Analytical characteristics and comparative evaluation of Aptima HCV quant Dx assay with the Abbott RealTime HCV assay and Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative test v2.0

Background The Aptima HCV Quant Dx assay (Aptima assay) is a fully automated quantitative assay on the Panther® system. This assay is intended for confirmation of diagnosis and monitoring of HCV RNA in plasma and serum specimens. The purpose of the testing described in this paper was to evaluate the performance of the Aptima assay. Methods The analytical sensitivity, analytical specificity, precision, and linearity of the Aptima assay were assessed. The performance of the Aptima assay was compared to two commercially available HCV assays; the Abbott RealTime HCV assay (Abbott assay, Abbott Labs Illinois, USA) and the Roche COBAS Ampliprep/COBAS Taqman HCV Quantitative Test v2.0 (Roche Assay, Roche Molecular Systems, Pleasanton CA, USA). The 95% Lower Limit of Detection (LoD) of the assay was determined from dilutions of the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) and HCV positive clinical specimens in HCV negative human plasma and serum. Probit analysis was performed to generate the 95% predicted detection limits. The Lower Limit of Quantitation (LLoQ) was established for each genotype by diluting clinical specimens and the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) in HCV negative human plasma and serum. Specificity was determined using 200 fresh and 536 frozen HCV RNA negative clinical specimens including 370 plasma specimens and 366 serum specimens. Linearity for genotypes 1 to 6 was established by diluting armored RNA or HCV positive clinical specimens in HCV negative serum or plasma from 8.08 log IU/mL to below 1 log IU/mL. Precision was tested using a 10 member panel made by diluting HCV positive clinical specimens or spiking armored RNA into HCV negative plasma and serum. A method comparison was conducted against the Abbott assay using 1058 clinical specimens and against the Roche assay using 608 clinical specimens from HCV infected patients. In addition, agreement between the Roche assay and the Aptima assay using specimens with low HCV concentrations (</= 25 IU/mL by Roche) was tested using 107 clinical specimens. Results The 95% LoD was 5.1 IU/mL or lower for serum and 4.8 IU/mL or lower for plasma depending on the HCV genotype. The LLoQ for the assay was 10 IU/mL. Specificity was 100% with 95% confidence intervals of 99.6 to 100% for serum and plasma data combined. The assay demonstrated good linearity across the range for all genotypes. The Precision as estimated by the standard deviation (sd) was 0.17 log or lower across the range of the assay for both serum and plasma. HCV viral load results were compared using the Aptima assay and the Abbott assay giving a slope of 1.06, an intercept of 0.08 and an $ R^{2} $ of 0.98. HCV viral load results were compared for the Aptima and Roche assays giving a slope of 1.05, an intercept of −0.12 and an $ R^{2} $ of 0.96. Positive and negative agreement for the Aptima assay vs the Roche assay was 89% for low level specimens. Conclusion The Aptima assay is a highly sensitive and specific assay. The assay gave comparable HCV viral load results when compared to the Abbott and Roche assays. The performance of the Aptima assay makes it an excellent candidate for the detection and monitoring of HCV. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Worlock, A. [verfasserIn] Blair, D. Hunsicker, M. Le-Nguyen, T. Motta, C. Nguyen, C. Papachristou, E. Pham, J. Williams, A. Vi, M. Vinluan, B. Hatzakis, A.

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2017

Schlagwörter:	Sustained Virological Response Roche Assay Abbott Assay Panther System

Anmerkung:	© The Author(s). 2017

Übergeordnetes Werk:	Enthalten in: Virology journal - London : BioMed Central, 2004, 14(2017), 1 vom: 04. Apr.
Übergeordnetes Werk:	volume:14 ; year:2017 ; number:1 ; day:04 ; month:04

Links:	Volltext

DOI / URN:	10.1186/s12985-017-0727-3

Katalog-ID:	SPR029265398

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100	1		\|a Worlock, A. \|e verfasserin \|4 aut
245	1	0	\|a Analytical characteristics and comparative evaluation of Aptima HCV quant Dx assay with the Abbott RealTime HCV assay and Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative test v2.0
264		1	\|c 2017
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500			\|a © The Author(s). 2017
520			\|a Background The Aptima HCV Quant Dx assay (Aptima assay) is a fully automated quantitative assay on the Panther® system. This assay is intended for confirmation of diagnosis and monitoring of HCV RNA in plasma and serum specimens. The purpose of the testing described in this paper was to evaluate the performance of the Aptima assay. Methods The analytical sensitivity, analytical specificity, precision, and linearity of the Aptima assay were assessed. The performance of the Aptima assay was compared to two commercially available HCV assays; the Abbott RealTime HCV assay (Abbott assay, Abbott Labs Illinois, USA) and the Roche COBAS Ampliprep/COBAS Taqman HCV Quantitative Test v2.0 (Roche Assay, Roche Molecular Systems, Pleasanton CA, USA). The 95% Lower Limit of Detection (LoD) of the assay was determined from dilutions of the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) and HCV positive clinical specimens in HCV negative human plasma and serum. Probit analysis was performed to generate the 95% predicted detection limits. The Lower Limit of Quantitation (LLoQ) was established for each genotype by diluting clinical specimens and the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) in HCV negative human plasma and serum. Specificity was determined using 200 fresh and 536 frozen HCV RNA negative clinical specimens including 370 plasma specimens and 366 serum specimens. Linearity for genotypes 1 to 6 was established by diluting armored RNA or HCV positive clinical specimens in HCV negative serum or plasma from 8.08 log IU/mL to below 1 log IU/mL. Precision was tested using a 10 member panel made by diluting HCV positive clinical specimens or spiking armored RNA into HCV negative plasma and serum. A method comparison was conducted against the Abbott assay using 1058 clinical specimens and against the Roche assay using 608 clinical specimens from HCV infected patients. In addition, agreement between the Roche assay and the Aptima assay using specimens with low HCV concentrations (</= 25 IU/mL by Roche) was tested using 107 clinical specimens. Results The 95% LoD was 5.1 IU/mL or lower for serum and 4.8 IU/mL or lower for plasma depending on the HCV genotype. The LLoQ for the assay was 10 IU/mL. Specificity was 100% with 95% confidence intervals of 99.6 to 100% for serum and plasma data combined. The assay demonstrated good linearity across the range for all genotypes. The Precision as estimated by the standard deviation (sd) was 0.17 log or lower across the range of the assay for both serum and plasma. HCV viral load results were compared using the Aptima assay and the Abbott assay giving a slope of 1.06, an intercept of 0.08 and an $ R^{2} $ of 0.98. HCV viral load results were compared for the Aptima and Roche assays giving a slope of 1.05, an intercept of −0.12 and an $ R^{2} $ of 0.96. Positive and negative agreement for the Aptima assay vs the Roche assay was 89% for low level specimens. Conclusion The Aptima assay is a highly sensitive and specific assay. The assay gave comparable HCV viral load results when compared to the Abbott and Roche assays. The performance of the Aptima assay makes it an excellent candidate for the detection and monitoring of HCV.
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650		4	\|a Panther System \|7 (dpeaa)DE-He213
700	1		\|a Blair, D. \|4 aut
700	1		\|a Hunsicker, M. \|4 aut
700	1		\|a Le-Nguyen, T. \|4 aut
700	1		\|a Motta, C. \|4 aut
700	1		\|a Nguyen, C. \|4 aut
700	1		\|a Papachristou, E. \|4 aut
700	1		\|a Pham, J. \|4 aut
700	1		\|a Williams, A. \|4 aut
700	1		\|a Vi, M. \|4 aut
700	1		\|a Vinluan, B. \|4 aut
700	1		\|a Hatzakis, A. \|4 aut
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773	1	8	\|g volume:14 \|g year:2017 \|g number:1 \|g day:04 \|g month:04
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912			\|a GBV_ILN_11
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
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912			\|a GBV_ILN_206
912			\|a GBV_ILN_213
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912			\|a GBV_ILN_285
912			\|a GBV_ILN_293
912			\|a GBV_ILN_602
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912			\|a GBV_ILN_2001
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912			\|a GBV_ILN_2050
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912			\|a GBV_ILN_2056
912			\|a GBV_ILN_2057
912			\|a GBV_ILN_2061
912			\|a GBV_ILN_2111
912			\|a GBV_ILN_2113
912			\|a GBV_ILN_2190
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
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allfields	10.1186/s12985-017-0727-3 doi (DE-627)SPR029265398 (SPR)s12985-017-0727-3-e DE-627 ger DE-627 rakwb eng Worlock, A. verfasserin aut Analytical characteristics and comparative evaluation of Aptima HCV quant Dx assay with the Abbott RealTime HCV assay and Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative test v2.0 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 Background The Aptima HCV Quant Dx assay (Aptima assay) is a fully automated quantitative assay on the Panther® system. This assay is intended for confirmation of diagnosis and monitoring of HCV RNA in plasma and serum specimens. The purpose of the testing described in this paper was to evaluate the performance of the Aptima assay. Methods The analytical sensitivity, analytical specificity, precision, and linearity of the Aptima assay were assessed. The performance of the Aptima assay was compared to two commercially available HCV assays; the Abbott RealTime HCV assay (Abbott assay, Abbott Labs Illinois, USA) and the Roche COBAS Ampliprep/COBAS Taqman HCV Quantitative Test v2.0 (Roche Assay, Roche Molecular Systems, Pleasanton CA, USA). The 95% Lower Limit of Detection (LoD) of the assay was determined from dilutions of the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) and HCV positive clinical specimens in HCV negative human plasma and serum. Probit analysis was performed to generate the 95% predicted detection limits. The Lower Limit of Quantitation (LLoQ) was established for each genotype by diluting clinical specimens and the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) in HCV negative human plasma and serum. Specificity was determined using 200 fresh and 536 frozen HCV RNA negative clinical specimens including 370 plasma specimens and 366 serum specimens. Linearity for genotypes 1 to 6 was established by diluting armored RNA or HCV positive clinical specimens in HCV negative serum or plasma from 8.08 log IU/mL to below 1 log IU/mL. Precision was tested using a 10 member panel made by diluting HCV positive clinical specimens or spiking armored RNA into HCV negative plasma and serum. A method comparison was conducted against the Abbott assay using 1058 clinical specimens and against the Roche assay using 608 clinical specimens from HCV infected patients. In addition, agreement between the Roche assay and the Aptima assay using specimens with low HCV concentrations (</= 25 IU/mL by Roche) was tested using 107 clinical specimens. Results The 95% LoD was 5.1 IU/mL or lower for serum and 4.8 IU/mL or lower for plasma depending on the HCV genotype. The LLoQ for the assay was 10 IU/mL. Specificity was 100% with 95% confidence intervals of 99.6 to 100% for serum and plasma data combined. The assay demonstrated good linearity across the range for all genotypes. The Precision as estimated by the standard deviation (sd) was 0.17 log or lower across the range of the assay for both serum and plasma. HCV viral load results were compared using the Aptima assay and the Abbott assay giving a slope of 1.06, an intercept of 0.08 and an $ R^{2} $ of 0.98. HCV viral load results were compared for the Aptima and Roche assays giving a slope of 1.05, an intercept of −0.12 and an $ R^{2} $ of 0.96. Positive and negative agreement for the Aptima assay vs the Roche assay was 89% for low level specimens. Conclusion The Aptima assay is a highly sensitive and specific assay. The assay gave comparable HCV viral load results when compared to the Abbott and Roche assays. The performance of the Aptima assay makes it an excellent candidate for the detection and monitoring of HCV. Sustained Virological Response (dpeaa)DE-He213 Roche Assay (dpeaa)DE-He213 Abbott Assay (dpeaa)DE-He213 Panther System (dpeaa)DE-He213 Blair, D. aut Hunsicker, M. aut Le-Nguyen, T. aut Motta, C. aut Nguyen, C. aut Papachristou, E. aut Pham, J. aut Williams, A. aut Vi, M. aut Vinluan, B. aut Hatzakis, A. aut Enthalten in Virology journal London : BioMed Central, 2004 14(2017), 1 vom: 04. Apr. (DE-627)394165004 (DE-600)2160640-7 1743-422X nnns volume:14 year:2017 number:1 day:04 month:04 https://dx.doi.org/10.1186/s12985-017-0727-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 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_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 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_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 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 14 2017 1 04 04
spelling	10.1186/s12985-017-0727-3 doi (DE-627)SPR029265398 (SPR)s12985-017-0727-3-e DE-627 ger DE-627 rakwb eng Worlock, A. verfasserin aut Analytical characteristics and comparative evaluation of Aptima HCV quant Dx assay with the Abbott RealTime HCV assay and Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative test v2.0 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 Background The Aptima HCV Quant Dx assay (Aptima assay) is a fully automated quantitative assay on the Panther® system. This assay is intended for confirmation of diagnosis and monitoring of HCV RNA in plasma and serum specimens. The purpose of the testing described in this paper was to evaluate the performance of the Aptima assay. Methods The analytical sensitivity, analytical specificity, precision, and linearity of the Aptima assay were assessed. The performance of the Aptima assay was compared to two commercially available HCV assays; the Abbott RealTime HCV assay (Abbott assay, Abbott Labs Illinois, USA) and the Roche COBAS Ampliprep/COBAS Taqman HCV Quantitative Test v2.0 (Roche Assay, Roche Molecular Systems, Pleasanton CA, USA). The 95% Lower Limit of Detection (LoD) of the assay was determined from dilutions of the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) and HCV positive clinical specimens in HCV negative human plasma and serum. Probit analysis was performed to generate the 95% predicted detection limits. The Lower Limit of Quantitation (LLoQ) was established for each genotype by diluting clinical specimens and the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) in HCV negative human plasma and serum. Specificity was determined using 200 fresh and 536 frozen HCV RNA negative clinical specimens including 370 plasma specimens and 366 serum specimens. Linearity for genotypes 1 to 6 was established by diluting armored RNA or HCV positive clinical specimens in HCV negative serum or plasma from 8.08 log IU/mL to below 1 log IU/mL. Precision was tested using a 10 member panel made by diluting HCV positive clinical specimens or spiking armored RNA into HCV negative plasma and serum. A method comparison was conducted against the Abbott assay using 1058 clinical specimens and against the Roche assay using 608 clinical specimens from HCV infected patients. In addition, agreement between the Roche assay and the Aptima assay using specimens with low HCV concentrations (</= 25 IU/mL by Roche) was tested using 107 clinical specimens. Results The 95% LoD was 5.1 IU/mL or lower for serum and 4.8 IU/mL or lower for plasma depending on the HCV genotype. The LLoQ for the assay was 10 IU/mL. Specificity was 100% with 95% confidence intervals of 99.6 to 100% for serum and plasma data combined. The assay demonstrated good linearity across the range for all genotypes. The Precision as estimated by the standard deviation (sd) was 0.17 log or lower across the range of the assay for both serum and plasma. HCV viral load results were compared using the Aptima assay and the Abbott assay giving a slope of 1.06, an intercept of 0.08 and an $ R^{2} $ of 0.98. HCV viral load results were compared for the Aptima and Roche assays giving a slope of 1.05, an intercept of −0.12 and an $ R^{2} $ of 0.96. Positive and negative agreement for the Aptima assay vs the Roche assay was 89% for low level specimens. Conclusion The Aptima assay is a highly sensitive and specific assay. The assay gave comparable HCV viral load results when compared to the Abbott and Roche assays. The performance of the Aptima assay makes it an excellent candidate for the detection and monitoring of HCV. Sustained Virological Response (dpeaa)DE-He213 Roche Assay (dpeaa)DE-He213 Abbott Assay (dpeaa)DE-He213 Panther System (dpeaa)DE-He213 Blair, D. aut Hunsicker, M. aut Le-Nguyen, T. aut Motta, C. aut Nguyen, C. aut Papachristou, E. aut Pham, J. aut Williams, A. aut Vi, M. aut Vinluan, B. aut Hatzakis, A. aut Enthalten in Virology journal London : BioMed Central, 2004 14(2017), 1 vom: 04. Apr. (DE-627)394165004 (DE-600)2160640-7 1743-422X nnns volume:14 year:2017 number:1 day:04 month:04 https://dx.doi.org/10.1186/s12985-017-0727-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 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_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 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_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 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 14 2017 1 04 04
allfields_unstemmed	10.1186/s12985-017-0727-3 doi (DE-627)SPR029265398 (SPR)s12985-017-0727-3-e DE-627 ger DE-627 rakwb eng Worlock, A. verfasserin aut Analytical characteristics and comparative evaluation of Aptima HCV quant Dx assay with the Abbott RealTime HCV assay and Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative test v2.0 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 Background The Aptima HCV Quant Dx assay (Aptima assay) is a fully automated quantitative assay on the Panther® system. This assay is intended for confirmation of diagnosis and monitoring of HCV RNA in plasma and serum specimens. The purpose of the testing described in this paper was to evaluate the performance of the Aptima assay. Methods The analytical sensitivity, analytical specificity, precision, and linearity of the Aptima assay were assessed. The performance of the Aptima assay was compared to two commercially available HCV assays; the Abbott RealTime HCV assay (Abbott assay, Abbott Labs Illinois, USA) and the Roche COBAS Ampliprep/COBAS Taqman HCV Quantitative Test v2.0 (Roche Assay, Roche Molecular Systems, Pleasanton CA, USA). The 95% Lower Limit of Detection (LoD) of the assay was determined from dilutions of the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) and HCV positive clinical specimens in HCV negative human plasma and serum. Probit analysis was performed to generate the 95% predicted detection limits. The Lower Limit of Quantitation (LLoQ) was established for each genotype by diluting clinical specimens and the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) in HCV negative human plasma and serum. Specificity was determined using 200 fresh and 536 frozen HCV RNA negative clinical specimens including 370 plasma specimens and 366 serum specimens. Linearity for genotypes 1 to 6 was established by diluting armored RNA or HCV positive clinical specimens in HCV negative serum or plasma from 8.08 log IU/mL to below 1 log IU/mL. Precision was tested using a 10 member panel made by diluting HCV positive clinical specimens or spiking armored RNA into HCV negative plasma and serum. A method comparison was conducted against the Abbott assay using 1058 clinical specimens and against the Roche assay using 608 clinical specimens from HCV infected patients. In addition, agreement between the Roche assay and the Aptima assay using specimens with low HCV concentrations (</= 25 IU/mL by Roche) was tested using 107 clinical specimens. Results The 95% LoD was 5.1 IU/mL or lower for serum and 4.8 IU/mL or lower for plasma depending on the HCV genotype. The LLoQ for the assay was 10 IU/mL. Specificity was 100% with 95% confidence intervals of 99.6 to 100% for serum and plasma data combined. The assay demonstrated good linearity across the range for all genotypes. The Precision as estimated by the standard deviation (sd) was 0.17 log or lower across the range of the assay for both serum and plasma. HCV viral load results were compared using the Aptima assay and the Abbott assay giving a slope of 1.06, an intercept of 0.08 and an $ R^{2} $ of 0.98. HCV viral load results were compared for the Aptima and Roche assays giving a slope of 1.05, an intercept of −0.12 and an $ R^{2} $ of 0.96. Positive and negative agreement for the Aptima assay vs the Roche assay was 89% for low level specimens. Conclusion The Aptima assay is a highly sensitive and specific assay. The assay gave comparable HCV viral load results when compared to the Abbott and Roche assays. The performance of the Aptima assay makes it an excellent candidate for the detection and monitoring of HCV. Sustained Virological Response (dpeaa)DE-He213 Roche Assay (dpeaa)DE-He213 Abbott Assay (dpeaa)DE-He213 Panther System (dpeaa)DE-He213 Blair, D. aut Hunsicker, M. aut Le-Nguyen, T. aut Motta, C. aut Nguyen, C. aut Papachristou, E. aut Pham, J. aut Williams, A. aut Vi, M. aut Vinluan, B. aut Hatzakis, A. aut Enthalten in Virology journal London : BioMed Central, 2004 14(2017), 1 vom: 04. Apr. (DE-627)394165004 (DE-600)2160640-7 1743-422X nnns volume:14 year:2017 number:1 day:04 month:04 https://dx.doi.org/10.1186/s12985-017-0727-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 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_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 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_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 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 14 2017 1 04 04
allfieldsGer	10.1186/s12985-017-0727-3 doi (DE-627)SPR029265398 (SPR)s12985-017-0727-3-e DE-627 ger DE-627 rakwb eng Worlock, A. verfasserin aut Analytical characteristics and comparative evaluation of Aptima HCV quant Dx assay with the Abbott RealTime HCV assay and Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative test v2.0 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 Background The Aptima HCV Quant Dx assay (Aptima assay) is a fully automated quantitative assay on the Panther® system. This assay is intended for confirmation of diagnosis and monitoring of HCV RNA in plasma and serum specimens. The purpose of the testing described in this paper was to evaluate the performance of the Aptima assay. Methods The analytical sensitivity, analytical specificity, precision, and linearity of the Aptima assay were assessed. The performance of the Aptima assay was compared to two commercially available HCV assays; the Abbott RealTime HCV assay (Abbott assay, Abbott Labs Illinois, USA) and the Roche COBAS Ampliprep/COBAS Taqman HCV Quantitative Test v2.0 (Roche Assay, Roche Molecular Systems, Pleasanton CA, USA). The 95% Lower Limit of Detection (LoD) of the assay was determined from dilutions of the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) and HCV positive clinical specimens in HCV negative human plasma and serum. Probit analysis was performed to generate the 95% predicted detection limits. The Lower Limit of Quantitation (LLoQ) was established for each genotype by diluting clinical specimens and the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) in HCV negative human plasma and serum. Specificity was determined using 200 fresh and 536 frozen HCV RNA negative clinical specimens including 370 plasma specimens and 366 serum specimens. Linearity for genotypes 1 to 6 was established by diluting armored RNA or HCV positive clinical specimens in HCV negative serum or plasma from 8.08 log IU/mL to below 1 log IU/mL. Precision was tested using a 10 member panel made by diluting HCV positive clinical specimens or spiking armored RNA into HCV negative plasma and serum. A method comparison was conducted against the Abbott assay using 1058 clinical specimens and against the Roche assay using 608 clinical specimens from HCV infected patients. In addition, agreement between the Roche assay and the Aptima assay using specimens with low HCV concentrations (</= 25 IU/mL by Roche) was tested using 107 clinical specimens. Results The 95% LoD was 5.1 IU/mL or lower for serum and 4.8 IU/mL or lower for plasma depending on the HCV genotype. The LLoQ for the assay was 10 IU/mL. Specificity was 100% with 95% confidence intervals of 99.6 to 100% for serum and plasma data combined. The assay demonstrated good linearity across the range for all genotypes. The Precision as estimated by the standard deviation (sd) was 0.17 log or lower across the range of the assay for both serum and plasma. HCV viral load results were compared using the Aptima assay and the Abbott assay giving a slope of 1.06, an intercept of 0.08 and an $ R^{2} $ of 0.98. HCV viral load results were compared for the Aptima and Roche assays giving a slope of 1.05, an intercept of −0.12 and an $ R^{2} $ of 0.96. Positive and negative agreement for the Aptima assay vs the Roche assay was 89% for low level specimens. Conclusion The Aptima assay is a highly sensitive and specific assay. The assay gave comparable HCV viral load results when compared to the Abbott and Roche assays. The performance of the Aptima assay makes it an excellent candidate for the detection and monitoring of HCV. Sustained Virological Response (dpeaa)DE-He213 Roche Assay (dpeaa)DE-He213 Abbott Assay (dpeaa)DE-He213 Panther System (dpeaa)DE-He213 Blair, D. aut Hunsicker, M. aut Le-Nguyen, T. aut Motta, C. aut Nguyen, C. aut Papachristou, E. aut Pham, J. aut Williams, A. aut Vi, M. aut Vinluan, B. aut Hatzakis, A. aut Enthalten in Virology journal London : BioMed Central, 2004 14(2017), 1 vom: 04. Apr. (DE-627)394165004 (DE-600)2160640-7 1743-422X nnns volume:14 year:2017 number:1 day:04 month:04 https://dx.doi.org/10.1186/s12985-017-0727-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 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_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 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_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 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 14 2017 1 04 04
allfieldsSound	10.1186/s12985-017-0727-3 doi (DE-627)SPR029265398 (SPR)s12985-017-0727-3-e DE-627 ger DE-627 rakwb eng Worlock, A. verfasserin aut Analytical characteristics and comparative evaluation of Aptima HCV quant Dx assay with the Abbott RealTime HCV assay and Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative test v2.0 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 Background The Aptima HCV Quant Dx assay (Aptima assay) is a fully automated quantitative assay on the Panther® system. This assay is intended for confirmation of diagnosis and monitoring of HCV RNA in plasma and serum specimens. The purpose of the testing described in this paper was to evaluate the performance of the Aptima assay. Methods The analytical sensitivity, analytical specificity, precision, and linearity of the Aptima assay were assessed. The performance of the Aptima assay was compared to two commercially available HCV assays; the Abbott RealTime HCV assay (Abbott assay, Abbott Labs Illinois, USA) and the Roche COBAS Ampliprep/COBAS Taqman HCV Quantitative Test v2.0 (Roche Assay, Roche Molecular Systems, Pleasanton CA, USA). The 95% Lower Limit of Detection (LoD) of the assay was determined from dilutions of the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) and HCV positive clinical specimens in HCV negative human plasma and serum. Probit analysis was performed to generate the 95% predicted detection limits. The Lower Limit of Quantitation (LLoQ) was established for each genotype by diluting clinical specimens and the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) in HCV negative human plasma and serum. Specificity was determined using 200 fresh and 536 frozen HCV RNA negative clinical specimens including 370 plasma specimens and 366 serum specimens. Linearity for genotypes 1 to 6 was established by diluting armored RNA or HCV positive clinical specimens in HCV negative serum or plasma from 8.08 log IU/mL to below 1 log IU/mL. Precision was tested using a 10 member panel made by diluting HCV positive clinical specimens or spiking armored RNA into HCV negative plasma and serum. A method comparison was conducted against the Abbott assay using 1058 clinical specimens and against the Roche assay using 608 clinical specimens from HCV infected patients. In addition, agreement between the Roche assay and the Aptima assay using specimens with low HCV concentrations (</= 25 IU/mL by Roche) was tested using 107 clinical specimens. Results The 95% LoD was 5.1 IU/mL or lower for serum and 4.8 IU/mL or lower for plasma depending on the HCV genotype. The LLoQ for the assay was 10 IU/mL. Specificity was 100% with 95% confidence intervals of 99.6 to 100% for serum and plasma data combined. The assay demonstrated good linearity across the range for all genotypes. The Precision as estimated by the standard deviation (sd) was 0.17 log or lower across the range of the assay for both serum and plasma. HCV viral load results were compared using the Aptima assay and the Abbott assay giving a slope of 1.06, an intercept of 0.08 and an $ R^{2} $ of 0.98. HCV viral load results were compared for the Aptima and Roche assays giving a slope of 1.05, an intercept of −0.12 and an $ R^{2} $ of 0.96. Positive and negative agreement for the Aptima assay vs the Roche assay was 89% for low level specimens. Conclusion The Aptima assay is a highly sensitive and specific assay. The assay gave comparable HCV viral load results when compared to the Abbott and Roche assays. The performance of the Aptima assay makes it an excellent candidate for the detection and monitoring of HCV. Sustained Virological Response (dpeaa)DE-He213 Roche Assay (dpeaa)DE-He213 Abbott Assay (dpeaa)DE-He213 Panther System (dpeaa)DE-He213 Blair, D. aut Hunsicker, M. aut Le-Nguyen, T. aut Motta, C. aut Nguyen, C. aut Papachristou, E. aut Pham, J. aut Williams, A. aut Vi, M. aut Vinluan, B. aut Hatzakis, A. aut Enthalten in Virology journal London : BioMed Central, 2004 14(2017), 1 vom: 04. Apr. (DE-627)394165004 (DE-600)2160640-7 1743-422X nnns volume:14 year:2017 number:1 day:04 month:04 https://dx.doi.org/10.1186/s12985-017-0727-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 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_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 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_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 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 14 2017 1 04 04
language	English
source	Enthalten in Virology journal 14(2017), 1 vom: 04. Apr. volume:14 year:2017 number:1 day:04 month:04
sourceStr	Enthalten in Virology journal 14(2017), 1 vom: 04. Apr. volume:14 year:2017 number:1 day:04 month:04
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Sustained Virological Response Roche Assay Abbott Assay Panther System
isfreeaccess_bool	true
container_title	Virology journal
authorswithroles_txt_mv	Worlock, A. @@aut@@ Blair, D. @@aut@@ Hunsicker, M. @@aut@@ Le-Nguyen, T. @@aut@@ Motta, C. @@aut@@ Nguyen, C. @@aut@@ Papachristou, E. @@aut@@ Pham, J. @@aut@@ Williams, A. @@aut@@ Vi, M. @@aut@@ Vinluan, B. @@aut@@ Hatzakis, A. @@aut@@
publishDateDaySort_date	2017-04-04T00:00:00Z
hierarchy_top_id	394165004
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language_de	englisch
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This assay is intended for confirmation of diagnosis and monitoring of HCV RNA in plasma and serum specimens. The purpose of the testing described in this paper was to evaluate the performance of the Aptima assay. Methods The analytical sensitivity, analytical specificity, precision, and linearity of the Aptima assay were assessed. The performance of the Aptima assay was compared to two commercially available HCV assays; the Abbott RealTime HCV assay (Abbott assay, Abbott Labs Illinois, USA) and the Roche COBAS Ampliprep/COBAS Taqman HCV Quantitative Test v2.0 (Roche Assay, Roche Molecular Systems, Pleasanton CA, USA). The 95% Lower Limit of Detection (LoD) of the assay was determined from dilutions of the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) and HCV positive clinical specimens in HCV negative human plasma and serum. Probit analysis was performed to generate the 95% predicted detection limits. The Lower Limit of Quantitation (LLoQ) was established for each genotype by diluting clinical specimens and the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) in HCV negative human plasma and serum. Specificity was determined using 200 fresh and 536 frozen HCV RNA negative clinical specimens including 370 plasma specimens and 366 serum specimens. Linearity for genotypes 1 to 6 was established by diluting armored RNA or HCV positive clinical specimens in HCV negative serum or plasma from 8.08 log IU/mL to below 1 log IU/mL. Precision was tested using a 10 member panel made by diluting HCV positive clinical specimens or spiking armored RNA into HCV negative plasma and serum. A method comparison was conducted against the Abbott assay using 1058 clinical specimens and against the Roche assay using 608 clinical specimens from HCV infected patients. In addition, agreement between the Roche assay and the Aptima assay using specimens with low HCV concentrations (</= 25 IU/mL by Roche) was tested using 107 clinical specimens. Results The 95% LoD was 5.1 IU/mL or lower for serum and 4.8 IU/mL or lower for plasma depending on the HCV genotype. The LLoQ for the assay was 10 IU/mL. Specificity was 100% with 95% confidence intervals of 99.6 to 100% for serum and plasma data combined. The assay demonstrated good linearity across the range for all genotypes. The Precision as estimated by the standard deviation (sd) was 0.17 log or lower across the range of the assay for both serum and plasma. HCV viral load results were compared using the Aptima assay and the Abbott assay giving a slope of 1.06, an intercept of 0.08 and an $ R^{2} $ of 0.98. HCV viral load results were compared for the Aptima and Roche assays giving a slope of 1.05, an intercept of −0.12 and an $ R^{2} $ of 0.96. Positive and negative agreement for the Aptima assay vs the Roche assay was 89% for low level specimens. Conclusion The Aptima assay is a highly sensitive and specific assay. The assay gave comparable HCV viral load results when compared to the Abbott and Roche assays. 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author	Worlock, A.
spellingShingle	Worlock, A. misc Sustained Virological Response misc Roche Assay misc Abbott Assay misc Panther System Analytical characteristics and comparative evaluation of Aptima HCV quant Dx assay with the Abbott RealTime HCV assay and Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative test v2.0
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topic_title	Analytical characteristics and comparative evaluation of Aptima HCV quant Dx assay with the Abbott RealTime HCV assay and Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative test v2.0 Sustained Virological Response (dpeaa)DE-He213 Roche Assay (dpeaa)DE-He213 Abbott Assay (dpeaa)DE-He213 Panther System (dpeaa)DE-He213
topic	misc Sustained Virological Response misc Roche Assay misc Abbott Assay misc Panther System
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title	Analytical characteristics and comparative evaluation of Aptima HCV quant Dx assay with the Abbott RealTime HCV assay and Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative test v2.0
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title_full	Analytical characteristics and comparative evaluation of Aptima HCV quant Dx assay with the Abbott RealTime HCV assay and Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative test v2.0
author_sort	Worlock, A.
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author_browse	Worlock, A. Blair, D. Hunsicker, M. Le-Nguyen, T. Motta, C. Nguyen, C. Papachristou, E. Pham, J. Williams, A. Vi, M. Vinluan, B. Hatzakis, A.
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title_sort	analytical characteristics and comparative evaluation of aptima hcv quant dx assay with the abbott realtime hcv assay and roche cobas ampliprep/cobas taqman hcv quantitative test v2.0
title_auth	Analytical characteristics and comparative evaluation of Aptima HCV quant Dx assay with the Abbott RealTime HCV assay and Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative test v2.0
abstract	Background The Aptima HCV Quant Dx assay (Aptima assay) is a fully automated quantitative assay on the Panther® system. This assay is intended for confirmation of diagnosis and monitoring of HCV RNA in plasma and serum specimens. The purpose of the testing described in this paper was to evaluate the performance of the Aptima assay. Methods The analytical sensitivity, analytical specificity, precision, and linearity of the Aptima assay were assessed. The performance of the Aptima assay was compared to two commercially available HCV assays; the Abbott RealTime HCV assay (Abbott assay, Abbott Labs Illinois, USA) and the Roche COBAS Ampliprep/COBAS Taqman HCV Quantitative Test v2.0 (Roche Assay, Roche Molecular Systems, Pleasanton CA, USA). The 95% Lower Limit of Detection (LoD) of the assay was determined from dilutions of the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) and HCV positive clinical specimens in HCV negative human plasma and serum. Probit analysis was performed to generate the 95% predicted detection limits. The Lower Limit of Quantitation (LLoQ) was established for each genotype by diluting clinical specimens and the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) in HCV negative human plasma and serum. Specificity was determined using 200 fresh and 536 frozen HCV RNA negative clinical specimens including 370 plasma specimens and 366 serum specimens. Linearity for genotypes 1 to 6 was established by diluting armored RNA or HCV positive clinical specimens in HCV negative serum or plasma from 8.08 log IU/mL to below 1 log IU/mL. Precision was tested using a 10 member panel made by diluting HCV positive clinical specimens or spiking armored RNA into HCV negative plasma and serum. A method comparison was conducted against the Abbott assay using 1058 clinical specimens and against the Roche assay using 608 clinical specimens from HCV infected patients. In addition, agreement between the Roche assay and the Aptima assay using specimens with low HCV concentrations (</= 25 IU/mL by Roche) was tested using 107 clinical specimens. Results The 95% LoD was 5.1 IU/mL or lower for serum and 4.8 IU/mL or lower for plasma depending on the HCV genotype. The LLoQ for the assay was 10 IU/mL. Specificity was 100% with 95% confidence intervals of 99.6 to 100% for serum and plasma data combined. The assay demonstrated good linearity across the range for all genotypes. The Precision as estimated by the standard deviation (sd) was 0.17 log or lower across the range of the assay for both serum and plasma. HCV viral load results were compared using the Aptima assay and the Abbott assay giving a slope of 1.06, an intercept of 0.08 and an $ R^{2} $ of 0.98. HCV viral load results were compared for the Aptima and Roche assays giving a slope of 1.05, an intercept of −0.12 and an $ R^{2} $ of 0.96. Positive and negative agreement for the Aptima assay vs the Roche assay was 89% for low level specimens. Conclusion The Aptima assay is a highly sensitive and specific assay. The assay gave comparable HCV viral load results when compared to the Abbott and Roche assays. The performance of the Aptima assay makes it an excellent candidate for the detection and monitoring of HCV. © The Author(s). 2017
abstractGer	Background The Aptima HCV Quant Dx assay (Aptima assay) is a fully automated quantitative assay on the Panther® system. This assay is intended for confirmation of diagnosis and monitoring of HCV RNA in plasma and serum specimens. The purpose of the testing described in this paper was to evaluate the performance of the Aptima assay. Methods The analytical sensitivity, analytical specificity, precision, and linearity of the Aptima assay were assessed. The performance of the Aptima assay was compared to two commercially available HCV assays; the Abbott RealTime HCV assay (Abbott assay, Abbott Labs Illinois, USA) and the Roche COBAS Ampliprep/COBAS Taqman HCV Quantitative Test v2.0 (Roche Assay, Roche Molecular Systems, Pleasanton CA, USA). The 95% Lower Limit of Detection (LoD) of the assay was determined from dilutions of the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) and HCV positive clinical specimens in HCV negative human plasma and serum. Probit analysis was performed to generate the 95% predicted detection limits. The Lower Limit of Quantitation (LLoQ) was established for each genotype by diluting clinical specimens and the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) in HCV negative human plasma and serum. Specificity was determined using 200 fresh and 536 frozen HCV RNA negative clinical specimens including 370 plasma specimens and 366 serum specimens. Linearity for genotypes 1 to 6 was established by diluting armored RNA or HCV positive clinical specimens in HCV negative serum or plasma from 8.08 log IU/mL to below 1 log IU/mL. Precision was tested using a 10 member panel made by diluting HCV positive clinical specimens or spiking armored RNA into HCV negative plasma and serum. A method comparison was conducted against the Abbott assay using 1058 clinical specimens and against the Roche assay using 608 clinical specimens from HCV infected patients. In addition, agreement between the Roche assay and the Aptima assay using specimens with low HCV concentrations (</= 25 IU/mL by Roche) was tested using 107 clinical specimens. Results The 95% LoD was 5.1 IU/mL or lower for serum and 4.8 IU/mL or lower for plasma depending on the HCV genotype. The LLoQ for the assay was 10 IU/mL. Specificity was 100% with 95% confidence intervals of 99.6 to 100% for serum and plasma data combined. The assay demonstrated good linearity across the range for all genotypes. The Precision as estimated by the standard deviation (sd) was 0.17 log or lower across the range of the assay for both serum and plasma. HCV viral load results were compared using the Aptima assay and the Abbott assay giving a slope of 1.06, an intercept of 0.08 and an $ R^{2} $ of 0.98. HCV viral load results were compared for the Aptima and Roche assays giving a slope of 1.05, an intercept of −0.12 and an $ R^{2} $ of 0.96. Positive and negative agreement for the Aptima assay vs the Roche assay was 89% for low level specimens. Conclusion The Aptima assay is a highly sensitive and specific assay. The assay gave comparable HCV viral load results when compared to the Abbott and Roche assays. The performance of the Aptima assay makes it an excellent candidate for the detection and monitoring of HCV. © The Author(s). 2017
abstract_unstemmed	Background The Aptima HCV Quant Dx assay (Aptima assay) is a fully automated quantitative assay on the Panther® system. This assay is intended for confirmation of diagnosis and monitoring of HCV RNA in plasma and serum specimens. The purpose of the testing described in this paper was to evaluate the performance of the Aptima assay. Methods The analytical sensitivity, analytical specificity, precision, and linearity of the Aptima assay were assessed. The performance of the Aptima assay was compared to two commercially available HCV assays; the Abbott RealTime HCV assay (Abbott assay, Abbott Labs Illinois, USA) and the Roche COBAS Ampliprep/COBAS Taqman HCV Quantitative Test v2.0 (Roche Assay, Roche Molecular Systems, Pleasanton CA, USA). The 95% Lower Limit of Detection (LoD) of the assay was determined from dilutions of the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) and HCV positive clinical specimens in HCV negative human plasma and serum. Probit analysis was performed to generate the 95% predicted detection limits. The Lower Limit of Quantitation (LLoQ) was established for each genotype by diluting clinical specimens and the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) in HCV negative human plasma and serum. Specificity was determined using 200 fresh and 536 frozen HCV RNA negative clinical specimens including 370 plasma specimens and 366 serum specimens. Linearity for genotypes 1 to 6 was established by diluting armored RNA or HCV positive clinical specimens in HCV negative serum or plasma from 8.08 log IU/mL to below 1 log IU/mL. Precision was tested using a 10 member panel made by diluting HCV positive clinical specimens or spiking armored RNA into HCV negative plasma and serum. A method comparison was conducted against the Abbott assay using 1058 clinical specimens and against the Roche assay using 608 clinical specimens from HCV infected patients. In addition, agreement between the Roche assay and the Aptima assay using specimens with low HCV concentrations (</= 25 IU/mL by Roche) was tested using 107 clinical specimens. Results The 95% LoD was 5.1 IU/mL or lower for serum and 4.8 IU/mL or lower for plasma depending on the HCV genotype. The LLoQ for the assay was 10 IU/mL. Specificity was 100% with 95% confidence intervals of 99.6 to 100% for serum and plasma data combined. The assay demonstrated good linearity across the range for all genotypes. The Precision as estimated by the standard deviation (sd) was 0.17 log or lower across the range of the assay for both serum and plasma. HCV viral load results were compared using the Aptima assay and the Abbott assay giving a slope of 1.06, an intercept of 0.08 and an $ R^{2} $ of 0.98. HCV viral load results were compared for the Aptima and Roche assays giving a slope of 1.05, an intercept of −0.12 and an $ R^{2} $ of 0.96. Positive and negative agreement for the Aptima assay vs the Roche assay was 89% for low level specimens. Conclusion The Aptima assay is a highly sensitive and specific assay. The assay gave comparable HCV viral load results when compared to the Abbott and Roche assays. The performance of the Aptima assay makes it an excellent candidate for the detection and monitoring of HCV. © The Author(s). 2017
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title_short	Analytical characteristics and comparative evaluation of Aptima HCV quant Dx assay with the Abbott RealTime HCV assay and Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative test v2.0
url	https://dx.doi.org/10.1186/s12985-017-0727-3
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author2Str	Blair, D. Hunsicker, M. Le-Nguyen, T. Motta, C. Nguyen, C. Papachristou, E. Pham, J. Williams, A. Vi, M. Vinluan, B. Hatzakis, A.
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This assay is intended for confirmation of diagnosis and monitoring of HCV RNA in plasma and serum specimens. The purpose of the testing described in this paper was to evaluate the performance of the Aptima assay. Methods The analytical sensitivity, analytical specificity, precision, and linearity of the Aptima assay were assessed. The performance of the Aptima assay was compared to two commercially available HCV assays; the Abbott RealTime HCV assay (Abbott assay, Abbott Labs Illinois, USA) and the Roche COBAS Ampliprep/COBAS Taqman HCV Quantitative Test v2.0 (Roche Assay, Roche Molecular Systems, Pleasanton CA, USA). The 95% Lower Limit of Detection (LoD) of the assay was determined from dilutions of the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) and HCV positive clinical specimens in HCV negative human plasma and serum. Probit analysis was performed to generate the 95% predicted detection limits. The Lower Limit of Quantitation (LLoQ) was established for each genotype by diluting clinical specimens and the 2nd HCV WHO International Standard (NIBSC 96/798 genotype 1) in HCV negative human plasma and serum. Specificity was determined using 200 fresh and 536 frozen HCV RNA negative clinical specimens including 370 plasma specimens and 366 serum specimens. Linearity for genotypes 1 to 6 was established by diluting armored RNA or HCV positive clinical specimens in HCV negative serum or plasma from 8.08 log IU/mL to below 1 log IU/mL. Precision was tested using a 10 member panel made by diluting HCV positive clinical specimens or spiking armored RNA into HCV negative plasma and serum. A method comparison was conducted against the Abbott assay using 1058 clinical specimens and against the Roche assay using 608 clinical specimens from HCV infected patients. In addition, agreement between the Roche assay and the Aptima assay using specimens with low HCV concentrations (</= 25 IU/mL by Roche) was tested using 107 clinical specimens. Results The 95% LoD was 5.1 IU/mL or lower for serum and 4.8 IU/mL or lower for plasma depending on the HCV genotype. The LLoQ for the assay was 10 IU/mL. Specificity was 100% with 95% confidence intervals of 99.6 to 100% for serum and plasma data combined. The assay demonstrated good linearity across the range for all genotypes. The Precision as estimated by the standard deviation (sd) was 0.17 log or lower across the range of the assay for both serum and plasma. HCV viral load results were compared using the Aptima assay and the Abbott assay giving a slope of 1.06, an intercept of 0.08 and an $ R^{2} $ of 0.98. HCV viral load results were compared for the Aptima and Roche assays giving a slope of 1.05, an intercept of −0.12 and an $ R^{2} $ of 0.96. Positive and negative agreement for the Aptima assay vs the Roche assay was 89% for low level specimens. Conclusion The Aptima assay is a highly sensitive and specific assay. The assay gave comparable HCV viral load results when compared to the Abbott and Roche assays. 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Analytical characteristics and comparative evaluation of Aptima HCV quant Dx assay with the Abbott RealTime HCV assay and Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative test v2.0

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