RESUMEN
Multiparametric toxicology research is mainly based on immunochromatography [IC] and chromatography methods. A new automated method using an immunoenzymatic (IE) assay based on a biochip array technology combines short turning around time and analytical performances close to chromatography in terms of positivity cut-off. The aim of our study was to compare IE versus IC and chromatography methods using urines samples from clinical cases. Seventy-two samples were analyzed by IC (amphetamines, opiates, benzodiazepines, THC, methadone, cocaine), IE and chromatography (previous classes plus opioids and cathinone). Immunochromatography results were read by at least 7 operators to assess reading subjectivity. Immunoenzymatic, IC, and chromatrography results were compared with each other. Chromatographic quantification was analyzed to understand discrepancies. Significant discrepancies (29-64%) were observed between IC and IE for most of the drug families investigated except for benzodiazepines, methadone and opiates. These discrepancies were not identified between IE and chromatography, except for some substances (28% to 67% discrepancies for buprenorphine, tramadol and oxycodone, 100% for cathinone). In contrast to IC, the performance of IE approached those of chromatography, except for some substances for which cross-reactions must be investigated. Reading discrepancies were frequent with IC (33% of samples) and made robust result output challenging. In conclusion, the Multistat® is an interesting method for first-line toxicological screening for laboratories without chromatography method.
La recherche des toxiques multiparamétrique repose principalement sur des méthodes immunochromatographie [IC] et de chromatographie (CL). Une nouvelle méthode automatisée immunoenzymatique (IE) (Multistat®) en biopuce, combine un rendu de résultats rapide et des performances analytiques, en termes de seuils de positivité, proche de la CL. L'objectif de notre étude a été de comparer l'IE à des méthodes d'IC et de CL sur des échantillons hospitaliers. Soixante-douze échantillons ont été analysés par IC (amphétamines, opiacés, benzodiazépines, THC, méthadone, cocaïne), IE et CL (classes précédentes plus opioïdes et dérivés de la cathinone). Les résultats d'IC étaient lus par au moins 7 personnes pour évaluer la subjectivité des lectures. Les résultats d'IE, d'IC et de CL étaient comparés entre eux. La quantification en CL était exploitée pour expliquer les discordances. Une forte proportion de discordances (de 29 à 64 %) était observée entre IC et IE sur la plupart des toxiques explorées sauf pour les benzodiazépines, la méthadone et les opiacés. Ces discordances n'étaient pas retrouvées entre IE et CL, hormis pour certaines substances (28 % à 67 % de divergences pour buprénorphine, tramadol et oxycodone, 100 % pour les dérivés de la cathinone). À l'inverse de l'IC, les performances de l'IE se rapprochaient de celles de la CL, sauf pour certaines substances pour lesquelles des réactions croisées doivent être recherchées. Les discordances de lecture étaient fréquentes en IC et rendent difficile un rendu de résultat robuste. En conclusion, le Multistat® est une méthode intéressante pour un criblage en première intention pour les laboratoires sans CL.
Asunto(s)
Analgésicos Opioides , Alcaloides Opiáceos , Benzodiazepinas , Cromatografía de Afinidad , Cromatografía Liquida/métodos , Humanos , Espectrometría de Masas/métodos , MetadonaRESUMEN
BACKGROUND: Telephone consultations in general practice are on the increase. However, data on their efficiency in terms of out-of-hours general practitioner (GP) workload, visits to hospital emergency departments (ED), cost, patient safety and satisfaction are relatively scant. The aim of this trial is to assess the effectiveness of telephone consultations provided by French emergency call centres in patients presenting with isolated fever or symptoms of gastroenteritis, mainly encountered diseases. METHODS/DESIGN: This is a prospective, open-label, multicentre, pragmatic, cluster randomised clinical trial of an estimated 2880 patients making an out-of-hours call to one of six French emergency call centres for assistance with either fever or symptoms of gastroenteritis without seriousness criteria. Each call is handled by a call centre physician. Out-of-hours is 8 p.m. to 7.59 a.m. on weekdays, 1 p.m. to 7.59 a.m. on Saturdays and round-the-clock on Sundays and school holidays. Patients will be enrolled over 1 year. In the intervention arm, a telephone consultation based on a protocol, the formal Telephone Medical Advice (fTMA), is offered to each patient calling. This protocol aims to overcome a physical consultation during out-of-hours periods. It offers reassurance and explanations, advice on therapeutic management which may include, in addition to hygiene and diet measures, a telephone prescription of antipyretic, analgesic, rehydration medication or others, and recommendations on surveillance of the patient and any action to be taken. The patient is invited to call again if the condition worsens or new symptoms develop and to make an appointment with their family GP during office hours. In the control arm, the call centre physician handles calls as usual. This physician can carry out a telephone consultation with or without a telephone prescription, dispatch an on-duty GP, the fire brigade or an ambulance to the patient, or refer the patient to an on-duty physician or to the ED. Each patient will receive a follow-up call on day 15. The primary endpoint is the frequency of out-of-hours, face-to-face GP consultations or visits to the ED during the 15 days following the index call. The secondary endpoints measured on day 15 are the number of stays in intensive care, the number of hospital admissions, the number of interventions by the fire brigade, emergency medical and ambulance services, the number and length of prescribed sick-leave episodes, all-cause mortality, morbidity, clinical outcome, patient compliance, patient satisfaction, the number of renewed calls to the call centre, the number of patients receiving multiple face-to-face GP consultations and costs incurred. DISCUSSION: This trial will assess the effectiveness and the cost-effectiveness of a formalised response to calls for assistance with fever or symptoms of gastroenteritis without seriousness criteria. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02286245 , registered on 9 September 2014.
