This present disclosure relates to specimen collection devices and kits that for the collection of biological samples.
Papanicolau tests (“pap tests”) are still currently the primary method of screening for cervical cancer in women. Recently, however, molecular diagnostic tests for human papillomavirus (HPV), the virus that causes cervical cancer, have become a viable alternative. Because HPV diagnostics are testing for viral DNA, as opposed to the pap test which is a cytology test performed on cells, the requirements of sample collection for the two tests are different.
The pap test requires that cells be collected from the transformation zone of the cervix. This procedure requires trained personnel with a line of sight to the cervix. Many view this process as invasive, and this coupled with other factors, such as inconvenience, or lack of access, can lead to irregular screening or complete avoidance. The avoidance of screening by many women is one of the limiting factors on the greater efficacy of the pap test. Pap tests are also relatively resource-intensive and women in rural and underdeveloped locales do not always have access to the facilities or medical staff required.
With the HPV test, it becomes technically possible for patients to collect their own sample. The HPV virus can be detected in vaginal fluid and in biological material sloughed off from the cervix. Clinical studies have shown that the quality of samples collected by patients themselves can be comparable to physician collected samples, potentially allowing patients to screen themselves. A repeatable and reliable method for women to collect their own samples from near the cervix would be potentially beneficial as it may reduce the barriers that inhibit adequate screening.