Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle<

AbstractMonkeypox virus (MPXV) infection confirmation needs reliable polymerase chain reaction (PCR) assays; in addition, viral clade attribution is a key factor in containment measures, considering a more severe syndrome in clade I and possibility of simultaneous circulation. This study aims to eva...
Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Alessandro Mancon [verfasserIn] Angelo Raccagni [verfasserIn] Gloria Gagliardi [verfasserIn] Davide Moschese [verfasserIn] Alberto Rizzo [verfasserIn] Andrea Giacomelli [verfasserIn] Miriam Cutrera [verfasserIn] Federica Salari [verfasserIn] Fiorenza Bracchitta [verfasserIn] Spinello Antinori [verfasserIn] Andrea Gori [verfasserIn] Giuliano Rizzardini [verfasserIn] Antonella Castagna [verfasserIn] Maria Rita Gismondo [verfasserIn] Silvia Nozza [verfasserIn] Davide Mileto [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2024

Schlagwörter:	monkeypox virus clade determination methods comparison all-in-one RealTime-PCR

Übergeordnetes Werk:	In: Emerging Microbes and Infections - Taylor & Francis Group, 2013, (2024)
Übergeordnetes Werk:	year:2024

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1080/22221751.2024.2337666

Katalog-ID:	DOAJ095900977

Internformat


LEADER	01000naa a22002652 4500
001	DOAJ095900977
003	DE-627
005	20240413125640.0
007	cr uuu---uuuuu
008	240413s2024 xx \|\|\|\|\|o 00\| \|\|eng c
024	7		\|a 10.1080/22221751.2024.2337666 \|2 doi
035			\|a (DE-627)DOAJ095900977
035			\|a (DE-599)DOAJa1c79515d0914cfea3d062b26569ff12
040			\|a DE-627 \|b ger \|c DE-627 \|e rakwb
041			\|a eng
050		0	\|a RC109-216
050		0	\|a QR1-502
100	0		\|a Alessandro Mancon \|e verfasserin \|4 aut
245	1	0	\|a Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle<
264		1	\|c 2024
336			\|a Text \|b txt \|2 rdacontent
337			\|a Computermedien \|b c \|2 rdamedia
338			\|a Online-Ressource \|b cr \|2 rdacarrier
520			\|a AbstractMonkeypox virus (MPXV) infection confirmation needs reliable polymerase chain reaction (PCR) assays; in addition, viral clade attribution is a key factor in containment measures, considering a more severe syndrome in clade I and possibility of simultaneous circulation. This study aims to evaluate the performance of all-in-one STANDARD M10 MPX/OPX (SD BIOSENSOR, South Korea – M10). Frozen samples from 205 subjects were selected and stratified according to routine test results (RealStar® Orthopoxvirus PCR Kit 1.0, altona DIAGNOTICS, Germany – RS; RS-1): in details, 100 negative skin lesions (SL) and 200 positive samples at variable stage of infection were analyzed. Positive samples were retested with RS (RS-2). Positive and Negative Percent Agreement (PPA, NPA) were calculated. The median (IQR) Ct values of RS and M10 (OPXV target) assays were highly similar. The PPA of M10 compared to RS-1 was 89.5% considering system interpretation, and 96.0%, when the operator classified results as positive if any target was detected; NPA was 100%. Comparing RS-2 run and M10, an overall concordance of 95.3% between assays was found; however, considering operator interpretation, M10 returned more positive results than RS-2. The occurrence of False Negative results was likely associated to influence of thawing on low viral concentration; no False Positive tests were observed. All samples collected at the time of Mpox diagnosis were positive and M10 correctly attributed the clade (West-Africa/II). M10 MPX/OPX assay demonstrated high reliability in confirming MPXV infection and clade attribution.
650		4	\|a monkeypox virus
650		4	\|a clade determination
650		4	\|a methods comparison
650		4	\|a all-in-one RealTime-PCR
653		0	\|a Infectious and parasitic diseases
653		0	\|a Microbiology
700	0		\|a Angelo Raccagni \|e verfasserin \|4 aut
700	0		\|a Gloria Gagliardi \|e verfasserin \|4 aut
700	0		\|a Davide Moschese \|e verfasserin \|4 aut
700	0		\|a Alberto Rizzo \|e verfasserin \|4 aut
700	0		\|a Andrea Giacomelli \|e verfasserin \|4 aut
700	0		\|a Miriam Cutrera \|e verfasserin \|4 aut
700	0		\|a Federica Salari \|e verfasserin \|4 aut
700	0		\|a Fiorenza Bracchitta \|e verfasserin \|4 aut
700	0		\|a Spinello Antinori \|e verfasserin \|4 aut
700	0		\|a Andrea Gori \|e verfasserin \|4 aut
700	0		\|a Giuliano Rizzardini \|e verfasserin \|4 aut
700	0		\|a Antonella Castagna \|e verfasserin \|4 aut
700	0		\|a Maria Rita Gismondo \|e verfasserin \|4 aut
700	0		\|a Silvia Nozza \|e verfasserin \|4 aut
700	0		\|a Davide Mileto \|e verfasserin \|4 aut
773	0	8	\|i In \|t Emerging Microbes and Infections \|d Taylor & Francis Group, 2013 \|g (2024) \|w (DE-627)726120715 \|w (DE-600)2681359-2 \|x 22221751 \|7 nnns
773	1	8	\|g year:2024
856	4	0	\|u https://doi.org/10.1080/22221751.2024.2337666 \|z kostenfrei
856	4	0	\|u https://doaj.org/article/a1c79515d0914cfea3d062b26569ff12 \|z kostenfrei
856	4	0	\|u https://www.tandfonline.com/doi/10.1080/22221751.2024.2337666 \|z kostenfrei
856	4	2	\|u https://doaj.org/toc/2222-1751 \|y Journal toc \|z kostenfrei
912			\|a GBV_USEFLAG_A
912			\|a SYSFLAG_A
912			\|a GBV_DOAJ
912			\|a GBV_ILN_20
912			\|a GBV_ILN_22
912			\|a GBV_ILN_23
912			\|a GBV_ILN_24
912			\|a GBV_ILN_31
912			\|a GBV_ILN_39
912			\|a GBV_ILN_40
912			\|a GBV_ILN_60
912			\|a GBV_ILN_62
912			\|a GBV_ILN_63
912			\|a GBV_ILN_65
912			\|a GBV_ILN_69
912			\|a GBV_ILN_70
912			\|a GBV_ILN_73
912			\|a GBV_ILN_74
912			\|a GBV_ILN_95
912			\|a GBV_ILN_105
912			\|a GBV_ILN_110
912			\|a GBV_ILN_151
912			\|a GBV_ILN_161
912			\|a GBV_ILN_170
912			\|a GBV_ILN_206
912			\|a GBV_ILN_213
912			\|a GBV_ILN_230
912			\|a GBV_ILN_285
912			\|a GBV_ILN_293
912			\|a GBV_ILN_602
912			\|a GBV_ILN_2014
912			\|a GBV_ILN_4012
912			\|a GBV_ILN_4037
912			\|a GBV_ILN_4112
912			\|a GBV_ILN_4125
912			\|a GBV_ILN_4126
912			\|a GBV_ILN_4249
912			\|a GBV_ILN_4305
912			\|a GBV_ILN_4306
912			\|a GBV_ILN_4307
912			\|a GBV_ILN_4313
912			\|a GBV_ILN_4322
912			\|a GBV_ILN_4323
912			\|a GBV_ILN_4324
912			\|a GBV_ILN_4325
912			\|a GBV_ILN_4338
912			\|a GBV_ILN_4367
912			\|a GBV_ILN_4700
951			\|a AR
952			\|j 2024

Indexfelder

author_variant	a m am a r ar g g gg d m dm a r ar a g ag m c mc f s fs f b fb s a sa a g ag g r gr a c ac m r g mrg s n sn d m dm
matchkey_str	article:22221751:2024----::vlainfnltclefracotetnadm1mxpasyoteiutnosndtcinncaetrbtoomnepxiu
hierarchy_sort_str	2024
callnumber-subject-code	RC
publishDate	2024
allfields	10.1080/22221751.2024.2337666 doi (DE-627)DOAJ095900977 (DE-599)DOAJa1c79515d0914cfea3d062b26569ff12 DE-627 ger DE-627 rakwb eng RC109-216 QR1-502 Alessandro Mancon verfasserin aut Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle< 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier AbstractMonkeypox virus (MPXV) infection confirmation needs reliable polymerase chain reaction (PCR) assays; in addition, viral clade attribution is a key factor in containment measures, considering a more severe syndrome in clade I and possibility of simultaneous circulation. This study aims to evaluate the performance of all-in-one STANDARD M10 MPX/OPX (SD BIOSENSOR, South Korea – M10). Frozen samples from 205 subjects were selected and stratified according to routine test results (RealStar® Orthopoxvirus PCR Kit 1.0, altona DIAGNOTICS, Germany – RS; RS-1): in details, 100 negative skin lesions (SL) and 200 positive samples at variable stage of infection were analyzed. Positive samples were retested with RS (RS-2). Positive and Negative Percent Agreement (PPA, NPA) were calculated. The median (IQR) Ct values of RS and M10 (OPXV target) assays were highly similar. The PPA of M10 compared to RS-1 was 89.5% considering system interpretation, and 96.0%, when the operator classified results as positive if any target was detected; NPA was 100%. Comparing RS-2 run and M10, an overall concordance of 95.3% between assays was found; however, considering operator interpretation, M10 returned more positive results than RS-2. The occurrence of False Negative results was likely associated to influence of thawing on low viral concentration; no False Positive tests were observed. All samples collected at the time of Mpox diagnosis were positive and M10 correctly attributed the clade (West-Africa/II). M10 MPX/OPX assay demonstrated high reliability in confirming MPXV infection and clade attribution. monkeypox virus clade determination methods comparison all-in-one RealTime-PCR Infectious and parasitic diseases Microbiology Angelo Raccagni verfasserin aut Gloria Gagliardi verfasserin aut Davide Moschese verfasserin aut Alberto Rizzo verfasserin aut Andrea Giacomelli verfasserin aut Miriam Cutrera verfasserin aut Federica Salari verfasserin aut Fiorenza Bracchitta verfasserin aut Spinello Antinori verfasserin aut Andrea Gori verfasserin aut Giuliano Rizzardini verfasserin aut Antonella Castagna verfasserin aut Maria Rita Gismondo verfasserin aut Silvia Nozza verfasserin aut Davide Mileto verfasserin aut In Emerging Microbes and Infections Taylor & Francis Group, 2013 (2024) (DE-627)726120715 (DE-600)2681359-2 22221751 nnns year:2024 https://doi.org/10.1080/22221751.2024.2337666 kostenfrei https://doaj.org/article/a1c79515d0914cfea3d062b26569ff12 kostenfrei https://www.tandfonline.com/doi/10.1080/22221751.2024.2337666 kostenfrei https://doaj.org/toc/2222-1751 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2024
spelling	10.1080/22221751.2024.2337666 doi (DE-627)DOAJ095900977 (DE-599)DOAJa1c79515d0914cfea3d062b26569ff12 DE-627 ger DE-627 rakwb eng RC109-216 QR1-502 Alessandro Mancon verfasserin aut Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle< 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier AbstractMonkeypox virus (MPXV) infection confirmation needs reliable polymerase chain reaction (PCR) assays; in addition, viral clade attribution is a key factor in containment measures, considering a more severe syndrome in clade I and possibility of simultaneous circulation. This study aims to evaluate the performance of all-in-one STANDARD M10 MPX/OPX (SD BIOSENSOR, South Korea – M10). Frozen samples from 205 subjects were selected and stratified according to routine test results (RealStar® Orthopoxvirus PCR Kit 1.0, altona DIAGNOTICS, Germany – RS; RS-1): in details, 100 negative skin lesions (SL) and 200 positive samples at variable stage of infection were analyzed. Positive samples were retested with RS (RS-2). Positive and Negative Percent Agreement (PPA, NPA) were calculated. The median (IQR) Ct values of RS and M10 (OPXV target) assays were highly similar. The PPA of M10 compared to RS-1 was 89.5% considering system interpretation, and 96.0%, when the operator classified results as positive if any target was detected; NPA was 100%. Comparing RS-2 run and M10, an overall concordance of 95.3% between assays was found; however, considering operator interpretation, M10 returned more positive results than RS-2. The occurrence of False Negative results was likely associated to influence of thawing on low viral concentration; no False Positive tests were observed. All samples collected at the time of Mpox diagnosis were positive and M10 correctly attributed the clade (West-Africa/II). M10 MPX/OPX assay demonstrated high reliability in confirming MPXV infection and clade attribution. monkeypox virus clade determination methods comparison all-in-one RealTime-PCR Infectious and parasitic diseases Microbiology Angelo Raccagni verfasserin aut Gloria Gagliardi verfasserin aut Davide Moschese verfasserin aut Alberto Rizzo verfasserin aut Andrea Giacomelli verfasserin aut Miriam Cutrera verfasserin aut Federica Salari verfasserin aut Fiorenza Bracchitta verfasserin aut Spinello Antinori verfasserin aut Andrea Gori verfasserin aut Giuliano Rizzardini verfasserin aut Antonella Castagna verfasserin aut Maria Rita Gismondo verfasserin aut Silvia Nozza verfasserin aut Davide Mileto verfasserin aut In Emerging Microbes and Infections Taylor & Francis Group, 2013 (2024) (DE-627)726120715 (DE-600)2681359-2 22221751 nnns year:2024 https://doi.org/10.1080/22221751.2024.2337666 kostenfrei https://doaj.org/article/a1c79515d0914cfea3d062b26569ff12 kostenfrei https://www.tandfonline.com/doi/10.1080/22221751.2024.2337666 kostenfrei https://doaj.org/toc/2222-1751 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2024
allfields_unstemmed	10.1080/22221751.2024.2337666 doi (DE-627)DOAJ095900977 (DE-599)DOAJa1c79515d0914cfea3d062b26569ff12 DE-627 ger DE-627 rakwb eng RC109-216 QR1-502 Alessandro Mancon verfasserin aut Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle< 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier AbstractMonkeypox virus (MPXV) infection confirmation needs reliable polymerase chain reaction (PCR) assays; in addition, viral clade attribution is a key factor in containment measures, considering a more severe syndrome in clade I and possibility of simultaneous circulation. This study aims to evaluate the performance of all-in-one STANDARD M10 MPX/OPX (SD BIOSENSOR, South Korea – M10). Frozen samples from 205 subjects were selected and stratified according to routine test results (RealStar® Orthopoxvirus PCR Kit 1.0, altona DIAGNOTICS, Germany – RS; RS-1): in details, 100 negative skin lesions (SL) and 200 positive samples at variable stage of infection were analyzed. Positive samples were retested with RS (RS-2). Positive and Negative Percent Agreement (PPA, NPA) were calculated. The median (IQR) Ct values of RS and M10 (OPXV target) assays were highly similar. The PPA of M10 compared to RS-1 was 89.5% considering system interpretation, and 96.0%, when the operator classified results as positive if any target was detected; NPA was 100%. Comparing RS-2 run and M10, an overall concordance of 95.3% between assays was found; however, considering operator interpretation, M10 returned more positive results than RS-2. The occurrence of False Negative results was likely associated to influence of thawing on low viral concentration; no False Positive tests were observed. All samples collected at the time of Mpox diagnosis were positive and M10 correctly attributed the clade (West-Africa/II). M10 MPX/OPX assay demonstrated high reliability in confirming MPXV infection and clade attribution. monkeypox virus clade determination methods comparison all-in-one RealTime-PCR Infectious and parasitic diseases Microbiology Angelo Raccagni verfasserin aut Gloria Gagliardi verfasserin aut Davide Moschese verfasserin aut Alberto Rizzo verfasserin aut Andrea Giacomelli verfasserin aut Miriam Cutrera verfasserin aut Federica Salari verfasserin aut Fiorenza Bracchitta verfasserin aut Spinello Antinori verfasserin aut Andrea Gori verfasserin aut Giuliano Rizzardini verfasserin aut Antonella Castagna verfasserin aut Maria Rita Gismondo verfasserin aut Silvia Nozza verfasserin aut Davide Mileto verfasserin aut In Emerging Microbes and Infections Taylor & Francis Group, 2013 (2024) (DE-627)726120715 (DE-600)2681359-2 22221751 nnns year:2024 https://doi.org/10.1080/22221751.2024.2337666 kostenfrei https://doaj.org/article/a1c79515d0914cfea3d062b26569ff12 kostenfrei https://www.tandfonline.com/doi/10.1080/22221751.2024.2337666 kostenfrei https://doaj.org/toc/2222-1751 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2024
allfieldsGer	10.1080/22221751.2024.2337666 doi (DE-627)DOAJ095900977 (DE-599)DOAJa1c79515d0914cfea3d062b26569ff12 DE-627 ger DE-627 rakwb eng RC109-216 QR1-502 Alessandro Mancon verfasserin aut Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle< 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier AbstractMonkeypox virus (MPXV) infection confirmation needs reliable polymerase chain reaction (PCR) assays; in addition, viral clade attribution is a key factor in containment measures, considering a more severe syndrome in clade I and possibility of simultaneous circulation. This study aims to evaluate the performance of all-in-one STANDARD M10 MPX/OPX (SD BIOSENSOR, South Korea – M10). Frozen samples from 205 subjects were selected and stratified according to routine test results (RealStar® Orthopoxvirus PCR Kit 1.0, altona DIAGNOTICS, Germany – RS; RS-1): in details, 100 negative skin lesions (SL) and 200 positive samples at variable stage of infection were analyzed. Positive samples were retested with RS (RS-2). Positive and Negative Percent Agreement (PPA, NPA) were calculated. The median (IQR) Ct values of RS and M10 (OPXV target) assays were highly similar. The PPA of M10 compared to RS-1 was 89.5% considering system interpretation, and 96.0%, when the operator classified results as positive if any target was detected; NPA was 100%. Comparing RS-2 run and M10, an overall concordance of 95.3% between assays was found; however, considering operator interpretation, M10 returned more positive results than RS-2. The occurrence of False Negative results was likely associated to influence of thawing on low viral concentration; no False Positive tests were observed. All samples collected at the time of Mpox diagnosis were positive and M10 correctly attributed the clade (West-Africa/II). M10 MPX/OPX assay demonstrated high reliability in confirming MPXV infection and clade attribution. monkeypox virus clade determination methods comparison all-in-one RealTime-PCR Infectious and parasitic diseases Microbiology Angelo Raccagni verfasserin aut Gloria Gagliardi verfasserin aut Davide Moschese verfasserin aut Alberto Rizzo verfasserin aut Andrea Giacomelli verfasserin aut Miriam Cutrera verfasserin aut Federica Salari verfasserin aut Fiorenza Bracchitta verfasserin aut Spinello Antinori verfasserin aut Andrea Gori verfasserin aut Giuliano Rizzardini verfasserin aut Antonella Castagna verfasserin aut Maria Rita Gismondo verfasserin aut Silvia Nozza verfasserin aut Davide Mileto verfasserin aut In Emerging Microbes and Infections Taylor & Francis Group, 2013 (2024) (DE-627)726120715 (DE-600)2681359-2 22221751 nnns year:2024 https://doi.org/10.1080/22221751.2024.2337666 kostenfrei https://doaj.org/article/a1c79515d0914cfea3d062b26569ff12 kostenfrei https://www.tandfonline.com/doi/10.1080/22221751.2024.2337666 kostenfrei https://doaj.org/toc/2222-1751 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2024
allfieldsSound	10.1080/22221751.2024.2337666 doi (DE-627)DOAJ095900977 (DE-599)DOAJa1c79515d0914cfea3d062b26569ff12 DE-627 ger DE-627 rakwb eng RC109-216 QR1-502 Alessandro Mancon verfasserin aut Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle< 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier AbstractMonkeypox virus (MPXV) infection confirmation needs reliable polymerase chain reaction (PCR) assays; in addition, viral clade attribution is a key factor in containment measures, considering a more severe syndrome in clade I and possibility of simultaneous circulation. This study aims to evaluate the performance of all-in-one STANDARD M10 MPX/OPX (SD BIOSENSOR, South Korea – M10). Frozen samples from 205 subjects were selected and stratified according to routine test results (RealStar® Orthopoxvirus PCR Kit 1.0, altona DIAGNOTICS, Germany – RS; RS-1): in details, 100 negative skin lesions (SL) and 200 positive samples at variable stage of infection were analyzed. Positive samples were retested with RS (RS-2). Positive and Negative Percent Agreement (PPA, NPA) were calculated. The median (IQR) Ct values of RS and M10 (OPXV target) assays were highly similar. The PPA of M10 compared to RS-1 was 89.5% considering system interpretation, and 96.0%, when the operator classified results as positive if any target was detected; NPA was 100%. Comparing RS-2 run and M10, an overall concordance of 95.3% between assays was found; however, considering operator interpretation, M10 returned more positive results than RS-2. The occurrence of False Negative results was likely associated to influence of thawing on low viral concentration; no False Positive tests were observed. All samples collected at the time of Mpox diagnosis were positive and M10 correctly attributed the clade (West-Africa/II). M10 MPX/OPX assay demonstrated high reliability in confirming MPXV infection and clade attribution. monkeypox virus clade determination methods comparison all-in-one RealTime-PCR Infectious and parasitic diseases Microbiology Angelo Raccagni verfasserin aut Gloria Gagliardi verfasserin aut Davide Moschese verfasserin aut Alberto Rizzo verfasserin aut Andrea Giacomelli verfasserin aut Miriam Cutrera verfasserin aut Federica Salari verfasserin aut Fiorenza Bracchitta verfasserin aut Spinello Antinori verfasserin aut Andrea Gori verfasserin aut Giuliano Rizzardini verfasserin aut Antonella Castagna verfasserin aut Maria Rita Gismondo verfasserin aut Silvia Nozza verfasserin aut Davide Mileto verfasserin aut In Emerging Microbes and Infections Taylor & Francis Group, 2013 (2024) (DE-627)726120715 (DE-600)2681359-2 22221751 nnns year:2024 https://doi.org/10.1080/22221751.2024.2337666 kostenfrei https://doaj.org/article/a1c79515d0914cfea3d062b26569ff12 kostenfrei https://www.tandfonline.com/doi/10.1080/22221751.2024.2337666 kostenfrei https://doaj.org/toc/2222-1751 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2024
language	English
source	In Emerging Microbes and Infections (2024) year:2024
sourceStr	In Emerging Microbes and Infections (2024) year:2024
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	monkeypox virus clade determination methods comparison all-in-one RealTime-PCR Infectious and parasitic diseases Microbiology
isfreeaccess_bool	true
container_title	Emerging Microbes and Infections
authorswithroles_txt_mv	Alessandro Mancon @@aut@@ Angelo Raccagni @@aut@@ Gloria Gagliardi @@aut@@ Davide Moschese @@aut@@ Alberto Rizzo @@aut@@ Andrea Giacomelli @@aut@@ Miriam Cutrera @@aut@@ Federica Salari @@aut@@ Fiorenza Bracchitta @@aut@@ Spinello Antinori @@aut@@ Andrea Gori @@aut@@ Giuliano Rizzardini @@aut@@ Antonella Castagna @@aut@@ Maria Rita Gismondo @@aut@@ Silvia Nozza @@aut@@ Davide Mileto @@aut@@
publishDateDaySort_date	2024-01-01T00:00:00Z
hierarchy_top_id	726120715
id	DOAJ095900977
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000naa a22002652 4500</leader><controlfield tag="001">DOAJ095900977</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20240413125640.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">240413s2024 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1080/22221751.2024.2337666</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ095900977</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJa1c79515d0914cfea3d062b26569ff12</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">RC109-216</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">QR1-502</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">Alessandro Mancon</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle<</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2024</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">AbstractMonkeypox virus (MPXV) infection confirmation needs reliable polymerase chain reaction (PCR) assays; in addition, viral clade attribution is a key factor in containment measures, considering a more severe syndrome in clade I and possibility of simultaneous circulation. This study aims to evaluate the performance of all-in-one STANDARD M10 MPX/OPX (SD BIOSENSOR, South Korea – M10). Frozen samples from 205 subjects were selected and stratified according to routine test results (RealStar® Orthopoxvirus PCR Kit 1.0, altona DIAGNOTICS, Germany – RS; RS-1): in details, 100 negative skin lesions (SL) and 200 positive samples at variable stage of infection were analyzed. Positive samples were retested with RS (RS-2). Positive and Negative Percent Agreement (PPA, NPA) were calculated. The median (IQR) Ct values of RS and M10 (OPXV target) assays were highly similar. The PPA of M10 compared to RS-1 was 89.5% considering system interpretation, and 96.0%, when the operator classified results as positive if any target was detected; NPA was 100%. Comparing RS-2 run and M10, an overall concordance of 95.3% between assays was found; however, considering operator interpretation, M10 returned more positive results than RS-2. The occurrence of False Negative results was likely associated to influence of thawing on low viral concentration; no False Positive tests were observed. All samples collected at the time of Mpox diagnosis were positive and M10 correctly attributed the clade (West-Africa/II). M10 MPX/OPX assay demonstrated high reliability in confirming MPXV infection and clade attribution.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">monkeypox virus</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">clade determination</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">methods comparison</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">all-in-one RealTime-PCR</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Infectious and parasitic diseases</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Microbiology</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Angelo Raccagni</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Gloria Gagliardi</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Davide Moschese</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Alberto Rizzo</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Andrea Giacomelli</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Miriam Cutrera</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Federica Salari</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Fiorenza Bracchitta</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Spinello Antinori</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Andrea Gori</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Giuliano Rizzardini</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Antonella Castagna</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Maria Rita Gismondo</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Silvia Nozza</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Davide Mileto</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">In</subfield><subfield code="t">Emerging Microbes and Infections</subfield><subfield code="d">Taylor & Francis Group, 2013</subfield><subfield code="g">(2024)</subfield><subfield code="w">(DE-627)726120715</subfield><subfield code="w">(DE-600)2681359-2</subfield><subfield code="x">22221751</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">year:2024</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doi.org/10.1080/22221751.2024.2337666</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doaj.org/article/a1c79515d0914cfea3d062b26569ff12</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://www.tandfonline.com/doi/10.1080/22221751.2024.2337666</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="u">https://doaj.org/toc/2222-1751</subfield><subfield code="y">Journal toc</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_DOAJ</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_20</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_22</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_23</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_24</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_31</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_39</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_40</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_60</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_62</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_63</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_65</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_69</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_70</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_73</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_74</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_95</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_105</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_110</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_151</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_161</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_170</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_206</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_213</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_230</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_285</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_293</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_602</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2014</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4012</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4037</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4112</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4125</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4126</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4249</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4305</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4306</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4307</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4313</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4322</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4323</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4324</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4325</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4338</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4367</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4700</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="j">2024</subfield></datafield></record></collection>
callnumber-first	R - Medicine
author	Alessandro Mancon
spellingShingle	Alessandro Mancon misc RC109-216 misc QR1-502 misc monkeypox virus misc clade determination misc methods comparison misc all-in-one RealTime-PCR misc Infectious and parasitic diseases misc Microbiology Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle<
authorStr	Alessandro Mancon
ppnlink_with_tag_str_mv	@@773@@(DE-627)726120715
format	electronic Article
delete_txt_mv	keep
author_role	aut aut aut aut aut aut aut aut aut aut aut aut aut aut aut aut
collection	DOAJ
remote_str	true
callnumber-label	RC109-216
illustrated	Not Illustrated
issn	22221751
topic_title	RC109-216 QR1-502 Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle< monkeypox virus clade determination methods comparison all-in-one RealTime-PCR
topic	misc RC109-216 misc QR1-502 misc monkeypox virus misc clade determination misc methods comparison misc all-in-one RealTime-PCR misc Infectious and parasitic diseases misc Microbiology
topic_unstemmed	misc RC109-216 misc QR1-502 misc monkeypox virus misc clade determination misc methods comparison misc all-in-one RealTime-PCR misc Infectious and parasitic diseases misc Microbiology
topic_browse	misc RC109-216 misc QR1-502 misc monkeypox virus misc clade determination misc methods comparison misc all-in-one RealTime-PCR misc Infectious and parasitic diseases misc Microbiology
format_facet	Elektronische Aufsätze Aufsätze Elektronische Ressource
format_main_str_mv	Text Zeitschrift/Artikel
carriertype_str_mv	cr
hierarchy_parent_title	Emerging Microbes and Infections
hierarchy_parent_id	726120715
hierarchy_top_title	Emerging Microbes and Infections
isfreeaccess_txt	true
familylinks_str_mv	(DE-627)726120715 (DE-600)2681359-2
title	Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle<
ctrlnum	(DE-627)DOAJ095900977 (DE-599)DOAJa1c79515d0914cfea3d062b26569ff12
title_full	Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle<
author_sort	Alessandro Mancon
journal	Emerging Microbes and Infections
journalStr	Emerging Microbes and Infections
callnumber-first-code	R
lang_code	eng
isOA_bool	true
recordtype	marc
publishDateSort	2024
contenttype_str_mv	txt
author_browse	Alessandro Mancon Angelo Raccagni Gloria Gagliardi Davide Moschese Alberto Rizzo Andrea Giacomelli Miriam Cutrera Federica Salari Fiorenza Bracchitta Spinello Antinori Andrea Gori Giuliano Rizzardini Antonella Castagna Maria Rita Gismondo Silvia Nozza Davide Mileto
class	RC109-216 QR1-502
format_se	Elektronische Aufsätze
author-letter	Alessandro Mancon
doi_str_mv	10.1080/22221751.2024.2337666
author2-role	verfasserin
title_sort	evaluation of analytical performance of the standardtm m10 mpx/opx assay for the simultaneous dna detection and clade attribution of monkeypox virus<subtitle<emerging microbes & infections</subtitle<
callnumber	RC109-216
title_auth	Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle<
abstract	AbstractMonkeypox virus (MPXV) infection confirmation needs reliable polymerase chain reaction (PCR) assays; in addition, viral clade attribution is a key factor in containment measures, considering a more severe syndrome in clade I and possibility of simultaneous circulation. This study aims to evaluate the performance of all-in-one STANDARD M10 MPX/OPX (SD BIOSENSOR, South Korea – M10). Frozen samples from 205 subjects were selected and stratified according to routine test results (RealStar® Orthopoxvirus PCR Kit 1.0, altona DIAGNOTICS, Germany – RS; RS-1): in details, 100 negative skin lesions (SL) and 200 positive samples at variable stage of infection were analyzed. Positive samples were retested with RS (RS-2). Positive and Negative Percent Agreement (PPA, NPA) were calculated. The median (IQR) Ct values of RS and M10 (OPXV target) assays were highly similar. The PPA of M10 compared to RS-1 was 89.5% considering system interpretation, and 96.0%, when the operator classified results as positive if any target was detected; NPA was 100%. Comparing RS-2 run and M10, an overall concordance of 95.3% between assays was found; however, considering operator interpretation, M10 returned more positive results than RS-2. The occurrence of False Negative results was likely associated to influence of thawing on low viral concentration; no False Positive tests were observed. All samples collected at the time of Mpox diagnosis were positive and M10 correctly attributed the clade (West-Africa/II). M10 MPX/OPX assay demonstrated high reliability in confirming MPXV infection and clade attribution.
abstractGer	AbstractMonkeypox virus (MPXV) infection confirmation needs reliable polymerase chain reaction (PCR) assays; in addition, viral clade attribution is a key factor in containment measures, considering a more severe syndrome in clade I and possibility of simultaneous circulation. This study aims to evaluate the performance of all-in-one STANDARD M10 MPX/OPX (SD BIOSENSOR, South Korea – M10). Frozen samples from 205 subjects were selected and stratified according to routine test results (RealStar® Orthopoxvirus PCR Kit 1.0, altona DIAGNOTICS, Germany – RS; RS-1): in details, 100 negative skin lesions (SL) and 200 positive samples at variable stage of infection were analyzed. Positive samples were retested with RS (RS-2). Positive and Negative Percent Agreement (PPA, NPA) were calculated. The median (IQR) Ct values of RS and M10 (OPXV target) assays were highly similar. The PPA of M10 compared to RS-1 was 89.5% considering system interpretation, and 96.0%, when the operator classified results as positive if any target was detected; NPA was 100%. Comparing RS-2 run and M10, an overall concordance of 95.3% between assays was found; however, considering operator interpretation, M10 returned more positive results than RS-2. The occurrence of False Negative results was likely associated to influence of thawing on low viral concentration; no False Positive tests were observed. All samples collected at the time of Mpox diagnosis were positive and M10 correctly attributed the clade (West-Africa/II). M10 MPX/OPX assay demonstrated high reliability in confirming MPXV infection and clade attribution.
abstract_unstemmed	AbstractMonkeypox virus (MPXV) infection confirmation needs reliable polymerase chain reaction (PCR) assays; in addition, viral clade attribution is a key factor in containment measures, considering a more severe syndrome in clade I and possibility of simultaneous circulation. This study aims to evaluate the performance of all-in-one STANDARD M10 MPX/OPX (SD BIOSENSOR, South Korea – M10). Frozen samples from 205 subjects were selected and stratified according to routine test results (RealStar® Orthopoxvirus PCR Kit 1.0, altona DIAGNOTICS, Germany – RS; RS-1): in details, 100 negative skin lesions (SL) and 200 positive samples at variable stage of infection were analyzed. Positive samples were retested with RS (RS-2). Positive and Negative Percent Agreement (PPA, NPA) were calculated. The median (IQR) Ct values of RS and M10 (OPXV target) assays were highly similar. The PPA of M10 compared to RS-1 was 89.5% considering system interpretation, and 96.0%, when the operator classified results as positive if any target was detected; NPA was 100%. Comparing RS-2 run and M10, an overall concordance of 95.3% between assays was found; however, considering operator interpretation, M10 returned more positive results than RS-2. The occurrence of False Negative results was likely associated to influence of thawing on low viral concentration; no False Positive tests were observed. All samples collected at the time of Mpox diagnosis were positive and M10 correctly attributed the clade (West-Africa/II). M10 MPX/OPX assay demonstrated high reliability in confirming MPXV infection and clade attribution.
collection_details	GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700
title_short	Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle<
url	https://doi.org/10.1080/22221751.2024.2337666 https://doaj.org/article/a1c79515d0914cfea3d062b26569ff12 https://www.tandfonline.com/doi/10.1080/22221751.2024.2337666 https://doaj.org/toc/2222-1751
remote_bool	true
author2	Angelo Raccagni Gloria Gagliardi Davide Moschese Alberto Rizzo Andrea Giacomelli Miriam Cutrera Federica Salari Fiorenza Bracchitta Spinello Antinori Andrea Gori Giuliano Rizzardini Antonella Castagna Maria Rita Gismondo Silvia Nozza Davide Mileto
author2Str	Angelo Raccagni Gloria Gagliardi Davide Moschese Alberto Rizzo Andrea Giacomelli Miriam Cutrera Federica Salari Fiorenza Bracchitta Spinello Antinori Andrea Gori Giuliano Rizzardini Antonella Castagna Maria Rita Gismondo Silvia Nozza Davide Mileto
ppnlink	726120715
callnumber-subject	RC - Internal Medicine
mediatype_str_mv	c
isOA_txt	true
hochschulschrift_bool	false
doi_str	10.1080/22221751.2024.2337666
callnumber-a	RC109-216
up_date	2024-07-03T17:16:32.187Z
_version_	1803579023360524288
fullrecord_marcxml	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000naa a22002652 4500</leader><controlfield tag="001">DOAJ095900977</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20240413125640.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">240413s2024 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1080/22221751.2024.2337666</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ095900977</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJa1c79515d0914cfea3d062b26569ff12</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">RC109-216</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">QR1-502</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">Alessandro Mancon</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle<</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2024</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">AbstractMonkeypox virus (MPXV) infection confirmation needs reliable polymerase chain reaction (PCR) assays; in addition, viral clade attribution is a key factor in containment measures, considering a more severe syndrome in clade I and possibility of simultaneous circulation. This study aims to evaluate the performance of all-in-one STANDARD M10 MPX/OPX (SD BIOSENSOR, South Korea – M10). Frozen samples from 205 subjects were selected and stratified according to routine test results (RealStar® Orthopoxvirus PCR Kit 1.0, altona DIAGNOTICS, Germany – RS; RS-1): in details, 100 negative skin lesions (SL) and 200 positive samples at variable stage of infection were analyzed. Positive samples were retested with RS (RS-2). Positive and Negative Percent Agreement (PPA, NPA) were calculated. The median (IQR) Ct values of RS and M10 (OPXV target) assays were highly similar. The PPA of M10 compared to RS-1 was 89.5% considering system interpretation, and 96.0%, when the operator classified results as positive if any target was detected; NPA was 100%. Comparing RS-2 run and M10, an overall concordance of 95.3% between assays was found; however, considering operator interpretation, M10 returned more positive results than RS-2. The occurrence of False Negative results was likely associated to influence of thawing on low viral concentration; no False Positive tests were observed. All samples collected at the time of Mpox diagnosis were positive and M10 correctly attributed the clade (West-Africa/II). M10 MPX/OPX assay demonstrated high reliability in confirming MPXV infection and clade attribution.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">monkeypox virus</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">clade determination</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">methods comparison</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">all-in-one RealTime-PCR</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Infectious and parasitic diseases</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Microbiology</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Angelo Raccagni</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Gloria Gagliardi</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Davide Moschese</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Alberto Rizzo</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Andrea Giacomelli</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Miriam Cutrera</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Federica Salari</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Fiorenza Bracchitta</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Spinello Antinori</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Andrea Gori</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Giuliano Rizzardini</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Antonella Castagna</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Maria Rita Gismondo</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Silvia Nozza</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Davide Mileto</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">In</subfield><subfield code="t">Emerging Microbes and Infections</subfield><subfield code="d">Taylor & Francis Group, 2013</subfield><subfield code="g">(2024)</subfield><subfield code="w">(DE-627)726120715</subfield><subfield code="w">(DE-600)2681359-2</subfield><subfield code="x">22221751</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">year:2024</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doi.org/10.1080/22221751.2024.2337666</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doaj.org/article/a1c79515d0914cfea3d062b26569ff12</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://www.tandfonline.com/doi/10.1080/22221751.2024.2337666</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="u">https://doaj.org/toc/2222-1751</subfield><subfield code="y">Journal toc</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_DOAJ</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_20</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_22</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_23</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_24</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_31</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_39</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_40</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_60</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_62</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_63</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_65</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_69</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_70</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_73</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_74</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_95</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_105</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_110</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_151</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_161</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_170</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_206</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_213</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_230</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_285</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_293</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_602</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2014</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4012</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4037</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4112</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4125</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4126</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4249</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4305</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4306</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4307</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4313</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4322</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4323</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4324</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4325</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4338</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4367</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4700</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="j">2024</subfield></datafield></record></collection>
score	7.402936

Nicht das Richtige dabei?

Schreiben Sie uns!

Evaluation of Analytical Performance of the STANDARDTM M10 MPX/OPX Assay for the Simultaneous DNA Detection and Clade Attribution of Monkeypox virus<subtitle<Emerging Microbes & Infections</subtitle<

Nicht das Richtige dabei?

Zugang & Verfügbarkeit

Vorhandene Bände

Nicht das Richtige dabei?