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1.
《Cirugía espa?ola》2023,101(5):325-332
IntroductionIn our institution, the study of selective sentinel node biopsy (SLNB) is performed intraoperatively. The main objective of our study is to know the proportion of patients who benefits from the waiting of the results of SLNB.MethodsA retrospective analysis of patients operated on our center between January 1 st, 2018 and June 30, 2019 was carried out. We included women diagnosed with T1–T2 tumors, treated by lumpectomy and SLNB studied using OSNA method.ResultsOur study included 149 women. There were not statistically significant differences in terms of demographic data between the group treated with axillary lymph node dissection (ALND) and exclusively SLNB group. After analysis of SLN intraoperatively, there were performed 18 axillary lymphadenectomies. Only in six of these 18 cases, three or more sentinel nodes were founded. The location of the tumor, the presence of lymphovascular permeation and the total tumor load (TTL) showed statistically significant differences between groups. Only the TTL was established as the independent factor of the need for ALND.ConclusionsObtaining a deferred result of the SLNB allowed reducing the time of anesthesia and occupation of the operating room, since in a high percentage of cases an additional procedure is not performed.  相似文献   
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PurposeCartridge based nucleic acid amplification test (CBNAAT) has been endorsed by the WHO as the screening test for diagnosing extrapulmonary tuberculosis (EPTB). In the present study we report the agreement between CBNAAT (Xpert MTB/RIF), liquid culture (LC) and line probe assay (LPA) for diagnosis of Mycobacterium tuberculosis and detection of drug resistance among EPTB cases.MethodsThe EP samples were subjected to CBNAAT (Xpert MTB/RIF, Cepheid, USA) and wherever possible, to LC (MGIT 960, Becton Dickinson, USA) followed sequentially by first line and second line-LPA (FL-LPA, SL-LPA, Hain Lifescience, Germany) on the isolates.ResultsTotal 566/4080 (13.9%) EP samples were detected positive for M. tuberculosis on CBNAAT. Aspirates from lymph nodes were most often positive (11/30; 36.6%), followed by pus (240/873; 27.5%) and CSF samples (166/104; 15.8%). The detection of M. tuberculosis was more in adults than children except in tissue biopsy samples. Rifampicin resistance was also higher among adults except CSF in which resistance was more in children. Total 185 of 566 (32.7%) CBNAAT positive and 770 of 3510 (21.9%) CBNAAT negative samples could be cultured of which 110/185 (59.4%) and 33/770 (4.3%) respectively turned positive. FL-LPA and SL-LPA of 143 culture isolates showed that 27 isolates had drug resistance, of which 3 (2.1%) were XDR, 11 (7.7%) were Pre-XDR (FQ) and 13 (9.1%) were MDR. Of these 27 resistant isolates, 12 were negative by CBNAAT and two were mislabeled as Rifampicin sensitive or indeterminate based on the unique RpoB gene mutation patterns on LPA. The positive and negative agreements between LC and CBNAAT for detection of M. tuberculosis were 67.1% and 92.7% respectively and between LPA and CBNAAT for rifampicin resistance detection were 98.9% and 92.9% respectively.ConclusionsFor EPTB, CBNAAT should be accompanied with LC wherever possible irrespective of the CBNAAT result.  相似文献   
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IntroductionSmart Gene is a point-of-care (POC)-type automated molecular testing platform that can be performed with 1 min of hands-on-time. Smart Gene SARS-CoV-2 is a newly developed Smart Gene molecular assay for the detection of SARS-CoV-2. The analytical and clinical performance of Smart Gene SARS-CoV-2 has not been evaluated.MethodsNasopharyngeal and anterior nasal samples were prospectively collected from subjects referred to the local PCR center from March 25 to July 5, 2021. Two swabs were simultaneously obtained for the Smart Gene SARS-CoV-2 assay and the reference real-time RT-PCR assay, and the results of Smart Gene SARS-CoV-2 were compared to the reference real-time RT-PCR assay.ResultsAmong a total of 1150 samples, 68 of 791 nasopharyngeal samples and 51 of 359 anterior nasal samples were positive for SARS-CoV-2 in the reference real-time RT-PCR assay. In the testing of nasopharyngeal samples, Smart Gene SARS-CoV-2 showed the total, positive and negative concordance of 99.2% (95% confidence interval [CI]: 98.4–99.7%), 94.1% (95% CI: 85.6–98.4%) and 99.7% (95% CI: 99.0–100%), respectively. For anterior nasal samples, Smart Gene SARS-CoV-2 showed the total, positive and negative concordance of 98.9% (95% CI: 97.2–99.7%), 98.0% (95% CI: 89.6–100%) and 99.0% (95% CI: 97.2–99.8%), respectively. In total, 5 samples were positive in the reference real-time RT-PCR assay and negative in the Smart Gene SARS-CoV-2 assay, whereas 5 samples were negative in the reference real-time RT-PCR assay and positive in the Smart Gene SARS-CoV-2 assay.ConclusionSmart Gene SARS-CoV-2 showed sufficient analytical performance for the detection of SARS-CoV-2 in nasopharyngeal and anterior nasal samples.  相似文献   
4.
IntroductionThe Tokyo Metropolitan Government (TMG) conducted an external quality assessment (EQA) survey of pathogen nucleic acid amplification tests (NAATs) as a TMG EQA program for SARS-CoV-2 for clinical laboratories in Tokyo.MethodsWe diluted and prepared a standard product manufactured by Company A to about 2,500 copies/mL to make a positive control and distribute it with a negative control. The participants reported the use of the NAATs methods for SARS-CoV-2, the name of the real-time RT-PCR kit, the name of the detection device, the target gene(s), nucleic acid extraction kit, Threshold Cycle value in the case of RT-PCR and the Threshold time value and Differential calculation value in the case of Loop-Mediated Isothermal Amplification (LAMP) method.ResultsAs a result, 17 laboratories using fully automated equipment and 34 laboratories using the RT-PCR method reported generally appropriate results in this EQA survey. On the other hand, among the laboratories that adopted the LAMP method, there were a plurality of laboratories that judged positive samples to be negative.ConclusionThe false negative result is considered to be due to the fact that the amount of virus genome contained in the quality control reagent used this time was below the detection limit of the LAMP method combined with the rapid extraction reagent for influenza virus. On the other hand, false positive results are considered to be due to the non-specific reaction of the NAATs. The EQA program must be continued for the proper implementation of the pathogen NAATs.  相似文献   
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背景:儿童新型冠状(新冠)病毒Omicron变异株流行期间,免疫抑制状态儿童新冠病毒清除时间定量分析研究较少。 目的:探讨新冠病毒Omicron株感染后免疫抑制和非免疫抑制儿童病毒清除的时间差别,为公共卫生政策制定和精准疫情防控措施提供临床数据。 设计:回顾性队列研究。 方法:以新冠病毒Omicron变异株感染住院患儿为队列人群,分为免疫抑制组和非免疫抑制组,免疫抑制分为绝对免疫抑制、相对免疫抑制和实施免疫抑制疗法,以免疫抑制组病例的性别、年龄和新冠病毒感染的分型与非免疫抑制组行1∶3匹配。以鼻咽拭子新冠病毒PCR检测拷贝数阈(Ct)值≥35为队列终点。 主要结局指标:新冠病毒清除时间。 结果:2022年4月12日至2022年5月12日在上海市新冠病毒感染定点收治医院符合本文共同纳入和排除标准的连续病例728例。免疫抑制组33例,其中绝对免疫抑制8例,相对免疫抑制23例,接受免疫抑制疗法2例(不包括绝对和相对免疫抑制患儿)。非免疫抑制组匹配后99例。2组临床症状、新冠病毒感染治疗和疫苗接种次数差异均无统计学意义。免疫抑制组和非免疫抑制组新冠病毒清除时间分别为(16.5±6.8)和(10.3±4.4)d,差异有统计学意义。免疫抑制组和非免疫抑制组新冠病毒感染轻型病例病毒清除时间分别为(14.0 ± 8.3)和(9.7 ± 3.1)d,普通型病例病毒清除时间分别为(18.3 ± 4.9)和(11.2 ± 5.9)d,差异均有统计学意义。2组单日病毒清除率在第9~14天时差异有统计学意义(P为0.005~0.039)。2组普通型病例单日病毒清除率在第10~15天时差异有统计学意义。免疫抑制组新冠病毒感染2周后核酸检测再次呈阳性3例(9%),临床分型均较前轻,3例均未接种新冠疫苗。 结论:Omicron株感染的免疫抑制患儿病毒清除时间较非免疫抑制患儿显著延长,主要反映在第9~14天,免疫抑制患儿病毒复阳风险高,提示需要更长的隔离时间和转阴后严格的病毒监测。  相似文献   
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目的比较3种检测方法在不同类型结核病中的诊断价值。方法选取2020年1-12月于该院住院的患者140例为研究对象,其中结核病组111例(肺结核组103例和肺外结核组8例),非结核病组29例。同时采用外周全血γ-干扰素释放试验(IGRA)、结核分枝杆菌培养、实时荧光定量核酸扩增检测(Xpert MTB/RIF)3种方法检测各组患者的标本,比较3种检测方法的诊断价值。结果IGRA、结核分枝杆菌培养和Xpert MTB/RIF在结核病组患者中的阳性率分别为87.39%、37.84%和64.86%,与非结核病组比较(27.59%、0.00%、0.00%),差异有统计学意义(P<0.05)。肺结核组与肺外结核组3种检测方法的阳性率比较差异无统计学意义(P>0.05)。IGRA在菌阳患者和菌阴患者中的阳性率比较,差异无统计学意义(P>0.05)。IGRA和结核分枝杆菌培养联合检测的灵敏度、特异度、曲线下面积(AUC)、阳性预测值和阴性预测值分别为90.99%、72.41%、0.869、92.7%、67.7%。IGRA和Xpert MTB/RIF联合检测的灵敏度、特异度、AUC、阳性预测值和阴性预测值分别为96.40%、72.41%、0.934、93.0%、84.0%。结论IGRA诊断结核病的阳性率最高;IGRA和Xpert MTB/RIF联合检测的灵敏度、AUC、阳性预测值和阴性预测值均优于IGRA和结核分枝杆菌培养联合检测,可为临床医生诊断结核病提供参考。  相似文献   
8.
 目的 建立一种简单,快速的重组酶聚合酶核酸扩增技术检测鼠疫耶尔森氏菌的方法。方法 基于耶尔森氏菌的特异性序列设计引物及探针;通过对不同温度的检测来优化反应温度;通过对不同菌株的DNA模板进行检测评价该方法的特异性;通过对不同稀释浓度的样本DNA模板进行检测来确定灵敏性;通过模拟样品进行应用评价。结果 基于鼠疫耶尔森菌的DNA腺嘌呤甲基化酶基因设计特异性引物和探针所建立的荧光重组酶聚合酶扩增方法,35 ℃反应20 min内可成功检出低至100个拷贝的鼠疫耶尔森菌基因,而且与其他菌无交叉反应,对模拟样品的检测准确性达到98.0%。结论 重组酶聚合酶核酸扩增可广泛应用于简陋条件下鼠疫耶尔森菌的临床检测,促进鼠疫的防控。  相似文献   
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IntroductionRapid diagnostic tests have been developed recently for rapid species or resistance genes identification, offering the potential to improve the selection of appropriate antibiotics. The newly developed FilmArray Blood Culture Identification 2 (BCID2) panel, which can identify more species and resistance genes, such as extended-spectrum beta-lactamase, is expected to make an impact on antimicrobial practice.MethodsThe consecutive 50 inpatients with Gram-negative bacilli bacteremia were enrolled to this retrospective single-center study. In addition to the existing FilmArray Blood Culture Identification (BCID) panel, we have implemented BCID2 panel for positive blood culture. The sensitivity and specificity of BCID and BCID2 panel were respectively calculated, and a simulation study of time to effective, optimal and de-escalation therapy was performed based on BCID or BCID2 result.ResultsA total of 52 Gram-negative organisms in 50 patients were identified from blood cultures. Of these, 45 (87%) organisms were detected by BCID2 panel, which was more than BCID panel (41 organisms, 79%). BCID2 panel detected 5 CTX-M genes, which were concordant with conventional method. The time to effective therapy did not differ between BCID arm and BCID2 arm; however, the median time to optimal therapy (34 h in BCID arm and 26 h in BCID2 arm, P = 0.0007) and the median time to de-escalation therapy (42 h in BCID arm and 22 h in BCID2 arm, P = 0.0005) were significantly shortened.ConclusionsThis simulation study of BCID2 panel showed high sensitivity and specificity, and the potential impact on shortening the time to optimal and de-escalation therapy.  相似文献   
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