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Sampling system

Sampling system description/claims

The present invention relates generally to the field of screening and health control. More specifically the invention relates to a novel sampling system and associated methods suitable, for example, in testing to detect virus-associated cervical cancer, microbial infections and pathological changes.

Cervical cancer is the second most common form of cancer in women world-wide. Invasive cervical carcinoma develops by progression of less severe epithelial changes, known as dysplacia and cervical intraepithelial neoplacia (CIN I-II-III), into cervical carcinomas in situ (CIS).

Using vaginal aspirates (Pap smears), the epithelial changes can be detected and classified by common cytological methods. It is particularly important to notice that invasive cervical carcinoma is preceded by its dysplastic precursor lesions, which can be present for months or years before cervical carcinoma develops. Furthermore, progression to carcinoma can effectively be stopped by a simple operation (conization) if the precursor lesions are detected.

Many developed countries have experienced up to a 50% reduction in the incidence of and mortality from invasive cervical carcinoma after the introduction of organized screening programs. Despite this fact, about 500,000 women in the world are struck by cervical cancer each year. In the U.S., close to 5,000 women die each year from this disease. This number would drop further if more women were tested on a regular basis.

Of those who die of cervical cancer, 50% have not had a Pap test done in 5 or more years. Indeed, those women who do not participate in the gynecological health control and those who show false negative cytology are the highest risk groups for cervical cancer. The efficacy and reliability of the sampling method and the sample's analysis are therefore primary issues. This involves, in the first place, reaching those women who do not now participate in the gynecological screening by providing a simple and reliable device for sampling, and secondly, to increase the discriminating efficacy of the analytical methods to diagnose infections, precancerous lesions or cancerous lesions.

Association between papillomavirus (HPV) infection and cervical carcinoma was postulated in the 1970's. The International Biological Study on Cervical Cancer reported a world-wide prevalence of infection with HPV of 93% in women with invasive cervical cancer. In addition, the subtypes HPV 16 and HPV 18 are the most significant risk factors in its aetiology. HPV infection is also an important risk factor for progression of CIN.

Recent studies with improved methods of polymerase chain reaction (PCR) imply an overall HPV prevalence of almost 100% and that the PCR results correlate with the histological findings. These results reinforce the rational for HPV testing in combination with, or even instead of, cytology in population-based screening programs.

Determination of squamous intraepithelial lesions, or cervical dysplacia, is commonly used as an indication of progression to cervical cancer. Alternatively, the presence of HPV nucleic acid in a patient sample, following amplification by PCR, is taken as a risk factor for progression to cervical cancer. From the above, it is obvious that cytology and PCR analysis of HPV infection provide very efficient means to detect individuals at risk to develop cervical cancer.

Recently published evidence-based consensus guidelines for the management of women with cervical cytological abnormalities and cervical cancer precursors state that women with atypical squamous cells of undetermined significance (ASCUS) should be managed using a program of 2 repeat cytology tests, immediate colposcopy, or DNA testing for high-risk types of HPV. Testing for HPV DNA is the preferred approach when liquid-based cytology is used for screening.

The limiting factor in order to further decrease the incidence of and mortality from cervical cancer appears therefore to be related to reaching the non attending women and providing a simple sampling device giving relevant samples for HPV analysis and/or cytology.

Traditionally, sampling of vaginal smear requires scraping of a woman's cervix with a sampling device, such as a spatula or a brush. This sampling is generally performed by medical professionals like gynecologists, midwifes or nurses in a clinical environment. Many women, who now refrain from such gynecological testing, would participate if the sampling could be carried out at home and/or by the women themselves. Self and home sampling would therefore increase the participation in the gynecological screening, and by that means, decrease the incidence of cervical cancer.

In addition to the above, sampling systems are also in demand for DNA analysis. Law enforcement officials, paternity agents, etc. are constantly taking DNA samples to help solve crimes, determine paternity, etc. As the results of the tests done on these samples dramatically affect people's lives and may be desired as evidence in legal proceedings, the sampling must be done in a manner in which the sample contamination is reduced or avoided. As such, there is a need for an improved sampling system.

In view of the need for an improved sampling device and a system easily adaptable to present health screening procedures, the present invention therefore provides improvement over the currently available devices and systems.

In one embodiment, the present invention comprises a sampling system comprising: a) a mailing package; b) a cell sampling device comprising: i) a flexible shaft having a handle at one end, wherein the shaft is configured to allow an individual to self collect a cell sample from mucous tissue, and ii) a sample collecting element removably connectable with the other end of the shaft and operable to collect a cell sample from mucous tissue of an individual; and c) a sealable unit, wherein the unit is configured to store the sample collecting element having a cell sample thereon and to be received within the mailing package in its sealed form. The sampling system may optionally further include a transport package configured to receive components a)-c) for delivery to a user.

In another embodiment, the present invention comprises a sampling system comprising: a) a mailing package; b) an instruction sheet; c) a flexible shaft; d) a sample collecting element connected with an end of the shaft and having a plurality of raised portions and grooves; e) a bar coded unit including an air tight cover and configured to receive the sample collecting element therein and to be received in the mailing package; and f) a bar-coded transport package configured to receive components a)-e) for delivery to a user.

The sampling systems of the invention may be used by medical personnel for patient sampling and/or may be used by individuals for self-sampling. The sampling systems are particularly advantageous for use by an individual in conduct self-sampling in testing to detect, for example, virus-associated cervical cancer, microbial infections and pathological changes. These and additional embodiments and advantages may be more fully apparent in view of the detailed description.

• Provisional Patent
• Utility Patent

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