Performance of the HerpeSelect (Focus) and Kalon Enzyme-Linked Immunosorbent Assays for Detection of Antibodies against Herpes Simplex Virus Type 2 by Use of Monoclonal Antibody-Blocking Enzyme Immunoassay and Clinicovirological Reference Standards in Brazil

DOI: 10.1128/JCM.00144-07

Article Figures & Data

TABLE 1.

Antibodies to HSV-2 detected by MAb-EIA, Kalon ELISA, and HerpeSelect ELISA, by population group, in Brazil^a

Population group	No. of samples positive/no. tested (%)
	Positive results				Equivocal results
	MAb-EIA	Kalon ELISA	HerpeSelect ELISA		MAb-EIA	HerpeSelect ELISA
	MAb-EIA	Kalon ELISA	CO > 1.1	CO > 3.5	MAb-EIA	CO > 1.1	CO > 3.5
1. AIDS/HSV-2 ulcer (n = 30)	26/30 (87)	30/30 (100)	29/29 (100)	26/29 (90)	0/30 (0)	0/29 (0)	3/29 (10)
2. AIDS/no ulcer (n = 40)	25/40 (62)	26/40 (65)	32/40 (80)	22/40 (55)	1/40 (2.5)	2/40 (5)	12/40 (30)
3. STI clinic (n = 137)	70/137 (51)	66/130 (51)	62/109 (57)	50/109 (46)	3/137 (2.2)	2/109 (2)	13/109 (12)
4. HIV-negative MSM (n = 29)	13/29 (45)	13/29 (45)	15/29 (51)	10/29 (34)	1/29 (3.4)	0/29 (0)	5/29 (17)
5. College students (n = 100)	5/100 (5)	6/97 (6.2)	27/89 (30)	4/89 (4)	2/100 (2)	10/89 (11)	32/89 (36)
6. Children (n = 249)	4/249 (1.6)	8/250 (3.2)	14/233 (6)	2/233 (0.9)	1/249 (0.4)	4/233 (2)	16/233 (7)
Total (n = 585)	143/585 (25)	149/576 (26)	179/529 (34)	114/529 (21)	8/585 (1.4)	18/529 (3.4)	81/529 (15.3)

↵a CO, cutoff; STI, sexually transmitted infection; MSM, men who have sex with men.

TABLE 2.

Performance of HSV-2 serological assays compared to those of serological (MAb-EIA) and clinicovirological reference standards in Brazil^a

Assay	Performance indicators against MAb-EIA (n = 577)^b			Performance indicators against clinicovirological standard (n = 280)^c
Assay	No. of samples positive/no. tested (%)	% Sensitivity (95% CI)	% Specificity (95% CI)	No. of samples positive/no. tested (%)	% Sensitivity (95% CI)	% Specificity (95% CI)
MAb-EIA	143/577 (24.8)	NA	NA	30/278 (10.8)	86.7 (69-96)	98.4 (96-100)
Kalon	145/566 (25.6)	93.5 (88-97)	96.5 (94-98)	38/280 (13.6)	100 (88-100)	96.8 (94-99)
HerpeSelect (CO > 1.1)	172/519 (33.1)	93.8 (88-97)	86.9 (83-90)	43/262 (16.4)	100 (88-100)	94.0 (90-97)
HerpeSelect (CO > 3.5)	111/519 (21.4)	81.4 (74-88)	98.5 (97-99)	28/262 (10.7)	89.7 (73-98)	99.1 (97-100)

↵a CO, cutoff; NA, not applicable.
↵b The MAb-EIA reference standard comprised 143 positive and 434 negative samples, after the exclusion of 8 samples with equivocal results.
↵c clinicovirological reference standard comprised samples from AIDS patients with HSV-2 ulcers (group 1) considered positive (n = 30) and children <2 years of age (group 6) considered negative (n = 250).