Development of field-applicable endogenous internally controlled recombinase-aided amplification (EIC-RAA) assays for the detection of human papillomavirus genotypes 6 and 11 using sample releasing agent
Objective: Human papillomavirus (HPV) 6 and 11 are the two most common low-risk HPV subtypes, accounting for more than 90% of condyloma acuminatum. A simple, accurate and rapid screening method to be applied in community-level hospitals is in high demand. Methods: Endogenous internally controlled re...
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2022-11-01
|
| Series: | Heliyon |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2405844022026111 |
| _version_ | 1828180743001473024 |
|---|---|
| author | Anna He Cheng Fang Yue Ming He Tan Mengyi Zhang Ruiqing Zhang Jingyi Li Mingzhu Nie Fengyu Li Yaxin Hu Xinxin Shen Xiuge Rong Xuejun Ma |
| author_facet | Anna He Cheng Fang Yue Ming He Tan Mengyi Zhang Ruiqing Zhang Jingyi Li Mingzhu Nie Fengyu Li Yaxin Hu Xinxin Shen Xiuge Rong Xuejun Ma |
| author_sort | Anna He |
| collection | DOAJ |
| description | Objective: Human papillomavirus (HPV) 6 and 11 are the two most common low-risk HPV subtypes, accounting for more than 90% of condyloma acuminatum. A simple, accurate and rapid screening method to be applied in community-level hospitals is in high demand. Methods: Endogenous internally controlled recombinase-assisted amplification (EIC-RAA) assays for HPV6 and 11 were performed in a single closed-tube at 39 °C within 30 min. The sensitivity and specificity of EIC-RAA were examined using recombinant plasmids and pre-tested HPV DNA. A total of 233 clinical samples were collected, and the DNA was extracted by traditional multi-step extraction, or sample releasing agent, before analysis by EIC-RAA. For comparison, HPV detection via Quantitative real-time PCR (qPCR) was also performed. Results: The sensitivity of EIC-RAA analysis was 10 copies/reaction for HPV6, 100 copies/reaction for HPV11, and 100 copies/reaction for the human β-globin gene. No cross-reaction was observed with other HPV subtypes. Clinical performance of the EIC-RAA assay achieved a 100% of concordance rate with the commercial HPV qPCR kit. Further, the EIC-RAA assay achieved a 100% of concordance rate when using multi-step extracted DNA and sample releasing agent-processed DNA. Summary: The EIC-RAA assay for HPV6 and 11 detection possesses the advantages of accuracy, simplicity and rapidity, and demonstrates great potential to be used in community-level hospitals for field investigation. |
| first_indexed | 2024-04-12T05:50:10Z |
| format | Article |
| id | doaj.art-f92346cc7b474d139077f0f481a75948 |
| institution | Directory Open Access Journal |
| issn | 2405-8440 |
| language | English |
| last_indexed | 2024-04-12T05:50:10Z |
| publishDate | 2022-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Heliyon |
| spelling | doaj.art-f92346cc7b474d139077f0f481a759482022-12-22T03:45:20ZengElsevierHeliyon2405-84402022-11-01811e11323Development of field-applicable endogenous internally controlled recombinase-aided amplification (EIC-RAA) assays for the detection of human papillomavirus genotypes 6 and 11 using sample releasing agentAnna He0Cheng Fang1Yue Ming2He Tan3Mengyi Zhang4Ruiqing Zhang5Jingyi Li6Mingzhu Nie7Fengyu Li8Yaxin Hu9Xinxin Shen10Xiuge Rong11Xuejun Ma12North China University of Science and Technology, Tangshan, 063210, China; Tangshan Gongren Hospital, Tangshan, 063003, Hebei, China; NHC Key Laboratory of Medical Virology and Viral Diseases, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Street, Changping District, Beijing 102206, ChinaTangshan Gongren Hospital, Tangshan, 063003, Hebei, ChinaQiqihar Medical University, Qiqihar, Heilongjiang, 161000, ChinaHebei General Hospital, Shijiazhuang, 050051, Hebei, ChinaNorth China University of Science and Technology, Tangshan, 063210, China; Tangshan Gongren Hospital, Tangshan, 063003, Hebei, China; NHC Key Laboratory of Medical Virology and Viral Diseases, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Street, Changping District, Beijing 102206, ChinaNHC Key Laboratory of Medical Virology and Viral Diseases, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Street, Changping District, Beijing 102206, ChinaNHC Key Laboratory of Medical Virology and Viral Diseases, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Street, Changping District, Beijing 102206, China; Hebei General Hospital, Shijiazhuang, 050051, Hebei, ChinaNHC Key Laboratory of Medical Virology and Viral Diseases, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Street, Changping District, Beijing 102206, China; Hebei General Hospital, Shijiazhuang, 050051, Hebei, ChinaNHC Key Laboratory of Medical Virology and Viral Diseases, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Street, Changping District, Beijing 102206, China; Hebei General Hospital, Shijiazhuang, 050051, Hebei, ChinaNHC Key Laboratory of Medical Virology and Viral Diseases, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Street, Changping District, Beijing 102206, China; Hebei General Hospital, Shijiazhuang, 050051, Hebei, ChinaNHC Key Laboratory of Medical Virology and Viral Diseases, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Street, Changping District, Beijing 102206, China; Corresponding author.Tangshan Gongren Hospital, Tangshan, 063003, Hebei, China; Corresponding author.NHC Key Laboratory of Medical Virology and Viral Diseases, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Street, Changping District, Beijing 102206, China; Corresponding author.Objective: Human papillomavirus (HPV) 6 and 11 are the two most common low-risk HPV subtypes, accounting for more than 90% of condyloma acuminatum. A simple, accurate and rapid screening method to be applied in community-level hospitals is in high demand. Methods: Endogenous internally controlled recombinase-assisted amplification (EIC-RAA) assays for HPV6 and 11 were performed in a single closed-tube at 39 °C within 30 min. The sensitivity and specificity of EIC-RAA were examined using recombinant plasmids and pre-tested HPV DNA. A total of 233 clinical samples were collected, and the DNA was extracted by traditional multi-step extraction, or sample releasing agent, before analysis by EIC-RAA. For comparison, HPV detection via Quantitative real-time PCR (qPCR) was also performed. Results: The sensitivity of EIC-RAA analysis was 10 copies/reaction for HPV6, 100 copies/reaction for HPV11, and 100 copies/reaction for the human β-globin gene. No cross-reaction was observed with other HPV subtypes. Clinical performance of the EIC-RAA assay achieved a 100% of concordance rate with the commercial HPV qPCR kit. Further, the EIC-RAA assay achieved a 100% of concordance rate when using multi-step extracted DNA and sample releasing agent-processed DNA. Summary: The EIC-RAA assay for HPV6 and 11 detection possesses the advantages of accuracy, simplicity and rapidity, and demonstrates great potential to be used in community-level hospitals for field investigation.http://www.sciencedirect.com/science/article/pii/S2405844022026111Human papillomavirus 6 and 11Human β-globin geneEndogenous internally controlled recombinase-assisted amplificationSample releasing agent |
| spellingShingle | Anna He Cheng Fang Yue Ming He Tan Mengyi Zhang Ruiqing Zhang Jingyi Li Mingzhu Nie Fengyu Li Yaxin Hu Xinxin Shen Xiuge Rong Xuejun Ma Development of field-applicable endogenous internally controlled recombinase-aided amplification (EIC-RAA) assays for the detection of human papillomavirus genotypes 6 and 11 using sample releasing agent Heliyon Human papillomavirus 6 and 11 Human β-globin gene Endogenous internally controlled recombinase-assisted amplification Sample releasing agent |
| title | Development of field-applicable endogenous internally controlled recombinase-aided amplification (EIC-RAA) assays for the detection of human papillomavirus genotypes 6 and 11 using sample releasing agent |
| title_full | Development of field-applicable endogenous internally controlled recombinase-aided amplification (EIC-RAA) assays for the detection of human papillomavirus genotypes 6 and 11 using sample releasing agent |
| title_fullStr | Development of field-applicable endogenous internally controlled recombinase-aided amplification (EIC-RAA) assays for the detection of human papillomavirus genotypes 6 and 11 using sample releasing agent |
| title_full_unstemmed | Development of field-applicable endogenous internally controlled recombinase-aided amplification (EIC-RAA) assays for the detection of human papillomavirus genotypes 6 and 11 using sample releasing agent |
| title_short | Development of field-applicable endogenous internally controlled recombinase-aided amplification (EIC-RAA) assays for the detection of human papillomavirus genotypes 6 and 11 using sample releasing agent |
| title_sort | development of field applicable endogenous internally controlled recombinase aided amplification eic raa assays for the detection of human papillomavirus genotypes 6 and 11 using sample releasing agent |
| topic | Human papillomavirus 6 and 11 Human β-globin gene Endogenous internally controlled recombinase-assisted amplification Sample releasing agent |
| url | http://www.sciencedirect.com/science/article/pii/S2405844022026111 |
| work_keys_str_mv | AT annahe developmentoffieldapplicableendogenousinternallycontrolledrecombinaseaidedamplificationeicraaassaysforthedetectionofhumanpapillomavirusgenotypes6and11usingsamplereleasingagent AT chengfang developmentoffieldapplicableendogenousinternallycontrolledrecombinaseaidedamplificationeicraaassaysforthedetectionofhumanpapillomavirusgenotypes6and11usingsamplereleasingagent AT yueming developmentoffieldapplicableendogenousinternallycontrolledrecombinaseaidedamplificationeicraaassaysforthedetectionofhumanpapillomavirusgenotypes6and11usingsamplereleasingagent AT hetan developmentoffieldapplicableendogenousinternallycontrolledrecombinaseaidedamplificationeicraaassaysforthedetectionofhumanpapillomavirusgenotypes6and11usingsamplereleasingagent AT mengyizhang developmentoffieldapplicableendogenousinternallycontrolledrecombinaseaidedamplificationeicraaassaysforthedetectionofhumanpapillomavirusgenotypes6and11usingsamplereleasingagent AT ruiqingzhang developmentoffieldapplicableendogenousinternallycontrolledrecombinaseaidedamplificationeicraaassaysforthedetectionofhumanpapillomavirusgenotypes6and11usingsamplereleasingagent AT jingyili developmentoffieldapplicableendogenousinternallycontrolledrecombinaseaidedamplificationeicraaassaysforthedetectionofhumanpapillomavirusgenotypes6and11usingsamplereleasingagent AT mingzhunie developmentoffieldapplicableendogenousinternallycontrolledrecombinaseaidedamplificationeicraaassaysforthedetectionofhumanpapillomavirusgenotypes6and11usingsamplereleasingagent AT fengyuli developmentoffieldapplicableendogenousinternallycontrolledrecombinaseaidedamplificationeicraaassaysforthedetectionofhumanpapillomavirusgenotypes6and11usingsamplereleasingagent AT yaxinhu developmentoffieldapplicableendogenousinternallycontrolledrecombinaseaidedamplificationeicraaassaysforthedetectionofhumanpapillomavirusgenotypes6and11usingsamplereleasingagent AT xinxinshen developmentoffieldapplicableendogenousinternallycontrolledrecombinaseaidedamplificationeicraaassaysforthedetectionofhumanpapillomavirusgenotypes6and11usingsamplereleasingagent AT xiugerong developmentoffieldapplicableendogenousinternallycontrolledrecombinaseaidedamplificationeicraaassaysforthedetectionofhumanpapillomavirusgenotypes6and11usingsamplereleasingagent AT xuejunma developmentoffieldapplicableendogenousinternallycontrolledrecombinaseaidedamplificationeicraaassaysforthedetectionofhumanpapillomavirusgenotypes6and11usingsamplereleasingagent |