Abstract：
BACKGROUND:External quality assurance (EQA) programs for diagnostic tests based on nucleic acid amplification have not been widely implemented in clinical laboratories and remain limited to few tests. Development of specific EQA programs based on application-based proficiency testing for any diagnostic molecular target is challenging. Development of EQA trials based on methodologic proficiency testing and directed to the evaluation of analytical aspects common to the majority of PCR-based tests may be valuable. METHODS:We developed an EQA program for evaluation of DNA extraction and amplification and analysis of products after PCR. Participants received a package containing primers and reference materials to evaluate three specific controls for, respectively, DNA extraction (quality and quantity), PCR performance (specificity and efficiency), and interpretation of results after electrophoresis. Each participant was asked to return to the organizers a form with their numerical results and an aliquot of all amplified samples for joint evaluation. RESULTS:Results varied in all phases of the experimental procedure: preamplification, amplification, and post-PCR interpretation. To give a general estimation on the quality of performances for each laboratory, we designed a score scheme in which the results of any specific action were evaluated on the basis of the distribution around the median consensus values. The maximum possible score was 84. On the basis of total score obtained by each laboratory, we created a qualitative ranking list that provided the final interpretation of results as excellent (>63 points; n = 4 laboratories), good (53-63 points; n = 13), sufficient (42-52 points; n = 15), poor (31-41 points; n = 3), and not acceptable (<31 points; n = 4). CONCLUSIONS:This survey demonstrates the importance of EQA trials based on methodologic proficiency testing directed to evaluation of analytical aspects common to the majority of PCR-based tests.
journal_name
Clin Chemjournal_title
Clinical chemistryauthors
Raggi CC,Pinzani P,Paradiso A,Pazzagli M,Orlando Cdoi
10.1373/49.5.782subject
Has Abstractpub_date
2003-05-01 00:00:00pages
782-91issue
5eissn
0009-9147issn
1530-8561journal_volume
49pub_type
杂志文章abstract：:Market forces have dramatically influenced the environment in which healthcare is delivered, but these changes do not need to be interpreted negatively by community laboratorians. Only total vertical integration of laboratory medicine can control episode-of-care cost. Opportunities also exist for horizontal integratio...
journal_title：Clinical chemistry
pub_type： 杂志文章,评审
doi：
更新日期：1996-05-01 00:00:00
abstract：:Comparison of two methods for determining a substance is a common procedure in clinical chemistry. Almost without exception, normal theory statistics are used with the tacit assumption that the data under test show gaussian distributions. Experience has led us to question this assumption for populations of differences...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1975-03-01 00:00:00
abstract：:This highly sensitive method for determining retinol-binding protein in human serum and urine is based on a double-antibody "sandwich"-type enzyme-linked immunosorbent assay. The assayable concentration range is 0.8-48 micrograms/L, the detection limit 0.2 micrograms/L. Within-assay coefficients of variation for 10 de...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1984-01-01 00:00:00
abstract：:We have developed a succinyldicholine-based assay for serum cholinesterase (EC 3.1.1.8) to help establish whether patients with suspected sensitivity to drugs of this type have enzyme abnormalities that cannot be detected by conventional laboratory techniques. Although the method discriminates between cholinesterase a...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1986-08-01 00:00:00
abstract：:Two patients with Paget's disease of bone were subjected to plasmapheresis. Alkaline phosphatase activities of serum declined sharply, but returned to preplasmapheresis values within eight to 10 days. The biological half-life of circulating skeletal alkaline phosphatase, as calculated from these experiments, is betwee...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1982-01-01 00:00:00
abstract：:We report results of a quality-control survey of radioimmunoassay (RIA) of eight analytes, participated in by 249 laboratories of various types throughout Japan. For the purpose of the external control survey, lyophilized specimens containing two different concentrations of each analyte were sent to the participating ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1983-08-01 00:00:00
abstract：:We describe a new method for quantitatively measuring substances of clinical interest by high-performance liquid affinity chromatography (HPLAC). As a model system we selected analysis for transferrin in human serum with immobilized antibodies in a high-performance liquid chromatographic system. SelectiSpher-10 Activa...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1988-10-01 00:00:00
abstract：:We describe a chromatographic system involving a high-performance chemically-bonded reverse-phase column and fluorescence detection for measurement of indoles in urine. We controlled retention and selectivity by optimizing the methanol content and pH of the mobile phase. Six reference indoles were separated in less th...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1976-02-01 00:00:00
abstract：BACKGROUND:Noninvasive prenatal testing (NIPT) uses cell-free DNA (cfDNA) as an analyte to detect copy-number alterations in the fetal genome. Because maternal and fetal cfDNA contributions are comingled, changes in the maternal genome can manifest as abnormal NIPT results. Circulating tumor DNA (ctDNA) present in case...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2017.277517
更新日期：2018-02-01 00:00:00
abstract：:Three different techniques of lipase (EC 3.1.1.3) determination (titrimetry, nephelometry, and enzyme immunoassay) were used to investigate an interesting effect of ionic strength on enzyme activity. Both activation in the presence of NaCl (140 mmol/L) and strong immunoinhibition were observed for lipase from plasma o...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1984-03-01 00:00:00
abstract：:o-Phthaldialdehdye reagent was used in assaying urea with a miniature centrifugal analyzer. Seventeen samples can be assayed kinetically in 2 min at a current cost of less than a penny per test. The reaction is initiated in the instrument upon simultaneous mixing of the o-phthaldialdehyde reagent containing 10 microli...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1978-12-01 00:00:00
abstract：BACKGROUND:TMPRSS2:ERG fusions are promising prostate cancer biomarkers. Because they can occur in multiple forms in a single cancer specimen, we developed a quantitative PCR test that detects both type III and type VI TMPRSS2:ERG fusions. The assay is quantified from a standard curve determined with a plasmid-cloned t...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2008.108845
更新日期：2008-12-01 00:00:00
abstract：:We present the results of measurements of alkaline phosphatase activity from interlaboratory transferability studies conducted by 12 laboratories in five countries. The variability, as demonstrated by within-day precision (CV less than or equal to 2.6%), between-day precision (CV less than or equal to 3.6%), and betwe...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1984-05-01 00:00:00
abstract：:Adrenocortical causes of hypertension are established by examining the mineralocorticoid hormones produced in the zona glomerulosa and zona fasciculata. In the zona glomerulosa, aldosterone excess leads to hypertension, hypokalemia, and suppressed plasma renin activity, with increased concentrations of urinary aldoste...
journal_title：Clinical chemistry
pub_type： 杂志文章,评审
doi：
更新日期：1991-10-01 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 analyzed pancreatic enzyme data from 508 patients with suspected pancreatitis by neural network analysis, by an Expert multirule generation protocol, and by receiver-operator characteristic (ROC) curve analysis of a single test result. Neural network analysis showed that use of lipase provided the best means for di...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1993-09-01 00:00:00
abstract：BACKGROUND:Galectin-3 has emerged as a potential useful novel biomarker for heart failure and cardiovascular disease (CVD). However, it remains unclear whether galectin-3 is associated with recurrent cardiovascular events during long-term follow-up of patients with stable coronary heart disease (CHD) after adjustment f...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2016.257550
更新日期：2016-10-01 00:00:00
abstract：:The isoenzymes of lactate dehydrogenase (EC 1.1.1.27) were separated with excellent resolution in less than 1 h by high-pressure anion-exchange chromatography. These isoenzymes were determined in some tissue extracts and high-activity serum samples by this technique. ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1976-04-01 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：BACKGROUND:We sought to develop a tandem mass spectrometry assay in which the enzymatic activities of 3 lysosomal enzymes (α-glucosidase, α-galactosidase A, and α-l-iduronidase) could be quantified in dried blood spots by using a single assay buffer. METHODS:A 3-mm dried blood spot punch was incubated in a single assa...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2010.152009
更新日期：2010-12-01 00:00:00
abstract：:Clottable fibrinogen in human plasma was determined by measuring spectrophotometrically the increase in turbidity with time due to the fibrinogen-fibrin conversion with thrombin. From the maximal absorbance, Amax, at 450 nm obtained 2 min or less after thrombin as added to plasma, we estimated the fibrinogen concentra...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1978-02-01 00:00:00
abstract：:We devised a method for assaying serum lactate dehydrogenase isoenzyme 1 (LD-1) activity specifically by preincubation with alpha-chymotrypsin and guanidine. Cleavage of phenylalanine bonds in the loop of A and B subunits of LD-3, LD-4, and LD-5 isoenzymes (residues 117-119) by incubation with alpha-chymotrypsin for a...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1992-11-01 00:00:00
abstract：:Based on the quantitative determination of creatinine, total protein, albumin, alpha 1-microglobulin, IgG, alpha 2-macroglobulin, and N-acetyl-beta, D-glucosaminidase in urine in combination with a test strip screening, the findings of hematuria, leukocyturia, and proteinuria can be assigned to prerenal, renal, or pos...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1996-08-01 00:00:00
abstract：:A radioimmunoassay for 1,25-dihydroxycholecalciferol which did not cross react with 1,25-dihydroxyergocalciferol is described. IgG fractions were prepared from the serum of rabbits that had been immunized with 1,25-dihydroxycholecalciferol-3-hemisuccinate coupled to bovine albumin. Radioligand binding by the IgG fract...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1981-03-01 00:00:00
abstract：BACKGROUND:Kallikrein-related peptidase 6 (KLK6), a member of the serine protease family of kallikrein (KLK) genes, is dysregulated in ovarian carcinomas (OCa) and its overexpression is associated with poor prognosis. Regulation of its expression is poorly understood and is likely to be influenced by multiple mechanism...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2012.193060
更新日期：2013-01-01 00:00:00
abstract：:Lyophilized serum specimens were manufactured in such a way that fixed quantitative interspecimen relationships were established. The specimens were analyzed for about twenty constituents by several thousand laboratories in 1971, 1972, and 1973. Most of the consensus mean values derived from these analyses were found ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1976-07-01 00:00:00
abstract：BACKGROUND:An assay using a mouse antisialyl Lewis X (sLeX) antibody (CSLEX-1) is used clinically for screening and monitoring patients with breast cancer in Japan. However, the IgM isoform of CSLEX-1 is not preferred for the assay because the bulkiness of IgM generally causes poor accessibility to the antigen. To solv...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2016.260968
更新日期：2016-11-01 00:00:00
abstract：BACKGROUND:Recent studies show that the haptoglobin phenotype in individuals with diabetes mellitus is an important factor for predicting the risk of myocardial infarction, cardiovascular death, and stroke. Current methods for haptoglobin phenotyping include PCR and gel electrophoresis. A need exists for a reliable met...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2015.244004
更新日期：2016-01-01 00:00:00
abstract：BACKGROUND:The management of critically ill infants and neonates includes frequent determination of arterial blood gas, electrolyte, and hematocrit values. An objective of attached point-of-care patient monitoring is to provide clinically relevant data without the adverse consequences associated with serial phlebotomy....
journal_title：Clinical chemistry
pub_type： 杂志文章,多中心研究
doi：
更新日期：2002-11-01 00:00:00
abstract：:In the present clinical evaluation of Triage immunoassay for detection of drugs of abuse, we examined a possible connection between the laboratory skills of the personnel using it and the quality of analytical results; we also evaluated the degree of concordance between the Triage results and those obtained by an inst...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1996-09-01 00:00:00
