to normal urines, we found that this ph...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1984-11-01 00:00:00
abstract：BACKGROUND:The goal of this study was to establish a plasma microRNA profile by use of next-generation sequencing that could aid in assessment of patient prognosis in nasopharyngeal carcinoma (NPC). METHODS:Two panels of NPC patients and healthy controls (HCs) were recruited for this study. We used deep sequencing to ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2013.214213
更新日期：2014-05-01 00:00:00
abstract：:Kappa Bence Jones proteinuria was found by immunoelectrophoretic techniques in a patient with plasma cell leukemia, who presented with no M-proteins either in serum or urine. However, a significant decrease in normal immunoglobulins was observed. On microscopic examination of kidney sections obtained a autopsy, protei...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1975-10-01 00:00:00
abstract：:Cardiac troponin I (cTnI) is a regulatory protein unique to myocardium. We used a cardiospecific 30-min ELISA to measure cTnI in EDTA-plasma samples serially drawn from 28 patients before and after coronary artery bypass grafting (CABG)--26 elective and 2 salvage cases. The cTnI increase in 22 of the elective CABG pat...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1994-11-01 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：:The S-peptide and S-protein fragments of ribonuclease S (RNase S, no EC no. assigned) have been immobilized onto separate Sepharose gels via a "leash" of polycytidylic acid substrate. Each of these gels releases its RNase fragment when treated with the complementary enzyme fragment or with RNase A (EC 3.1.27.5), and t...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1986-09-01 00:00:00
abstract：:To correct the results of a radioimmunoassay for beta-thyrotropin (TSH) subunit by eliminating the proportion ascribable to intact TSH, we have devised a method that experimentally reproduces the conditions under which the interference develops. Beta-TSH subunit was assayed in several preparations containing known con...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1987-05-01 00:00:00
abstract：BACKGROUND:Noninvasive prenatal diagnosis of monogenic disorders using maternal plasma and targeted massively parallel sequencing is being investigated actively. We previously demonstrated that comprehensive genetic diagnosis of a Duchenne muscular dystrophy (DMD) patient is feasible using a single targeted sequencing ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2014.236380
更新日期：2015-06-01 00:00:00
abstract：BACKGROUND:Rapid detection of biological threat agents is critical for timely therapeutic administration. Fluorogenic PCR provides a rapid, sensitive, and specific tool for molecular identification of these agents. We compared the performance of assays for 7 biological threat agents on the Idaho Technology, Inc. R.A.P....
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2005.052522
更新日期：2006-01-01 00:00:00
abstract：:We evaluated a new multiple-channel chemistry analyzer, the Boehringer Mannheim "Diagnostic M." This instrument can perform 25 tests at the rate of 120 1.3-mL serum samples per hour. The instrument may be run in either a profile mode or single-test mode. In the single-test mode only the necessary reagent is pumped. th...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1982-01-01 00:00:00
abstract：BACKGROUND:Few data compare cardiac troponin T (cTnT) and cardiac troponin I (cTnI) in a general population. We sought to evaluate the distribution and association between cTnT, cTnI, and cardiovascular risk factors in a large general population cohort. METHODS:High-sensitivity cTnT and cTnI were measured in serum fro...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2018.292086
更新日期：2018-11-01 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 compared relative increases in creatine kinase (EC 2.7.3.2) MB isoenzyme (CK-MB) after reperfusion in myocardial infarction for four popular methods: electrophoresis, immunoinhibition, the "Magic Lite" (Ciba-Corning) system, and the Stratus (Dade). In a method comparison study, we confirmed that all four methods co...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1990-08-01 00:00:00
abstract：:Glucose was measured by the ferricyanide, the Beckman glucose oxidase, and the hexokinase procedures in 228 plasma samples taken during standard oral glucose-tolerance tests in 17 normal subjects and in 21 chemical diabetics. The neocuproine method was also used to measure glucose concentration in 156 samples (78 befo...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1982-12-01 00:00:00
abstract：BACKGROUND:Clinical assessment of vitamin D status often relies on measuring total circulating 25-hydroxyvitamin D3 (25OHD3), but much of each vitamin D metabolite is bound to plasma vitamin D-binding protein (DBP), such that the percentage of free vitamin is very low. We hypothesized that measurement of free rather th...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2005.059568
更新日期：2006-02-01 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 compared three radioligands for use in a cytoplasmic estrogen-receptor assay, using pooled cytosol from human breast adenocarcinomas. The estrogen receptor content was determined in vitro by a dextran-coated charcoal method involving a 4-h incubation with and without diethylstilbestrol. Tritiated moxestrol failed t...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1982-03-01 00:00:00
abstract：:We detected increased concentrations of lipoperoxidation products, as malondialdehyde, in the serum of an infant with classic hemolytic-uremic syndrome. The concentrations declined when peritoneal dialysis was initiated and eventually returned to normal after clinical recovery. Our observation adds to the existing bod...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1988-11-01 00:00:00
abstract：:We compared cotinine, carboxyhemoglobin, and thiocyanate concentrations in blood sampled from 187 cigarette smokers and 181 non-smokers. All three differed significantly between smokers and non-smokers. Cotinine performed best as a test for assessing smoking status, with a sensitivity of 98% as compared with 94% for c...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1984-08-01 00:00:00
abstract：:We describe an enzyme-linked immunosorbent assay for determination of light-chain ratios for IgG, IgA, and IgM in serum. A commercial serum with known overall kappa and lambda concentrations was used as standard. To capture the respective immunoglobulins, we used antibodies to gamma, lambda and mu chains coated onto m...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1990-03-01 00:00:00
abstract：:The advent of hybridoma technology has provided the immunotechnologist a finely tunable instrument that should permit a marked advance in the immunologic sciences. The ability to choose the precise antibody required and the virtually unlimited availability of easily purified antibodies have already resulted in the sim...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1981-09-01 00:00:00
abstract：BACKGROUND:Detection of melanoma cells in circulation may be important in assessing tumor progression. The objective of this study was to develop a specific, reliable multimarker quantitative real-time reverse transcription-PCR (qRT) assay for detecting melanoma cells in patients' blood. METHODS:We developed qRT assay...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2004.045096
更新日期：2005-06-01 00:00:00
abstract：:The Dutch Foundation for Quality Assessment in Clinical Chemistry (SKZL) is the professional organization that conducts external quality-assessment schemes in The Netherlands. However, such schemes in fact assess the performance of the internal quality-control systems of the participating laboratories. In this paper w...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1991-07-01 00:00:00
abstract：BACKGROUND:Blockade of the renin-angiotensin system (RAS) represents a main strategy in the therapy of heart failure with reduced ejection fraction (HFrEF), but the role of active renin concentration (ARC) for guiding therapy in the presence of an RAS blockade remains to be established. This study assessed angiotensin ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2017.278705
更新日期：2018-03-01 00:00:00
abstract：:A potential genetic marker for hypertriglyceridemia and coronary disease, an apolipoprotein-CIII gene allele displaying a single nucleotide substitution, was found in 71% of Arabs with primary hypertriglyceridemia. Over 96% of the unrelated adults possessing this allele showed hypertriglyceridemia. The same allele was...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1989-02-01 00:00:00
