HPV Test Results May Lead to False Negatives, Risk of Cervical Cancer

Fears of cervical cancer lead many women to get tested for HPV, human papillomavirus, which is the main cause of the deadly cancer, but because of faulty tests, many of those women may think they are HPV-free when they are not.

And those women are more likely to unknowingly develop cervical cancer, since they're not receiving treatment for HPV.

"Some of the largest national labs have for a decade routinely used test kits that contain a preservative, BD SurePath, that is approved for Pap tests but not HPV testing," wrote the Arizona Republic. "The labs continue to use the tests despite an FDA warning June 8 that HPV tests using SurePath can produce false negatives and national guidelines that call for using only FDA-approved tests, an Arizona Republic investigation has found."

Gynecologists seem unaware of the problems with the tests, because only labs were alerted about the issue, not doctors.

"Those of us out here in the trenches have no idea; we just use whatever the lab gives us," said gynecologist Kathleen Fry.

About three million SurePath tests are administered each year, "Because no federal agency tracks HPV testing, hard data on SurePath's rate of false-negative HPV tests isn't publicly available. However, extrapolating from the findings of a Johns Hopkins University study suggests a thousand or more women tested each year using SurePath may be told they are HPV-free when they are not," reported the Arizona Republic.

Though not all HPV cases develop into cervical cancer, HPV is the leading cause of cervical cancer, an aggressive disease with an astonishingly-high mortality rate. Over 12,000 women each year are diagnosed with cervical cancer in the United States, and over 4,000 die.

Some doctors say those numbers are higher because of false negatives.

"Everybody's afraid to talk about these cases at their institutions. These cases are out there, but they aren't being noticed and systematically studied," said Marshall Austin, director of cytopathology at Magee-Women's Hospital in Pittsburgh.

"Nobody is looking back systematically to find these women with negative results several years before they were diagnosed with cancer. I have no doubt that if we could get access to the laboratories' databases, we could find these women."