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h cervical cancer after two negative HPV tests in the previous four years. Her tests had used Becton Dickinsons SurePath test kits. He told me that SurePath was widely used for HPV testing, even though it has FDA approval only for use with Pap tests. This seemed odd to me, so I began digging.
As I looked into this, I found a bulletin that Becton Dickinson and the FDA issued last June warning labs of SurePaths potential for false-negative HPV tests. That led me to look into how the false-negative rate compares to that of FDA-approved HPV test kits. ??
2. How often does SurePath yield false-negative results, and how does that rate compare to the false-negative rate for other leading brands?
For the several rival FDA-approved HPV tests, the false-negative rate is under ten percent, according to data from clinical trials. Comparable hard data on SurePath isnt publicly available. At least three times in the last decade, Becton Dickinson (or its predecessor) withdrew applications for FDA approval to use SurePath for HPV tests. Companies often withdraw applications if a denial seems likely; this allows them to keep the clinical trial data private. However, the limited public data available suggests that SurePath can have a false-negative rate of more than 50 percent.
3. What impact are these extra false-negatives having on womens health?
Women and their doctors may think theyre free of HPV when they arent. That can allow the virus, or the cervical cancer it causes, to become established and harder to treat. I found cases of women who died or had to undergo more invasive treatments, such as a radical hysterectomy, after repeated false-negative results using SurePath.
4. Unlike other leading brands, SurePath is not FDA-approved to test for HPV. Why not?
Legally, a laboratory can use non-FDA approved tests as long as it conducts its own study to establish the tests accuracy. But by law, the manufacturer cant give labs guidance on how to use its product for a non-FDA approved purpose. And critics charge that many of these lab validation tests are flawed. Federal laws dont require the labs to provide their validation studies to the FDA or to any other federal agency.
5. Is SurePath the only widely-used HPV test that isnt FDA-approved for HPV testing?
Some labs do use other non-FDA approved HPV tests, but none of those tests account for even one percent of the HPV test market. SurePath accounts for one-third of that market.
6. The manufacturer claims that false-negatives dont become an issue unless the sample is held for at.
this research, CD8+ T cells were known to exist in the gut mucosa. Much of the research on CD8+ T cells has focused on studying them in the circulating blood, which has a dominant phenotype of CD8+. Fred Hutch and UW scientists compared the two types of CD8+ T cells and found that only the CD8+ T cells persist in the skin while CD8+ T cells diminished from the tissue after healing of a herpes lesion.
We did not expect to find CD8+ T cells in the skin, Zhu said. This was a surprise.
The research involved using novel technologies to examine the T cells in human tissues. In all, the work provides a roadmap that can be applied to other human diseases, according to Zhu.
Zhu said the studies the research group performed in humans are unique. To our knowledge, we are the only research group to use sequential human biopsies to study CD8+ T cell function in situ, in their natural spatial distribution and at their original physiological state, she said.
According to the federal Centers for Disease Control and Prevention, 776,000 people in the United States are newly infected with herpes annually. Nationwide, 16.2 percent, or about one out of six people aged 14 to 49 years have genital HSV-2 infection. Generally, a person can only get HSV-2 infection during sexual contact with someone who has a genital HSV-2 infection. Transmission can occur from an infected partner who does not have a visible sore and may not know that he or she is infected.
Most individuals infected with HSV-2 or the related HSV-1, which causes genital herpes and cold sores, experience either no symptoms or have very mild symptoms that go unnoticed or are mistaken for another skin condition. Because of this, most people infected with HSV-2 are not aware of their infection.