目的:评价适合临床使用的检测幽门螺杆菌(Helicobacter pylori,Hp)的方法。方法:186例入选患者进行细菌培养,快速尿素酶,病理组织学,现症感染血清学抗体快速检测法(CIM-GLD’s Hp RT),细菌培养阳性或另3项中2项阳性认为有Hp感染。结果:...目的:评价适合临床使用的检测幽门螺杆菌(Helicobacter pylori,Hp)的方法。方法:186例入选患者进行细菌培养,快速尿素酶,病理组织学,现症感染血清学抗体快速检测法(CIM-GLD’s Hp RT),细菌培养阳性或另3项中2项阳性认为有Hp感染。结果:细菌培养,CIM-GLD’s Hp RT,病理组织学,快速尿素酶法敏感性分别为89.32%、95.15%、91.26%、79.61%;特异性分别为97.59%、93.98%、95.18%、92.77%。结论:CIM-GLD’s Hp RT具有较高的准确诊断Hp感染的价值。展开更多
[Objective] This study aimed to compare the detection results of antibodies against infectious bursal disease virus with test strips and agar gel immunodiffusion method. [Method] Antibodies against infectious bursal d...[Objective] This study aimed to compare the detection results of antibodies against infectious bursal disease virus with test strips and agar gel immunodiffusion method. [Method] Antibodies against infectious bursal disease virus in chicken serum were detected using test strips developed in our laboratory, and the results were comparad^with that using traditional agar diffusion method. [Result] The comparative study of the two methods showed that the sensitivity of test strips was eight times over agar gel immunodiffusion; test strips showed higher detection rate in the deter- mination test of 216 clinical samples, with high specificity, easy preservation, and simple and rapid operation, thereby being more suitable for the monitoring of clinical antibodies. [Conclusion] Test strips could replace the existing serological methods, having great promotion and application value in antibody monitoring.展开更多
Potency is one of the most important indexes of inactivated vaccines.A number of methods have been established to assay the potency,of which the NIH test and single-dose mouse protection test are the "prescribed ...Potency is one of the most important indexes of inactivated vaccines.A number of methods have been established to assay the potency,of which the NIH test and single-dose mouse protection test are the "prescribed methods".Here,we report a method to semi-quantitatively assay the potency of an inactivated rabies vaccine,which uses fewer animals and takes less time to complete.Depending on the quality requirements of a vaccine(e.g.minimum potency),a rabies reference vaccine is,for example,diluted to the minimum potency,and 50 μL of the dilution is taken to inoculate 10 mice.The same amount of the test rabies vaccine is inoculated into another 10 mice.After two weeks,all mice are bled and serum samples are assayed for viral neutralizing antibody by the fluorescent antibody virus neutralization(FAVN) test.By comparing the median and interquartile range of antibody titers of the reference vaccine with those of the test vaccine,the test vaccine potency can be semi-quantitatively judged as to whether it is in accord with the required quality.The reliability of this method was also confirmed in dogs.The procedure can be recommended for batch potency testing during inactivated rabies vaccine production.展开更多
Coronavirus disease 2019(COVID-19),caused by SARS-CoV-2,has rapidly spread and caused a severe global pandemic.Because no specific drugs are available for COVID-19 and few vaccines are available for SARS-CoV-2,accurat...Coronavirus disease 2019(COVID-19),caused by SARS-CoV-2,has rapidly spread and caused a severe global pandemic.Because no specific drugs are available for COVID-19 and few vaccines are available for SARS-CoV-2,accurate and rapid diagnosis of COVID-19 has been the most crucial measure to control this pandemic.Here,we developed a portable bifunctional electrical detector based on graphene fieldeffect transistors for SARS-CoV-2 through either nucleic acid hybridization or antigen-antibody protein interaction,with ultra-low limits of detection of~0.1 and~1 fg mL^(−1) in phosphate buffer saline,respectively.We validated our method by assessment of RNA extracts from the oropharyngeal swabs of ten COVID-19 patients and eight healthy subjects,and the IgM/IgG antibodies from serum specimens of six COVID-19 patients and three healthy subjects.Here we show that the diagnostic results are in excellent agreement with the findings of polymerase chain reaction-based optical methods;they also exhibit rapid detection speed(~10 min for nucleic acid detection and~5 min for immunoassay).Therefore,our assay provides an efficient,accurate tool for high-throughput point-of-care testing.展开更多
文摘目的:评价适合临床使用的检测幽门螺杆菌(Helicobacter pylori,Hp)的方法。方法:186例入选患者进行细菌培养,快速尿素酶,病理组织学,现症感染血清学抗体快速检测法(CIM-GLD’s Hp RT),细菌培养阳性或另3项中2项阳性认为有Hp感染。结果:细菌培养,CIM-GLD’s Hp RT,病理组织学,快速尿素酶法敏感性分别为89.32%、95.15%、91.26%、79.61%;特异性分别为97.59%、93.98%、95.18%、92.77%。结论:CIM-GLD’s Hp RT具有较高的准确诊断Hp感染的价值。
文摘[Objective] This study aimed to compare the detection results of antibodies against infectious bursal disease virus with test strips and agar gel immunodiffusion method. [Method] Antibodies against infectious bursal disease virus in chicken serum were detected using test strips developed in our laboratory, and the results were comparad^with that using traditional agar diffusion method. [Result] The comparative study of the two methods showed that the sensitivity of test strips was eight times over agar gel immunodiffusion; test strips showed higher detection rate in the deter- mination test of 216 clinical samples, with high specificity, easy preservation, and simple and rapid operation, thereby being more suitable for the monitoring of clinical antibodies. [Conclusion] Test strips could replace the existing serological methods, having great promotion and application value in antibody monitoring.
基金the China National"863"Program(Approval No.2011AA10A212)Special Fund for Agro-Scientific Research in the Public Interest(ApprovalNo.201203056)
文摘Potency is one of the most important indexes of inactivated vaccines.A number of methods have been established to assay the potency,of which the NIH test and single-dose mouse protection test are the "prescribed methods".Here,we report a method to semi-quantitatively assay the potency of an inactivated rabies vaccine,which uses fewer animals and takes less time to complete.Depending on the quality requirements of a vaccine(e.g.minimum potency),a rabies reference vaccine is,for example,diluted to the minimum potency,and 50 μL of the dilution is taken to inoculate 10 mice.The same amount of the test rabies vaccine is inoculated into another 10 mice.After two weeks,all mice are bled and serum samples are assayed for viral neutralizing antibody by the fluorescent antibody virus neutralization(FAVN) test.By comparing the median and interquartile range of antibody titers of the reference vaccine with those of the test vaccine,the test vaccine potency can be semi-quantitatively judged as to whether it is in accord with the required quality.The reliability of this method was also confirmed in dogs.The procedure can be recommended for batch potency testing during inactivated rabies vaccine production.
基金the National Key R&D Program of China(2017YFA0204901)the National Natural Science Foundation of China(21727806,21772003 and 21933001)+1 种基金the Tencent Foundation through the XPLORER PRIZE,Guangdong Major Project of Basic and Applied Basic Research(2019B030302007)Beijing National Laboratory for Molecular Sciences(BNLMS201901)。
文摘Coronavirus disease 2019(COVID-19),caused by SARS-CoV-2,has rapidly spread and caused a severe global pandemic.Because no specific drugs are available for COVID-19 and few vaccines are available for SARS-CoV-2,accurate and rapid diagnosis of COVID-19 has been the most crucial measure to control this pandemic.Here,we developed a portable bifunctional electrical detector based on graphene fieldeffect transistors for SARS-CoV-2 through either nucleic acid hybridization or antigen-antibody protein interaction,with ultra-low limits of detection of~0.1 and~1 fg mL^(−1) in phosphate buffer saline,respectively.We validated our method by assessment of RNA extracts from the oropharyngeal swabs of ten COVID-19 patients and eight healthy subjects,and the IgM/IgG antibodies from serum specimens of six COVID-19 patients and three healthy subjects.Here we show that the diagnostic results are in excellent agreement with the findings of polymerase chain reaction-based optical methods;they also exhibit rapid detection speed(~10 min for nucleic acid detection and~5 min for immunoassay).Therefore,our assay provides an efficient,accurate tool for high-throughput point-of-care testing.
