pH、过氧化氢、白细胞酯酶、乙酰氨基葡萄糖苷酶联合筛查、诊断阴道炎评价

目的：评价pH、过氧化氢、白细胞酯酶、乙酰氨基葡萄糖苷酶联合筛查、辅助诊断阴道炎的方法可行性。方法选择阴道分泌物检查患者236例,分别进行p H、过氧化氢、白细胞酯酶、乙酰氨基葡萄糖苷酶四项联合检查,未染色显微镜检查,及相关确诊实验,通过诊断标准对患者确诊。对四联检测,应用独立项目判读结果的判读方案一,及应用两项联合判读结果的判读方案二,获得两种检测结果。用χ2检验分别统计四项联合检测两种结果与显微镜结果及诊断结果的一致性,并对四项联合检测实验进行诊断效能评价。结果四项联合检测两种结果均与显微镜结果及诊断结果一致程度较好,P值均为0．000（＜0．05）,但判读方案二有更高的kappa值,分别是0．914及0．862;四项联合检测判读方式一达到的诊断的灵敏度为94．2％、特异度为87．7％、Youden指数为81．9％;判读方式二达到的诊断灵敏度为90．5％、特异度为96．9％、Youden指数为87．4％。结论：pH、过氧化氢、白细胞酯酶、乙酰氨基葡萄糖苷酶四项联合检查,在不同结果判读方式下,对诊断阴道炎的特异度、灵敏度有影响。灵敏度高的判读方案一,较适用于筛查用途;而Youden指数更高的判读方案二,比较适合辅助诊断;可在此基础上进一步优化专项检测卡,用于基础医疗卫生的筛查与诊断。     

两种方法验证乙型肝炎病毒标志物室间质量控制结果分析

目的对比酶联免疫吸附法(ELISA)和胶体金免疫层析法(GIGA)检测乙肝五项指标的结果差异,验证HBV标志物室间质量控制的方法选择。方法使用ELISA检测试剂和GIGA试条对420份标本检测乙肝五项指标,并对两种方法检测均阳性的标本做1∶256倍稀释后检测相关抗原抗体,对结果进行统计学分析。结果两种方法结果除乙肝表面抗原结果无显著差异外,其他指标均有显著差异,稀释后结果差异更加明显。结论 GIGA法检测乙肝五项指标较ELISA法灵敏度低,有一定的漏检率,不适用于室间质量控制检测,应用ELISA法加以确证。     

Current molecular genetics strategies for the diagnosis of lysosomal storage disorders

Lysosomal storage disorders (LSDs) are a group of almost 50 monogenic diseases characterized by mutations causing deficiency of lysosomal enzymes or non-enzyme proteins involved in transport across the lysosomal membrane, protein maturation or lysosomal biogenesis. Usually, affected patients are normal at birth and have a progressive and severe disease with high morbidity and reduced life expectancy. The overall incidence of LSDs is usually estimated as 1:5000, but newborn screening studies are indicating that it could be much higher. Specific therapies were already developed for selected LSDs, making the timely and correct diagnosis very important for successful treatment and also for genetic counseling. In most LSD cases the biochemical techniques provide a reliable diagnosis. However, the identification of pathogenic mutations by genetic analysis is being increasingly recommended to provide additional information. In this paper we discuss the conventional methods for genetic analysis used in the LSDs [restriction fragment length polymorphism (RFLP), amplification-refractory mutation system (ARMS), single strand conformation polymorphism (SSCP), denaturing high performance liquid chromatography (dHPLC), real-time polymerase chain reaction, high resolution melting (HRM), multiplex ligation-dependent probe amplification (MLPA), Sanger sequencing] and also the newer approaches [massive parallel sequencing, array comparative genomic hybridization (CGH)].     

微板速率法检测丙氨酸氨基转移酶的研究

目的探讨全自动酶联免疫分析系统微板速率法检测丙氨酸氨基转移酶(ALT)的方法评价和临床应用。方法参照国际临床化学联合会(IFCC)的推荐方法,结合分析系统建立微板速率法,通过方法学试验,评价其线性、批内和批间重复性;比较823例体检者血清标本采用微板速率法与常规生化分析仪法检测ALT的结果,并评价方法的临床应用。结果微板速率法检测ALT,在活性303U/L以下具有良好的线性;批内和批间变异系数均小于1/5TEa,其检测结果与常规生化分析仪的相关性良好。结论全自动酶联免疫分析系统微板速率法检测ALT,为大批量标本同时检测ALT和ELISA项目提供了很好的选择,值得临床推广使用。     

Clostridioides (Clostridium) difficile infection in Japanese hospitals 2008–2017: A real-world nationwide analysis of treatment pattern,incidence and testing density

ObjectiveTo characterize treatment pattern, incidence and diagnosis of hospital-onset Clostridioides difficile infection (CDI) in Japan, cases were studied over a 9-year period using a large, administrative database.MethodsThis was a retrospective, cross-sectional analysis of inpatients at 320 Japanese Diagnosis-Procedure Combination (DPC) hospitals. Hospitalizations between April 2008 and March 2017 were extracted for patients aged ≥18 years. CDI was defined as CDI treatment plus CDI diagnosis or positive enzyme immunoassay (EIA) result. Endpoints included treatment (type, route, daily dose, duration), time to CDI onset from admission, and time to recurrence (rCDI) from the end of treatment. Chronological changes were reported for treatment pattern, CDI incidence and EIA testing.ResultsThe analysis included 11,823 CDI hospitalizations, 1359 with rCDI. Overall, oral metronidazole (MNZ), oral vancomycin (VCM), and intravenous MNZ were used in 50.2%, 42.1% and 1.2% of CDI hospitalizations, respectively. From 2009 to 2017, CDI hospitalizations treated with MNZ more than doubled and VCM more than halved. Median (Q1–Q3) time to CDI and rCDI onset was 25 (11–52) days and 10 (6–17.5) days, respectively. Median treatment duration ranged from 8 to 10 days and median dose was 1 g/day for both MNZ and VCM. CDI incidence remained steady from 2010 until 2017 (0.99/10,000 patient-days) and EIA testing density doubled from 2008 to 2017 (24.46/10,000 patient-days).ConclusionOral MNZ has become the primary CDI treatment in Japanese DPC hospitals. The treatment duration and dose were aligned to the package insert. CDI diagnostic testing density increased over time, CDI incidence did not.Clinical trial registration numberN/A.     

艰难梭菌实验室不同检测方法的比较

目的比较不同方法检测艰难梭菌(CD)的临床可行性。方法选取2016年疑似抗菌药物相关腹泻患者大便标本,采用酶联免疫吸附试验(ELISA)和鉴定培养基培养法进行检测,比较两种检测方法的灵敏性、特异性和一致性。结果 ELISA检出抗原阳性标本29例,其中毒素阳性25例,毒素阴性4例;鉴定培养基培养法检出可疑菌株29例,经质谱仪鉴定,其结果为CD28例,1例未检出种属;ELISA和鉴定培养基培养法的灵敏度和特异度分别为97%、100%和93%、95%,两者有极好的一致性(Kappa=0.92)。结论 ELISA具有快速、高效、省时、操作简单、判读容易等特点,可快速准确地筛检CD相关性腹泻病患;培养基培养法特异性好,可以快速得到感染株;二者联合使用可大大提高CD检出率,并对后期治疗有很大帮助。     

5项血清肿瘤标志物联合检测在肺癌诊断中的价值

目的检测肺癌及肺良性病变患者血清血清癌胚抗原(CEA)、神经元特异性烯醇化酶(NSE)、非小细胞肺癌相关抗原21-1(CYFRA21-1)、糖类抗原125(CA125)及铁蛋白(Fer)的水平,探讨其在肺癌诊断中的应用价值。方法采用电化学发光法检测103例肺癌和32例肺良性病变患者及40例健康人群血清中的CEA、NSE、CYFRA21-1、CA125及Fer水平,并进行比较。结果肺癌组CEA、NSE、CYFRA21-1、CA125及Fer的水平分别为(110.2±95.5)ng/mL、(50.6±43.4)ng/mL、(32.8±29.5)ng/L、(122.7±110.4)U/L、(854.6±497.2)ng/mL,明显高于对照组和肺良性病变组(t=6.21、5.71、6.75、6.62、7.74,P0.05;t=5.26、4.86、5.81、5.20、6.26,P0.05);CEA、NSE、CYFRA21-1、CA125及Fer诊断肺癌的灵敏度分别为39.81%、24.27%、71.84%、68.93%、77.66%,5项指标联合检测灵敏度为96.12%、特异度为95.00%。结论 5项肿瘤标记物联合检测能明显提高肺癌的检出率,有利于肺癌的早期诊断,可以广泛应用于临床中。