关于我国体外诊断试剂监督管理改革的建议

本文综述了美国、欧盟、日本、中国目前对体外诊断产品（试剂）监督管理的现状以及我国存在的问题。并根据我国具体情况提出了对体外诊断试剂监督管理的改革建议。     

五种国产乙型肝炎病毒表面抗原试剂盒的评价

[目的]评价5种乙肝病毒表面抗原(HBsAg)诊断试剂盒,筛选高质量的诊断试剂,确保血样HBsAg检测结果准确无误。[方法]5种HBsAg试剂盒均采用ELISA方法,对购买的国家参考品和收集的180份临床血浆标本进行检测,分别与参考品标准和本单位经北京万泰和上海科华双试剂检测一致的结果比较。[结果]5种试剂对灵敏度和精密度参考品的检测均符合要求;检测23份参考品结果的总符合率为96.52%,阳性符合率为100.00%,阴性符合率为96.00%;检测180份临床标本,总符合率为98.56%,阳性符合率为99.00%,阴性符合率为98.67%;检测阳性临床标本的δ值为-6.55(C)~-37.61(E);检测阴性临床标本的δ值为0.92(A)~1.65(E)。[结论]5种试剂在灵敏度、特异性、符合性、准确性方面存在差异,综合评价C试剂质量最符合要求。     

国内外结核菌聚合酶链反应试剂盒的临床检测结果比较

目的用相同标本比较国内外结核菌聚合酶链反应诊断试剂盒的临床检测效果,并初步探讨结核菌聚合酶链反应荧光诊断试剂盒在临床应用中定量检测结核菌数量的可行性。方法用聚合酶链反应技术,荧光探针杂交技术、酶联免疫反应技术以及常规细菌学方法检测并经双盲编号的84份临床痰标本和8份含痰结核菌标准品。结果在59例结核病患者痰标本中,国产PCR-酶联免疫检测试剂盒与PCR荧光试剂盒分别检出26例阳性和24例阳性,国外试剂盒检出24例阳性;在25例非结核病患者痰标本中,国产PCR-酶联免疫检测试剂盒与PCR荧光试剂盒分别检出21例真阴性和24例真阴性,国外试剂盒检出23例真阴性;细菌学各级别检查结果与PCR荧光检测CT值不呈递减关系。结论国内外结核菌聚合酶链反应诊断试剂盒对临床标本的检测结果无显著性差异;结核菌聚合酶链反应荧光诊断试剂盒尚不能定量检测痰标本中的结核菌数量,有待更多的临床数据加以证实。     

Factory packed and expired – about emergency insect sting kits

Background: Patients allergic to insect venom are instructed to always carry emergency medication–an emergency kit. According to the current guidelines, these emergency kits should contain a H1‐receptor‐blocking antihistamine and corticosteroid for oral use, as well as an epinephrine inhaler and in particular situations an epinephrine auto‐injector. Patients and Methods: For quality management reasons patients with wasp venom allergy who presented for sting challenge provocation test were told to demonstrate their emergency kits. Concomitantly, constituents of the patient's emergency kits were checked for date of expiry of the medication and the patients were interviewed on storage and use of the emergency kits. Results: In total 42 patients with a median duration time of systemic immunotherapy of 2.5 year were evaluated. Medication post date of expiration was found in 54% of the kits (n = 39). Only 31% of the patients could demonstrate how to use the kits correctly. Problems were especially evident concerning for using the application of the inhaler and auto‐injector. 50% of the patients demonstrated using epinephrine auto‐injectors in such way that an accidental injection into the fingers would have resulted. Conclusion: To assure safe and effective handling of all components of the emergency kit, continuous training and repeated supervised practice is necessary.     

Comparison of pyridoxal phosphate-supplemented reagent kits for alanine aminotransferase using centrifugal analysis

The addition of pyridoxal-5-phosphate for assay of alanine aminotransferase has been recommended. The referral methods are inconvenient for high volume instrumentation due to use of multiple reagents and blanks. We adapted a well-documented method to the centrifugal analyzer as a reference for adaptation of two kit methods. Reference intervals obtained and linearity determined were all similar. The kit methods compared favorably to the referral method. Linear regression analysis yielded the following: DOW = 1.011 BERG + 1.666, r = 0.9965; SKI = 0.938 BERG + 4.559, r = 0.9926; and DSKI = 1.028 BERG + 1.051, r = 0.9889. Precision of the assays was acceptable. We concluded that automation of reagent kits incorporating pyridoxal-5-phosphate is feasible and the assays compared favorably to a recommended method. High volume instrumentation can be used without denigration of analytical quality and to allow comparability to a documented method for interlaboratory review.     

标准化配置换药包预防骨科PICC导管相关性感染的研究

目的探讨标准化配置换药包对预防骨科PICC导管相关性感染的疗效。方法选择急诊收治的98例符合PICC中心静脉置管适应症的骨科患者为研究对象,随机将其分为对照组和观察组,各49例,置管过程中对照组使用常规换药包,观察组使用标准化配置换药包,对比分析两组导管相关性感染相关指标。结果观察组患者导管相关性血流感染率、出口部位感染发生率、感染发生率均低于对照组(P0.05);2组PICC置管术后在白细胞计数、抗生素使用时间、维护依从性及住院时间等方面比较,观察组均优于对照组(P0.05)。结论标准化配置换药包在预防骨科PICC导管相关性感染方面疗效确切,值得临床推广应用。     

Mercuric Chloride Poisoning Due to Ingestion of a Stool Fixative

Abstract

We present a case of ingestion of a commonly used stool fixative containing 675?mg of mercuric chloride per 15 mL vial. Early chelator therapy with dimercaprol and aggressive hydration were initiated and the patient remained asymptomatic. Safety packaging of this product is recommended.     

丙型肝炎病毒抗体诊断试剂盒的诊断性能评价

目的 通过与Ortho3．0丙型肝炎病毒（HCV）抗体诊断试剂盒比较，分析评价EIAgenHCV抗体诊断试剂盒（EIAgen）的诊断性能。方法应用考核试剂EIAgen和参比试剂Ortho3．0HCV抗体诊断试剂盒对2881份样本进行检测，检测结果不一致时，应用重组免疫印迹试验（RIBA）确证试剂RIBAHCV3．0或核酸试验（NAT）确证试剂进行确证，以对结果进行综合分析。结果2881份样本中，考核试剂及参比试剂检测结果均为阳性，且参比试剂的测量值／临界值（S／CO）≥3．8，或检测结果符合确证试验阳性结果的阳性标本为274份，考核试剂及参比试剂检测结果均为阳性且参比试剂的S／CO〈3．8为59份，阴性标本2539份，不确定的9份被剔除。考核试剂检测真阳性274份，无假阴性结果；真阴性2527份，假阳性12份。考核试剂敏感度为100％，高于参比试剂的98，91％；特异度为99．53％，略低于参比试剂的99．88％。考核试剂对部分国内常见HCV基因型（1a型、1b型、2a型、3型和6型）样本27份，均为真阳性，敏感度为100％，对于非HCV感染的病毒性肝炎、自身免疫性疾病及妊娠样本具有良好的特异度，特异度均为100％。溶血、脂血样本对考核试剂检测结果无影响。考核试剂阳性预测值为95．80％，阴性预测值为100％，准确性为99．57％。考核试剂S／CO≥5．9的样本301份，其中用参比试剂检测S／CO≥3，8占88．70％；考核试剂S／CO〈5．9的29份，其中用参比试剂检测S／CO〈3．8占86．21％。结论EIAgen敏感度100％，特异度较好，是一种优秀的检测抗-HCVEIAgen试剂，尤其适用于阳性样本的筛选。采用EIAgen试剂检测样本，当S／CO≥5．9时，样本的阳性预测值较高。     

G实验和真菌培养联合检测对临床深部真菌感染的诊断价值

目的评估血清1,3-β-D-葡聚糖定量分析(G实验)和真菌培养联合检测对临床深部真菌感染的诊断意义。方法通过回顾性分析75例怀疑深部真菌感染住院患者的G实验和真菌培养结果,分别计算两种方法及联合检测的灵敏度、特异度、阳性和阴性预测值。结果 G实验和真菌培养联合检测的灵敏度、特异度、阳性和阴性预测值分别为88.0%、96.0%、91.7%和94.1%。G实验的灵敏度和阳性预测值高,真菌培养的特异度高。结论G实验和真菌培养联合检测可提高实验的灵敏度,减少假阴性的发生,对早期诊断深部真菌感染有一定临床意义。     

结核分枝杆菌IFN-γ体外检测试剂的生产质量控制与临床研究探讨

依据《体外诊断试剂注册管理办法(试行)》等相关的法律法规,分别针对结核分枝杆菌IFN-γ（interferon gamma,γ干扰素）体外检测试剂盒的主要原材料、生产工艺、产品质量控制,以及临床研究的技术要求进行了概述,为该类试剂盒的研发和注册提供技术支撑。