Human Papillomavirus (HPV)

What is HPV?

Human Papillomavirus (HPV) is the most common sexually transmitted viral disease worldwide. Some types of the virus cause common skin warts, while other types of HPV are considered high risk (e.g. HPV-16 and HPV-18) and have been associated with anogenital cancer, particularly cervical cancer. Recently, clinical studies have confirmed that infection due to the high-risk types of HPV is the primary cause of cervical cancer. Due to the limitations of solely relying on physical examinations and self-reported medical histories, Cryogenic Laboratories, Inc (CLI)  sought an improved and more direct method of screening for this potentially dangerous virus.

What does FDA require for HPV detection?

The FDA requires screening donors for HPV by physical exam and medical histories but does not require HPV DNA based testing of sperm donors.

What is Cryogenic Laboratories, Inc. (CLI) doing for HPV detection?

CLI screens donors for HPV by medical history and physical exam, meeting the FDA standard. In addition we exceed the standard, having added DNA based testing of donor sperm in 2001. We are looking for the two strains of HPV that are most frequently associated with cervical cancer.

What is the medical evidence that supports this additional testing?

We cite a study (Human Papillomavirus DNA Detection in Sperm Using Polymerase Chain Reaction, Obstet Gynecol 2001;97:357-60) that concludes: "HPV is present in sperm cells from infected and apparently healthy subjects, and sperm washing does not eliminate the risk of HPV transmission to recipients. We suggest that HPV DNA testing should be done on the semen of prospective donors, and those with positive tests should be excluded from donation."

Why is CLI doing more than is required by the FDA?

Our view is that self-reported medical histories and physical examinations are insufficient to screen for HPV and that a DNA based test provides an additional level of safety to our donor sperm. At CLI we believe that all donor sperm should be both screened for HPV and tested for the most prevalent strains of HPV that cause cervical cancer. The medical literature supports our position.

How is the testing for HPV performed on the donors?

Since 2001, we test the semen of our donors for HPV at the time they are being screened for initial donor eligibility, and thereafter every three months while they are donating. By testing semen samples at 3 month intervals, we increase the chances of detecting the presence of HPV earlier than via the visual detection methods typically performed during a routine physical examination given at 6 month intervals in most tissue banking operations. Donors who do not have the testing completed are indicated as such on their medical or summary profiles.

Is the lab doing the HPV DNA test experienced with this kind of testing?

The protocol and validation of our HPV testing was developed at the Molecular Infectious Disease Laboratory (MIDL) of the Genetics & IVF Institute. MIDL was established in 1998, and is a cutting edge CLIA certified facility dedicated to infectious disease diagnostics using exclusively high sensitivity PCR (DNA) amplification methods. All in-house protocols presently in use must pass a multi-part validation process. Prior to offering the HPV test in 2001 approximately 10,000 assays were performed.

In addition to supporting the activities of various GIVF divisions, of which Fairfax Cryobank is one, MIDL provides high priority testing for prenatal and neonatal units for hospitals in the Washington, D.C. metro. MIDL is directed by Brian D. Mariani, Ph.D., who has 25 years experience in molecular genetics, microbiology and biotechnology. Trained at Stanford and Harvard universities, Dr. Mariani has applied his expertise at MIDL to the design of molecular genetic-based detection assays for a variety of infectious microorganisms from diverse clinical specimen types.

Has the testing accuracy been validated by outside agencies?

The Molecular Infectious Disease Lab (MIDL) of Genetics & IVF Institute performs in-house validated assays under CLIA certification (#49D0952503) according to all established guidelines. The lab director is qualified for Molecular Virology under N.Y. State Dept of Health guidelines. The lab participates in the College of American Pathology nucleic-acid amplification survey program (including HPV detection) and maintains a 100% accuracy score.

Why aren't all sperm banks offering this testing?

It is expensive and requires a relationship with a sophisticated infectious disease laboratory that has experience with semen testing. CLI has benefited tremendously from our relationship with Genetics & IVF Institute, our parent company. Since our inception as a sperm bank, we have always been at the forefront of genetic screening of our donors.