Venient Fx STI Basic
Test Description
Venient Fx STI Basic is a disruptive, non-invasive test for the assessment of sexually transmitted infections (STI). Based on a routine blood and urine analysis, this test is powered by a combination of public and proprietary machine learning (ML) algorithms, ensuring precise primary diagnostic information, including the likelihood of various types of STI, including hepatitis B, hepatitis C, human immunodeficiency virus (HIV), syphilis, chlamydia trachomatis, mycoplasma genitalium, mycoplasma hominis, neisseria gonorrhoeae, trichomonas vaginalis, ureaplasma parvum, and ureaplasma urealyticum.
As a first-line test, the measured parameters orientate through the diagnostic, prognostic and therapeutic options. While these results usually provide preliminary guidance, in certain scenarios, they can be decisive.
Upon a positive result, the diagnostic report suggests conducting a specific second-line test to deepen into diagnostic information, confirm treatment approaches, establish prognoses and/or facilitate disease monitoring. If a STI is suggested, the second-line test incorporates more laboratory determinations to wider the spectrum of detection of many other STI.
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 Basic 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), syphilis, chlamydia trachomatis, mycoplasma genitalium, mycoplasma hominis, neisseria gonorrhoeae, trichomonas vaginalis, ureaplasma parvum, and ureaplasma urealyticum.
Intended Use
The intended population of Venient Fx STI Basic are patients with clinical symptoms or suspicion of the following infections: hepatitis B, hepatitis C, human immunodeficiency virus (HIV), syphilis, chlamydia trachomatis, mycoplasma genitalium, mycoplasma hominis, neisseria gonorrhoeae, trichomonas vaginalis, ureaplasma parvum, and ureaplasma urealyticum.
Sample Clinical Vignette
A 32-year-old female presented to the clinic for medical evaluation after a five month history of painful urination, lower back pain, vaginal discharge, bleeding between periods, and rectal pain. 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, Syphilis by Rapid Plasma Reagin (RPR)—; Polymerase Chain Reaction (PCR) in Urine —Chlamydia trachomatis, Mycoplasma genitalium, Mycoplasma hominis, Neisseria gonorrhoeae, Trichomonas vaginalis, Ureaplasma parvum, Ureaplasma urealyticum—.