Background Information

HPV refers to the human papillomavirus.  Human Papilloma Viruses are small viruses that infect body tissue through tiny cuts and abrasions that expose cells in lower layers of body tissue. Research worldwide has clearly shown that virtually all cervical cancer is caused by human papillomavirus (HPV).  

Globally, cervical cancer is the second most common form of female cancer with incidence of over 500,000 new cases and 300,000 deaths each year.  However, if detected early, cervical cancer precursors can be treated effectively.  Women persistently infected with certain carcinogenic types are at increased risk of developing severe dysplasia leading to cervical cancer.  Cervical cancer prevention programs in both developed and developing nations generally have relied on cytological testing using the Papanicolaou (Pap) smear test.  Pap smears require that a health care provider obtain a sample of cells from the uterine cervix of each woman screened.  Trained cytotechnologists and pathologists then examine the Pap smear for changes in cells known to precede the development of cervical cancer.  Such screening programs can be prone to error and are less sensitive.  Recent studies have demonstrated that molecular HPV tests are more sensitive than Pap smears in detecting cervical cancer.  As a result, American Cancer Society, American College of Obstetricians and Gynecologists, and American Society of Colposcopy and Cervical Pathology recommend HPV testing for cervical cancer screening.

The majority of genital HPV infections are sexually transmitted.  Some infections can persist for many years and may develop into malignant tumors.  Persistent high-risk HPV infection is the most significant risk factor for cervical cancer.  There are over 100 different HPV types.  The individual virus types are defined by their unique DNA sequences.  There are 15 HPV types that are the highest-risk types.  They are identified by number (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73, and 82).  Recent studies show that not all HPV types are equally likely to cause cancer.  For example, the risk of developing cervical cancer with the presence of HPV16 is 434 times greater than without HPV16, whereas it is 45 times greater in the presence of HPV45 than without HPV45.

The Pap test has historically been the most effective screening test for cervical cancer, but it still has limited sensitivity to detect conditions leading to cancer.  To reduce the chances of missing a condition that could lead to cancer, Physicians Reference Laboratory has developed a molecular test that specifically identifies the individual highest risk types of HPV.  The test is called the COMPLeTe Care HPV (patent pending).  It is highly sensitive, specific, reliable, and the most comprehensive HPV test available.  The COMPLeTe Care HPV test represents a revolutionary step in the prevention of cervical cancer.  This extremely precise molecular screening test will provide more accurate early diagnosis, drastically reducing the need for expensive and invasive treatment and ultimately reducing the risk of developing cervical cancer.

The COMPLeTe Care HPV test has many benefits which make it preferable to other currently available molecular tests including: (a) detection of all 15 high risk carcinogenic HPV types known to cause cervical cancer; (b) higher sensitivity and specificity; (c) type-specific detection to increase specificity; (d) type-specific detection to assess the risk, as not all HPV types are equally prevalent or cancer causing; (e) detection of single versus co-infections; (f) detection of new versus old infections; (g) pre-vaccination screening to identify patients who are already infected with HPV 16 and 18 and will not benefit from vaccines; (h) post-vaccination monitoring for the detection of infection by other HPV types than vaccine types or genomic variant of HPV types 16 and 18; and (i) built in internal control for higher accuracy.  

Frequently Asked Questions

1. How can I get tested?
1. Your physician can order the COMPLeTe Care HPV test via Pap, cervical swab or tissue sample.
2. Can I request or order my own test?
1. Only a physician can order the test for you.
3. Is the test covered by my insurance?
1. The COMPLeTe Care HPV test is covered by most major health insurance.
4. Is it different from other tests offered by my healthcare provider?
1. Yes, the COMPLeTe Care HPV test has several advantages over tests currently available to you
   1. Detection of all 15 high risk carcinogenic HPV types known to cause cervical cancer;
   2. Higher sensitivity and specificity;
   3. Type-specific detection to increase specificity;
   4. Type-specific detection to assess the risk, as not all HPV types are equally prevalent or cancer causing;
   5. Detection of single versus co-infections;
   6. Detection of new versus old infections;
   7. Pre-vaccination screening to identify patients who are already infected with HPV 16 and 18 and will not benefit from vaccines;
   8. Post-vaccination monitoring for the detection of infection by other HPV types than vaccine types or genomic variant of HPV types 16 and 18;
   9. Built in internal control for higher accuracy
2. If I have a positive result what are my options?
1. Your options for treatment should be discussed with your healthcare provider.