Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer

Introduction: This study evaluated the clinical and analytical performances of the Access HBsAg and the Access HBsAg Confirmatory assays on the DxI 9000 Access Immunoassay Analyzer (Beckman Coulter, Inc.). Materials and methods: Diagnostic specificity and sensitivity of the Access HBsAg and Access H...
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Autor*in:	Benoit Visseaux [verfasserIn] Jérémie Gautier [verfasserIn] Françoise Le Boulaire [verfasserIn] Catherine Coignard [verfasserIn] Claire Vincent [verfasserIn] Sandrine Gréaume [verfasserIn] Isabelle Voisin [verfasserIn] Veronique Lemée [verfasserIn] Jean-Christophe Plantier [verfasserIn] Yves-Edouard Herpe [verfasserIn] Etienne Brochot [verfasserIn] Stephanie Bord [verfasserIn] Marc Turini [verfasserIn] Vanessa Roulet [verfasserIn] Juliane Hey [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2024

Schlagwörter:	Hepatitis B infection HBsAg Chemiluminescence immunoassay Analytical performances Clinical performances

Übergeordnetes Werk:	In: Practical Laboratory Medicine - Elsevier, 2017, 39(2024), Seite e00390-
Übergeordnetes Werk:	volume:39 ; year:2024 ; pages:e00390-

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1016/j.plabm.2024.e00390

Katalog-ID:	DOAJ099779005

Internformat


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050		0	\|a R5-920
050		0	\|a QD1-999
100	0		\|a Benoit Visseaux \|e verfasserin \|4 aut
245	1	0	\|a Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer
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520			\|a Introduction: This study evaluated the clinical and analytical performances of the Access HBsAg and the Access HBsAg Confirmatory assays on the DxI 9000 Access Immunoassay Analyzer (Beckman Coulter, Inc.). Materials and methods: Diagnostic specificity and sensitivity of the Access HBsAg and Access HBsAg Confirmatory assays were evaluated by comparing the Access assays to the final HBsAg sample status determined using the Architect, PRISM, or Elecsys HBsAg assays, along with Architect or PRISM HBsAg Confirmatory assays. Imprecision, sensitivity on seroconversion panels, analytical sensitivity on WHO, and recognition of HBV variants were also evaluated. Results: A total of 7534 samples were included in the analysis (6047 blood donors, 1032 hospitalized patients, 455 positive patients’ samples). Access HBsAg assay sensitivity and specificity were at 100.00% (99.19–100.0) and 99.92% (99.82–99.97), respectively. Sensitivity of Access HBsAg Confirmatory assay was 100.00% (99.21–100.0) on the 464 HBsAg positive samples. The use of a high positive algorithm for the Access HBsAg assay, wherein samples with S/CO ≥ 100.00 were considered positive without requiring repeat or confirmatory testing, was successfully evaluated with all 450 specimens with S/CO greater than 100.00 (sensitivity 100.00%; 99.19–100.0). Access HBsAg assay demonstrated good analytical performance, equivalent recognition of seroconversion panels compared to Architect assay, and an analytical sensitivity between 0.022 and 0.025 IU/mL. All HBV genotypes, subtypes and mutants were well detected without analytical sensitivity loss. Conclusion: Access HBsAg and Access HBsAg Confirmatory assays demonstrated robust performances. They provide low samples volume requirements and a simplified process, no systematic retesting for high positive samples.
650		4	\|a Hepatitis B infection
650		4	\|a HBsAg
650		4	\|a Chemiluminescence immunoassay
650		4	\|a Analytical performances
650		4	\|a Clinical performances
653		0	\|a Medicine (General)
653		0	\|a Chemistry
700	0		\|a Jérémie Gautier \|e verfasserin \|4 aut
700	0		\|a Françoise Le Boulaire \|e verfasserin \|4 aut
700	0		\|a Catherine Coignard \|e verfasserin \|4 aut
700	0		\|a Claire Vincent \|e verfasserin \|4 aut
700	0		\|a Sandrine Gréaume \|e verfasserin \|4 aut
700	0		\|a Isabelle Voisin \|e verfasserin \|4 aut
700	0		\|a Veronique Lemée \|e verfasserin \|4 aut
700	0		\|a Jean-Christophe Plantier \|e verfasserin \|4 aut
700	0		\|a Yves-Edouard Herpe \|e verfasserin \|4 aut
700	0		\|a Etienne Brochot \|e verfasserin \|4 aut
700	0		\|a Stephanie Bord \|e verfasserin \|4 aut
700	0		\|a Marc Turini \|e verfasserin \|4 aut
700	0		\|a Vanessa Roulet \|e verfasserin \|4 aut
700	0		\|a Juliane Hey \|e verfasserin \|4 aut
773	0	8	\|i In \|t Practical Laboratory Medicine \|d Elsevier, 2017 \|g 39(2024), Seite e00390- \|w (DE-627)835590879 \|w (DE-600)2834973-8 \|x 23525517 \|7 nnns
773	1	8	\|g volume:39 \|g year:2024 \|g pages:e00390-
856	4	0	\|u https://doi.org/10.1016/j.plabm.2024.e00390 \|z kostenfrei
856	4	0	\|u https://doaj.org/article/f25e264df1ef4d41b1f5d892282f85c0 \|z kostenfrei
856	4	0	\|u http://www.sciencedirect.com/science/article/pii/S2352551724000362 \|z kostenfrei
856	4	2	\|u https://doaj.org/toc/2352-5517 \|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_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_224
912			\|a GBV_ILN_230
912			\|a GBV_ILN_285
912			\|a GBV_ILN_293
912			\|a GBV_ILN_602
912			\|a GBV_ILN_2001
912			\|a GBV_ILN_2003
912			\|a GBV_ILN_2005
912			\|a GBV_ILN_2006
912			\|a GBV_ILN_2007
912			\|a GBV_ILN_2008
912			\|a GBV_ILN_2009
912			\|a GBV_ILN_2010
912			\|a GBV_ILN_2011
912			\|a GBV_ILN_2014
912			\|a GBV_ILN_2015
912			\|a GBV_ILN_2020
912			\|a GBV_ILN_2021
912			\|a GBV_ILN_2025
912			\|a GBV_ILN_2026
912			\|a GBV_ILN_2027
912			\|a GBV_ILN_2034
912			\|a GBV_ILN_2038
912			\|a GBV_ILN_2044
912			\|a GBV_ILN_2048
912			\|a GBV_ILN_2050
912			\|a GBV_ILN_2055
912			\|a GBV_ILN_2056
912			\|a GBV_ILN_2059
912			\|a GBV_ILN_2061
912			\|a GBV_ILN_2064
912			\|a GBV_ILN_2088
912			\|a GBV_ILN_2106
912			\|a GBV_ILN_2110
912			\|a GBV_ILN_2112
912			\|a GBV_ILN_2122
912			\|a GBV_ILN_2129
912			\|a GBV_ILN_2143
912			\|a GBV_ILN_2152
912			\|a GBV_ILN_2153
912			\|a GBV_ILN_2190
912			\|a GBV_ILN_2232
912			\|a GBV_ILN_2336
912			\|a GBV_ILN_2470
912			\|a GBV_ILN_2507
912			\|a GBV_ILN_4012
912			\|a GBV_ILN_4035
912			\|a GBV_ILN_4037
912			\|a GBV_ILN_4112
912			\|a GBV_ILN_4125
912			\|a GBV_ILN_4126
912			\|a GBV_ILN_4242
912			\|a GBV_ILN_4249
912			\|a GBV_ILN_4251
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_4326
912			\|a GBV_ILN_4333
912			\|a GBV_ILN_4334
912			\|a GBV_ILN_4338
912			\|a GBV_ILN_4367
912			\|a GBV_ILN_4393
912			\|a GBV_ILN_4700
951			\|a AR
952			\|d 39 \|j 2024 \|h e00390-

Indexfelder

author_variant	b v bv j g jg f l b flb c c cc c v cv s g sg i v iv v l vl j c p jcp y e h yeh e b eb s b sb m t mt v r vr j h jh
matchkey_str	article:23525517:2024----::efraceautootecesbaadcesbacnimtrasyotex9
hierarchy_sort_str	2024
callnumber-subject-code	R
publishDate	2024
allfields	10.1016/j.plabm.2024.e00390 doi (DE-627)DOAJ099779005 (DE-599)DOAJf25e264df1ef4d41b1f5d892282f85c0 DE-627 ger DE-627 rakwb eng R5-920 QD1-999 Benoit Visseaux verfasserin aut Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction: This study evaluated the clinical and analytical performances of the Access HBsAg and the Access HBsAg Confirmatory assays on the DxI 9000 Access Immunoassay Analyzer (Beckman Coulter, Inc.). Materials and methods: Diagnostic specificity and sensitivity of the Access HBsAg and Access HBsAg Confirmatory assays were evaluated by comparing the Access assays to the final HBsAg sample status determined using the Architect, PRISM, or Elecsys HBsAg assays, along with Architect or PRISM HBsAg Confirmatory assays. Imprecision, sensitivity on seroconversion panels, analytical sensitivity on WHO, and recognition of HBV variants were also evaluated. Results: A total of 7534 samples were included in the analysis (6047 blood donors, 1032 hospitalized patients, 455 positive patients’ samples). Access HBsAg assay sensitivity and specificity were at 100.00% (99.19–100.0) and 99.92% (99.82–99.97), respectively. Sensitivity of Access HBsAg Confirmatory assay was 100.00% (99.21–100.0) on the 464 HBsAg positive samples. The use of a high positive algorithm for the Access HBsAg assay, wherein samples with S/CO ≥ 100.00 were considered positive without requiring repeat or confirmatory testing, was successfully evaluated with all 450 specimens with S/CO greater than 100.00 (sensitivity 100.00%; 99.19–100.0). Access HBsAg assay demonstrated good analytical performance, equivalent recognition of seroconversion panels compared to Architect assay, and an analytical sensitivity between 0.022 and 0.025 IU/mL. All HBV genotypes, subtypes and mutants were well detected without analytical sensitivity loss. Conclusion: Access HBsAg and Access HBsAg Confirmatory assays demonstrated robust performances. They provide low samples volume requirements and a simplified process, no systematic retesting for high positive samples. Hepatitis B infection HBsAg Chemiluminescence immunoassay Analytical performances Clinical performances Medicine (General) Chemistry Jérémie Gautier verfasserin aut Françoise Le Boulaire verfasserin aut Catherine Coignard verfasserin aut Claire Vincent verfasserin aut Sandrine Gréaume verfasserin aut Isabelle Voisin verfasserin aut Veronique Lemée verfasserin aut Jean-Christophe Plantier verfasserin aut Yves-Edouard Herpe verfasserin aut Etienne Brochot verfasserin aut Stephanie Bord verfasserin aut Marc Turini verfasserin aut Vanessa Roulet verfasserin aut Juliane Hey verfasserin aut In Practical Laboratory Medicine Elsevier, 2017 39(2024), Seite e00390- (DE-627)835590879 (DE-600)2834973-8 23525517 nnns volume:39 year:2024 pages:e00390- https://doi.org/10.1016/j.plabm.2024.e00390 kostenfrei https://doaj.org/article/f25e264df1ef4d41b1f5d892282f85c0 kostenfrei http://www.sciencedirect.com/science/article/pii/S2352551724000362 kostenfrei https://doaj.org/toc/2352-5517 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_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_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 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_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 39 2024 e00390-
spelling	10.1016/j.plabm.2024.e00390 doi (DE-627)DOAJ099779005 (DE-599)DOAJf25e264df1ef4d41b1f5d892282f85c0 DE-627 ger DE-627 rakwb eng R5-920 QD1-999 Benoit Visseaux verfasserin aut Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction: This study evaluated the clinical and analytical performances of the Access HBsAg and the Access HBsAg Confirmatory assays on the DxI 9000 Access Immunoassay Analyzer (Beckman Coulter, Inc.). Materials and methods: Diagnostic specificity and sensitivity of the Access HBsAg and Access HBsAg Confirmatory assays were evaluated by comparing the Access assays to the final HBsAg sample status determined using the Architect, PRISM, or Elecsys HBsAg assays, along with Architect or PRISM HBsAg Confirmatory assays. Imprecision, sensitivity on seroconversion panels, analytical sensitivity on WHO, and recognition of HBV variants were also evaluated. Results: A total of 7534 samples were included in the analysis (6047 blood donors, 1032 hospitalized patients, 455 positive patients’ samples). Access HBsAg assay sensitivity and specificity were at 100.00% (99.19–100.0) and 99.92% (99.82–99.97), respectively. Sensitivity of Access HBsAg Confirmatory assay was 100.00% (99.21–100.0) on the 464 HBsAg positive samples. The use of a high positive algorithm for the Access HBsAg assay, wherein samples with S/CO ≥ 100.00 were considered positive without requiring repeat or confirmatory testing, was successfully evaluated with all 450 specimens with S/CO greater than 100.00 (sensitivity 100.00%; 99.19–100.0). Access HBsAg assay demonstrated good analytical performance, equivalent recognition of seroconversion panels compared to Architect assay, and an analytical sensitivity between 0.022 and 0.025 IU/mL. All HBV genotypes, subtypes and mutants were well detected without analytical sensitivity loss. Conclusion: Access HBsAg and Access HBsAg Confirmatory assays demonstrated robust performances. They provide low samples volume requirements and a simplified process, no systematic retesting for high positive samples. Hepatitis B infection HBsAg Chemiluminescence immunoassay Analytical performances Clinical performances Medicine (General) Chemistry Jérémie Gautier verfasserin aut Françoise Le Boulaire verfasserin aut Catherine Coignard verfasserin aut Claire Vincent verfasserin aut Sandrine Gréaume verfasserin aut Isabelle Voisin verfasserin aut Veronique Lemée verfasserin aut Jean-Christophe Plantier verfasserin aut Yves-Edouard Herpe verfasserin aut Etienne Brochot verfasserin aut Stephanie Bord verfasserin aut Marc Turini verfasserin aut Vanessa Roulet verfasserin aut Juliane Hey verfasserin aut In Practical Laboratory Medicine Elsevier, 2017 39(2024), Seite e00390- (DE-627)835590879 (DE-600)2834973-8 23525517 nnns volume:39 year:2024 pages:e00390- https://doi.org/10.1016/j.plabm.2024.e00390 kostenfrei https://doaj.org/article/f25e264df1ef4d41b1f5d892282f85c0 kostenfrei http://www.sciencedirect.com/science/article/pii/S2352551724000362 kostenfrei https://doaj.org/toc/2352-5517 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_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_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 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_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 39 2024 e00390-
allfields_unstemmed	10.1016/j.plabm.2024.e00390 doi (DE-627)DOAJ099779005 (DE-599)DOAJf25e264df1ef4d41b1f5d892282f85c0 DE-627 ger DE-627 rakwb eng R5-920 QD1-999 Benoit Visseaux verfasserin aut Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction: This study evaluated the clinical and analytical performances of the Access HBsAg and the Access HBsAg Confirmatory assays on the DxI 9000 Access Immunoassay Analyzer (Beckman Coulter, Inc.). Materials and methods: Diagnostic specificity and sensitivity of the Access HBsAg and Access HBsAg Confirmatory assays were evaluated by comparing the Access assays to the final HBsAg sample status determined using the Architect, PRISM, or Elecsys HBsAg assays, along with Architect or PRISM HBsAg Confirmatory assays. Imprecision, sensitivity on seroconversion panels, analytical sensitivity on WHO, and recognition of HBV variants were also evaluated. Results: A total of 7534 samples were included in the analysis (6047 blood donors, 1032 hospitalized patients, 455 positive patients’ samples). Access HBsAg assay sensitivity and specificity were at 100.00% (99.19–100.0) and 99.92% (99.82–99.97), respectively. Sensitivity of Access HBsAg Confirmatory assay was 100.00% (99.21–100.0) on the 464 HBsAg positive samples. The use of a high positive algorithm for the Access HBsAg assay, wherein samples with S/CO ≥ 100.00 were considered positive without requiring repeat or confirmatory testing, was successfully evaluated with all 450 specimens with S/CO greater than 100.00 (sensitivity 100.00%; 99.19–100.0). Access HBsAg assay demonstrated good analytical performance, equivalent recognition of seroconversion panels compared to Architect assay, and an analytical sensitivity between 0.022 and 0.025 IU/mL. All HBV genotypes, subtypes and mutants were well detected without analytical sensitivity loss. Conclusion: Access HBsAg and Access HBsAg Confirmatory assays demonstrated robust performances. They provide low samples volume requirements and a simplified process, no systematic retesting for high positive samples. Hepatitis B infection HBsAg Chemiluminescence immunoassay Analytical performances Clinical performances Medicine (General) Chemistry Jérémie Gautier verfasserin aut Françoise Le Boulaire verfasserin aut Catherine Coignard verfasserin aut Claire Vincent verfasserin aut Sandrine Gréaume verfasserin aut Isabelle Voisin verfasserin aut Veronique Lemée verfasserin aut Jean-Christophe Plantier verfasserin aut Yves-Edouard Herpe verfasserin aut Etienne Brochot verfasserin aut Stephanie Bord verfasserin aut Marc Turini verfasserin aut Vanessa Roulet verfasserin aut Juliane Hey verfasserin aut In Practical Laboratory Medicine Elsevier, 2017 39(2024), Seite e00390- (DE-627)835590879 (DE-600)2834973-8 23525517 nnns volume:39 year:2024 pages:e00390- https://doi.org/10.1016/j.plabm.2024.e00390 kostenfrei https://doaj.org/article/f25e264df1ef4d41b1f5d892282f85c0 kostenfrei http://www.sciencedirect.com/science/article/pii/S2352551724000362 kostenfrei https://doaj.org/toc/2352-5517 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_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_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 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_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 39 2024 e00390-
allfieldsGer	10.1016/j.plabm.2024.e00390 doi (DE-627)DOAJ099779005 (DE-599)DOAJf25e264df1ef4d41b1f5d892282f85c0 DE-627 ger DE-627 rakwb eng R5-920 QD1-999 Benoit Visseaux verfasserin aut Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction: This study evaluated the clinical and analytical performances of the Access HBsAg and the Access HBsAg Confirmatory assays on the DxI 9000 Access Immunoassay Analyzer (Beckman Coulter, Inc.). Materials and methods: Diagnostic specificity and sensitivity of the Access HBsAg and Access HBsAg Confirmatory assays were evaluated by comparing the Access assays to the final HBsAg sample status determined using the Architect, PRISM, or Elecsys HBsAg assays, along with Architect or PRISM HBsAg Confirmatory assays. Imprecision, sensitivity on seroconversion panels, analytical sensitivity on WHO, and recognition of HBV variants were also evaluated. Results: A total of 7534 samples were included in the analysis (6047 blood donors, 1032 hospitalized patients, 455 positive patients’ samples). Access HBsAg assay sensitivity and specificity were at 100.00% (99.19–100.0) and 99.92% (99.82–99.97), respectively. Sensitivity of Access HBsAg Confirmatory assay was 100.00% (99.21–100.0) on the 464 HBsAg positive samples. The use of a high positive algorithm for the Access HBsAg assay, wherein samples with S/CO ≥ 100.00 were considered positive without requiring repeat or confirmatory testing, was successfully evaluated with all 450 specimens with S/CO greater than 100.00 (sensitivity 100.00%; 99.19–100.0). Access HBsAg assay demonstrated good analytical performance, equivalent recognition of seroconversion panels compared to Architect assay, and an analytical sensitivity between 0.022 and 0.025 IU/mL. All HBV genotypes, subtypes and mutants were well detected without analytical sensitivity loss. Conclusion: Access HBsAg and Access HBsAg Confirmatory assays demonstrated robust performances. They provide low samples volume requirements and a simplified process, no systematic retesting for high positive samples. Hepatitis B infection HBsAg Chemiluminescence immunoassay Analytical performances Clinical performances Medicine (General) Chemistry Jérémie Gautier verfasserin aut Françoise Le Boulaire verfasserin aut Catherine Coignard verfasserin aut Claire Vincent verfasserin aut Sandrine Gréaume verfasserin aut Isabelle Voisin verfasserin aut Veronique Lemée verfasserin aut Jean-Christophe Plantier verfasserin aut Yves-Edouard Herpe verfasserin aut Etienne Brochot verfasserin aut Stephanie Bord verfasserin aut Marc Turini verfasserin aut Vanessa Roulet verfasserin aut Juliane Hey verfasserin aut In Practical Laboratory Medicine Elsevier, 2017 39(2024), Seite e00390- (DE-627)835590879 (DE-600)2834973-8 23525517 nnns volume:39 year:2024 pages:e00390- https://doi.org/10.1016/j.plabm.2024.e00390 kostenfrei https://doaj.org/article/f25e264df1ef4d41b1f5d892282f85c0 kostenfrei http://www.sciencedirect.com/science/article/pii/S2352551724000362 kostenfrei https://doaj.org/toc/2352-5517 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_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_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 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_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 39 2024 e00390-
allfieldsSound	10.1016/j.plabm.2024.e00390 doi (DE-627)DOAJ099779005 (DE-599)DOAJf25e264df1ef4d41b1f5d892282f85c0 DE-627 ger DE-627 rakwb eng R5-920 QD1-999 Benoit Visseaux verfasserin aut Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction: This study evaluated the clinical and analytical performances of the Access HBsAg and the Access HBsAg Confirmatory assays on the DxI 9000 Access Immunoassay Analyzer (Beckman Coulter, Inc.). Materials and methods: Diagnostic specificity and sensitivity of the Access HBsAg and Access HBsAg Confirmatory assays were evaluated by comparing the Access assays to the final HBsAg sample status determined using the Architect, PRISM, or Elecsys HBsAg assays, along with Architect or PRISM HBsAg Confirmatory assays. Imprecision, sensitivity on seroconversion panels, analytical sensitivity on WHO, and recognition of HBV variants were also evaluated. Results: A total of 7534 samples were included in the analysis (6047 blood donors, 1032 hospitalized patients, 455 positive patients’ samples). Access HBsAg assay sensitivity and specificity were at 100.00% (99.19–100.0) and 99.92% (99.82–99.97), respectively. Sensitivity of Access HBsAg Confirmatory assay was 100.00% (99.21–100.0) on the 464 HBsAg positive samples. The use of a high positive algorithm for the Access HBsAg assay, wherein samples with S/CO ≥ 100.00 were considered positive without requiring repeat or confirmatory testing, was successfully evaluated with all 450 specimens with S/CO greater than 100.00 (sensitivity 100.00%; 99.19–100.0). Access HBsAg assay demonstrated good analytical performance, equivalent recognition of seroconversion panels compared to Architect assay, and an analytical sensitivity between 0.022 and 0.025 IU/mL. All HBV genotypes, subtypes and mutants were well detected without analytical sensitivity loss. Conclusion: Access HBsAg and Access HBsAg Confirmatory assays demonstrated robust performances. They provide low samples volume requirements and a simplified process, no systematic retesting for high positive samples. Hepatitis B infection HBsAg Chemiluminescence immunoassay Analytical performances Clinical performances Medicine (General) Chemistry Jérémie Gautier verfasserin aut Françoise Le Boulaire verfasserin aut Catherine Coignard verfasserin aut Claire Vincent verfasserin aut Sandrine Gréaume verfasserin aut Isabelle Voisin verfasserin aut Veronique Lemée verfasserin aut Jean-Christophe Plantier verfasserin aut Yves-Edouard Herpe verfasserin aut Etienne Brochot verfasserin aut Stephanie Bord verfasserin aut Marc Turini verfasserin aut Vanessa Roulet verfasserin aut Juliane Hey verfasserin aut In Practical Laboratory Medicine Elsevier, 2017 39(2024), Seite e00390- (DE-627)835590879 (DE-600)2834973-8 23525517 nnns volume:39 year:2024 pages:e00390- https://doi.org/10.1016/j.plabm.2024.e00390 kostenfrei https://doaj.org/article/f25e264df1ef4d41b1f5d892282f85c0 kostenfrei http://www.sciencedirect.com/science/article/pii/S2352551724000362 kostenfrei https://doaj.org/toc/2352-5517 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_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_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 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_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 39 2024 e00390-
language	English
source	In Practical Laboratory Medicine 39(2024), Seite e00390- volume:39 year:2024 pages:e00390-
sourceStr	In Practical Laboratory Medicine 39(2024), Seite e00390- volume:39 year:2024 pages:e00390-
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Hepatitis B infection HBsAg Chemiluminescence immunoassay Analytical performances Clinical performances Medicine (General) Chemistry
isfreeaccess_bool	true
container_title	Practical Laboratory Medicine
authorswithroles_txt_mv	Benoit Visseaux @@aut@@ Jérémie Gautier @@aut@@ Françoise Le Boulaire @@aut@@ Catherine Coignard @@aut@@ Claire Vincent @@aut@@ Sandrine Gréaume @@aut@@ Isabelle Voisin @@aut@@ Veronique Lemée @@aut@@ Jean-Christophe Plantier @@aut@@ Yves-Edouard Herpe @@aut@@ Etienne Brochot @@aut@@ Stephanie Bord @@aut@@ Marc Turini @@aut@@ Vanessa Roulet @@aut@@ Juliane Hey @@aut@@
publishDateDaySort_date	2024-01-01T00:00:00Z
hierarchy_top_id	835590879
id	DOAJ099779005
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">DOAJ099779005</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20240414053648.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">240414s2024 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/j.plabm.2024.e00390</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ099779005</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJf25e264df1ef4d41b1f5d892282f85c0</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">R5-920</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">QD1-999</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">Benoit Visseaux</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer</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">Introduction: This study evaluated the clinical and analytical performances of the Access HBsAg and the Access HBsAg Confirmatory assays on the DxI 9000 Access Immunoassay Analyzer (Beckman Coulter, Inc.). Materials and methods: Diagnostic specificity and sensitivity of the Access HBsAg and Access HBsAg Confirmatory assays were evaluated by comparing the Access assays to the final HBsAg sample status determined using the Architect, PRISM, or Elecsys HBsAg assays, along with Architect or PRISM HBsAg Confirmatory assays. Imprecision, sensitivity on seroconversion panels, analytical sensitivity on WHO, and recognition of HBV variants were also evaluated. Results: A total of 7534 samples were included in the analysis (6047 blood donors, 1032 hospitalized patients, 455 positive patients’ samples). Access HBsAg assay sensitivity and specificity were at 100.00% (99.19–100.0) and 99.92% (99.82–99.97), respectively. Sensitivity of Access HBsAg Confirmatory assay was 100.00% (99.21–100.0) on the 464 HBsAg positive samples. The use of a high positive algorithm for the Access HBsAg assay, wherein samples with S/CO ≥ 100.00 were considered positive without requiring repeat or confirmatory testing, was successfully evaluated with all 450 specimens with S/CO greater than 100.00 (sensitivity 100.00%; 99.19–100.0). Access HBsAg assay demonstrated good analytical performance, equivalent recognition of seroconversion panels compared to Architect assay, and an analytical sensitivity between 0.022 and 0.025 IU/mL. All HBV genotypes, subtypes and mutants were well detected without analytical sensitivity loss. Conclusion: Access HBsAg and Access HBsAg Confirmatory assays demonstrated robust performances. 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callnumber-first	R - Medicine
author	Benoit Visseaux
spellingShingle	Benoit Visseaux misc R5-920 misc QD1-999 misc Hepatitis B infection misc HBsAg misc Chemiluminescence immunoassay misc Analytical performances misc Clinical performances misc Medicine (General) misc Chemistry Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer
authorStr	Benoit Visseaux
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topic_title	R5-920 QD1-999 Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer Hepatitis B infection HBsAg Chemiluminescence immunoassay Analytical performances Clinical performances
topic	misc R5-920 misc QD1-999 misc Hepatitis B infection misc HBsAg misc Chemiluminescence immunoassay misc Analytical performances misc Clinical performances misc Medicine (General) misc Chemistry
topic_unstemmed	misc R5-920 misc QD1-999 misc Hepatitis B infection misc HBsAg misc Chemiluminescence immunoassay misc Analytical performances misc Clinical performances misc Medicine (General) misc Chemistry
topic_browse	misc R5-920 misc QD1-999 misc Hepatitis B infection misc HBsAg misc Chemiluminescence immunoassay misc Analytical performances misc Clinical performances misc Medicine (General) misc Chemistry
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title	Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer
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title_full	Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer
author_sort	Benoit Visseaux
journal	Practical Laboratory Medicine
journalStr	Practical Laboratory Medicine
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author_browse	Benoit Visseaux Jérémie Gautier Françoise Le Boulaire Catherine Coignard Claire Vincent Sandrine Gréaume Isabelle Voisin Veronique Lemée Jean-Christophe Plantier Yves-Edouard Herpe Etienne Brochot Stephanie Bord Marc Turini Vanessa Roulet Juliane Hey
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author-letter	Benoit Visseaux
doi_str_mv	10.1016/j.plabm.2024.e00390
author2-role	verfasserin
title_sort	performance evaluation of the access hbsag and access hbsag confirmatory assays on the dxi 9000 access immunoassay analyzer
callnumber	R5-920
title_auth	Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer
abstract	Introduction: This study evaluated the clinical and analytical performances of the Access HBsAg and the Access HBsAg Confirmatory assays on the DxI 9000 Access Immunoassay Analyzer (Beckman Coulter, Inc.). Materials and methods: Diagnostic specificity and sensitivity of the Access HBsAg and Access HBsAg Confirmatory assays were evaluated by comparing the Access assays to the final HBsAg sample status determined using the Architect, PRISM, or Elecsys HBsAg assays, along with Architect or PRISM HBsAg Confirmatory assays. Imprecision, sensitivity on seroconversion panels, analytical sensitivity on WHO, and recognition of HBV variants were also evaluated. Results: A total of 7534 samples were included in the analysis (6047 blood donors, 1032 hospitalized patients, 455 positive patients’ samples). Access HBsAg assay sensitivity and specificity were at 100.00% (99.19–100.0) and 99.92% (99.82–99.97), respectively. Sensitivity of Access HBsAg Confirmatory assay was 100.00% (99.21–100.0) on the 464 HBsAg positive samples. The use of a high positive algorithm for the Access HBsAg assay, wherein samples with S/CO ≥ 100.00 were considered positive without requiring repeat or confirmatory testing, was successfully evaluated with all 450 specimens with S/CO greater than 100.00 (sensitivity 100.00%; 99.19–100.0). Access HBsAg assay demonstrated good analytical performance, equivalent recognition of seroconversion panels compared to Architect assay, and an analytical sensitivity between 0.022 and 0.025 IU/mL. All HBV genotypes, subtypes and mutants were well detected without analytical sensitivity loss. Conclusion: Access HBsAg and Access HBsAg Confirmatory assays demonstrated robust performances. They provide low samples volume requirements and a simplified process, no systematic retesting for high positive samples.
abstractGer	Introduction: This study evaluated the clinical and analytical performances of the Access HBsAg and the Access HBsAg Confirmatory assays on the DxI 9000 Access Immunoassay Analyzer (Beckman Coulter, Inc.). Materials and methods: Diagnostic specificity and sensitivity of the Access HBsAg and Access HBsAg Confirmatory assays were evaluated by comparing the Access assays to the final HBsAg sample status determined using the Architect, PRISM, or Elecsys HBsAg assays, along with Architect or PRISM HBsAg Confirmatory assays. Imprecision, sensitivity on seroconversion panels, analytical sensitivity on WHO, and recognition of HBV variants were also evaluated. Results: A total of 7534 samples were included in the analysis (6047 blood donors, 1032 hospitalized patients, 455 positive patients’ samples). Access HBsAg assay sensitivity and specificity were at 100.00% (99.19–100.0) and 99.92% (99.82–99.97), respectively. Sensitivity of Access HBsAg Confirmatory assay was 100.00% (99.21–100.0) on the 464 HBsAg positive samples. The use of a high positive algorithm for the Access HBsAg assay, wherein samples with S/CO ≥ 100.00 were considered positive without requiring repeat or confirmatory testing, was successfully evaluated with all 450 specimens with S/CO greater than 100.00 (sensitivity 100.00%; 99.19–100.0). Access HBsAg assay demonstrated good analytical performance, equivalent recognition of seroconversion panels compared to Architect assay, and an analytical sensitivity between 0.022 and 0.025 IU/mL. All HBV genotypes, subtypes and mutants were well detected without analytical sensitivity loss. Conclusion: Access HBsAg and Access HBsAg Confirmatory assays demonstrated robust performances. They provide low samples volume requirements and a simplified process, no systematic retesting for high positive samples.
abstract_unstemmed	Introduction: This study evaluated the clinical and analytical performances of the Access HBsAg and the Access HBsAg Confirmatory assays on the DxI 9000 Access Immunoassay Analyzer (Beckman Coulter, Inc.). Materials and methods: Diagnostic specificity and sensitivity of the Access HBsAg and Access HBsAg Confirmatory assays were evaluated by comparing the Access assays to the final HBsAg sample status determined using the Architect, PRISM, or Elecsys HBsAg assays, along with Architect or PRISM HBsAg Confirmatory assays. Imprecision, sensitivity on seroconversion panels, analytical sensitivity on WHO, and recognition of HBV variants were also evaluated. Results: A total of 7534 samples were included in the analysis (6047 blood donors, 1032 hospitalized patients, 455 positive patients’ samples). Access HBsAg assay sensitivity and specificity were at 100.00% (99.19–100.0) and 99.92% (99.82–99.97), respectively. Sensitivity of Access HBsAg Confirmatory assay was 100.00% (99.21–100.0) on the 464 HBsAg positive samples. The use of a high positive algorithm for the Access HBsAg assay, wherein samples with S/CO ≥ 100.00 were considered positive without requiring repeat or confirmatory testing, was successfully evaluated with all 450 specimens with S/CO greater than 100.00 (sensitivity 100.00%; 99.19–100.0). Access HBsAg assay demonstrated good analytical performance, equivalent recognition of seroconversion panels compared to Architect assay, and an analytical sensitivity between 0.022 and 0.025 IU/mL. All HBV genotypes, subtypes and mutants were well detected without analytical sensitivity loss. Conclusion: Access HBsAg and Access HBsAg Confirmatory assays demonstrated robust performances. They provide low samples volume requirements and a simplified process, no systematic retesting for high positive samples.
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title_short	Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer
url	https://doi.org/10.1016/j.plabm.2024.e00390 https://doaj.org/article/f25e264df1ef4d41b1f5d892282f85c0 http://www.sciencedirect.com/science/article/pii/S2352551724000362 https://doaj.org/toc/2352-5517
remote_bool	true
author2	Jérémie Gautier Françoise Le Boulaire Catherine Coignard Claire Vincent Sandrine Gréaume Isabelle Voisin Veronique Lemée Jean-Christophe Plantier Yves-Edouard Herpe Etienne Brochot Stephanie Bord Marc Turini Vanessa Roulet Juliane Hey
author2Str	Jérémie Gautier Françoise Le Boulaire Catherine Coignard Claire Vincent Sandrine Gréaume Isabelle Voisin Veronique Lemée Jean-Christophe Plantier Yves-Edouard Herpe Etienne Brochot Stephanie Bord Marc Turini Vanessa Roulet Juliane Hey
ppnlink	835590879
callnumber-subject	R - General Medicine
mediatype_str_mv	c
isOA_txt	true
hochschulschrift_bool	false
doi_str	10.1016/j.plabm.2024.e00390
callnumber-a	R5-920
up_date	2024-07-04T00:18:09.056Z
_version_	1803605549051281408
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Materials and methods: Diagnostic specificity and sensitivity of the Access HBsAg and Access HBsAg Confirmatory assays were evaluated by comparing the Access assays to the final HBsAg sample status determined using the Architect, PRISM, or Elecsys HBsAg assays, along with Architect or PRISM HBsAg Confirmatory assays. Imprecision, sensitivity on seroconversion panels, analytical sensitivity on WHO, and recognition of HBV variants were also evaluated. Results: A total of 7534 samples were included in the analysis (6047 blood donors, 1032 hospitalized patients, 455 positive patients’ samples). Access HBsAg assay sensitivity and specificity were at 100.00% (99.19–100.0) and 99.92% (99.82–99.97), respectively. Sensitivity of Access HBsAg Confirmatory assay was 100.00% (99.21–100.0) on the 464 HBsAg positive samples. The use of a high positive algorithm for the Access HBsAg assay, wherein samples with S/CO ≥ 100.00 were considered positive without requiring repeat or confirmatory testing, was successfully evaluated with all 450 specimens with S/CO greater than 100.00 (sensitivity 100.00%; 99.19–100.0). Access HBsAg assay demonstrated good analytical performance, equivalent recognition of seroconversion panels compared to Architect assay, and an analytical sensitivity between 0.022 and 0.025 IU/mL. All HBV genotypes, subtypes and mutants were well detected without analytical sensitivity loss. Conclusion: Access HBsAg and Access HBsAg Confirmatory assays demonstrated robust performances. They provide low samples volume requirements and a simplified process, no systematic retesting for high positive samples.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Hepatitis B infection</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">HBsAg</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Chemiluminescence immunoassay</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Analytical performances</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Clinical performances</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Medicine (General)</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Chemistry</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Jérémie Gautier</subfield><subfield code="e">verfasserin</subfield><subfield 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Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer

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