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Table 3 Diagnostic accuracy of the Kalon HSV-2 IgG ELISA compared to UW-WB in South African and Zambian sera (N = 600) a

From: Precision of the Kalon Herpes Simplex Virus Type 2 IgG ELISA: an international inter-laboratory assessment

Characteristic

Country of origin

HIV status

Total (n/N)

South Africa

Zambia

HIV negative

HIV positive

HSV-2 Prevalence by UW-WB, % (95 % CI)

82.1 (77.2, 86.3)

81.6 (76.6, 85.9)

63.9 (58.0, 69.4)

99.3 (97.6, 99.9)

81.9 (478/584)

GUD Presentation by Physical Exam, % (95 % CI)

1.4 (0.4, 3.4)

3.5 (1.7, 6.3)

0.7 (0.1, 0.2)

4.1 (2.1, 7.0)

2.4 (14/583)

Medical History of GUD in past 3 months, % (95 % CI)

1.7 (0.6, 3.9)

3.1 (1.4, 5.8)

0.7 (0.1, 0.2)

4.1 (2.1, 7.0)

2.4 (14/583)

HIV Prevalence, % (95 % CI)

49.7 (43.8, 55.5)

51.7 (45.8, 57.6)

–

–

50.7 (296/584)

Median Age (IQR)

31.6 (27.1, 37.4)

32.2 (27.2, 41.7)

33.4 (28.0, 39.6)

31.1 (26.3, 37.6)

32.0 (27.1, 38.7)

Kalon Performance (cut-off = 1.1)

 Sensitivity, % (95 % CI)

94.2 (90.5, 96.8)

97.0 (94.0, 98.8)

94.0 (89.6, 97.0)

96.6 (93.8, 98.4)

95.6 (93.4, 97.3)

 Specificity, % (95 % CI)

98.1 (89.9, 100.0)

88.7 (77.0, 95.7)

94.2 (87.9, 97.9)

–

93.4 (86.9, 97.3)

 AUC (95 % CI)

0.96 (0.94, 0.99)

0.93 (0.88, 0.97)

0.94 (0.91, 0.97)

–

0.95 (0.92, 0.97)

Kalon Performance (cut-off = 1.5)

 Sensitivity, % (95 % CI)

92.2 (88.1, 95.2)

92.3 (88.2, 95.4)

88.6 (83.1, 92.8)

94.6 (91.3, 96.9)

92.3 (89.5, 94.5)

 Specificity, % (95 % CI)

98.1 (89.9, 100.0)

92.5 (81.8, 97.9)

96.2 (90.4, 98.9)

–

95.3 (89.3, 98.5)

 AUC (95 % CI)

0.95 (0.93, 0.98)

0.92 (0.88, 0.96)

0.92 (0.89, 0.95)

–

0.94 (0.91, 0.96)

  1. Abbreviations: UW-WB, University of Washington HSV Western Blot; CI, confidence interval; GUD, Genital Ulcer Disease, AUC, area under the curve
  2. aIndeterminate results by UW-WB were excluded in the analysis (n = 16). Kalon data are based on its performance by Technologist-Sr. at the HPTN Laboratory Center, and indeterminate results by Kalon (n = 10) were considered seronegative