BioMed Research International

Review Article

Performance of HCV Antigen Testing for the Diagnosis and Monitoring of Antiviral Treatment: A Systematic Review and Meta-Analysis

Table 1

Main characteristic of studies that used HCV Ag testing to evaluate diagnosis of active HCV infection.


Year	Author (reference)	Country	HCV-GT	Study	HCV Ag assay	Gold standard		Sample	Correlation HCV Ag to HCV RNA	SE (%)	SP (%)

Chemiluminescence immunoassays
2019	Bo Feng et al. [39]	China	1, 2, and 3	Prospective	Architect HCV Ag (Abbott Diagnostics, Wiesbaden Germany)	HCV RNA	782	Serum	NA	90.6%	96.6%
2019	Łucejko et al. [40]	Poland	1	Prospective	Architect HCV Ag (Abbott Diagnostics, Wiesbaden Germany)	HCV RNA	514	Serum	Before ; during ; after	97.1%	99.6%
2019	Catlett et al. [41]	Australia	NA	Cohort study	Architect HCV Ag (Abbott Diagnostics)	HCV RNA	186	Plasma/DBS	(plasma) (DBS)	98.1-100% (plasma), 90.7-92.5 (DBS)	100% (plasma/DBS)
2019	Perez- Garcia et al. [42]	Spain	1a, 1b, 2, 3, and 4	Prospective	Architect HCV Ag (Abbott Diagnostics)	HCV RNA	124	Serum/plasma		97%	95%
2019	Fan et al. [36]	China	1b	Retrospective	Architect HCV Ag (Abbott Diagnostics, Wiesbaden Germany)	COBAS AmpliPrep/COBAS TaqMan HCV test, v2.0 (Roche Molecular Systems, Pleasanton, CA, USA)	135	Serum		80.2%	89.7%
2019	Xiang et al. [43]	China	1b, 2a, 3a, 3b, 6a, 1b/3b	Prospective	Architect HCV Ag (Abbott Diagnostics)	System (Roche Diagnostics)	106	Serum		100%	NA
2018	van Tilborg et al. [44]	Canada	1a, 1b, 1(unspecified), 2, 3, 4, 5, 6	Retrospective	Architect HCV Ag (Abbott Diagnostics)	COBAS AmpliPrep/COBAS TaqMan HCV v2.0 (Roche)	10006	Serum		99.0%	NA
2018	Nguyen et al. [24]	Vietnam	NA	Prospective	Architect HCV Ag (Abbott Diagnostics)	COBAS AmpliPrep/COBAS TaqMan v2 (Roche)	104	DBS		87.2%	100%
2018	Adland et al. [45]	United Kingdom	1, 3	Retrospective	Architect HCV Ag (Abbott Diagnostics)	Abbott RealTime HCV assay (Abbott Molecular, Des Plaines, IL)	305	NA		97.7%	NA
2018	Lamoury et al. [28]	Australia	1a, 1b, 2, 3a, 6	Prospective	Architect HCV Ag (Abbott Diagnostics)	COBAS AmpliPrep/COBAS TaqMan HCV test v2.0 (Roche Diagnostics)	120	Plasma/DBS	Plasma DBS	91.6% plasma and 82.9% DBS	100% plasma and 96.1% no DBS
2018	Chevaliez et al. [14]	NA	1b	Retrospective	Architect HCV Ag (Abbott Diagnostics)	Roche High-Pure system/COBAS TaqMan HCV test v2.0 (Roche)	631	Plasma		99.80%	NA
2017	Wasitthankasem et al. [29]	Thailand	1a, 1b, 3a, 3b, 6c, 6f, 6i, 6n	Transversal	Architect HCV Ag (Abbott Diagnostics)	Abbott RealTime HCV (Abbott Molecular)	290	Serum		100%	97.1%
2017	Mohamed et al. [27]	Tanzania	1a, 4a	Prospective	Architect HCV Ag (Abbott Diagnostics)	COBAS AmpliPrep/COBAS TaqMan HCV test v2.0 (Roche Molecular)	153	Serum/DBS		99.1% serum and 76.7% DBS	94.4% serum and 97.3% DBS
2017	Lucejko et al. [46]	Europe	1a/1b/3a/4-2/29/0/2	Longitudinal	Architect HCV Ag (Abbott Diagnostics)	COBAS AmpliPrep HCV test (Roche Molecular Systems, Pleasanton, CA, USA)	33	Serum/plasma		100%	NA
2017	Talal et al. [47]	EUA	1a, 1b, 2, 3, 4	Prospective	Architect HCV Ag (Abbott Diagnostics)	COBAS TaqMan assay (Roche Diagnostics)	109	Serum		97.9%	100%
2017	Rockstroh et at [15].	NA	1	Retrospective	Architect HCV Ag (Abbott Diagnostics)	Roche High-Pure /COBAS TaqMan HCV test v2.0 (Roche Diagnostics)	737	Plasma		99.05%	100%
2017	Loggi et al. [48]	Italy	1a, 1b, 1(subtype not available), 2, 3, 4	Longitudinal	Architect HCV Ag (Abbott Diagnostics)	COBAS AmpliPrep/COBAS TaqMan HCV test v2.0 (Roche Diagnostics)	96	Serum		100%	NA
2017	Arboledas et al. [49]	Spain	1a, 1b, 2, 3, 4	Prospective	Architect HCV Ag (Abbott Diagnostics)	COBAS AmpliPrep/COBAS TaqMan HCV assay (Roche Diagnostics)	262	Plasma		98.7%	NA
2017	Arboledas et al. [49]	Spain	1a, 1b, 2, 3, 4	Retrospective	Architect HCV Ag (Abbott Diagnostics)	COBAS AmpliPrep/COBAS TaqMan HCV assay (Roche Diagnostics)	132	Plasma		98.5%	NA
2017	Lamoury et al. [11]	Australia	1, 2, 3	Prospective	Architect HCV Ag (Abbott Diagnostics)	COBAS AmpliPrep/COBAS TaqMan HCV test v2.0 (Roche Diagnostics)	92	Plasma		94%	NA
2017	Alonso et al. [50]	Spain	1a, 1b, 2c, 3, 4	Retrospective	Architect HCV Ag (Abbott Diagnostics)	COBAS AmpliPrep/COBAS TaqMan HCV assay (Roche Diagnostics)	28	Serum	NA	96.2%	100%
2016	Aghemo et al. [13]	Italy	1, 2, 3, 4, 5	Prospective	Architect HCV Ag (Abbott Diagnostics)	Abbott RealTime HCV (Abbott Molecular)	58	Serum	NA	100%	NA
2016	Pischke et al. [51]	Germany	1, 2, 3, 4	Retrospective longitudinal	Architect HCV Ag (Abbott Diagnostics)	COBAS AmpliPrep/COBAS TaqMan HCV test v2.0 (Roche Diagnostics)	20	NA	NA	100%	NA
2016	Kim et al. [52]	South Korea	1, 2	Retrospective	Architect HCV Ag (Abbott Diagnostics)	COBAS AmpliPrep/COBAS TaqMan HCV assay(Roche Diagnostics)	92	Serum		98.9%	NA
2015	Kamal et al. [53]	Egypt	4	Prospective longitudinal	Architect HCV Ag (Abbott Diagnostics)	COBAS Amplicor version 2.0 (Roche Molecular)	410	Serum		99.5%	96.8%
2015	Garbuglia et al. [54]	Italy	1a, 1b	Prospective	Architect HCV Ag (Abbott Diagnostics)	Abbott RealTime HCV (Abbott Molecular)	23	Plasma/serum	Day 0: day 1: day 4:	100%	NA
2014	Chevaliez et al. [55]	NA	1, 2, 3a, 4, 5a, 6	NA	Architect HCV Ag (Abbott Diagnostics)	COBAS AmpliPrep/COBAS TaqMan HCV test v2.0 (Roche Diagnostics)	514	NA		100%	100%
2014	Garbuglia et al. [56]	Italy	1a, 1b, 1c, 1a/b, 2a, 2c/b, 3a, 4a	Retrospective	Architect HCV Ag (Abbott Diagnostics)	Abbott RealTime HCV (Abbott Molecular)	292	Plasma		90.4%	87.5%
2014	Heidrich et al. [57]	Germany	1n, 2n, 3n	Prospective	Architect HCV Ag (Abbott Diagnostics)	COBAS TaqMan assay v1.0 (Roche Diagnostics)	596	Serum		92.9%	98.9%
2014	Florea et al. [35]	Romania	NA	Retrospective	Architect HCV Ag (Abbott Diagnostics)	COBAS TaqMan assay (Roche Diagnostics)	76	Serum		82.4%	100%
2014	Long et al. [26]	China	1b, 1a	Retrospective longitudinal	Architect HCV Ag (Abbott Diagnostics)	Abbott RealTime HCV (Abbott Molecular)	227	Plasma	HCV: HCV/HIV-1:	100%	NA
2013	Hadziyannis et al. [58]	Greece	1, 2, 3, 4	NA	Architect HCV Ag (Abbott Diagnostics)	COBAS Amplicor v2.0 (Roche Molecular)	89	Serum		93.2%	NA
2013	Tedder et al. [10]	UK	1a, 1b, 2, 3	Retrospective	Abbott Architect HCV (Abbott Diagnostics)	RT-PCR TaqMan in-house	54	Plasma		90.7%	NA
2012	Murayama et al. [22]	Japan	1a, 1b, 2a, 2b	Transversal	Architect HCV Ag (Abbott Diagnostics)	COBAS AmpliPrep/COBAS TaqMan (Roche Diagnostics) and Abbott RealTime HCV (Abbott Molecular)	80	Plasma		100%	NA
2012	Murayama et al. [22]	Japan	1a, 1b, 2a, 2b	Transversal	Lumipulse Ortho HCV Ag (Fujirebio, Tokyo, Japan)	COBAS AmpliPrep/COBAS TaqMan (Roche Diagnostics) and Abbott RealTime HCV(Abbott Molecular)	80	Plasma		95%	NA
2012	Vermehren et al. [59]	NA	1a, 1b	Prospective	Architect HCV Ag (Abbott Diagnostics)	Abbott RealTime HCV (Abbott Molecular)	160	Serum	(Versant HCV RNA Qualitative Assay) and ART (Abbott RealTime HCV assay)	99.3%	NA
2012	Mederacke et al. [25]	Germany	1a, 3a	Transversal	Architect HCV Ag (Abbott Diagnostics)	COBAS TaqMan assay (Roche Diagnostics)	238	Serum/plasma	HIV/HCV HCV/HBV	HCV/HIV: 95.7% HCV/HBV: 100%	HCV/HIV:1100% HCV/HBV:9100%
2011	Kesli et al. [60]	Turkey	1b	Retrospective	Architect HCV Ag (Abbott Diagnostics)	QIAamp viral RNA minikit (Qiagen)	212	Serum		96.3%	100%
2011	Moscato et al. [30]	Italy	1a, 1b, 2a, 2c, 3a, 4	Retrospective	Architect HCV Ag (Abbott Diagnostics)	COBAS TaqMan assay (Roche Diagnostics)	32	Serum		Group A:97.1% group B: 100%	GroupA:100% group B: 100%
2010	Miedouge et al. [61]	France	1, 1a, 1b, 1d, 2, 2a, 2b, 2c, 2k, 2i, 2r, 2x, 3a, 4a, 4c, 4d, 4r, 5a, 6	Cohort	Architect HCV Ag (Abbott Diagnostics)	COBAS TaqMan assay (Roche Diagnostics)	3009	Serum		100%	99.2%
2010	Ross et al. [62]	Germany	1a, 1b, 2a, 3a, 4a, 5a e 6f	Prospective	Architect HCV Ag (Abbott Diagnostics)	Versant HCV RNA v3.0 (Siemens Diagnostics)	394	Serum		100%	100%
2005	Masahiko Takahashi et al. [32]	Japan	NA	Prospective	Lumipulse Ortho HCV Ag (Ortho Clinical Diagnostics)	COBAS Amplicor version 2.0 (Roche Diagnostics)	44	Serum		90.9%	NA
ELISA
2017	Wang et al. [23]	China	NA	Longitudinal	ELISA HCV Ag (LaiBo Biotechnology)	Abbott RealTime HCV (Abbott Molecular)	333	Serum		88.9%	100%
2012	Murayama et al. [22]	Japan	1a, 1b, 2a, 2b	Transversal	ELISA-Ag (Ortho Clinical Diagnostics, Tokyo, Japan)	COBAS AmpliPrep/COBAS TaqMan (Roche Diagnostics) and Abbott RealTime HCV (Abbott Molecular)	80	Plasma		100%	NA
2012	Murayama et al. [22]	Japan	1a, 1b, 2a, 2b	Transversal	Ortho HCV Ag IRMA (Ortho Clinical Diagnostics, Tokyo, Japan	COBAS AmpliPrep/COBAS TaqMan (Roche Diagnostics) and Abbott RealTime HCV (Abbott Molecular)	80	Plasma		100%	NA
2012	Murayama et al. [22]	Japan	1a, 1b, 2a, 2b	Transversal	Lumispot Eiken HCV Ag (Eiken Chemical, Tokyo, Japan)	COBAS AmpliPrep/COBAS TaqMan (Roche Diagnostics) and Abbott RealTime HCV (Abbott Molecular)	80	Plasma		100%	NA
2008	Medhi et al. [63]	India	NA	Transversal	Orthotrak-C™ (Ortho Clinical Diagnostics) (Ortho HCV 3.0)	QIAamp viral RNA minikit (Qiagen) in-house RT-PCR and real-time PCR	250	Serum	NA	96%	100%
2006	Reddy et al. [34]	India	NA	Retrospective	Ortho HCV Ag (Ortho Clinical Diagnostics)	COBAS Amplicor HCV test v2.0 (Roche)	111	Serum	NA	60%	83%
2005	Bouzgarou et al. [64]	Tunisia	1a, 1b, 2c, 3a, 4c/4d	Retrospective	Orthotrak-C™ (Ortho Clinical Diagnostics)	In-house RT-PCR and COBAS Amplicor Monitor v2.0 (Roche version)	76	Serum	NA	84%	89%
2005	González et al. [21]	Spain	1	Cohort	Orthotrak-C™ (Ortho Clinical Diagnostics)	COBAS Amplicor HCV test v2.0 (Roche) and COBAS Amplicor HCV Monitor v2.0; Roche Diagnostics (RNA)	58	Serum		42.5%	100%
2005	Laperche et al. [7]	France	1, 1a, 1b, 2a/c, 3a, 4a, 4c/d	Cohort	Orthotrak-C™ (Ortho Clinical Diagnostics)	COBAS Amplicor HCV test v2.0 (Roche)	35	Plasma	NA	Panel 1 : 100% Panel 2: 96.3%	NA
2005	Massaguer et al. [65]	Spain	1, 2, 3, 4	Cohort	Orthotrak-C™ (Ortho Clinical Diagnostics)	COBAS Amplicor HCV test v2.0 (Roche)	116	Serum		92.1%	100%
2005	Fabrizi et al. [66]	Italy	NA	Prospective	Orthotrak-C™ (Ortho Clinical Diagnostics)	COBAS Amplicor HCV test v2.0 (Roche)	292	Serum		92.7%	97.4%
2004	Soffredini et al. [31]	Italy	1a, 1b, 2a/c, 3a, 4c/d	Prospective	Orthotrak-C™(Ortho Clinical Diagnostics)	Versant HCV RNA v3.0 (Siemens Diagnostics)	111	Serum		94%	NA
2004	Lorenzo et al. [67]	Spain	1a, 1b, 2a/c, 3a	Cohort	Orthotrak-C™ (Ortho Clinical Diagnostics)	COBAS Amplicor HCV test v2.0 (Roche)	16	Serum	NA	87.6%	40%
2004	Schütler et al. [20]	Germany	NA	Prospective	Orthotrak-C™ (Ortho Clinical Diagnostics)	In-house real-time PCR	23	Serum		98%	96.2%
2003	Tanaka et al. [68]	Japan	1b, 2a, 2b	Retrospective	In-house	COBAS Amplicor HCV test v1.0 (Roche)	207	Serum		97%	100%
Immunohistochemistry
1997	Ballardini et al. [19]	Italy	1a,1b,2,3a,4a	Retrospective	In-house	RT-PCR in-house	31	Liver tissue	NA	80.6%	NA

Legend: NA: not available; GT: genotype; SE: sensitivity; SP: specificity; V: version; BG: both genotypes; r and rho: correlation coefficient; r2: coefficient of determination.