Venient Fx STI Comprehensive

Test Description
Venient Cx STI Comprehensive is a groundbreaking blood and urine-based screening test for the assessment of sexually transmitted infections (STI). 

This is an Evidence-Based Laboratory Medicine (EBLM) test developed not only in compliance with the American Sexual Health Association (ASHA) guidelines, but also incorporating the latest scientific findings. 

Thanks to our proprietary machine learning (ML) algorithms, this test is able to accurately detect a wide range of STI, including hepatitis B, hepatitis C, human immunodeficiency virus (HIV), herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2), syphilis, chlamydia trachomatis, human papillomavirus, mycoplasma genitalium, mycoplasma hominis, neisseria gonorrhoeae, trichomonas vaginalis, ureaplasma parvum, and ureaplasma urealyticum.

United States Preventative Services Task Force (USPSTF) screening recommendations
Currently, the USPSTF generally recommends screening for sexually transmitted infections in women who are sexually active and have a higher risk to develop these diseases. However, Kience Inc. recommends our laboratory developed test (LDT) Venient Fx STI Comprehensive to address both men and women that present with clinical symptoms or suspicion of the following infections: hepatitis B, hepatitis C, human immunodeficiency virus (HIV), herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2), syphilis, chlamydia trachomatis, human papillomavirus, mycoplasma genitalium, mycoplasma hominis, neisseria gonorrhoeae, trichomonas vaginalis, ureaplasma parvum, and ureaplasma urealyticum.

Intended Use
The intended population of Venient Fx STI Comprehensive are patients with clinical symptoms or suspicion of the following infections hepatitis B, hepatitis C, human immunodeficiency virus (HIV), herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2), syphilis, chlamydia trachomatis, human papillomavirus, mycoplasma genitalium, mycoplasma hominis, neisseria gonorrhoeae, trichomonas vaginalis, ureaplasma parvum, and ureaplasma urealyticum.

Sample Clinical Vignette
A 33-year-old male presented to the clinical for medical evaluation after a 2 month history of a feeling of pressure in the stomach area and pain and itching in his genital area. Physical exam revealed that he had small red bumps and blisters around his genitals, which were the cause of itching. Serum and urine were submitted to detect if a sexually transmitted infection is the cause of her symptoms.

Required Laboratory Determinations
Serum Antibodies —Hepatitis B Surface Antigen (HBsAg) Quantitative, Hepatitis C Virus (HCV) Duo, Human Immunodeficiency Virus (HIV) Duo, Herpes Simplex Virus 1 (HSV-1) Immunoglobulin M (IgM) Antibodies, Herpes Simplex Virus 2 (HSV-2) Immunoglobulin M (IgM) Antibodies, Syphilis by Rapid Plasma Reagin (RPR)—; Polymerase Chain Reaction (PCR) in Urine —Chlamydia trachomatis, Human Papilloma Virus (HPV), Mycoplasma genitalium, Mycoplasma hominis, Neisseria gonorrhoeae, Trichomonas vaginalis, Ureaplasma parvum, Ureaplasma urealyticum—.