Table 4: Accuracy of hepatitis C virus screening immunoassays compared with RNA detection

Author, year	Index test	RNA-based reference test	No. of TP	No. of FP	No. of FN	No. of TN	Pr, %	% (95% CI)
Author, year	Index test	RNA-based reference test	No. of TP	No. of FP	No. of FN	No. of TN	Pr, %	Sn	Sp	PPV	NPV	FP rate	FN rate
Immunoassays that detect only antibodies to HCV
Tashkandy et al.,²² 2007	ELISA version 3.0 (Murex anti-HCV, Abbott)	RT-PCR (high pure viral nucleic acid reagent set, Roche)	18	2	7	79	23.6	72.0 (54.4-89.6)	97.5 (94.2-100)	90.0 (76.9-100)	91.9 (86.1-97.6)	2.5 (0-5.8)	28.0 (10.4-45.6)
Benouda et al.,²³ 2009*	ELISA version 3.0 (Murex anti-HCV, Abbott)	RT-PCR (Amplicor HCV version 2.0, Roche)	62	96	0	100	24.0	61.0 (8.9-96.2)†	98.8 (98.5-99.0)†	39.2 (31.6-46.9)	100 (100-100)	1.2 (1.0-1.5)†	39.0 (3.8-91.1)†
Kosan et al.,²⁶ 2010	ELISA version 3.0 (Innotest HCV Ab III, Innogenetics)	NAT (Procleix Ultrio kit, Chiron)	9	56	2	17 784	0.1	81.8 (59.0-100)	99.7 (99.6-99.8)	13.8 (5.4-22.2)	100 (100-100)	0.3 (0.2-0.4)	18.2 (0-41.0)
Immunoassay that detects both antibodies to HCV and viral antigen
Arora et al.,²⁹ 2016	ELISA version 4.0 (Monolisa Ag-Ab Ultra, BioRad)	NAT (Procleix Ultrio kit, Chiron)	37	46	4	21 028	0.2	90.2 (81.2-99.3)	99.8 (99.7-99.8)	44.6 (33.9-55.3)	100 (100-100)	0.2 (0.2-0.3)	9.8 (0.7-18.8)

Note: CI = confidence interval, ELISA = enzyme-linked immunosorbent assay, FN = false-negative result, FP = false-positive result, HCV = hepatitis C virus, NAT = nucleic acid amplification test, NPV = negative predictive value, PPV = positive predictive value, Pr = prevalence, RT-PCR = reverse-transcription polymerase chain reaction, Sn = sensitivity, Sp = specificity, TN = true-negative result, TP = true-positive result.

*The authors did not report on the comparison of ELISA version 3.0 to PCR; these data were obtained through personal communication (Amina Benouda, Hôpital universitaire Cheikh-Zaid, Rabat, Morocco: personal communication, 2016).

†Adjusted for verification bias.³²