Many factors have been identified as having the ability to affect the sensitivity of rapid antigen detection(RAD)tests for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2).This study aimed to identify the i...Many factors have been identified as having the ability to affect the sensitivity of rapid antigen detection(RAD)tests for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2).This study aimed to identify the impact of sample processing on the sensitivity of the RAD tests.We explored the effect of different inactivation methods,viral transport media(VTM)solutions,and sample preservation on the sensitivity of four RAD kits based on two SARS-CoV-2 strains.Compared with non-inactivation,heat inactivation significantly impacted the sensitivity of most RAD kits;however,β-propiolactone inactivation only had a minor effect.Some of the VTM solutions(VTM2,MANTACC)had a significant influence on the sensitivity of the RAD kits,especially for low viral-loads samples.The detection value of RAD kits was slightly decreased,while most of them were still in the detection range with the extension of preservation time and the increase of freeze–thaw cycles.Our results showed that selecting the appropriate inactivation methods and VTM solutions is necessary during reagent development,performance evaluation,and clinical application。展开更多
Importance:The use of the rapid antigen-detection test(RADT)has become the standard of care in the early diagnosis of group A beta-hemolytic Streptococcus(GAS)pharyngitis.Concern has been expressed over increased fals...Importance:The use of the rapid antigen-detection test(RADT)has become the standard of care in the early diagnosis of group A beta-hemolytic Streptococcus(GAS)pharyngitis.Concern has been expressed over increased false positives when the child had been treated recently for GAS pharyngitis,resulting in over use of antibiotics.Objective:To determine if the false positive rate for RADT is increased in children recently treated for GAS pharyngitis.Methods:We conducted a prospective study to evaluate 300 children from a private practice with acute pharyngitis who were treated for GAS pharyngitis within the preceding 28 days(study group)compared to 306 children of comparable age who had not been previously treated(control group).RADT and throat culture were performed on all children presenting with signs and symptoms of acute pharyngitis.The false positive and false negative rates were determined and compared in both groups.results:The false positive rate of 11.5%(23/200)in the study group was significantly higher than the false positive rate of 0 in the control group.False positives were more likely to occur in younger children.Interpretation:These data would indicate that while RADT is reliable in most children,it can lead to over treatment in children who have been recently treated for GAS.In children treated in the preceding 28 days for GAS pharyngitis,the presence of infection should be determined with a throat culture only.Treatment based on a positive RADT should be reserved for children not recently treated for GAS pharyngitis.展开更多
Middle East respiratory syndrome coronavirus(MERS-CoV)infection in humans has a high mortality of>30%.Dromedaries are the reservoir of MERS-CoV and the main source of human infections.However,MERS-CoV infections in...Middle East respiratory syndrome coronavirus(MERS-CoV)infection in humans has a high mortality of>30%.Dromedaries are the reservoir of MERS-CoV and the main source of human infections.However,MERS-CoV infections in dromedaries are usually subclinical.Rapid diagnosis of MERS-CoV infection in these animals is important in preventing camel-to-human transmission of the virus.The possible cross-reactivity of a previously reported rapid nucleocapsid protein-based antigen detection assay for MERS-CoV was examined with different CoVs,including Tylonycteris bat CoV HKU4,dromedary camel CoV UAE-HKU23,human CoV-229E,human CoV-OC43,severe acute respiratory syndrome CoV-2 and rabbit CoV HKU14,where none of them showed false-positive results.The assay was further validated using quantitative real-time reverse transcription-polymerase chain reaction-confirmed MERS-CoV-positive and MERS-CoV-negative dromedary nasal samples collected in Dubai,the United Arab Emirates,which showed that the rapid antigen detection assay has a specificity of 100%and sensitivity of 91.7%.展开更多
目的评价A族溶血性链球菌(group A streptococcus, GAS)抗原快速检测方法的敏感性和特异性,分析其药物敏感性。方法选取2017年1~12月首都儿科研究所附属儿童医院门诊考虑存在链球菌感染的患儿324例,采集咽拭子标本送检,同时以GAS抗原快...目的评价A族溶血性链球菌(group A streptococcus, GAS)抗原快速检测方法的敏感性和特异性,分析其药物敏感性。方法选取2017年1~12月首都儿科研究所附属儿童医院门诊考虑存在链球菌感染的患儿324例,采集咽拭子标本送检,同时以GAS抗原快速检测方法(胶体金法)和传统培养方法检测链球菌,进行药物敏感性试验。结果 324例咽拭子标本中,传统培养法链球菌阳性95例,阴性229例;胶体金法检测链球菌阳性98例,阴性226例,敏感性为90.5%,特异性为94.8%。药敏结果显示,所有菌株均对青霉素类及头孢类抗菌药物敏感,而对四环素及大环内酯类药物的耐药率已超过90%。结论胶体金法进行GAS抗原检测能满足临床急诊和门诊样本随时检测的需求,可用于儿童GAS感染的辅助诊断。青霉素类仍是首选治疗链球菌感染的药物。展开更多
AIM To determine the distribution of rotavirus VP7 gene in hospitalized children in Yunnan, China. METHODS A total of 366 stool specimens were collected from hospitalized children in hospitals in Yunnan Province from ...AIM To determine the distribution of rotavirus VP7 gene in hospitalized children in Yunnan, China. METHODS A total of 366 stool specimens were collected from hospitalized children in hospitals in Yunnan Province from September 2010 to December 2013. The genomic RNA electropherotypes and the G genotypes of the rotaviruses were determined. A phylogenetic analysis of the VP7 gene was performed. Rotavirus isolation was performed, and characterized by plaque, minimum essential medium, and all genes sequence analysis. Quantification of antibodies for inactivated vaccine prepared with ZTR-68 was examined by enzyme-linked immunosorbent assay and microneutralization assay.RESULTS Group A human rotavirus was detected in 177 of 366(48.4%) stool samples using a colloidal gold device assay. The temporal distribution of rotavirus cases showed significant correlation with the mean air temperature. Rotaviruses were isolated from 13% of the rotavirus-positive samples. The predominant genotype was G1(43.5%), followed by G3(21.7%), G9(17.4%), G2(4.3%), G4(8.7%), and mixed(4.3%) among a total of 23 rotavirus isolates. A rotavirus strain was isolated from a rotavirus-positive stool sample of a 4-month-old child in The First People's Hospital of Zhaotong(2010) for use as a candidate human inactivated rotavirus vaccine strain and for further research, and was designated ZTR-68. The genotype of 11 gene segments of strain ZTR-68(RVA/Human-wt/CHN/ZTR-68/2010/G1P[8]) was characterized. The genotype constellation of strain ZTR-68 was identified as G1-P[8]-I1-R1-C1-M1-A1-N1-T1-E1-H1. The VP7 and VP4 genotypes of strain ZTR-68 were similar to Wa-like strains.CONCLUSIONS A high prevalence of the G1, G2, and G3 genotypes was detected from 2010 to 2012. However, a dominant prevalence of the G9 genotype was identified as the cause of gastroenteritis in children in Yunnan, China, in 2013. A candidate human inactivated rotavirus vaccine strain, designated ZTR-68 was isolated, characterized, and showed immunogenicity. Our data will be useful for the展开更多
基金supported by China's National Science and Technology Major Project(2018ZX10102001)the Non-profit Central Research Institute Fund of Chinese Academy of Medical Sciences(2019PT3100292020PT310004).
文摘Many factors have been identified as having the ability to affect the sensitivity of rapid antigen detection(RAD)tests for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2).This study aimed to identify the impact of sample processing on the sensitivity of the RAD tests.We explored the effect of different inactivation methods,viral transport media(VTM)solutions,and sample preservation on the sensitivity of four RAD kits based on two SARS-CoV-2 strains.Compared with non-inactivation,heat inactivation significantly impacted the sensitivity of most RAD kits;however,β-propiolactone inactivation only had a minor effect.Some of the VTM solutions(VTM2,MANTACC)had a significant influence on the sensitivity of the RAD kits,especially for low viral-loads samples.The detection value of RAD kits was slightly decreased,while most of them were still in the detection range with the extension of preservation time and the increase of freeze–thaw cycles.Our results showed that selecting the appropriate inactivation methods and VTM solutions is necessary during reagent development,performance evaluation,and clinical application。
文摘Importance:The use of the rapid antigen-detection test(RADT)has become the standard of care in the early diagnosis of group A beta-hemolytic Streptococcus(GAS)pharyngitis.Concern has been expressed over increased false positives when the child had been treated recently for GAS pharyngitis,resulting in over use of antibiotics.Objective:To determine if the false positive rate for RADT is increased in children recently treated for GAS pharyngitis.Methods:We conducted a prospective study to evaluate 300 children from a private practice with acute pharyngitis who were treated for GAS pharyngitis within the preceding 28 days(study group)compared to 306 children of comparable age who had not been previously treated(control group).RADT and throat culture were performed on all children presenting with signs and symptoms of acute pharyngitis.The false positive and false negative rates were determined and compared in both groups.results:The false positive rate of 11.5%(23/200)in the study group was significantly higher than the false positive rate of 0 in the control group.False positives were more likely to occur in younger children.Interpretation:These data would indicate that while RADT is reliable in most children,it can lead to over treatment in children who have been recently treated for GAS.In children treated in the preceding 28 days for GAS pharyngitis,the presence of infection should be determined with a throat culture only.Treatment based on a positive RADT should be reserved for children not recently treated for GAS pharyngitis.
基金supported by the Health and Medical Research Fund-Commissioned Research on Control of Infectious Diseases(Phase IV,CID-HKU6)a donation of TE Health Consultant Company Limitedthe framework of the Higher Education Sprout Project by the Ministry of Education(MOE-111-S-023-A)in Taiwan.
文摘Middle East respiratory syndrome coronavirus(MERS-CoV)infection in humans has a high mortality of>30%.Dromedaries are the reservoir of MERS-CoV and the main source of human infections.However,MERS-CoV infections in dromedaries are usually subclinical.Rapid diagnosis of MERS-CoV infection in these animals is important in preventing camel-to-human transmission of the virus.The possible cross-reactivity of a previously reported rapid nucleocapsid protein-based antigen detection assay for MERS-CoV was examined with different CoVs,including Tylonycteris bat CoV HKU4,dromedary camel CoV UAE-HKU23,human CoV-229E,human CoV-OC43,severe acute respiratory syndrome CoV-2 and rabbit CoV HKU14,where none of them showed false-positive results.The assay was further validated using quantitative real-time reverse transcription-polymerase chain reaction-confirmed MERS-CoV-positive and MERS-CoV-negative dromedary nasal samples collected in Dubai,the United Arab Emirates,which showed that the rapid antigen detection assay has a specificity of 100%and sensitivity of 91.7%.
文摘目的评价A族溶血性链球菌(group A streptococcus, GAS)抗原快速检测方法的敏感性和特异性,分析其药物敏感性。方法选取2017年1~12月首都儿科研究所附属儿童医院门诊考虑存在链球菌感染的患儿324例,采集咽拭子标本送检,同时以GAS抗原快速检测方法(胶体金法)和传统培养方法检测链球菌,进行药物敏感性试验。结果 324例咽拭子标本中,传统培养法链球菌阳性95例,阴性229例;胶体金法检测链球菌阳性98例,阴性226例,敏感性为90.5%,特异性为94.8%。药敏结果显示,所有菌株均对青霉素类及头孢类抗菌药物敏感,而对四环素及大环内酯类药物的耐药率已超过90%。结论胶体金法进行GAS抗原检测能满足临床急诊和门诊样本随时检测的需求,可用于儿童GAS感染的辅助诊断。青霉素类仍是首选治疗链球菌感染的药物。
基金Supported by the CAMS Initiative for Innovative Medicine,No.2016-I2M-1-019 and No.2016-I2M-3-026National Natural Science Foundation of China,No.31700154+2 种基金Major Science and Technology Special Project of Yunnan Province(Biomedicine),No.2018ZF006Science and Technology Project of Yunnan Province-general program,No.2016FB034The State Project for Essential Drug Research and Development,the national "Twelfth Five-Year" plan,No.2014ZX09102041004
文摘AIM To determine the distribution of rotavirus VP7 gene in hospitalized children in Yunnan, China. METHODS A total of 366 stool specimens were collected from hospitalized children in hospitals in Yunnan Province from September 2010 to December 2013. The genomic RNA electropherotypes and the G genotypes of the rotaviruses were determined. A phylogenetic analysis of the VP7 gene was performed. Rotavirus isolation was performed, and characterized by plaque, minimum essential medium, and all genes sequence analysis. Quantification of antibodies for inactivated vaccine prepared with ZTR-68 was examined by enzyme-linked immunosorbent assay and microneutralization assay.RESULTS Group A human rotavirus was detected in 177 of 366(48.4%) stool samples using a colloidal gold device assay. The temporal distribution of rotavirus cases showed significant correlation with the mean air temperature. Rotaviruses were isolated from 13% of the rotavirus-positive samples. The predominant genotype was G1(43.5%), followed by G3(21.7%), G9(17.4%), G2(4.3%), G4(8.7%), and mixed(4.3%) among a total of 23 rotavirus isolates. A rotavirus strain was isolated from a rotavirus-positive stool sample of a 4-month-old child in The First People's Hospital of Zhaotong(2010) for use as a candidate human inactivated rotavirus vaccine strain and for further research, and was designated ZTR-68. The genotype of 11 gene segments of strain ZTR-68(RVA/Human-wt/CHN/ZTR-68/2010/G1P[8]) was characterized. The genotype constellation of strain ZTR-68 was identified as G1-P[8]-I1-R1-C1-M1-A1-N1-T1-E1-H1. The VP7 and VP4 genotypes of strain ZTR-68 were similar to Wa-like strains.CONCLUSIONS A high prevalence of the G1, G2, and G3 genotypes was detected from 2010 to 2012. However, a dominant prevalence of the G9 genotype was identified as the cause of gastroenteritis in children in Yunnan, China, in 2013. A candidate human inactivated rotavirus vaccine strain, designated ZTR-68 was isolated, characterized, and showed immunogenicity. Our data will be useful for the
