Saturday, August 2, 2008

Cervical Cancer
Self Pap Testing

Background: Thailand study, 1997. 552 women were trained to participate in a cervical cancer screening exercise using a self-scraping device. Results: 13 cases suspicious for malignancy were detected. Specimens obtained through examination by physicians confirmed 11 cases to be suspicious for malignancy. No false negative cases were found. In the detection of inflammation, the self-scraping methods was not as accurate as examination by a physician. The device was accepted by the females who participated in the study. The self-scraping method was successfully applied as an integral part of primary health care for mass screening for uterine cervical cancer.

A study published in 2000 concluded that the Human Papilloma Virus (HPV) testing is as effective as the Pap Smear for identifying women who are at risk of developing cervical cancer. Soon to be released in the USA is a self-administered pap test as an adjunct form of screening for cervical cancer. There is adequate evidence to suggest that all women over the age of 35 might benefit from regular self testing.

Self-Administered Pap Test technology review:

US Patent: 6936013 issued in 2005. Inventor: Patrick Pevoto. Marketed by Private Concepts, Inc. (Austin, TX) as the Pevlon device. It is a special tampon-like telescoping tube that has an absorbent soft mesh cover, which allows its to capture cells from the cervix and vagina within four hours of insertion. Once the device is removed, it is placed in a container with a special solution, which is provided with the device, and sent to a lab.

US Patent: 6,740,049 issued in 2004. Inventor: Ronald Wallach. A device is provided for self-sampling a body cavity, in particular the cervix, and a method is provided to use the device to obtain samples from the cervix for testing for the presence of human papillomavirus (HPV) DNA. The device includes elongated flexible bristles attached to a handle to form a mop-like sampling member. The sampling member is rotated to mop the cervix and obtain a sample of cervical cells on the elongated bristles. The sampling device is then withdrawn from the vaginal cavity and the sample is sent for analysis.

US Patent: 20030004435 issued in 2003. Inventors: Paul Crawford, et al. A device which is suitable for collecting cellular and DNA specimens from the upper vagina and lower cervix of a female patient's reproductive tract. The device can be self-administered by the patient and typically includes an expandible, cell-collecting insert disposed in a compressed configuration in a housing which is initially inserted in the woman's vagina. Upon controlled release from the housing, the insert expands into a generally spherical shape to contact the upper vaginal and lower cervical walls and remains in position for a selected period of time, such as eight hours, during which time some of the vaginal and cervical cells become trapped on the insert. After removal of the insert from the vagina, the insert is placed in a suitable specimen container and the cells thereon are tested for abnormal cytology or various medical conditions such as cancer or sexually transmitted diseases.

US Patent Application: 09/716648 issued in 2002. Inventor: Arthur Fournier. Marketed by Bay Point Group, Inc. (Miami, FL). A human female cervical specimen gathering device is disclosed which can be self administered by women. This device is an improvement over conventional cervical tissue sampling, which requires a speculum examination, and prior self-sampling devices, which are not compatible with thin-prep cytology easily adaptable to existing pap-smear technology, for thin smear cytology (automated or manual) microbial cultures and assays such as polymer-chain-reaction assays for human papilloma virus. The device consists of a cardboard tube that houses a retractable sponge. The handle is adapted to allow it to serve as a screw-cap lid, once the device is inserted into a conical tube containing fixative or preservative. After transport to the lab the tube can easily be agitated to liberate cells, centrifuged, and prepared as a thin smear for cytology or DNA probes.

US Patent: 6,302,853 issued in 2001. Inventor: Robert Sak. Marketed by R&G Medical and Development Corp. (Boca Raton, FL). A cervical sampling system for collecting a cervical sample for a Pap test. The cervical sampling system includes an insertion tube and an introduction guide that guides the insertion tube into a vaginal cavity. The vaginal insertion tube includes an insertion depth indicator to determine the appropriate depth to insert the tube. A cervical sampler is positioned within the vaginal insertion tube and extends into the vaginal cavity to collect samples. The insertion tube and sampler is rotated through a complete revolution. In 2006, Patent No. 7,087,028 was issued that furthers R&G's product to include an ethanol based fixative applied onto the collected sample before it is forwarded to a lab for slide preparation and diagnosis.

US Patent: 5,787,891 issued in 1998. Inventor: Robert Sak. A cervical sampling system includes a vaginal insert tube, a removable swab sleeve, a sampling swab, and a stem for pushing the swab into contact with the cervical tissue. Product developed for self testing.

US Patent: 5477863 issued in 1995. Inventor: Michael Grant. A collection kit includes a sample container with a cap and a sample collector. The sample collector includes a holder, a swab and a plunger. The holder is formed out of a tube which has a first end with a slot and a second end. The swab is formed out of a collection material with a first side-edge and a second side-edge. The swab is coupled to the slot of the holder adjacent to the first side-edge. The swab has a plurality of notches cut along the second side-edge. The holder draws the swab along a tissue surface in order to collect either cells or fluids for investigation. Once the sample collector has collected a tissue sample, the plunger is slidably inserted into the holder so that the plunger dislodges the swab from the slot in the holder in order for the swab to be deposited into the sample container.