Sexually Transmitted Diseases (STDs) spread primarily through person-to-person sexual contacts. Varied testing technologies used for the identification and analysis of the STD contracted comprise the definition of ‘diagnostic testing of STDs’. The location where diagnostic tests are delivered i.e. in the laboratories or at the point-of-care (POC) also encompasses the definition for ‘diagnostic testing of STDs’. The Medicines and Healthcare Products Regulatory Agency (MHRA) defines POC testing as ‘any analytical test performed for a patient by a healthcare professional outside the conventional laboratory setting’.
Undiagnosed (that often results in untreated cases) STDs can have critical implications for reproductive, maternal and newborn health. For instance, 10% – 15% of women with untreated Chlamydia infection may develop symptomatic pelvic inflammatory disease (PID); progression of ~10% – 15% of PID cases lead to tubal factor infertility. Human Papilloma Virus (HPV) is the causative agent for ~99% of cervical cancers in women. Globally, HPV infection results in ~500,000 cases of cervical cancer and ~300,000 cervical cancer deaths per year.
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Undiagnosed and untreated STDs such as Syphilis lead to Congenital Syphilis – that results in preterm labor with associated risks of pre-term birth, low birth weight, blindness and death of the neonate. Globally, over 1 million cases of Syphilis occur among pregnant women and a majority proportion of these were untreated or inadequately treated. Unless testing and treatment of Syphilis in pregnancy are readily available, over 50% of the pregnancies in women with Syphilis will result in adverse outcomes as stated above.
Prenatal transmission of Herpes Simplex Virus (HSV) infection is associated with a high risk of neurological problems and death. Undiagnosed and untreated STDs also increase the risk of both acquisition and transmission of Human Immunodeficiency Virus (HIV), by a factor of up to two- to three-fold. Timely diagnosis of STDs is thus imperative for prevention of transmission, control and reducing the risk of incurable and fatal STD infections.
STDs can broadly be categorized as STDs of the developed regions and STDs of the poor/developing regions. As STDs namely Chlamydia, Gonorrhea and P&S Syphilis are more prevalent in North America and Europe, these developed regions have a higher market share in terms of testing volume. While Chancroid is non-existent in these developed region, for instance, there are only about 8 – 10 cases in North America.
Moreover occurrence of these Chancroid cases in North America or Europe is solely a result of acquiring this infection i.e. travelling to the Rest of the World regions. As many of the viral STDs trace origin in the poor/developing regions such as the RoW; these regions have garnered a higher market share in terms of testing volume of STDs such as HIV, HSV and Chancroid.
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Laboratory testing is of high significance for diagnostic testing of STDs; as although many Point-Of-Care (POC) tests are available for all STDs, some STDs cannot be diagnosed by POC methods and devices. For example, HSV, Low-risk HPV and Chancroid that clinically manifest as warts, require physical examination by laboratory experts.
Also many of the POC methods and devices are not approved by the regulatory authorities such as the U.S. FDA; many of these fail to qualify the specificity and sensitivity norms prescribed by the regulatory authorities. Hence laboratory testing for diagnosis of STDs is considered reliable and the universally accepted diagnostic testing method.