Abstract：
BACKGROUND:Clinical proteomics presents great promise in biology and medicine because of its potential for improving our understanding of diseases at the molecular level and for detecting disease-related biomarkers for diagnosis, prognosis, and prediction of therapeutic responses. To realize its full potential to improve clinical outcome for patients, proteomic studies have to be well designed, from biosample cohorts to data and statistical analyses. One key component in the biomarker development pipeline is the understanding of the regulatory science that evaluates diagnostic assay performance through rigorous analytical and clinical review criteria. CONTENT:The National Cancer Institute's Clinical Proteomic Technologies for Cancer (CPTC) initiative has proposed an intermediate preclinical "verification" step to close the gap between protein-based biomarker discovery and clinical qualification. In collaboration with the US Food and Drug Administration (FDA), the CPTC network investigators recently published 2 mock submission review documents, first-of-their-kind educational materials that may help the scientific community interested in developing products for the clinic in understanding the likely analytical evaluation requirements for multiplex protein technology-based diagnostic tests. CONCLUSIONS:Building on this momentum, the CPTC continues with this report its collaboration with the FDA, as well as its interactions with the AACC and the Centers for Medicare and Medicaid Services, to further the understanding of regulatory requirements for approving multiplex proteomic platform-based tests and analytically validating multiple analytes.
journal_name
Clin Chemjournal_title
Clinical chemistryauthors
Boja ES,Jortani SA,Ritchie J,Hoofnagle AN,Težak Ž,Mansfield E,Keller P,Rivers RC,Rahbar A,Anderson NL,Srinivas P,Rodriguez Hdoi
10.1373/clinchem.2010.156034subject
Has Abstractpub_date
2011-04-01 00:00:00pages
560-7issue
4eissn
0009-9147issn
1530-8561pii
clinchem.2010.156034journal_volume
57pub_type
杂志文章abstract：:We used ion-exchange column chromatography and electrophoresis on polyacrylamide gel to compare the acid phosphatase isoenzymes of prostate and leukocytes. The major isoenzyme of the prostate is band 2A; only a trace of band 2B was observed. However, the major isoenzymes of leukocytes are band 4 and band 2B, and only ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1979-07-01 00:00:00
abstract：BACKGROUND:Epidemiologists have observed that blood donation is associated with decreased risk of type 2 diabetes and cardiovascular disease. METHODS:We investigated the relationship between iron stores and insulin sensitivity, after controlling for known confounding factors, and compared insulin sensitivity between b...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2004.046847
更新日期：2005-07-01 00:00:00
abstract：:Numerous papers have been written to show which combinations of Shewhart-type quality-control charts are optimal for detecting systematic shifts in the mean response of a process, increases in the random error of a process, and linear drift effects in the mean response across the assay batch. One paper by Westgard et ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1993-08-01 00:00:00
abstract：:Using "high performance" liquid chromatography, we studied non-protein-bound fractions and total concentrations of 18 solutes accumulating in sera from a group of 12 patients who were undergoing chronic ambulatory peritoneal dialysis (CAPD) and in predialysis sera from a group of 15 hemodialysis (HD) patients. We moni...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1988-01-01 00:00:00
abstract：:We measured changes in concentrations of magnesium, zinc, calcium, potassium, cholesterol [total and high-density lipoproteins (HDL)], total creatine kinase (CK), and CK isoenzyme-MB in plasma (PI) and/or erythrocytes (Erc) from apparently healthy subjects and from patients with either pre-infarction syndrome (PIS) or...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1988-10-01 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：BACKGROUND:PCR-based detection of minimal residual disease (MRD) in neuroblastoma (NB) patients can be used for initial staging and monitoring therapy response in bone marrow (BM) and peripheral blood (PB). PHOX2B has been identified as a sensitive and specific MRD marker; however, its expression varies between tumors....
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2008.117945
更新日期：2009-07-01 00:00:00
abstract：BACKGROUND:Extracellular vesicles (EVs) contain a rich cargo of different RNA species with specialized functions and clinical applications. However, the landscape and characteristics of extracellular vesicle long RNA (exLR) in human blood remain largely unknown. METHODS:We presented an optimized strategy for exLR sequ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2018.301291
更新日期：2019-06-01 00:00:00
abstract：:The new oral formulation of cyclosporine (CsA), Neoral (CsA-N), results in increased area under the curve (AUC) and decreased intra- and interindividual variation in blood concentrations and other pharmacokinetic (PK) parameters when compared with the current Sand-immune (CsA-S) formulation. The present study examines...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1997-01-01 00:00:00
abstract：:The characteristics of the Abbott selective fluorescence polarization immunoassay for cyclosporine in whole blood (TDXSP) were compared with the Incstar radioimmunoassay by using kit standards (INCSP) or TDXSP standards (INCTDX) with samples from adult (48) and pediatric (24) liver-transplant recipients and a further ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1992-01-01 00:00:00
abstract：:We describe a micro-scale method for determining serum theophylline. The chromatography system includes a muBondapack C18 column and acetonitrile, 70 ml/liter of sodium acetate buffer (10 mmol/liter, ph 4.0) as the mobile phase. Test serum or plasma, 30 mul, is mixed with an equal quantity of a solution containing the...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1977-03-01 00:00:00
abstract：:We describe the development of a stable reference material for prostatic acid phosphatase, derived from human prostatic tissue and human seminal fluid. The enzyme was purified by an L-tartramic acid affinity-chromatography technique. Two-dimensional electrophoresis revealed essentially no contaminating proteins, and s...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1984-08-01 00:00:00
abstract：:A competitive solid-phase fluoroenzymeimmunoassay has been developed for rapidly measuring 5 beta-pregnane-3 alpha, 20 alpha-diol-3 alpha-glucuronide (Pd-3G) directly in diluted specimens of pre-breakfast urine. The assay involves use of an antiserum to Pd-3G and enzyme-labeled antigen prepared by chemically linking g...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1984-02-01 00:00:00
abstract：:We compared five ion-selective electrodes (ISEs; AVL 985S, Baxter Lytening 2Z, Beckman EL-ISE, Ciba-Corning 654 Na/K/Li, and Nova CRT 11) and a colorimetric method (Ektachem) for determination of lithium with flame atomic absorption and atomic emission spectroscopy. We evaluated precision, recovery, interference by dr...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1994-06-01 00:00:00
abstract：:We report a procedure for determining fecal long-chain fatty acids (LCFA), triglycerides, and cholesterol after detergent extraction with 10 mL/L Triton X-100, 6 mL/L Brij 30, and 0.1 mol/L HCl in isotonic saline by enzymatic analysis of the extraction supernates. Mean recoveries of calibrators ranged from 105% to 117...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1994-12-01 00:00:00
abstract：:The molar absorptivity of unconjugated bilirubin in caffeine reagent is independent of the protein matrix. This finding, together with the simplicity of a dilution step for direct spectrophotometry, will improve the calibration methods of bilirubin and make them more nearly accurate. This is encouraging for the develo...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1986-07-01 00:00:00
abstract：:A method is presented for the assay of delta-aminolaevulinate dehydratase (EC 4.2.1.24) to be performed on 10 microL of whole blood. Results compare favorably with those obtained with an accepted method (J. Clin. Chem. Clin. Bio-chem. 12: 389-390, 1974) that involves use of 200 microL of blood. ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1981-01-01 00:00:00
abstract：:We compare measurement of total fast hemoglobin (HbA1) by "high-performance" liquid chromatography and by electrophoresis on agar gel. Blood samples were obtained from a diverse population (n = 222): offspring of two diabetic parents, diabetic patients with and without retinopathy, diabetic and non-diabetic pregnant w...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1981-03-01 00:00:00
abstract：:In this automated apoenzyme reactivation immunoassay system (Ames Optimate) for thyroxin-binding globulin (TBG), the sample and N6-aminohexylflavin adenine dinucleotide-labeled TBG react sequentially with antiserum. Then apoglucose oxidase is added to combine with the free fraction and generate glucose oxidase activit...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1986-05-01 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：:17 alpha-Hydroxyprogesterone, cortisol, and 11-deoxycortisol were extracted with methylene chloride, separated by liquid chromatography, identified by their retention times, and quantitated by monitoring the absorbance at 254 nm. The method is specific and sensitive to as little as 2.5 ng of 17 alpha-hydroxyprogestero...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1981-07-01 00:00:00
abstract：BACKGROUND:Increased concentrations of cell-free DNA have been found in several disorders and have been interpreted as evidence of increased rates of cell death or turnover. Evidence from in vitro and animal experiments suggests that DNA may play a role in the pathogenesis of rheumatoid arthritis (RA). METHODS:We meas...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2006.084509
更新日期：2007-09-01 00:00:00
abstract：:We describe a simple method in which a water-soluble mixture of triocatanoin and a surfactant, "Triton X-114," are used in preparing solutions of triglycerides (triacylglycerols) in either human serum, solutions of albumin, or water. Analytical recovery added triglyceride was quantitative by two methods. The addition ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1976-08-01 00:00:00
abstract：BACKGROUND:Testing for troponin has important clinical value for patients who present with typical symptoms of acute coronary syndromes (ACS) such as chest pain (CP). Much less is known about the value of troponin testing for patients who present with other symptoms of ACS (anginal equivalent symptoms). METHODS:The ut...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2003.016311
更新日期：2004-01-01 00:00:00
abstract：:This article reviews key advances in ion-selective electrode technology that have made potentiometric measurements of ionized calcium (Ca2+) reliable and precise. Our use of two second-generation Ca2+ analyzers (Radiometer ICA1 and NOVA 8) made possible uninterrupted service as volume increased to 31 640 patient tests...
journal_title：Clinical chemistry
pub_type： 杂志文章,评审
doi：
更新日期：1986-08-01 00:00:00
abstract：BACKGROUND:We evaluated assays to measure both total tissue plasminogen activator (tPA) and the three principle forms of tPA in plasma: active tPA, tPA complexed with plasminogen activator inhibitor type 1 (PAI-1), and tPA complexed with C1-inhibitor. METHODS:Active tPA was measured by use of an indirect amidolytic as...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：2000-01-01 00:00:00
abstract：:In this method, leukocytes were isolated from 6 mL of EDTA-blood by density-gradient centrifugation and subsequently incubated with rhodamine isothiocyanate (RITC)-conjugated high-density lipoproteins (HDL). The receptor-bound conjugate particles were determined by fluorescent flow cytometry and compared with 125I-lab...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1987-12-01 00:00:00
abstract：:This one-dimensional thin-layer chromatographic method is used for assay of phospholipids in the gastric aspirate of newborns. The solvent mixture (chloroform/hexane/methanol/glacial acetic acid/water, 12/7/4/3/0.3 by vol) completely resolves lecithin, sphingomyelin, phosphatidylinositol, phosphatidylserine, phosphati...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1988-04-01 00:00:00
abstract：:Under the Clinical Laboratory Improvement Act of 1967 the Health Care Financing Administration's proficiency-testing requirement applies to approximately 12,000 hospital, reference, and large-clinic laboratories in the United States. The Wisconsin State Laboratory of Hygiene is approved by the Health Care Financing Ad...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1992-07-01 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
