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Table 2 Diagnostic performance of plasma IS6110- and IS1081- dPCR assay for TB

From: Evaluation of digital PCR assay in detection of M.tuberculosis IS6110 and IS1081 in tuberculosis patients plasma

Ā 

Cut-off point (copies/20ā€‰Ī¼l)

AUC

Sensitivity(%)

Specificity(%)

LR+

LR-

PPV (%)

NPV (%)

Total TB (nĀ =ā€‰155) compared with HC (nĀ =ā€‰106)

ā€ƒIS6110-dPCR

7

0.79 (0.74ā€“0.85)

40.6 (32.8ā€“42.8) a,b

93.4 (86.9ā€“97.3)

6.2 (2.9ā€“12.9)

0.6 (0.6ā€“0.7)

90.0 (80.4ā€“95.9)

51.8 (44.5ā€“59.1)

ā€ƒIS1081-dPCR

5.5

0.72 (0.66ā€“0.78)

27.1 (20.3ā€“34.8)

93.4 (86.9ā€“97.3)

4.1 (1.9ā€“8.8)

0.8 (0.7ā€“0.9)

85.7 (72.8ā€“94.1)

46.7 (39.8ā€“53.7)

ā€ƒJoint detection IS6110 & IS1081-dPCR

ā€“

0.67 (0.60ā€“0.73)

42.6 (34.7ā€“50.8)

90.6 (83.3ā€“95.4)

4.5 (2.4ā€“8.4)

0.6 (0.5ā€“0.7)

86.8 (77.1ā€“93.5)

51.9 (44.4ā€“59.3)

Disseminated TB (16) compared with HC (nĀ =ā€‰106)

ā€ƒIS6110-dPCR

7

0.98 (0.97ā€“1.00)

100.0 (79.4ā€“100.0) c,d

93.4 (86.9ā€“97.3)

15.1 (7.4ā€“31.0)

0.0 (āˆ’)

69.6 (46.5ā€“87.1)

100.0 (96.3ā€“100.0)

ā€ƒIS1081-dPCR

5.5

0.95 (0.91ā€“0.99)

68.8 (41.3ā€“89.0) e,f

93.4 (86.9ā€“97.3)

10.4 (4.7ā€“22.9)

0.3 (0.2ā€“0.7)

61.1 (35.0ā€“83.2)

95.2 (89.1ā€“98.4)

Extrapulmonary TB (56) compared with HC (nĀ =ā€‰106)

ā€ƒIS6110-dPCR

7

0.83 (0.77ā€“0.90)

50.0 (36.3ā€“63.7)

93.4 (86.9ā€“97.3)

7.6 (3.5ā€“16.2)

0.5 (0.4ā€“0.7)

80.0 (62.8ā€“91.7)

78.0 (69.7ā€“84.8)

ā€ƒIS1081-dPCR

5.5

0.81 (0.74ā€“0.88)

39.3 (26.5ā€“53.5)

93.4 (86.9ā€“97.3)

4.2 (2.1ā€“8.2)

0.7 (0.5ā€“0.8)

68.7 (49.7ā€“84.1)

73.8 (65.4ā€“81.2)

Bilateral TB (111) compared with HC (nĀ =ā€‰106)

ā€ƒIS6110-dPCR

7

0.82 (0.76ā€“0.87)

43.2 (33.9ā€“53.0)

93.4 (86.9ā€“97.3)

6.6 (3.1ā€“13.8)

0.6 (0.5ā€“0.7)

87.3 (75.4ā€“94.8)

61.1 (53.1ā€“68.7)

ā€ƒIS1081-dPCR

5.5

0.75 (0.68ā€“0.81)

33.3 (24.7ā€“42.9)

93.4 (86.9ā€“97.3)

5.1 (2.4ā€“10.8)

0.7 (0.6ā€“0.8)

84.1 (69.7ā€“93.4)

57.2 (49.5ā€“64.7)

  1. AUC area under receiver operating characteristic (ROC) curve, LR+ positive likelihood ratio, LR- negative likelihood ratio, PPV positive predictive value, NPV negative predictive value
  2. a sensitivity comparison between IS6110- and IS1081- dPCR in total TB patients (pĀ <ā€‰0.001, McNemar test)
  3. b sensitivity comparison between IS6110- and IS6110- or IS1081- positive dPCR in total TB patients (pĀ =ā€‰0.250, McNemar test)
  4. c sensitivity comparison of IS6110-dPCR between Disseminated TB and Extrapulmonary TB patients (pĀ <ā€‰0.001, Pearson Chi-Square test)
  5. d sensitivity comparison of IS6110-dPCR between Disseminated TB and Bilateral TB patients (pĀ <ā€‰0.001, Pearson Chi-Square test)
  6. e sensitivity comparison of IS1081-dPCR between Disseminated TB and Extrapulmonary TB patients (pĀ =ā€‰0.037, Pearson Chi-Square test)
  7. f sensitivity comparison of IS1081-dPCR between Disseminated TB and Bilateral TB patients (pĀ =ā€‰0.006, Pearson Chi-Square test)