Point-of-care test

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  • 文章类型: Randomized Controlled Trial
    背景:A组β-溶血性链球菌(GAS)引起的咽炎被视为喉咙痛抗生素的主要适应症。在初级保健环境中,处方率远高于GAS的患病率。国际准则中的建议差异很大。德国指南建议对Centor或McIsaac评分≥3的患者考虑使用抗生素,首选是青霉素V7天,并为所有人推荐镇痛药。我们调查了,如果本指南的实施降低了抗生素处方率,如果在评分≥3的患者中进行快速抗原检测链球菌试验(RADT),则会进一步降低该比率。
    方法:HALS是一项开放的务实平行组三臂整群随机对照试验。德国北部的初级保健实践被随机分为三组:指南(GL组),对于评分≥3(GL-RADT组)或常规治疗(UC组)采用RADT的改良指南.研究小组(外展访问)对所有实践进行了访问和指导,并根据其小组提供了材料。这些做法被要求招募11名连续≥2年的急性喉咙痛患者,并且至少受到中度损害。每位患者都进行了GAS的研究咽拭子。首次咨询时的抗生素处方率是主要结果。
    结果:从2010年10月到2012年3月,68名全科医生在61个实践中招募了520名患者,516可以分析主要终点。两组之间的抗生素处方率没有差异(p=0.162),并且比GAS率高约三倍:GL组97/187名患者(52%;GAS=16%),GL-RADT-组74/172(43%;GAS=16%)和UC-组68/157(43%;GAS=14%)。在GL-RADT组中,55%的患者得分≥3,而GL组为35%(p<0.001)。调整后,在GL-RADT组中,与GL组相比,获得抗生素的OR为0.23(p=0.010),尽管90例Strep试验阴性的患者中有35例在GL-RADT组中使用了抗生素。每次实践的处方率涵盖了所有组的0%至100%的全部范围。
    结论:实施指南中提出的分数似乎不适合降低喉咙痛的抗生素处方,但从业者对阴性RADT的更好依从性应导致处方减少。
    背景:DRKS00013018,回顾性注册28.11.2017。
    Pharyngitis due to Group A beta-hemolytic streptococci (GAS) is seen as the main indication for antibiotics for sore throat. In primary care settings prescription rates are much higher than the prevalence of GAS. Recommendations in international guidelines differ considerably. A German guideline suggested to consider antibiotics for patients with Centor or McIsaac scores ≥ 3, first choice being penicillin V for 7 days, and recommended analgesics for all. We investigated, if the implementation of this guideline lowers the antibiotic prescription rate, and if a rapid antigen detection strep-test (RADT) in patients with scores ≥ 3 lowers the rate further.
    HALS was an open pragmatic parallel group three-arm cluster-randomized controlled trial. Primary care practices in Northern Germany were randomized into three groups: Guideline (GL-group), modified guideline with a RADT for scores ≥ 3 (GL-RADT-group) or usual care (UC-group). All practices were visited and instructed by the study team (outreach visits) and supplied with material according to their group. The practices were asked to recruit 11 consecutive patients ≥ 2 years with an acute sore throat and being at least moderately impaired. A study throat swab for GAS was taken in every patient. The antibiotic prescription rate at the first consultation was the primary outcome.
    From October 2010 to March 2012, 68 general practitioners in 61 practices recruited 520 patients, 516 could be analyzed for the primary endpoint. Antibiotic prescription rates did not differ between groups (p = 0.162) and were about three times higher than the GAS rate: GL-group 97/187 patients (52%; GAS = 16%), GL-RADT-group 74/172 (43%; GAS = 16%) and UC-group 68/157 (43%; GAS = 14%). In the GL-RADT-group 55% of patients had scores ≥ 3 compared to 35% in GL-group (p < 0.001). After adjustment, in the GL-RADT-group the OR was 0.23 for getting an antibiotic compared to the GL-group (p = 0.010), even though 35 of 90 patients with a negative Strep-test got an antibiotic in the GL-RADT-group. The prescription rates per practice covered the full range from 0 to 100% in all groups.
    The scores proposed in the implemented guideline seem inappropriate to lower antibiotic prescriptions for sore throat, but better adherence of practitioners to negative RADTs should lead to fewer prescriptions.
    DRKS00013018, retrospectively registered 28.11.2017.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    BACKGROUND: A multitude of troponin assays for the point-of-care (POC) have been developed showing a lack of analytical sensitivity and precision. We present a new platform solution for the high-sensitivity detection of cardiac troponin T (cTnT) in a 30 μL whole blood sample with a turnaround time of 11 min.
    METHODS: The immunoassay was completely run in a ready-to-use plastic disposable, a centrifugal microfluidic disc with fully integrated reagents. After the sample application, the assay was automatically processed by separating the cellular blood components via centrifugation, followed by incubation of a defined volume from the generated plasma with the immunoreagents. The fluorescence in the signal zone of a membrane was measured after its washing for the cTnT quantitation.
    RESULTS: A calibration curve, measured in whole blood samples spiked with native human cTnT, was generated covering a range up to a concentration of approximately 8300 ng/L. The lower detection limit was determined to be 3.0 ng/L. At a concentration of 14 ng/L, the 99th percentile value from the high-sensitivity cardiac troponin T (hs-cTnT) assay in the Elecsys® system, the imprecision (CV) was 3.8%. A CV profile indicated that the functional sensitivity for a CV <10% was 6.8 ng/L. The assay did not show any significant cross-reaction with human skeletal troponin T. We observed an excellent correlation with the hs-TnT Elecsys® assay for 49 clinical plasma samples (r=0.9744).
    CONCLUSIONS: The described technology shows that an analytical performance for a highly sensitive determination of cTnT can be achieved in a POC setting.
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  • 文章类型: Journal Article
    背景:西班牙的全科医生(GP)无法获得快速测试,并且对指南的遵守通常是次优的。该研究的目的是评估如果全科医生适当地使用这些测试并遵循指南,可以节省的抗生素的估计数量。
    方法:观察性研究。
    方法:来自西班牙八个自治区的初级保健中心。
    方法:未参与过抗生素合理使用研究的全科医生。
    方法:全科医生通过47项审核,登记了2015年15个工作日内所有咽炎和下呼吸道感染(LRTI)的病例。
    方法:实际全科医生的抗生素处方和根据最近的指南可以节省的抗生素估计数量。
    结果:共有126名全科医生记录了1012次咽炎和1928次LRTI。497例咽炎患者(49.1%)和963例LRTI患者(49.9%)给予抗生素或转诊。如果全科医生适当地使用了快速抗原检测测试和C反应蛋白测试,并且严格遵守了当前的指南,抗生素将被给予7.6%和15.1%,分别,喉咙痛患者估计可节省420种抗生素(估计可节省84.5%;95%CI:81.1-87.4%)和LRTIs中的672种抗生素(估计可节省69.8%,95%CI:67.1-72.5%)。
    结论:GP在西班牙的临床实践中遵守指南和正确引入快速测试可能会大大节省咽炎和LRTIs中不必要的抗生素处方。
    BACKGROUND: General practitioners (GP) in Spain do not have access to rapid tests and adherence to guidelines is usually suboptimal. The aim of the study is to evaluate the estimated number of antibiotics that could have been saved if GPs had appropriately used these tests and had followed the guidelines.
    METHODS: Observational study.
    METHODS: Primary care centres from eight Autonomous Communities in Spain.
    METHODS: GPs who had not participated in previous studies on rational use of antibiotics.
    METHODS: GPs registered all the cases of pharyngitis and lower respiratory tract infections (LRTI) during 15 working days in 2015, by means of a 47-item audit.
    METHODS: Actual GPs\' antibiotic prescription and estimated number of antibiotics that could have been saved according to recent guidelines.
    RESULTS: A total of 126 GPs registered 1012 episodes of pharyngitis and 1928 LRTIs. Antibiotics were given or patients were referred in 497 patients with pharyngitis (49.1%) and 963 patients with LRTI (49.9%). If GPs had appropriately used rapid antigen detection tests and C-reactive protein tests and had strictly followed current guidelines, antibiotics would have been given to 7.6% and 15.1%, respectively, with an estimated saving of 420 antibiotics in patients with sore throat (estimated saving of 84.5%; 95% CI: 81.1-87.4%) and 672 antibiotics in LRTIs (estimated saving of 69.8%,95% CI: 67.1-72.5%).
    CONCLUSIONS: GP adherence to guidelines and a correct introduction of rapid tests in clinical practice in Spain could result in a considerable saving of unnecessary prescription of antibiotics in pharyngitis and LRTIs.
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