Comparative Performance of Herpes Simplex Virus Type 1-Specific Serologic Assays from MRL and Meridian Diagnostics

Abstract

Two companies, MRL and Meridian Diagnostics, have developed Food and Drug Administration-approved herpes simplex virus type 1 type-specific enzyme immunoassays. The sensitivity, specificity, and overall testing efficiency of these assays were 98.2, 93.8, and 96.6% for MRL and 98.8, 99.0, and 98.1% for Meridian, making both of these kits suitable for use in the clinical lab.The herpes simplex viruses (herpes simplex virus type 1 [HSV-1] and HSV-2) are important causes of disease worldwide. HSV-1 is the primary cause of oral-facial and pharyngeal herpes infections and may cause herpetic whitlow, eye infections, and disseminated disease (1,2,8,15). HSV-1 also accounts for 10 to 15% of all genital herpetic infections (3, 6, 11). The proportion of genital infections with HSV-1 is reportedly even higher in some locations (4, 10, 13).Transmission of HSV-1 occurs following contact with fluid from vesicular lesions or contact with infected body fluids, such as saliva and genital secretions (4,8,9). Although HSV-1 has historically been acquired primarily in childhood, acquisition of the virus is now often seen during early adulthood (4,8,9). Seroprevalence studies from several sites worldwide have indicated that approximately 60 to 70% of adolescents have not developed antibodies to this virus and are therefore still susceptible to infection with HSV-1 (5, 7, 8).HSV-1 serostatus is also important with regard to the vaccine developed for HSV-2. The usefulness of the vaccine appears to be linked to the HSV-1 serostatus of the individual being immunized. Only female recipients with a negative HSV-1 serostatus prior to immunization appear to derive benefit from this vaccine (S. Spruance and The Herpes Vaccine Efficacy Study Group, Abstr. Addendum 40th Intersci. Conf. Antimicrob. Agents Chemother., abstr. L-6, p. 22, 2000). This, coupled with the role of HSV-1 as a significant etiologic agent for herpes genitalis, produces the need for a reliable HSV-1 immunoglobulin G (IgG) type-specific assay. This report focuses on the head-to-head comparison of two Food and Drug Administration (FDA)-approved HSV-1 type-specific EIAs.Serum from 532 blood donor specimens was collected from the Central Kentucky Blood Center, Lexington, Ky., and frozen in 2-ml aliquots at Ϫ70°C until testing. Serologic evaluation of HSV-1 antibodies was performed using glycoprotein G type-specific enzyme immunoassays from Meridian Diagnostics Inc. (Cincinnati, Ohio) and from MRL Diagnostics (Cypress, Calif.). All testing was performed according to the manufacturers' specifications. Absorbances were read on an automated ELx800 Universal Microplate Reader (Bio-Tek Instruments Inc.) at 405 nm for the Meridian assays and 450 nm for the MRL assays. For both manufacturers, absorbency cutoff values were those established by validation studies with a mean absorbency value: those with Ͼ0.99 times the reference absorbency were interpreted as positive, those with 0.91 to 0.99 times the reference absorption were interpreted as equivocal, and those with less than 0.91 time...

Association of Serum Antibodies to Herpes Simplex Virus 1 With Cognitive Deficits in Individuals With Schizophrenia

“…The selection of this cutoff was based on clinical trials indicating that the use of this cutoff results in a high correlation with gold standard assays such as Western blot and the ability to isolate infectious virus in cell culture. 55,56 Using this cutoff, we found that there is a statistically significant association between HSV-1 reactivity and the RBANS total score as well as the immediate memory index of the RBANS. The use of other cutoffs did not alter the statistical relationship between HSV-1 reactivity and the RBANS total score or the immediate memory score (Table 3).…”

Longitudinal Reliability of Focus Glycoprotein G-Based Type-Specific Enzyme Immunoassays for Detection of Herpes Simplex Virus Types 1 and 2 in Women

“…In cross-sectional studies, HSV-1 and HSV-2 gG enzyme immunoassays have demonstrated both high sensitivity and specificity (4,8,14,16,17). However, prior evaluations of type-specific assays have reportedly detected frequent changes in an individual's gG antibody status from positive to negative over time.…”

“…These assays use baculovirus recombinant gG constructs, are Food and Drug Administration approved for testing sexually active adults and pregnant women, and are commercially available. In comparison to Western blot assays, the sensitivity and specificity of the Focus HSV-2 ELISA are 98 and 95%, respec-tively, while those of the Focus HSV-1 ELISA are 98 and 94%, respectively (16,17). Laboratory Tests.…”

“…HSV-1 and HSV-2 exhibit a high degree of cross-reactivity, but an envelope glycoprotein, gG, is antigenically distinct between the two viruses, and the typespecific antibody response to gG provides evidence of infection with HSV-1 or HSV-2 or both (5). Type-specific gG serologic assays include Western blotting (2, 6), immunoblot strips (21), and enzyme-linked immunosorbent assays (ELISAs) (14,16,17). Although the Western blot assay is considered to be the "gold standard," it is expensive and labor-intensive and its interpretation is operator dependent (5).…”

Comparative Performance of a Novel Herpes Simplex Virus Type 2-Specific Enzyme-Linked Immunosorbent Assay Using a Targeted Chain Oligopeptide, Peptide 55

“…A variety of studies have concluded that only glycoprotein G (gG2) expresses epitopes specific for HSV-2 (14, 21). Consequently, this glycoprotein has been used as the basis of type-specific serological assays for the diagnosis of HSV-2 infection (1,2,7,19,20). However, epitope mapping of gG2 by Levi et al (11) suggested that some epitopes may cross-react with HSV-1-specific antibody.…”