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Two HSV-2
type-specific ELISA assays perform well enough to be useful as
diagnostic tests for HSV-2 infection in high prevalence populations.
Serologic herpes
testing in the real world. Validation of new type-specific serologic
herpes simplex virus tests in a public health laboratory.
Turner KR, Wong EH, Kent CK, Klausner JD. Turner
KR, Wong EH, Kent CK, Klausner JD
Sex Trans Dis.
2002;29:422-425
Summary:
Question
What are the performance characteristics of two new HSV-2 type-specific
serologic assays when used in a public health laboratory?
Design
This study describes a direct comparison of two commercial HSV-2
type-specific ELISA assays with a type-specific commercial strip
immunoblot assay for the serologic detection of HSV-2 infection.
Participants
Ninety-nine sera selected from 1635 stored sera obtained from the Young
Women's Survey, a cross-sectional, population-based survey of low-income
women between 18 and 29 years, in 5 counties in northern California, were
analyzed. The overall prevalence of HSV-2 in the study was 35% as
determined by a strip recombinant immunoblot (RIBA HSV Type1/Type 2 SIA,
Chiron Corporation, Emeryville, CA).
Description of Tests and Diagnostic
Standard
The sera were tested with 2 type-specific enzyme linked immunosorbent
assay serologic tests for HSV-2 infection: 1) the Premier Type Specific
HSV-2 IgG ELISA (Meridian Diagnostics, Inc., Cincinnati, OH) uses
affinity-purified HSV-2 gG2 antigen; and 2) the HSV-2 IgG ELISA (recently
renamed HerpeSelect 2 ELISA; Focus Technologies [previously MRL
Diagnostics], Cypress, CA) uses recombinant gG2 antigen. The reference
assay, Chiron RIBA Type1/Type 2 SIA, differentiates between HSV-1 and
HSV-2 antibodies on the basis of recombinant antigen bands for HSV-1 gG1,
gB1, and HSV-2 gG2, gD2.
Main Outcome Measures
The sensitivity, specificity, positive predictive value (PPV), and
negative predictive value (NPV) of two HSV-2 type-specific ELISA assays
compared to the reference assay for the detection of HSV-2 antibodies in
serum samples were determined.
Main Results
The HSV-2 prevalence was 44/99 (44%) as determined by the RIBA Immunoblot
assay. The sensitivity, specificity, PPV, and NPV of each of the two ELISA
assays compared to the immunoblot assay are shown in the table.
| Performance
of ELISA assays compared to an immunoblot assay for the detection of
HSV-2 antibodies in 99 serum samples from young women |
| Assay |
Sensitivity
(%) (CI) |
Specificity
(%) (CI) |
PPV
(%) |
NPV
(%) |
| Meridian
Premier |
95.5
(83.3, 99.2) |
98.2
(89.0, 99.9) |
97.6 |
97.0 |
| Focus
Technologies |
97.7
(86.5, 99.9) |
94.5
(83.9, 98.6) |
93.5 |
98.4 |
Authors' Conclusions
Both the ELISA tests performed well on the
samples tested, and either would be appropriate for use in an STD clinic
setting, where the high-prevalence population creates an adequate positive
predictive value that allows case identification without additional
testing.
Source of funding: None given
For correspondence: Jeffrey Klausner,
San Francisco Department of Public Health, STD Prevention and Control
Services, 1360 Mission St., Suite 401, San Francisco, CA 94103. E-mail
address: jeff_klausner@dph.sf.ca.us
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