Herpes virus is a ubiquitous pathogen whose primary infections are usually asymptomatic. There are two types of Herpes Simplex virus (HSV): HSV-1 is known to cause orofacial disease such as cold sores; while HSV-2 causes genital infections. Over 80% of the herpes infections are asymptomatic; symptomatic infections are presented with blistering sores, pain during urination, swollen lymph nodes, and fever. Period of latency and mode of reactivation of HSV is yet unclear.
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Herpes Simplex is a highly contagious virus which is passes through direct contact with infected patients. The virus is transferred through body fluids such as saliva, blood and semen. Some studies have also shown that the virus can be transferred through breast milk. HSV infection is also common in patients with compromised immune system. Thus transplant patients and human immunodeficiency virus (HIV) positive patients are at higher risk of acquiring HSV infections. Since majority of HSV infections are asymptomatic, physicians are dependent on diagnostic tests for accurate diagnosis and treatment. Currently, there are four types of tests available for HSV biomarker testing; these include cell culture tests, antigen tests, antibody tests, and polymerase chain reaction (PCR) tests. In cell culture tests, specimens from the skin lesions or blisters are taken to develop viral cultures. Although the test is more accurate, it is time consuming and may give false negative results if lesions are in process of healing. Antigen and antibody tests are enzyme linked Immunosorbent assay (ELISA) based tests and are the most widely used tests globally. Blood samples are usually tested for HSV antigens and antibodies. These rapid tests provide quick and accurate results, which helps in further diagnosis and treatments. PCR tests have been the most accurate tests used for HSV diagnosis. The test can also differentiate between HSV-1 and HSV-2 viral load.
According to prevalence statistics published by Centers for Disease Control and Prevention (CDC), HSV-2 prevalence was found to be over 16% in the U.S. citizens and mainly affected African-America female population. Public Health Agency of Canada mentions that prevalence of HSV-1 infection is greater than HSV-2 infections is most of the geographical regions. The data also shows that HSV-1 seroprevalence in adults in over 70% in developed countries, while almost 100% in developing and underdeveloped countries. Various publications also show that prevalence of HIV is higher in low and middle income countries. Thus it is expected that the prevalence of herpes simplex virus would remain high in these countries. Due to under developed economic conditions, cost effective diagnosed tests are in high demand. In spite of these conditions, North America and Europe lead the market owing to higher seroprevalence, and large number of transplant and HIV patients.
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In 2014, U.S. FDA approved Quest Diagnostics, Inc’s HSV diagnostic test Simplexa HSV 1 and 2 direct molecular test on the 3M Integrated Cycler. The Simplexa test is the first molecular test that has been approved by the U.S. FDA, that enables qualitative detection as well as differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF). Other diagnostic tests in the market include Capita IgG test by Trinity Biotech, IsoAmp HSV Assay by Biohelix and HerpeSelect by Focus Diagnostics. Some of the key players in the global herpes marker testing market include DiaSorin, Roche, Enzo Life Sciences and Thermo Fisher Scientific.
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