Rapid, Sensitive, and Specific Lateral-Flow Immunochromatographic Point-of-Care Device for Detection of Herpes Simplex Virus Type 2-Specific Immunoglobulin G Antibodies in Serum and Whole Blood

ABSTRACT 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.

[1]  Anna Wald,et al.  Serological testing for herpes simplex virus (HSV)-1 and HSV-2 infection. , 2002, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[2]  David R. Holtgrave,et al.  Counseling and testing for HIV prevention: costs, effects, and cost-effectiveness of more rapid screening tests. , 1996, Public health reports.

[3]  E. Petersen,et al.  Herpes simplex viruses. , 2009 .

[4]  Inaccuracy of certain commercial enzyme immunoassays in diagnosing genital infections with herpes simplex virus types 1 or 2. , 2003, American journal of clinical pathology.

[5]  A. Wald,et al.  Premarket Evaluation of the POCkit HSV‐2 Type‐Specific Serologic Test in Culture‐Documented Cases of Genital Herpes Simplex Virus Type 2 , 2000, Sexually transmitted diseases.

[6]  W. Hogrefe,et al.  Evaluation of an enzyme immunoassay system for measuring herpes simplex virus (HSV) Type 1‐specific and HSV Type 2‐specific IgG antibodies , 2000, Journal of clinical laboratory analysis.

[7]  J. Zeh,et al.  Genital shedding of herpes simplex virus among men. , 2002, The Journal of infectious diseases.

[8]  Steven McGee,et al.  Simplifying likelihood ratios , 2002, Journal of General Internal Medicine.

[9]  G. Burstein,et al.  Sexually transmitted diseases treatment guidelines , 2003, Current opinion in pediatrics.

[10]  A. Wald,et al.  Genital Herpes: Review of the Epidemic and Potential Use of Type-Specific Serology , 1999, Clinical Microbiology Reviews.

[11]  P. Meylan,et al.  Bmc Infectious Diseases Seroepidemiology of Herpes Simplex Virus Type 1 and 2 in Western and Southern Switzerland in Adults Aged 25–74 in 1992–93 : a Population-based Study , 2022 .

[12]  M. Slomka.  Seroepidemiology and control of genital herpes: the value of type specific antibodies to herpes simplex virus. , 1996, Communicable disease report. CDR review.

[13]  J. Malkin.  Epidemiology of genital herpes simplex virus infection in developed countries. , 2004, Herpes : the journal of the IHMF.

[14]  L. Haddow,et al.  Increase in rates of herpes simplex virus type 1 as a cause of anogenital herpes in western Sydney, Australia, between 1979 and 2003 , 2006, Sexually Transmitted Infections.

[15]  B Roizman,et al.  Herpes simplex viruses. , 1998, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[16]  W. Hogrefe,et al.  Detection of Herpes Simplex Virus Type 2-Specific Immunoglobulin G Antibodies in African Sera by Using Recombinant gG2, Western Blotting, and gG2 Inhibition , 2002, Journal of Clinical Microbiology.

[17]  A. Wald,et al.  Natural History of Genital Herpes Simplex Virus Type 1 Infection , 2003, Sexually transmitted diseases.

[18]  R. Ashley.  Sorting out the new HSV type specific antibody tests , 2001, Sexually transmitted infections.

[19]  R. Ashley,et al.  Ability of a Rapid Serology Test To Detect Seroconversion to Herpes Simplex Virus Type 2 Glycoprotein G Soon after Infection , 1999, Journal of Clinical Microbiology.

[20]  Craig M. Roberts,et al.  Increasing Proportion of Herpes Simplex Virus Type 1 as a Cause of Genital Herpes Infection in College Students , 2003, Sexually transmitted diseases.

[21]  H. Kelly,et al.  Changing epidemiology of genital herpes simplex virus infection in Melbourne, Australia, between 1980 and 2003 , 2004, Sexually Transmitted Infections.

[22]  Ellen Jo Baron,et al.  Manual of clinical microbiology , 1975 .

[23]  J. Zeh,et al.  Changes in plasma human immunodeficiency virus type 1 RNA associated with herpes simplex virus reactivation and suppression. , 2002, The Journal of infectious diseases.