To determine the incidence, clinical and laboratory characteristics, and utility of molecular diagnosis of human monocytotropic ehrlichiosis (HME) in the primary care setting, we conducted a prospective study in an outpatient primary care clinic in Cape Girardeau, Missouri. One hundred and two patients with a history of fever for 3 days (>37.7°C), tick bite or exposure, and no other infectious disease diagnosis were enrolled between March 1997 and December 1999. HME was diagnosed in 29 patients by indirect immunofluorescent antibody assay and polymerase chain reaction (PCR). Clinical and laboratory manifestations included fever (100%), headache (72%), myalgia or arthralgia (69%), chills (45%), weakness (38%), nausea (38%), leukopenia (60%), thrombocytopenia (56%), and elevated aspartate aminotransferase level (52%). Hospitalization occurred in 41% of case-patients. PCR sensitivity was 56%; specificity, 100%. HME is a prevalent, potentially severe disease in southeastern Missouri that often requires hospitalization. Because clinical presentation of HME is nonspecific, PCR is useful in the diagnosis of acute HME.

Sera (n ‫؍‬ 781) from four African countries were used to determine the prevalence of herpes simplex virus type 2 (HSV-2) antibodies by using the HerpeSelect HSV-2 enzyme-linked immunosorbent assay (ELISA; Focus Technologies) and Western blotting (WB). Also, an HSV inhibition assay was developed to evaluate the discordant sample results between HerpesSelect and WB. The seroprevalence of HSV-2 ranged from 17% in the South African panel to nearly 70% in panels from Kenya, Uganda, and Zimbabwe. Overall, HerpeSelect was 100% sensitive and 88% specific compared to WB and 100% sensitive and 96% specific compared to the inhibition assay. There was 100% concordance among all three assays for samples from South Africa and Zimbabwe. The discordant results occurred in samples from Kenya and Uganda.The detection and differentiation of type-specific antibodies to herpes simplex virus type 1 (HSV-1) and HSV-2 has been limited to reference laboratories due to the limited laboratory tools for HSV type-specific antibody testing. Tests such as the monoclonal inhibition assay (14) and Western blotting (WB) (4,6,8) are tedious and require a high level of expertise to perform. It is now possible to take advantage of the immunological distinction of the glycoproteins gG1 and gG2 of HSV-1 and HSV-2, respectively, to differentiate type-specific HSV antibodies in an ELISA and immunoblot format. Since both gG1 and gG2 proteins are highly conserved in HSV, gG-based serology tests allow for the detection of type-specific antibody in individuals infected with HSV (1, 2, 7, 10, 12, 13). The development of gG-based serologic tests allows for expanded seroprevalence and natural history studies relating to HSV and genital herpes by facilitating the detection of HSV type-specific antibodies in routine laboratory settings worldwide.Seroprevalence studies have been initiated worldwide to support potential vaccine trials, aid in antiviral treatment, monitor sexually transmitted disease (STD) trends, and assess the risk of human immunodeficiency virus (HIV) transmission in the presence of STD. To date, various studies have shown a high degree of concordance in the United States and Europe between gG-based serologic assays and "gold standard" assays such as the HSV WB assay performed at the University of Washington (UW) (3,5,11). Recently, an HSV seroprevalence study conducted in Africa raised concern that the recombinant gG2 (rgG2) ELISA may give false-positive results in certain African sera (E. Van Dyck, A. Buvé, D. Brown, and M. Loga, Abstr. 14th ISSTDR/17th IUSTI, Berlin, Germany, abstr. T079, 2001). The current study is the largest to date to evaluate the presence of HSV antibody using a rgG2 ELISA and WB from various geographic locations in Africa. It appears that certain samples present interpretation difficulties regardless of the assay method used to detect HSV type-specific antibodies. In order to evaluate samples giving discordant results with ELISA and WB, an HSV-2 inhibition assay was developed. The assay is based on the ability of nati...

Herpes simplex virus type 2 (HSV-2) is a common human pathogen that can cause a variety of clinical manifestations in humans. In order to provide near-patient results to allow for faster counseling and treatment, a rapid point-of-care test that is accurate and simple to use is desirable. Here, we describe the development and evaluation of an HSV-2 immunoglobulin G (IgG)-specific antibody lateral-flow immunochromatographic assay (LFIA) based on colloidal gold nanoparticles. A total of 359 serum samples and 100 whole-blood samples were tested in the newly developed HSV-2 LFIA. Serum results were compared to those from the HerpeSelect HSV-2 enzyme-linked immunosorbent assay (ELISA), and whole-blood sample results were compared to those of both ELISA and HerpeSelect HSV-1 and -2 immunoblotting (IB). The sensitivity of the HSV-2 LFIA compared to that of the HerpeSelect ELISA was 100% (89/89), and the specificity was 97.3% (257/264). Cross-reactivity with HSV-1 IgG-positive serum samples was observed in 2.6% (5/196) of samples, 2.9% (1/34) for rubella virus, and 6.2% (1/16) for Epstein-Barr virus. No cross-reactivity in varicella-zoster virus or cytomegalovirus IgG-positive serum samples was observed. No interference was observed from bilirubin-, triglyceride-, albumin-, or hemoglobin-spiked samples. The concordance of the LFIA results between capillary whole blood, EDTA-treated venous whole blood, heparin-treated venous whole blood, and serum was 99% (99/100). In conclusion, the LFIA for HSV-2 IgG-specific antibodies demonstrated excellent sensitivity, specificity, and concordance for both serum and whole-blood samples compared to the sensitivity, specificity, and concordance of both HSV-2 ELISA and IB.Herpes simplex virus (HSV) is a common human pathogen found worldwide that causes a variety of diseases (6). HSV has been characterized into two different serotypes: HSV type 1 (HSV-1) generally is associated with infections in the tongue, mouth, lips, pharynx, and eyes, whereas HSV-2 primarily is associated with genital and neonatal infections (6). HSV infects neonates, children, and adults; by the age of 40, more than 90% of the adult population demonstrates antibodies to HSV-1 (6). In the United States, most young sexually active adults with genital ulcers have genital herpes (8).Primary HSV-2 infections usually are transmitted through sexual contact. HSV transmission can result from direct contact with infected secretions from symptomatic or asymptomatic individuals (19). The classic presentation is herpes genitalis, an infection characterized by lesions in the genital area, and it may be accompanied by fever, inguinal lymphadenopathy, and dysuria. Previous studies demonstrated that HSV-2 causes approximately 85% of symptomatic primary genital HSV cases, with HSV-1 infections causing the remainder (1). However, more recently it has been shown that approximately 30% of primary genital herpes infections presently are associated with 13,22). Despite the increase in genital herpes cases due to HSV-1, the HSV-1 recurren...

Two hundred forty-eight human immunodeficiency virus (HIV)-positive and 496 HIV-negative subjects in Uganda were tested by HerpeSelect herpes simplex virus type 2 enzyme-linked immunosorbent assay (ELISA) and Western blotting to optimize the ELISA for use in this population. A higher index cutoff value was required for optimal sensitivity and specificity, and overall performance of the assay was not affected by HIV status.