Venient Cx STI Basic
Test Description
Venient Cx STI Basic is a disruptive, non-invasive test for the evaluation of sexually transmitted infections (STIs).
It is based on routine blood and urine analysis and is powered by both proprietary machine learning and public algorithms, and provides highly accurate primary diagnostic information, including the likelihood of various types of STIs, such as 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 parameters measured provide guidance on diagnostic, prognostic and therapeutic options. Although these results usually provide preliminary guidance, in certain scenarios they can be decisive.
It is based on the evaluation of antibodies in blood and the determination of STI by polymerase chain reaction (PCR).
In case of a positive result, the diagnostic report may suggest a specific secondary test of choice to further diagnostic information, confirm therapies, establish prognoses or follow up the disease.
If an STI is suggested, other tests will be recommended as appropriate.
Screening recommendations
The United States Preventative Services Task Force (USPSTF) generally recommends screening for sexually transmitted infections in women who are sexually active and at increased risk for developing these diseases.
However, Kience Inc. recommends the Venient Cx STI Basic test to treat patients presenting with the following symptoms, signs or suspected disease: 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 target population for Venient Cx STI Basic is patients with clinical suspicion of: 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—.