Evaluation of the AxSYM monoclonal cyclosporin assay and comparison with radioimmunoassay.


:Recently, a semiautomated fluorescence polarization immunoassay (FPIA) for determination of parent cyclosporin (CsA) has been developed for the Abbott AxSYM system. The new CsA assay measures the drug from an extracted whole blood specimen. The authors report here the evaluation of this new assay and the comparison with a previously validated radioimmunoassay (RIA) method (CYCLO-Trac SP). To assess the imprecision, the authors used tri-level controls supplied by both Abbott and Bio-Rad manufacturers. The within-run CV ranged from 4.4% to 7.3% and the between-day CV ranged from 4.4% to 7.6%. Mean recovery of the drug from clinical specimens spiked with kit calibrators was 108.4%. Fluorescence polarization immunoassay AxSYM (y) was correlated to RIA (x) by using 132 trough blood specimens (44 renal, 44 liver, and 44 heart) from transplant recipients and resulted in the following Passing-Bablok linear regression equation: y = 6.7 + 0.97x, r = 0.989, S(x/y) = 12.9. The percentage of overestimation (mean, range) by FPIA AxSYM versus RIA was (3.8%, range -17.7% to 39.1%). The results observed with this new method from follow-up studies in patients during the early course after transplant were not consistently higher than those obtained by RIA. These findings contrast with previously reported results that compared FPIA TDx assay with RIA. The authors conclude that FPIA AxSYM is a precise method for measuring CsA and offers results similar to those obtained by RIA with a marked reduction in assay time.


Ther Drug Monit


Sabaté I,Ginard M,González JM,Baró E,Acebes G,Cuadros J,Lirón FJ




Has Abstract


2000-08-01 00:00:00












  • Evaluation of caffeine as an in vivo probe for CYP1A2 using measurements in plasma, saliva, and urine.

    abstract::Twenty-five healthy volunteers were given 100 mg caffeine orally and several estimates of cytochrome P450 1A2 (CYP1A2) activity were evaluated. The validation was performed by correlation of different parameters in plasma, saliva, and urine to two measures of caffeine clearance, CL(oral) and CL(137X-->17X) that served...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Carrillo JA,Christensen M,Ramos SI,Alm C,Dahl ML,Benitez J,Bertilsson L

    更新日期:2000-08-01 00:00:00

  • Antiretrovirals: simultaneous determination of five protease inhibitors and three nonnucleoside transcriptase inhibitors in human plasma by a rapid high-performance liquid chromatography--mass spectrometry assay.

    abstract::An analytical technique using liquid chromatography (LC) coupled with electrospray-mass spectrometry (ESI--MS) has been developed for the simultaneous determination of five protease inhibitors (PIs): saquinavir, indinavir, ritonavir, nelfinavir, and amprenavir; and three non-nucleoside reverse transcriptase inhibitors...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Villani P,Feroggio M,Gianelli L,Bartoli A,Montagna M,Maserati R,Regazzi MB

    更新日期:2001-08-01 00:00:00

  • Poor performance of laboratories assaying newly developed antiretroviral agents: results for darunavir, etravirine, and raltegravir from the international quality control program for therapeutic drug monitoring of antiretroviral drugs in human plasma/seru

    abstract:BACKGROUND:The International Interlaboratory Quality Control PROGRAM for Therapeutic Drug Monitoring of Antiretroviral Drugs in Human Plasma/Serum was initiated in 1999. We have previously published our experience during the first 10 years of the PROGRAM. Since 2010, 3 newly developed antiretroviral agents have been ad...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Burger D,Krens S,Robijns K,Aarnoutse R,Brüggemann R,Touw D

    更新日期:2014-12-01 00:00:00

  • Immunoassays for Measuring Serum Concentrations of Monoclonal Antibodies and Anti-biopharmaceutical Antibodies in Patients.

    abstract::Monoclonal antibodies (mAbs) may be used as biopharmaceuticals to treat various diseases, ranging from oncology to inflammatory and cardiovascular affections. Trustworthy analytical methods are necessary to study their pharmacokinetics, both during their development and in post-marketing studies. Because biopharmaceut...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章,评审


    authors: Darrouzain F,Bian S,Desvignes C,Bris C,Watier H,Paintaud G,de Vries A

    更新日期:2017-08-01 00:00:00

  • Solid-phase extraction and high-performance liquid chromatography for therapeutic monitoring of haloperidol levels.

    abstract::This laboratory has developed a simple and efficient solid-phase extraction method that is combined with a high-performance liquid chromatographic method for rapid and precise therapeutic monitoring of haloperidol (Haldol) blood levels. The solid-phase extraction utilizes a mixed bed column. Sensitivity of the chromat...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Hoffman DW,Edkins RD

    更新日期:1994-10-01 00:00:00

  • Effect of plasma exchange on phenytoin plasma concentration.

    abstract::The effect of plasma exchange on the concentrations of total and unbound phenytoin (DPH) was determined in one normal subject and four patients undergoing therapeutic plasma exchange (PE). The average percentage of plasma exchanged ranged from 57 to 70% among the five patients studied. The reduction in DPH concentrati...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Silberstein LE,Shaw LM

    更新日期:1986-01-01 00:00:00

  • Monitoring of plasma methadone: intercorrelation between immunoassay and gas chromatography-mass spectrometry.

    abstract::Determination of plasma methadone is essential in connection with dose adjustments for patients participating in methadone maintenance programs. We successfully adapted the existing fluorescence polarization immunoassay (FPIA) kit intended for urinary methadone to plasma assays. A concentration interval of 50-900 ng/m...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Beck O,Boreus LO,Borg S,Jacobsson G,Lafolie P,Stensiö M

    更新日期:1990-09-01 00:00:00

  • Quantification of Delta9-tetrahydrocannabinol and its major metabolites in meconium by gas chromatographic-mass spectrometric assay: assay validation and preliminary results of the "meconium project".

    abstract::A rapid and simple procedure based on gas chromatography-mass spectrometry (GC-MS) is described for determination of Delta-tetrahydrocannabinol (THC), 11-hydroxy-Delta-tetrahydrocannabinol (THC-OH) and 11-nor-Delta-tetrahydrocannabinol-9-carboxylic acid (THC-COOH) in meconium using Delta-tetrahydrocannabinol (Delta-TH...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Marchei E,Pellegrini M,Pacifici R,Palmi I,Lozano J,García-Algar O,Pichini S

    更新日期:2006-10-01 00:00:00

  • Quality management and accreditation in a mixed research and clinical hair testing analytical laboratory setting-a review.

    abstract:BACKGROUND:Quality management and accreditation in the analytical laboratory setting are developing rapidly and becoming the standard worldwide. Quality management refers to all the activities used by organizations to ensure product or service consistency. Accreditation is a formal recognition by an authoritative regul...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Fulga N

    更新日期:2013-06-01 00:00:00

  • A novel system for the determination of antidepressant concentrations in human breast milk.

    abstract::The high incidence of psychiatric illness in the postpartum period and the increasing percentage of women who breastfeed has focused attention on the treatment of breastfeeding women with psychotropic medications and, additionally, the exposure of nursing infants to these medications. Consequently, there has been an i...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Hostetter AL,Stowe ZN,Cox M,Ritchie JC

    更新日期:2004-02-01 00:00:00

  • Digoxin and Phenytoin analyses as part of consultations in clinical pharmacology: a study on the use of drugs.

    abstract::The clinical use of digoxin and phenytoin analyses (in 405 and 152 patients, respectively) furnished by our clinical pharmacological laboratory during a five-month period was evaluated prospectively from request forms. Of first-time analyses of digoxin, 12, 38, and 50% fell above, within, and below our recommended ran...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Bergman U,Rane A,Sjöqvist F,Wiholm BE

    更新日期:1981-01-01 00:00:00

  • No pharmacokinetic but pharmacodynamic interactions between cisapride and bromperidol or haloperidol.

    abstract::Pharmacokinetic and pharmacodynamic interactions between the gastrokinetic drug cisapride and the antipsychotic drugs bromperidol and haloperidol were studied in 29 schizophrenic inpatients. Fourteen patients were taking bromperidol (12-24 mg/d), and 15 were taking haloperidol (12-36 mg/d). Cisapride 10 mg/d was coadm...

    journal_title:Therapeutic drug monitoring

    pub_type: 临床试验,杂志文章


    authors: Mihara K,Otani K,Yasui N,Ishida M,Kondo T,Suzuki A,Furukori H,Nagashima U,Kaneko S,Inoue Y

    更新日期:1999-06-01 00:00:00

  • Rifampicin markedly decreases plasma concentration and hypnotic effect of brotizolam.

    abstract::The purpose of the present study was to examine the effects of rifampicin on the single oral dose pharmacokinetics and pharmacodynamics of brotizolam. Thirteen healthy male volunteers received rifampicin 450 mg/day, or matched placebo, for 7 days in a double-blind randomized crossover manner. On the sixth day they rec...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章,随机对照试验


    authors: Ujiie Y,Fukasawa T,Yasui-Furukori N,Suzuki A,Tateishi T,Otani K

    更新日期:2006-06-01 00:00:00

  • Development of an Enzyme-Linked Immune Sorbent Assay to Measure Nivolumab and Pembrolizumab Serum Concentrations.

    abstract:BACKGROUND:Treatment with monoclonal antibodies (mAbs) against programmed cell death protein 1 receptor is subject to high variation in treatment outcome among cancer patients. For these agents, no exposure-response (ER) relationships have been investigated in routine health care settings. However, ER relationships hav...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Basak EA,Wijkhuijs AJM,Mathijssen RHJ,Koolen SLW,Schreurs MWJ

    更新日期:2018-10-01 00:00:00

  • Some international approaches to aminoglycoside monitoring in the extended dosing interval era.

    abstract::Aminoglycosides have rightly remained a cost-effective anti-microbial strategy for the treatment of gram-positive infections for some 25 years. However, in recent years there has been a review of the traditional thrice-daily administration regimen in favor of an extended dosing interval strategy that takes into accoun...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章,评审


    authors: Morris RG,Sallustio BC,Vinks AA,LeGatt DF,Verjee ZH,El Desoky E

    更新日期:1999-08-01 00:00:00

  • High-performance liquid chromatography method for analyzing citalopram and desmethylcitalopram from human serum.

    abstract::This report describes a sensitive and specific method for analyzing a serotonin reuptake blocker, citalopram, and its active metabolite, desmethylcitalopram, in human serum. For high-performance liquid chromatography (HPLC) analysis, samples and standards are prepared with ASPEC automatic sample preparator using 100 m...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Akerman KK,Jolkkonen J,Huttunen H,Penttilä I

    更新日期:1998-02-01 00:00:00

  • Accurately Achieving Target Busulfan Exposure in Children and Adolescents With Very Limited Sampling and the BestDose Software.

    abstract:BACKGROUND:Busulfan dose adjustment is routinely guided by plasma concentration monitoring using 4-9 blood samples per dose adjustment, but a pharmacometric Bayesian approach could reduce this sample burden. METHODS:The authors developed a nonparametric population model with Pmetrics. They used it to simulate optimal ...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Neely M,Philippe M,Rushing T,Fu X,van Guilder M,Bayard D,Schumitzky A,Bleyzac N,Goutelle S

    更新日期:2016-06-01 00:00:00

  • Acute tolerance to pressor effects of cocaine in humans.

    abstract::We have suggested previously that acute tolerance to the chronotropic effect of cocaine develops and that tolerance is incomplete, such that the heart-rate decline in the presence of stable plasma cocaine concentrations approaches a plateau that exceeds the baseline heart rate. One possible mechanism for heart-rate de...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Ambre JJ

    更新日期:1993-12-01 00:00:00

  • Current Practice for Therapeutic Drug Monitoring of Biopharmaceuticals in Inflammatory Bowel Disease.

    abstract::Since the late 90s, biopharmaceuticals targeting tumor necrosis factor alpha have revolutionized the treatment of moderately to severely active inflammatory bowel disease. The robust efficacy witnessed in many patients stands in stark contrast with the observation of a proportion of patients who fail to respond or who...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章,评审


    authors: Detrez I,Van Stappen T,Martín Arranz MD,Papamichael K,Gils A

    更新日期:2017-08-01 00:00:00

  • Haloperidol plasma level monitoring in pediatric patients.

    abstract::Plasma levels of haloperidol were monitored in children and teenagers suffering from psychotic episodes and/or abnormal movements (tics and Gilles de la Tourette's syndrome). Steady-state concentrations of haloperidol ranged from 0.7 to 19 ng/ml without any apparent relationship with the administered dose (15--285 mic...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Morselli PL,Bianchetti G,Durand G,Le Heuzey MF,Zarifian E,Dugas M

    更新日期:1979-01-01 00:00:00

  • A prospective evaluation of therapeutic drug monitoring.

    abstract::Since therapeutic drug monitoring is rapidly becoming a widely used tool in clinical medicine, we prospectively assessed 390 serum drug assays over a 4-week period to determine the appropriateness of serum sample collection. The results of appropriately collected samples were used to evaluate the ability of the physic...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Bussey HI,Hoffman EW

    更新日期:1983-01-01 00:00:00

  • Multicenter analytical evaluation of the automated electrochemiluminescence immunoassay for cyclosporine.

    abstract:BACKGROUND:Cyclosporine A (CsA) is used as a posttransplantation immunosuppressant drug, and careful monitoring of CsA concentration in whole blood is essential. A new automated electrochemiluminescence immunoassay (ECLIA) for CsA measurement has been assessed in a multicenter evaluation. METHODS:Residual EDTA whole b...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章,多中心研究


    authors: Vogeser M,Shipkova M,Rigo-Bonnin R,Wallemacq P,Orth M,Widmann M,Verstraete AG

    更新日期:2014-10-01 00:00:00

  • Maternal hair analysis for the detection of illicit drugs, medicines, and alcohol exposure during pregnancy.

    abstract:BACKGROUND/OBJECTIVES:Drug of abuse consumption throughout pregnancy is a serious public health problem and an important economic cost to the health system. The aim of this work was to compare maternal interview and hair analysis to determine drug consumption throughout pregnancy and to study relations among maternal i...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Lendoiro E,González-Colmenero E,Concheiro-Guisán A,de Castro A,Cruz A,López-Rivadulla M,Concheiro M

    更新日期:2013-06-01 00:00:00

  • Population Pharmacokinetic Analysis of Meropenem in Critically Ill Patients With Acute Kidney Injury Treated With Continuous Hemodiafiltration.

    abstract:BACKGROUND:The aim of this study was to conduct a population pharmacokinetic (PK) analysis of meropenem and to explore the optimal dosing strategy for meropenem in critically ill patients with acute kidney injury receiving treatment with continuous hemodiafiltration (CHDF). METHODS:Blood samples were obtained on days ...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Niibe Y,Suzuki T,Yamazaki S,Suzuki T,Takahashi N,Hattori N,Nakada TA,Oda S,Ishii I

    更新日期:2020-08-01 00:00:00

  • Plasma assay of salbutamol by means of high-performance liquid chromatography with amperometric determination using a loop column for injection of plasma extracts. Application to the evaluation of subcutaneous administration of salbutamol.

    abstract::An isocratic high-performance liquid chromatography method with amperometric detection for the assay of plasma salbutamol is described. The plasma extract is injected into the chromatographic system via a loop column. This insures the purification of the injected extracts and allows a simple and rapid liquid-solid ext...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Tamisier-Karolak L,Delhotal-Landes B,Jolliet-Riant P,Milliez J,Jannet D,Barre J,Flouvat B

    更新日期:1992-06-01 00:00:00

  • The aminoglycoside panel: a new approach to monitoring aminoglycoside therapy.

    abstract::The aminoglycoside antibiotics gentamicin and tobramycin have been monitored traditionally by measuring peak and trough drug levels in serum. We found interpretation of these data to be hazardous, due to variations in the drug administration-specimen collection process and routine medical events and practices. We desc...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Gorsky JE,Latts JR

    更新日期:1983-06-01 00:00:00

  • In vitro stability of cocaine in whole blood and plasma including ecgonine as a target analyte.

    abstract::The in vitro stability of cocaine (COC) was monitored in fresh whole blood and plasma stabilized with potassium fluoride (0.25%) for as long as 15 days. The samples were stored at 4 degreesC, 20 degreesC and 40 degreesC. Additionally, fresh plasma samples containing either benzoylecgonine (BZE), ecgonine methyl ester ...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Skopp G,Klingmann A,Pötsch L,Mattern R

    更新日期:2001-04-01 00:00:00

  • High single dose of mitoxantrone and cytarabine in acute non-lymphocytic leukemia: a pharmacokinetic and clinical study.

    abstract::In a phase I-II study, the authors evaluated the intracellular pharmacokinetics, toxicity, and efficiency of a high dose of mitoxantrone given as first induction in acute non-lymphocytic leukemia. Twenty-two patients with previously untreated de novo ANLL were included and received 30 or 40 mg/m2 mitoxantrone on day 1...

    journal_title:Therapeutic drug monitoring

    pub_type: 临床试验,杂志文章


    authors: Möllgård L,Tidefelt U,Sundman-Engberg B,Löfgren C,Lehman S,Paul C

    更新日期:1998-12-01 00:00:00

  • High-performance liquid chromatography of clomipramine and metabolites in human plasma and urine.

    abstract::An isocratic, high-performance liquid chromatography method has been developed for simultaneous determination of the tricyclic antidepressant clomipramine and six metabolites: desmethylclomipramine, 2- and 8-hydroxy-clomipramine, 2- and 8-hydroxydesmethylclomipramine and didesmethyl-clomipramine in plasma and urine. I...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Nielsen KK,Brøsen K

    更新日期:1993-04-01 00:00:00

  • Validation of an LC-MS/MS method to measure tacrolimus in rat kidney and liver tissue and its application to human kidney biopsies.

    abstract:BACKGROUND:Tacrolimus (TAC) has a narrow therapeutic index and high interindividual and intraindividual pharmacokinetic variability, necessitating therapeutic drug monitoring to individualize dosage. Recent evidence suggests that intragraft TAC concentrations may better predict transplant outcomes. This study aimed to ...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Noll BD,Coller JK,Somogyi AA,Morris RG,Russ GR,Hesselink DA,Van Gelder T,Sallustio BC

    更新日期:2013-10-01 00:00:00