scholarly journals Clinical evaluation of the Triage analytic device for drugs-of-abuse testing

1996 ◽  
Vol 42 (9) ◽  
pp. 1433-1438 ◽  
Author(s):  
R de la Torre ◽  
A Domingo-Salvany ◽  
R Badia ◽  
G Gonzàlez ◽  
D McFarlane ◽  
...  
Keyword(s):  
Clinical Evaluation ◽  
Drugs Of Abuse ◽  
Clinical Situation ◽  
Drug Consumption ◽  
Gas Chromatography Mass Spectrometry ◽  
Fluorescence Polarization Immunoassay ◽  
Collection Site ◽  
Two Populations ◽  
Analytical Device

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 instrumented fluorescence polarization immunoassay (FPIA). Three groups of evaluators with different laboratory skills and two sets of urine samples from subjects with different rates of drug consumption prevalence were included in the study. Urines were analyzed by the Triage analytical device at the collection site. A second analysis was performed in a toxicology laboratory, and the results were compared with those obtained by FPIA. Nonconcordant results were confirmed by gas chromatography-mass spectrometry and HPLC. Results were independent of the laboratory skills of the evaluators. The agreement for each drug calculated for two populations with differences in prevalence of drug consumption was almost the same, except for benzodiazepines. No differences between Triage and FPIA results were observed for samples clearly over or under cutoff concentrations. Globally, the Triage device, in a clinical situation, demonstrated performance comparable with that of an instrument-based immunoassay and, in some cases (e.g., for benzodiazepines), the Triage performance was even better.

Enzyme immunoassay, kinetic microparticle immunoassay, radioimmunoassay, and fluorescence polarization immunoassay compared for drugs-of-abuse screening

1993 ◽  
Vol 39 (10) ◽  
pp. 2137-2146 ◽  
Author(s):  
D A Armbruster ◽  
R H Schwarzhoff ◽  
E C Hubster ◽  
M K Liserio
Keyword(s):  
Fluorescence Polarization ◽  
Drugs Of Abuse ◽  
High Volume ◽  
Gas Chromatography Mass Spectrometry ◽  
Fluorescence Polarization Immunoassay ◽  
Detection Rates ◽  
Degree Of Separation ◽  
Comparable Performance ◽  
Urine Testing ◽  
Speed Of Analysis

Abstract The newest formulation of the Syva EMIT assay for drugs of abuse, EMIT II, and a new immunoassay, OnLine (Roche), utilizing the kinetic interaction of microparticles in solution (KIMS) methodology, RIA tests, and TDx fluorescence polarization immunoassay (FPIA) procedures were compared for marijuana, cocaine, opiates, and barbiturates. Both EMIT II and OnLine immunoassays were performed with a Hitachi 717 analyzer. Calibration curves, the degree of separation between negative and cutoff calibrators, precision, likelihood of carryover from positive to negative samples, and overall ease and speed of analysis were evaluated. RIA and OnLine detected 99% of gas chromatography/mass spectrometry (GC/MS)-confirmed marijuana samples; TDx, 95%; and EMIT II, 88%. All four immunoassays detected approximately 99% of confirmed cocaine-positive urines. RIA, OnLine, and TDx all detected 100% of opiate-confirmed samples; EMIT II, 97%. Barbiturate assays exhibited the greatest disparity, with OnLine and TDx detecting 100% of confirmed positives; EMIT II, 88%; and RIA, 78%. For a variety of reasons, we prefer the fully automated EMIT II and OnLine assays for high-volume urine testing, in comparison with our laboratory's semiautomated RIA tests and the limited-throughput TDx system. The four immunoassays investigated delivered comparable performance in terms of detection rates for GC/MS-confirmed positives for some drugs but not for others.

Paepalanthus fabianeae (Eriocaulaceae): A New Microendemic Species from a Morphologically Coherent Clade

2020 ◽  
Vol 45 (4) ◽  
pp. 794-801
Author(s):  
Caroline Oliveira Andrino ◽  
Marcelo Fragomeni Simon ◽  
Jair Eustáquio Quintino Faria ◽  
André Luiz da Costa Moreira ◽  
Paulo Takeo Sano
Keyword(s):  
New Species ◽  
Iucn Red List ◽  
Phylogenetic Position ◽  
Similar Species ◽  
Infrageneric Classification ◽  
Espinhaço Range ◽  
Nuclear Its ◽  
Two Populations

Abstract—We describe and illustrate Paepalanthus fabianeae, a new species of Eriocaulaceae from the central portion of the Espinhaço Range in Minas Gerais, Brazil. Previous phylogenetic evidence based on analyses of nuclear (ITS and ETS) and plastid (trnL-trnF and psba-trnH) sequences revealed P. fabianeae as belonging to a strongly supported and morphologically coherent clade containing five other species, all of them microendemic, restricted to the Espinhaço range. Due to the infrageneric classification of Paepalanthus being highly artificial, we preferred not assigning P. fabianeae to any infrageneric group. Paepalanthus fabianeae is known from two populations growing in campos rupestres (highland rocky fields) in the meridional Espinhaço Range. The species is characterized by pseudodichotomously branched stems, small, linear, recurved, and reflexed leaves, urceolate capitula, and bifid stigmas. Illustrations, photos, the phylogenetic position, and a detailed description, as well as comments on habitat, morphology, and affinities with similar species are provided. The restricted area of occurrence allied with threats to the quality of the habitat, mainly due to quartzite mining, justifies the preliminary classification of the new species in the Critically Endangered (CR) category using the guidelines and criteria of the IUCN Red List.

scholarly journals Clinical evaluation of pulmonary hypertension using patient-reported outcomes: a cross-sectional study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Miguel Ángel Amor-García ◽  
Sara Ibáñez-García ◽  
Xandra García-González ◽  
Teresa Mombiela ◽  
Cristina Villanueva-Bueno ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Hypertension ◽  
Clinical Evaluation ◽  
Patient Reported Outcomes ◽  
Specific Treatment ◽  
Tertiary Hospital ◽  
Functional Class ◽  
Cross Sectional ◽  
Patient Reported

Abstract Background Patients with pulmonary hypertension (PH) have progressive and disabling symptoms, as well as a burden of treatments and a difficult clinical evaluation that make health-related quality of life a particularly relevant endpoint in this disease. The objective of the study was to evaluate patient-reported outcomes of patients receiving specific treatment for PH in a tertiary hospital using a specific questionnaire (Cambridge Pulmonary Hypertension Outcome Review-CAMPHOR) in the pharmacy consultation. Methods A cross-sectional, observational, descriptive study was conducted. It included all patients receiving specific treatment for PH in a tertiary hospital in Madrid, Spain. The inclusion period comprised between August to December 2019. CAMPHOR questionnaires containing three domains: symptoms, activities and quality of life were completed by the patients at the pharmacy consultation. Demographic and clinical variables, including WHO Functional Class (WHO FC), PH-specific tests and hemodynamic parameters, were recorded. Non-parametric analyses to assess relations between variables and CAMPHOR domains were performed. Results Thirty-six patients consented to participate in the study and completed the questionnaire. Median scores for symptoms, activities, and quality of life domains were 5.5 (2.5–10), 8.0 (4.5–10.5) and 3.5 (1–7.5), respectively. Statistically significant differences were found in the three domains when comparing by WHO FC, in the activities domain for 6-m walking test and in the quality of life domain for patients who had emergency visits or hospitalizations in the last year. Conclusions The CAMPHOR questionnaire could be useful as a complementary test to achieve an integrated evaluation of PH patients, who could complete it easily during their routine pharmacy visits.

scholarly journals Enhanced Neutralizing Antibody Response Induced by Respiratory Syncytial Virus Prefusion F Protein Expressed by a Vaccine Candidate

2015 ◽  
Vol 89 (18) ◽  
pp. 9499-9510 ◽  
Author(s):  
Bo Liang ◽  
Sonja Surman ◽  
Emerito Amaro-Carambot ◽  
Barbora Kabatova ◽  
Natalie Mackow ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
Clinical Evaluation ◽  
Genetic Stability ◽  
Vaccine Candidate ◽  
Early Passage ◽  
F Protein ◽  
Syncytial Virus ◽  
Human Parainfluenza Virus ◽  
Type 3

ABSTRACTRespiratory syncytial virus (RSV) and human parainfluenza virus type 3 (HPIV3) are the first and second leading viral agents of severe respiratory tract disease in infants and young children worldwide. Vaccines are not available, and an RSV vaccine is particularly needed. A live attenuated chimeric recombinant bovine/human PIV3 (rB/HPIV3) vector expressing the RSV fusion (F) glycoprotein from an added gene has been under development as a bivalent vaccine against RSV and HPIV3. Previous clinical evaluation of this vaccine candidate suggested that increased genetic stability and immunogenicity of the RSV F insert were needed. This was investigated in the present study. RSV F expression was enhanced 5-fold by codon optimization and by modifying the amino acid sequence to be identical to that of an early passage of the original clinical isolate. This conferred a hypofusogenic phenotype that presumably reflects the original isolate. We then compared vectors expressing stabilized prefusion and postfusion versions of RSV F. In a hamster model, prefusion F induced increased quantity and quality of RSV-neutralizing serum antibodies and increased protection against wild-type (wt) RSV challenge. In contrast, a vector expressing the postfusion F was less immunogenic and protective. The genetic stability of the RSV F insert was high and was not affected by enhanced expression or the prefusion or postfusion conformation of RSV F. These studies provide an improved version of the previously well-tolerated rB/HPIV3-RSV F vaccine candidate that induces a superior RSV-neutralizing serum antibody response.IMPORTANCERespiratory syncytial virus (RSV) and human parainfluenza virus type 3 (HPIV3) are two major causes of pediatric pneumonia and bronchiolitis. The rB/HPIV3 vector expressing RSV F protein is a candidate bivalent live vaccine against HPIV3 and RSV. Previous clinical evaluation indicated the need to increase the immunogenicity and genetic stability of the RSV F insert. Here, we increased RSV F expression by codon optimization and by modifying the RSV F amino acid sequence to conform to that of an early passage of the original isolate. This resulted in a hypofusogenic phenotype, which likely represents the original phenotype before adaptation to cell culture. We also included stabilized versions of prefusion and postfusion RSV F protein. Prefusion RSV F induced a larger quantity and higher quality of RSV-neutralizing serum antibodies and was highly protective. This provides an improved candidate for further clinical evaluation.

Assessing the quality of supervisors completed clinical evaluation reports

2008 ◽  
Vol 42 (8) ◽  
pp. 816-822 ◽  
Author(s):  
Nancy L Dudek ◽  
Meridith B Marks ◽  
Timothy J Wood ◽  
A Curtis Lee
Keyword(s):  
Clinical Evaluation

scholarly journals Improvement in staff compliance with a safety standard checklist in endoscopy in a tertiary centre

2018 ◽  
Vol 7 (3) ◽  
pp. e000294
Author(s):  
Matthew Charles Mason ◽  
Rebecca Katie Griggs ◽  
Rachel Withecombe ◽  
Eunice Yun Xing ◽  
Charlotte Sandberg ◽  
...  
Keyword(s):  
Clinical Situation ◽  
Invasive Procedures ◽  
Independent Observer ◽  
Safety Standards ◽  
Tertiary Centre ◽  
Time Out ◽  
Score Analysis ◽  
Ensure Patient Safety ◽  
Local Safety

National Health Service England published the National Safety Standards for Invasive Procedures (NatSSIP) in 2015. They mandated that individual trusts produce Local Safety Standards for Invasive Procedures (LocSSIPs), a set of safety standards drawn from the NatSSIP that apply to a particular clinical situation in a given department, for all invasive procedures.The project goal was to design and implement the LocSSIP within the endoscopy department. A draft LocSSIP was produced, and a pilot study conducted to gain initial feedback on its use. Version 1 of the checklist was produced and after approval, rolled out for use within the endoscopy department at ‘time out’ and ‘sign out’. A scoring system was developed that allowed the quality of the performance of LocSSIPs to be assessed and recorded as a ‘compliance score’.After 2 months, an independent observer spent a week assessing use of the checklist, recording completion and a compliance score. Analysis of this data led to a number of changes in performing the checklist, wider multidisciplinary team education and integration of the checklist into existing documentation, before reassessing at 12 months.In 2016, ‘time out’ checks were completed in 100% of cases, but full completion was only observed in 68%. ‘Sign out’ checks were completed in 91% of cases, with full completion in 71%. In 2017, ‘time out’ checks were completed in 100% of cases, with full completion in 85%. ‘Sign out’ checks were completed in 100% of cases, with full completion in 91%.The composite score for compliance in 2016 was 57% increasing to 90% in 2017.In conclusion, stronger departmental leadership, broadening education and integration of the checklist into routine documentation to reduce duplication led to significant improvements in compliance with use of the checklist. Ongoing education and assessment is imperative to ensure that compliance is maintained to ensure patient safety.

scholarly journals Investigation on heroin and cocaine quality in Luxembourg

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Adèle Bourmaud ◽  
Georges Dahm ◽  
François Meys ◽  
Nicolas Gengler ◽  
Alain Origer ◽  
...  
Keyword(s):  
Illicit Drugs ◽  
Statistical Evaluation ◽  
Drug Consumption ◽  
Local Market ◽  
Prevention Strategies ◽  
High Concentration ◽  
Concentration Changes ◽  
Harm Prevention ◽  
Local Levels

Abstract Background Heroin and cocaine are among the most dangerous illicit drugs available and their presence on the market is increasing. These facts have led to the investigation of the quality of heroin and cocaine samples seized in Luxembourg by police and customs but also collected at the national supervised drug consumption facilities. Methods Samples obtained from 2019 to 2020 were analyzed to determine their composition and content using GC–MS, HPLC-UV and LC-Q-ToF. The statistical evaluation of concentration changes depending on the source of collection is based on an ANOVA single factor test and a two-tailed t test. Results Results showed important differences between seizure and collection sources. For both drugs, customs samples had significantly higher concentrations than police samples and the latter had significantly higher concentrations than samples from drug consumption facilities, whereas for heroin two cutting steps were identified, for cocaine samples only one appears to occur on the local market. Indeed, cocaine samples seized by police consisted of a mixture of low and high concentration samples. Conclusion The results show that extensive adulteration with pharmacological active and inactive compounds takes place at local levels, which, however, are different for heroin and cocaine. This knowledge on variability of quality of drugs should be considered in the elaboration of drug and harm prevention strategies.

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