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Table 2 Performance of the Well assay according to the reference results of the Abbott assay

From: Evaluation of a new point-of-care oral anti-HCV test for screening of hepatitis C virus infection

Well oral anti-HCV assay

Serum anti-HCV (Abbott assay) (n = 1179)

Center 1 (n = 351)

Center 2 (n = 345)

Center 3 (n = 483)

Centers 1–3

Total

Positive

Negative

Positive

Negative

Positive

Negative

Positive

Negative

 

Positive, n

109

4

91

8

241

2

441

14

455

Negative, n

3

235

12

234

24

216

39

685

724

Total

112

239

103

242

265

218

480

699

1179

Sensitivitya (%) (95% CI)

97.32(91.79,99.31)

88.35(80.16,93.57)

90.94(86.66,93.99)

91.88(88.97,94.09)

Specificitya (%) (95% CI)

98.33(95.48,99.46)

96.69(93.35,98.45)

99.08(96.37,99.84)

98.00(96.58,98.86)

PPVa (%) (95% CI)

96.46(90.65,98.86)

91.92(84.24,96.19)

99.18(96.74,99.86)

96.92(94.77,98.24)

NPVa (%) (95% CI)

98.74(96.06,99.67)

95.12(91.42,97.34)

90.00(85.31,93.36)

94.61(92.64,96.09)

Accuracya (%) (95% CI)

98.01(95.86,99.11)

94.20(91.17,96.26)

94.62(92.20,96.33)

95.50(94.16,96.56)

Kappa valuea

0.954

0.860

0.892

0.906

  1. Note: aSensitivity, specificity, PPV, NPV, accuracy and Kappa value were calculated based on serum HCV antibody test results detected using the Abbott assay. n Number, PPV Positive predictive value, NPV Negative predictive value, 95%CI 95% confidence interval