Human Papillomavirus (HPV):
Human Papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the world. In the US, HPV has a prevalence of 42.5 million infections with a yearly incidence of 18.6 million infections in women aged 18-69. Patients with an HPV infection may be asymptomatic, but persistent high-risk HPV infection is a risk factor for developing cellular dysplasia which may lead to cancer, specifically cervical cancer but also anal, vulvar and certain types of oral and throat cancer.
HPV has more than 200 subtypes, of which 14 are associated with high risk (high-risk subtypes) of developing cancer. HPV 16 is responsible for ~60% and HPV 18 is responsible for 16% of cervical cancer cases among women aged 35-49. Furthermore, HPV subtypes 31, 33, 45, 52, and 58 have been shown to be associated with 20% of cervical cancers in the same age group.
The HPV Urine Test is a qualitative in vitro real-time PCR test for the detection of Human Papillomavirus (HPV) in first catch urine specimens self-collected at home or at a healthcare setting from women 18 years or older. The results from the test along with clinical symptoms and medical history may be used by healthcare providers to manage the infection, and guide decisions on medical care or additional screening requirements.
Positive results are indicative of an active HPV infection but may not be the definite cause of disease and may not rule out co-infection with other pathogens not detected by the test. Negative results do not necessarily indicate the absence of infection and may not rule out the presence of other microbes not detected by this test or those which may interfere with the test (refer to the Methodology statement).
These test results are not a substitute for medical care. Seek healthcare immediately if you are experiencing symptoms, your symptoms worsen or if you receive a positive result.
This test is used for clinical purposes. It should not be regarded as investigational or for research. Phase Scientific Medical Laboratory is certified under CLIA
as qualified to perform high complexity clinical laboratory testing.
The HPV Urine Test is a molecular Laboratory Developed Test (LDT) whose performance characteristics have been validated by Phase Scientific Medical Laboratory, Irvine, CA, but it has not been cleared or approved by the FDA. It is a qualitative Real-Time PCR test performed on DNA extracted from first-catch urine (40mL) to detect the fourteen (14) high-risk subtypes of HPV (HR HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) on the ThermoFisher QuantStudio5 Dx Real-Time PCR instrument. The test provides differentiated results for HPV16 and HPV18 and grouped results (HPV12+) for the remaining 12 high-risk HPV subtypes (HPV31,33,35,39,45,51,52,56,58,59,66,68). The test demonstrates an overall accuracy of 93% with a Limit of Detection (LOD) of 30 copies/mL urine for HPV16, and 15 copies/mL urine for all the remaining HR HPV subtypes. High levels organisms and substances that have been shown to interfere with the detection of HPV include, blood (≥1%), PBMC, C. albicans and T. vaginalis at 1x10^6 cells/40 mL urine.
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