Rapid antigen detection test

抗原快速检测试验
  • 文章类型: Journal Article
    本研究是COVAG研究的扩展。我们比较了两种RAT,PanbioCOVID-19Ag快速测试(雅培)和SD生物传感器QSARS-CoV-2快速抗原测试(罗氏),针对新变体的箔上的RT-PCR。
    我们在2021年10月20日至2022年3月18日期间在诊断中心纳入了888名全体人员。检查了Ct值≤32的RT-PCR阳性样品中的SARS-CoV-2变体。
    雅培RAT和罗氏RAT的灵敏度分别为65%和67%,分别。对于两种RAT,较低的Ct值与较高的敏感性显著相关。对于Ct值≤25的样品,罗氏RAT和雅培RAT的敏感性分别为96%和95%,对于Ct值25-30,两者均为19%,对于Ct值≥30,它们分别为6%和2%,分别。与无症状参与者相比,RAT在有症状参与者中的敏感性明显更高(76%,77%,vs.29,31%,对于Abbott-RAT,罗氏RAT,分别)和由初级保健医师转诊的参与者(84,85%),而由于卫生部门的转诊(55,58%)或Corona-Warn-App的警告而寻求检测的参与者(49,49%)。在自我报告以前的COVID-19患者中,敏感性明显低于没有以前的COVID-19的患者:27%75%的罗氏RAT和27%与Abbott-RAT的73%。我们没有发现疫苗接种状态和敏感性之间的显著相关性。检测到Omicron变体的灵敏度为94%和92%,对雅培-RAT和罗氏-RAT的敏感性为80%和80%的δ变体,分别。这种差异归因于与Delta样品相比,O微米样品的Ct值较低。当针对Ct值进行调整时,多变量逻辑回归未显示Omicron和Delta之间的显著差异.在敏感度方面,我们发现野生型与Omicron和Delta变体之间没有显着差异,但与其他变体相比,对α变体的敏感性明显较低。总体特异性>99%。
    UNASSIGNED: This study is the extension of the COVAG study. We compared two RATs, the Panbio COVID-19 Ag Rapid Test (Abbott) and the SD Biosensor Q SARS-CoV-2 Rapid Antigen Test (Roche), against RT-PCR on the foil of new variants.
    UNASSIGNED: We included 888 all-comers at a diagnostic center between October 20, 2021, and March 18, 2022. RT-PCR-positive samples with a Ct value ≤32 were examined for SARS-CoV-2 variants.
    UNASSIGNED: The sensitivity of the Abbott-RAT and Roche-RAT were 65 and 67%, respectively. For both RATs, lower Ct values were significantly correlated with higher sensitivity. For samples with Ct values ≤25, the sensitivities of the Roche-RAT and of the Abbott-RAT were 96 and 95%, for Ct values 25-30 both were 19%, and for Ct values ≥30 they were 6 and 2%, respectively. The RATs had substantially higher sensitivities in symptomatic than asymptomatic participants (76, 77%, vs. 29, 31%, for Abbott-RAT, Roche-RAT, respectively) and in participants referred to testing by their primary care physician (84, 85%) compared to participants who sought testing due to referral by the health department (55, 58%) or a warning by the Corona-Warn-App (49, 49%). In persons with self-reported previous COVID-19 sensitivities were markedly lower than in patients without previous COVID-19: 27% vs. 75% for Roche-RAT and 27% vs. 73% for Abbott-RAT. We did not find significant correlation between vaccination status and sensitivity. The Omicron variant was detected with a sensitivity of 94 and 92%, the delta variant with a sensitivity of 80 and 80% for Abbott-RAT and Roche-RAT, respectively. This difference is attributable to the lower Ct values of the Omicron samples compared to the Delta samples. When adjusted for the Ct value, a multivariate logistic regression did not show a significant difference between Omicron and Delta. In terms of sensitivity, we found no significant difference between the wild-type and the Omicron and Delta variants, but a significantly lower sensitivity to the alpha variant compared to the other variants.The specificities were > 99% overall.
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  • 文章类型: Observational Study
    背景:在瑞典和丹麦,A组链球菌(GAS)的快速抗原检测(RADT)和C反应蛋白(CRP)的即时检测通常用于咽喉炎患者,尽管CRP检测不受指南支持。我们旨在描述(1)接受RADT和/或CRP测试的患者比例,(2)检验结果与抗生素处方的关系,(3)CRP水平与微生物病因之间的关系。
    方法:我们在一项针对220名15-45岁被诊断为咽喉炎的患者的前瞻性病因学研究中,对初级卫生保健中收集的数据进行事后分析。RADTs和CRP测试结果与抗生素处方和微生物病因有关。
    结果:94%的患者使用了RADT。50%的患者使用CRP测试,但RADT阴性的患者(59%)比RADT阳性的患者(38%)更常见(p=0.005)。大多数(74%)CRP测试用于RADT阴性的患者。RADT阳性患者(96%)和RADT阴性患者(17%)之间的抗生素处方差异很大(p<0.001)。在RADT阴性的患者中,CRP值与抗生素处方之间呈正相关(OR1.05;95%CI1.02-1.07;p<0.001).CRP值≤30mg/l的患者很少使用抗生素。培养的GAS患者的CRP中位数最高(46mg/l),高于无GAS患者(8mg/l;p<0.001)。然而,在所调查的CRP水平下,GAS的阳性预测值从未超过0.60(95%CI0.31~0.83).
    结论:测试的广泛使用是与国家指南的重大偏离。大多数CRP测试用于RADT阴性的患者,表明人们相信CRP测试的附加值,CRP结果似乎影响抗生素处方。然而,作为病因测试,CRP对预测GAS没有用。
    Rapid antigen detection tests (RADT) for Group A streptococci (GAS) and point-of-care tests for C-reactive protein (CRP) are commonly used in patients with pharyngotonsillitis in Sweden and Denmark although CRP testing is not supported by guidelines. We aimed to describe (1) the proportion of patients tested with RADT and/or CRP, (2) the relation between test results and antibiotic prescribing, and (3) the association between CRP level and microbial aetiology.
    We used a post-hoc-analysis of data collected in primary health care in a prospective aetiological study of 220 patients 15-45 years old diagnosed with pharyngotonsillitis. The outcomes of RADTs and CRP tests were related to antibiotic prescribing and microbial aetiology.
    A RADT was used in 94% of the patients. A CRP test was used in 50% of the patients but more commonly in those with a negative RADT (59%) than in those with a positive RADT (38%) (p = 0.005). Most (74%) CRP tests were used in patients with a negative RADT. Antibiotic prescribing differed greatly between patients with a positive RADT (96%) and patients with a negative RADT (17%) (p < 0.001). In patients with a negative RADT, there was a positive association between CRP value and antibiotic prescribing (OR 1.05; 95% CI 1.02-1.07; p < 0.001). Patients with CRP values ≤ 30 mg/l were seldomly prescribed antibiotics. Patients with GAS in culture had the highest median CRP (46 mg/l), which was higher than in patients without GAS (8 mg/l; p < 0.001). However, the positive predictive value for GAS never exceeded 0.60 (95% CI 0.31-0.83) at the investigated CRP levels.
    The widespread use of tests is a major deviation from national guidelines. Most CRP tests were used in patients with a negative RADT, suggesting a belief in the added value of a CRP test, and the CRP result seemed to influence antibiotic prescribing. However, as an aetiological test, CRP is not useful for predicting GAS.
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  • 文章类型: Journal Article
    作为一项公共卫生政策,正在进行的2019年全球冠状病毒病疫苗接种活动需要持续跟踪,跟踪,和检测严重急性呼吸道综合征冠状病毒2(SARS-CoV-2)。诊断测试在病毒检测和了解其传播以便及时干预中很重要。这对于大多数人口仍未接受测试的低收入环境尤为重要。这一事实很好地支持了大约9%的肯尼亚人口已经接受了病毒检测。
    这是一项在肯尼亚基苏木和西亚亚转诊医院进行的横断面研究。在这里,我们报告了SARS-CoV-2的快速抗原检测测试(Ag-RDT)与使用粪便和鼻咽拭子样本的定量逆转录酶聚合酶链反应(RT-qPCR)相比的敏感性和特异性。Further,评估了肯尼亚西部有症状和无症状个体的平均免疫球蛋白M(IgM)和免疫球蛋白G(IgG)抗体水平.
    Ag-RDT的敏感性和特异性分别为76.3%(95%CI,59.8-88.6%)和96.3%(95%CI,87.3-99.5%),阴性和阳性预测值分别为85%(95%CI,73.8%-93.0%)和93%(95%CI,78.6%-99.2%)。Ag-RDT和鼻咽拭子RT-qPCR之间有88%的实质性一致性(Kappa值为0.75,95%CI,0.74-0.77),粪便和鼻咽拭子RT-qPCR结果(83.7%的一致性,卡帕值0.62,95%CI0.45-0.80)。对SARS-CoV-2的平均IgM和IgG抗体应答在无症状个体中没有差异,1.11(95%CI,0.78-1.44)和0.88(95%CI,0.65-1.11),与有症状的个体4.30(95%CI3.30-5.31)和4.16(95%CI3.32-5.00)相比。
    选择合适的SARS-CoV-2诊断方法,筛选,和监测测试应以具体的研究需求和合理的方法为指导,以获得最佳结果。
    UNASSIGNED: as a public health policy, the ongoing global coronavirus disease 2019 vaccination drives require continuous tracking, tracing, and testing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Diagnostic testing is important in virus detection and understanding its spread for timely intervention. This is especially important for low-income settings where the majority of the population remains untested. This is well supported by the fact that of about 9% of the Kenyan population had been tested for the virus.
    UNASSIGNED: this was a cross-sectional study conducted at the Kisumu and Siaya Referral Hospitals in Kenya. Here we report on the sensitivity and specificity of the rapid antigen detection test (Ag-RDT) of SARS-CoV-2 compared with the quantitative reverse transcriptase polymerase chain reaction (RT-qPCR) using stool and nasopharyngeal swab samples. Further, the mean Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibody levels among symptomatic and asymptomatic individuals in western Kenya were evaluated.
    UNASSIGNED: the sensitivity and specificity of Ag-RDT were 76.3% (95% CI, 59.8-88.6%) and 96.3% (95% CI, 87.3-99.5%) with a negative and positive predictive value of 85% (95% CI, 73.8%-93.0%) and 93% (95% CI, 78.6%-99.2%) respectively. There was substantial agreement of 88% (Kappa value of 0.75, 95% CI, 0.74-0.77) between Ag-RDT and nasopharyngeal swab RT-qPCR, and between stool and nasopharyngeal swab RT-qPCR results (83.7% agreement, Kapa value 0.62, 95% CI 0.45-0.80). The mean IgM and IgG antibody response to SARS-CoV-2 were not different in asymptomatic individuals, 1.11 (95% CI, 0.78-1.44) and 0.88 (95% CI, 0.65-1.11) compared to symptomatic individuals 4.30 (95% CI 3.30-5.31) and 4.16 (95% CI 3.32 -5.00).
    UNASSIGNED: the choice of an appropriate SARS-CoV-2 diagnostic, screening, and surveillance test should be guided by the specific study needs and a rational approach for optimal results.
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  • 文章类型: Journal Article
    这项研究的目的是评估胸膜液样本中化脓性链球菌(GAS)和肺炎链球菌的快速抗原检测测试(RADT)的可靠性,以诊断肺炎旁积液/脓胸(PPE)及其提高病原体识别率的潜力。从54例GAS和肺炎链球菌RADT(BinaxNOW)患者中收集了63个胸膜样本,文化,16SrRNAPCR,和肺炎链球菌特异性PCR。GASRADT的灵敏度为95.2%,特异性为100%。肺炎球菌RADT的敏感性为100%,特异性为88.6%。与培养物相比,两种RADT都提高了PPE中的病原体鉴定率。
    The aim of this study was to assess the reliability of rapid antigen detection tests (RADT) for Streptococcus pyogenes (GAS) and Streptococcus pneumoniae on pleural fluid samples for diagnosis of parapneumonic effusion/empyema (PPE) and their potential for improving pathogen identification rates. Sixty-three pleural samples were included from 54 patients on which GAS and S. pneumoniae RADT (BinaxNOW), culture, 16S rRNA PCR, and S. pneumoniae-specific PCR were performed. GAS RADT showed a sensitivity of 95.2% and a specificity of 100%. Pneumococcal RADT showed a sensitivity of 100% and specificity of 88.6%. Both RADT increased the pathogen identification rate in PPE compared to culture.
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  • 文章类型: Journal Article
    目的:与逆转录聚合酶链反应(RT-PCR)相比,用于SARS-CoV-2诊断的快速抗原检测测试(RADT)更快,更便宜,但也不太准确。RADT的性能是特定于环境的,并且取决于疾病的患病率。在现实世界的研究中,我们评估了RADT在整个COVID-19急诊阶段对住院患者的影响.
    方法:在这项配对的回顾性研究中,分析了2020年2月至2023年5月在一家大型医院进行的SARS-CoV-2RT-PCR和RADT实验室诊断的数据.要纳入研究,用于RT-PCR和RADT的样本必须在同一天收集.
    结果:在278,867个RT-PCR测试中,13,321个当天的RADTs可以与RT-PCR匹配。在整个时期,RADT的敏感性和特异性分别为76.4%和99.4%,分别。观察到的阳性率为9.4%,阳性和阴性预测值分别为92.7%和97.6%,分别。与Alpha和Delta关注变量(VOCs)主导的时期相比,在0微米阶段,RADT精度略低。
    结论:这一现实世界的经验表明,尽管敏感性欠佳,但主要VOC和阳性患病率存在一定差异,使用RADT在医院环境中很有用。讨论了对公共卫生的影响。
    OBJECTIVE: Compared with reverse transcription polymerase chain reaction (RT-PCR), rapid antigen detection tests (RADTs) for SARS-CoV-2 diagnostics are faster, less expensive, but also less accurate. Performance of RADTs is context-specific and depends on disease prevalence. In this real-world study, we assessed impact of RADTs in an inpatient setting through the entire COVID-19 emergency phase.
    METHODS: In this matched retrospective study, data on RT-PCR and RADT laboratory diagnoses of SARS-CoV-2 made between February 2020 and May 2023 in a large hospital were analyzed. To be included in the study, samples used for both RT-PCR and RADT had to be collected on the same day.
    RESULTS: Of 278,867 RT-PCR tests available, 13,321 same-day RADTs could be matched to RT-PCR. Over the entire period, RADT sensitivity and specificity were 76.4% and 99.4%, respectively. With the observed positivity rate of 9.4%, positive and negative predictive values were 92.7% and 97.6%, respectively. Compared with the periods dominated by the Alpha and Delta variants of concern, RADT accuracy was slightly lower during the Omicron phase.
    CONCLUSIONS: This real-world experience demonstrates that despite suboptimal sensitivity and some variation by predominant variants of concern and positivity prevalence, the use of RADTs is useful in hospital settings. Public health implications were discussed.
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  • 文章类型: Journal Article
    SARS-CoV-2,COVID-19大流行的病原体,继续影响健康,经济,全球稳定。SARS-CoV-2的诊断测试对于遏制COVID-19大流行很重要。随着经认证的抗原(Ag)快速诊断测试(RDT)的商业可用性,介绍了一种易于使用的工具,可用于识别SARS-CoV-2的感染。自我测试可以提供优势,以补充专业管理的快速抗原检测或核酸扩增测试(NAAT)。与实时聚合酶链反应(RT-PCR)相比,Ag-RDT成本低廉,不需要专门的实验室设备,促进高通量测试。然而,Ag-RDT敏感性强烈依赖于样本内的病毒载量,到目前为止,这限制了它们在临床环境中的应用。Ag-RDT的方法局限性可能会产生假阴性测试结果,特别是当标本与低病毒载量进行检查。如果错误地解除保护性测量,这可能会促进病毒传播。
    SARS-CoV-2, the causative agent of the COVID-19 pandemic, continues to influence health, economy, and stability worldwide. Diagnostic testing for SARS-CoV-2 is important to contain the COVID-19 pandemic. With the commercial availability of certified antigen (Ag) rapid diagnostic tests (RDTs), which can be used to identify an infection with SARS-CoV-2 an easy-to-use tool was introduced. Self-tests can offer advantages to complement professionally administered rapid antigen detection or nucleic acid amplification testing (NAAT). Compared to real-time polymerase chain reaction (RT-PCR), Ag-RDTs are cost inexpensive, do not need specialized laboratory equipment, facilitating high-throughput testing. However, Ag-RDT sensitivities are strongly dependent on the viral load within the specimen, which has limited their application in clinical settings so far. The methodical limitations of Ag-RDTs may produce false negative test results, particularly when specimens with low viral loads are examined. This may facilitate viral transmissions if protective measurements are lifted mistakenly.
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  • 文章类型: Case Reports
    脓胸是肺炎的严重并发症,发病率和死亡率高。快速诊断和定制抗生素治疗对于这些严重的细菌性肺部感染的治疗成功至关重要。肺炎链球菌(S.肺炎)从胸腔积液而不是尿液样本中提取的抗原测试已被发现与尿抗原测试具有同等的诊断效用。这些测试之间的不一致是罕见的。我们报告了一例69岁的女性,其CT影像学表现与脓胸和支气管肺瘘一致。一个快速的S.尿标本肺炎抗原试验呈阴性,但从患者胸膜液标本中抽取时呈阳性。最终的胸膜液培养导致星座链球菌(S.constellatus)。此病例显示尿和胸腔积液肺炎链球菌抗原试验结果不一致,代表在胸膜液样本上使用快速抗原检测的潜在陷阱。S.的误报由于不同链球菌物种中细胞壁蛋白的交叉反应性,已记录了绿草链球菌感染患者的肺炎抗原。遇到病因不明的细菌性肺炎并发脓胸的医师应了解使用这种诊断方法的不一致和假阳性的可能性。
    Empyema is a severe complication of pneumonia with high morbidity and mortality rates. Rapid diagnosis and tailoring of antibiotic therapy are crucial to treatment success for these severe bacterial lung infections. A Streptococcus pneumoniae (S. pneumonia) antigen test drawn from the pleural fluid rather than a urine sample has been found to have equivalent diagnostic utility to the urinary antigen test. Discordance between these tests is rare. We report a case of a 69-year-old female with CT imaging findings consistent with empyema and a bronchopulmonary fistula. A rapid S. pneumonia antigen test was negative from the urinary sample but positive when drawn from a patient\'s pleural fluid sample. Final pleural fluid cultures resulted in Streptococcus constellatus (S. constellatus). This case demonstrates discordance between the results of urinary and pleural fluid S. pneumoniae antigen tests, representing a potential pitfall in using rapid antigen testing on pleural fluid samples. False positives for the S. pneumoniae antigen in patients with viridans streptococci infections have been documented due to the cross-reactivity of cell wall proteins in different streptococcal species. Physicians encountering bacterial pneumonia of unknown etiology complicated by empyema should understand the potential for discordance and false positives using this diagnostic method.
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  • 文章类型: Multicenter Study
    背景:Molnupiravir是针对2019年冠状病毒病(COVID-19)的必需口服抗病毒药物;但是,其真实世界的有效性尚未在接受血液透析(HD)的患者中进行评估.
    方法:我们进行了一项多中心回顾性研究,纳入225例最初患有轻度或无症状COVID-19的HD患者,以比较接受和未接受莫努比拉韦的患者进行30天COVID-19相关急性护理就诊的风险。此外,在疾病发作后第7天,我们通过快速抗原检测(RAD)检测结果对接受莫诺比拉韦治疗的患者进行了分层,以评估快速引入莫诺比拉韦是否加速了病毒清除.
    结果:在我们的分析中,据报道,30天与COVID-19相关的急性护理访视占莫诺比拉韦组和对照组的9.41%和21.74%,分别,在通过倾向评分加权(风险比(95%置信区间(CI))调整基线特征后,使用莫那普拉韦显著降低了急性护理就诊的风险,0.218(0.074-0.642);p=0.006)。莫努比拉韦在入选患者中的耐受性通常是可以接受的,只有11.88%的莫努普拉韦使用者报告轻度不良事件。此外,在COVID-19发病后一天内快速开始莫努比拉韦是疾病发作后第7天RAD测试结果阴性的独立预测因子(比值比(95%CI),6.207(2.509-15.358);p<0.001)。
    结论:Molnupiravir耐受性良好,降低了接受HD的COVID-19患者的医疗需求。此外,在患有COVID-19的HD患者中,molnupiravir的快速启动加速了病毒清除.我们的发现强调了莫努比拉韦对这一脆弱人群的治疗作用。
    BACKGROUND: Molnupiravir is an essential oral antiviral agent against coronavirus disease 2019 (COVID-19); however, its real-world effectiveness has not been evaluated in patients undergoing haemodialysis (HD).
    METHODS: This multi-centre retrospective study, involving 225 patients undergoing HD with initially mild or asymptomatic COVID-19, was conducted to compare the risks of 30-day COVID-19-related acute care visits between patients receiving and not receiving molnupiravir. Patients who received molnupiravir were stratified by rapid antigen detection (RAD) test results on day 7 after disease onset to assess whether rapid molnupiravir introduction accelerated viral clearance.
    RESULTS: Thirty-day COVID-19-related acute care visits were reported in 9.41% and 21.74% of the molnupiravir and control groups, respectively, and use of molnupiravir markedly reduced the risk of acute care visits after adjusting for baseline characteristics via propensity score weighting [hazard ratio 0.218, 95% confidence interval (CI) 0.074-0.642; P=0.006]. The tolerability of molnupiravir in the enrolled patients was generally acceptable, with only 11.88% of molnupiravir users reporting mild adverse events. Moreover, rapid initiation of molnupiravir within 1 day of COVID-19 onset was an independent predictor of conversion to a negative RAD test result on day 7 after disease onset (odds ratio 6.207, 95% CI 2.509-15.358; P<0.001).
    CONCLUSIONS: Molnupiravir is well tolerated and decreases the medical needs in patients with COVID-19 undergoing HD. Furthermore, the rapid initiation of molnupiravir accelerates viral clearance in patients with COVID-19 undergoing HD. These findings highlight the therapeutic role of molnupiravir for this vulnerable population.
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  • 文章类型: Journal Article
    背景关于快速抗原检测测试(RDT)在检测SARS-CoV-2Omicron(B.1.1.529)变体中的性能的报道相互矛盾;但是,这些测试仍然经常被用于检测具有高病毒载量的潜在传染性个体。目的这项研究的目的是通过选择20个RDT和有限的一组合并的口-和鼻咽临床Delta和Omicron标本来研究Delta(B.1.617.2)和Omicron变体的比较检测。方法我们使用2022年1月在柏林收集的一组合并临床标本,测试了20个CE标记的RDT检测SARS-CoV-2Delta和Omicron的性能,德国。结果我们观察到大多数RDT的Delta和Omicron的等效检测性能,灵敏度与我们之前的Delta/Omicron评估基本一致。对于Delta和Omicron检测,观察到个体RDT的一些变化,或者与以前的评估相比,这可以通过不同的面板大小导致不同的数据稳健性和批次间一致性的潜在限制来解释。使用未合并的常规临床样品进行的三个RDT的其他实验证实了检测Delta与Omicron的相当性能。总的来说,先前正面评估的RDT对于Delta和Omicron变体也保留了良好的性能。结论我们的发现表明,目前可用的RDT足以检测SARS-CoV-2Delta和Omicron变体。
    BackgroundThere are conflicting reports on the performance of rapid antigen detection tests (RDT) in the detection of the SARS-CoV-2 Omicron (B.1.1.529) variant; however, these tests continue to be used frequently to detect potentially contagious individuals with high viral loads.AimThe aim of this study was to investigate comparative detection of the Delta (B.1.617.2) and Omicron variants by using a selection of 20 RDT and a limited panel of pooled combined oro- and nasopharyngeal clinical Delta and Omicron specimens.MethodsWe tested 20 CE-marked RDT for their performance to detect SARS-CoV-2 Delta and Omicron by using a panel of pooled clinical specimens collected in January 2022 in Berlin, Germany.ResultsWe observed equivalent detection performance for Delta and Omicron for most RDT, and sensitivity was widely in line with our previous pre-Delta/Omicron evaluation. Some variation for individual RDT was observed either for Delta vs Omicron detection, or when compared with the previous evaluation, which may be explained both by different panel sizes resulting in different data robustness and potential limitation of batch-to-batch consistency. Additional experiments with three RDT using non-pooled routine clinical samples confirmed comparable performance to detect Delta vs Omicron. Overall, RDT that were previously positively evaluated retained good performance also for Delta and Omicron variants.ConclusionOur findings suggest that currently available RDT are sufficient for the detection of SARS-CoV-2 Delta and Omicron variants.
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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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