WO2006081621A1

WO2006081621A1 - Personal cervicovaginal-cell screening system

Info

Publication number: WO2006081621A1
Application number: PCT/AU2006/000134
Authority: WO
Inventors: David Hammer
Original assignee: Tam Pap Pty Limited
Priority date: 2005-02-04
Filing date: 2006-02-06
Publication date: 2006-08-10

Abstract

The present invention relates to a method for monitoring cells taken from an individual's cervicovaginal tract for the presence of abnormalities. The method comprises obtaining a sample kit from a distribution outlet (22) and using the kit to self-obtain a sample of cells from said individual's cervicovaginal tract. Upon obtaining the sample it is submitted for analysis (26, 28) and the results of the analysis are forwarded to the individual (30).

Description

"Personal cervicovaginal-cell screening system"

Cross-Reference to Related Applications

The present application claims priority from Australian Provisional Patent

2005900516 filed on 4 February 2005, the content of which is incorporated herein by reference.

Field of the Invention

The present invention relates generally to a method for detecting abnormalities in cervical cells taken from an individual's cervicovaginal tract and a screening system for analysing self obtained cervicovaginal samples.

Background to the Invention

Collection of cells from the female genital tract has become an important aspect of proper routine monitoring of women for pathological changes in this region of the body, particularly in relation to infections, cervical cancer and pre-cancer screening.

Over the past 50 years, the most common procedure for obtaining cells from the cervix for testing has been via a cytological procedure known as the Papanicolau (Pap) test [Papanicolaou GN & Traunt HF 1943 Harvard Univ Press]. Traditionally, the Pap test is a relatively invasive procedure that requires a woman to routinely visit a clinic whereby a medical practitioner manually obtains a desired amount of cervical tissue for laboratory analysis. Typically, the medical practitioner inserts a speculum into the patient's vagina to expose the cervix, whereby the surface of the cervix is scraped by a brush, stick or swab to loosen the cells therefrom for further analysis. This procedure as well as causing considerable pain and discomfort to the woman, is also often a source of embarrassment to the woman. For many, even attending the doctor to discuss sexual matters can be confronting for some women, especially if the doctor is male. As a result participation in screening programs by women, although strongly encouraged by government and health authorities, is far from optimum, and in particular, non- participation among certain ethnic and religious subsections of the community is considerable [Hislop TG. BC Med J 1.995; 37: 697-99; Hislop TG et al Can J Public Health 2003; 94: 68-73]. Further, traditional Pap tests have been shown to be unreliable [Fahey MT et al. Am J Epidemiol 1995; 141: 680-89], resulting in a relatively high percentage of samples of undetermined significance requiring unnecessary farther testing as well as having a relatively high false negative rate [. Such a false negative rate is probably due to inadequate sampling of the exfoliated cells or to an incorrect cytological interpretation when the sample is viewed under the microscope by a person or device utilized for that purpose. Typically, further testing may be required in the form of a colposcopy whereby a medical practitioner performs a farther examination of the cervix at increased resolution, removing affected cells during the process [Wright TC, Jr et al, J Am Med Assoc 2002; 287: 2120-29]. Due to the unreliability of Pap tests, this can result in some women being unnecessarily referred for colposcopy resulting in unnecessary removal of cells from the cervix as well as unnecessary expense and inconvenience to the patient. This also contributes to the relatively low participation by women in cervical screening programmes.

Over recent years considerable evidence has emerged in support of a fresh approach to cervical screening. It has been found that viruses have been implicated in the causation of cervical cancer and in particular the presence of high-risk types of human papillomavirus (HPV) cause virtually all (greater than 99%) cases of cervical cancer [zur Hausen H, Cancer 1987; 59: .1962-9; Bosch FX et aL J Natl Cancer Inst 1995; 87: 796-802; Bosch FX et al. Biomed Pharmocother 1997; 51: 268-75; Bosch FX et al. J Clin Pathol 2002; 55: 244-265; Walbooraers JM et al. J Pathol 1999; 189: 12- 19; Franco BL et al. Cancer J 2003; 9: 348-359]. HPV infection is common, and being sexually transmitted, many women and men come into contact with the virus not long after they become sexually active. In this regard, a major focus is placed upon cervical screening for HPV because the epidemic of HPV infection worldwide coupled with its absolute causation of cervical dysplasia which can progress to cervical cancer with potentially fatal consequences.

Moreover, it is widely believed that HPV detection provides a far more accurate indication of the likelihood of cervical cancer occurring than cytological testing [Marios MM et al. J Am Med Assoc 1999; 281: 1605-10; Solomon D et al. J Natl Cancer Inst 2001; 93: 293-99], which, as mentioned above, has an unacceptably high, false negative rate. Also, as persistent HPV infection has been shown to foster progression to cancer, regular monitoring of the presence of HPV infection, and other organisms in women, should further reduce the incidence of cervical cancer and other complications. Moreover, the latest American Society of Colposcopy and Cervical Pathology Consensus Guidelines strongly endorse the use of HPV testing for women with atypical squamous cells (ASC) of undetermined significance (ASCUS) [Wright TC, Jr et al. J Am Med Assoc 2002; 287: 2120-29].

Testing for HPVs can be carried out by a variety of known methods. One such method is by molecular hybridization as described in numerous research publications such as [Henderson BR et al, J Med Virol 1988] and by use of a commercial test - Hybrid Capture II, manufactured by Digene Corporation, USA [ALTS Group. .T Natl

Cancer Inst 2000; 92: 397-402].

Recently a more sensitive test has been developed that utilizes the polymerase chain reaction (PCR) for HPV detection and is described in more detail in issued United States of America Patent Nos. 5,783,412 and 6,218,104, as well as in publications [Morris BJ et al. Lancet 1988; ii(8624): 1368; Dallas PB et al, J Med Virol 1989; 27: 105-11; Morris BJ et al. J Med Virol 1990; 32: 22-30; Morris BJ, Clin Chem Lab Med 2005; 43: 1171-77] and a current commercial kits [Venturoli S et al. J Virol Methods 2002; 105: 49-56; Monsonego J et al. Gynecol Oncol 2005; 99: 160-168]. Whilst the older hybridization, tests identified above require adequate amounts of cervical tissue to function, PCR testing is exquisitely sensitive, meaning that it can readily detect virus in a simple sample of exfoliated cells taken from the vagina as a lavage or tampon specimen, as vaginal fluids contain exfoliated cells that harbour HPV if HPV has infected any cells within the cervicovaginal canal [Burk RD et al. Am J Obstet Gynecol 1986; 154; 982-89; Goldberg GL et al. Am J Obstet Gynecol 1989; 161 : 1669-72; Vermund SH et al. Am J Obstet Gynecol 1989; 160: 304-08; Morris BJ et al. J Med Virol 1990; 32: 22-30; Coutlée F et al. J Med Virol 1992; 37; 22-29; Morrison EA et al. Am J Obstet Gynecol 1992; 167: 104-07; Coutlée F et al. J Clin Microbiol 1995; 33: 1973-1978], Both tampons (Fairley CK ct al. J Infect Dis 1992; 165: 1103-06) and lavages (Burk RD et al Am J Obstet Gynecol 1986; 154: 982-89) give a high yield of cells and DNA for HPV testing. In a Melbourne study positivity for HPV by PCR was 73% in conventional cervical scrapes and 69% in specimens from tampons (Meds Tegular; Johnson & Johnson, St Leonards, Australia), which the women were asked to insert, withdraw immediately, then place in a sterile specimen jar to bring to the doctor (Fairley CK et al. 1992). Self-collected swab specimens can moreover yield slightly higher HPV positivity than physician-collected swab specimens [Ogilvie GS et al. Sex Transm infect 2005; 81: 207-212], suggesting the reliability of this approach to specimen collection for screening purposes.

Therefore, use of HPV PCR for cervical screening, is not restricted to the use of cervical scrapes, but can utilize more readily accessible samples that the woman can collect herself from,, for example, a tampon or similar device. In this regard, such a test need not be restricted to the collection of cervicovaginal samples for HPV testing, as PCR may also be used to detect Chlamydia trachomatis that may be present in cervicovaginal samples [Class HC et al. Bur J Clin Microbiol Infect Dis 1990; 9: 864- 868; Nather H et al. Genitourin Med 1991; 67: 211-214; Ratti G et al. J Clin Pathol 1991; 44: 564-568; Riley DE et al. J Clin Microbiol 1992; 30; 465-472; Williams TW et al. Eur J Clin microbial .Infect Dis 1992; 11: 233-236], as well as Herpes simplex virus I and E [Rogers BB et al. Am J Pathol 1991; 139: 1-6], Mycoplasma genitalium [Palmer HM et al, FEMS Microbiol Lett 1991; 77: 199-204], HIV, Hepatitis B, etc. Moreover, other types of testing and other constituents of the vagina may be sampled and tested in samples from normal women or those suffering from a pathological medical condition.

In this regard, there is a need to provide a cervical monitoring and screening system that encourages widespread participation of women from all socio-economic backgrounds, which enables self-collection of cervicovaginal samples for subsequent analysis without requiring the subject to undergo a clinical sampling procedure, and which offers confidentiality and offers control of the process to the individual.

Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is solely for the purpose of providing a context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.

Summary of the Invention

Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other clement, integer or step, or group of elements, integers or steps.

According to a iirst aspect, the present invention is a method for monitoring cells taken from an. individual's cervicovaginal tract for the presence of abnormalities, comprising: obtaining a sample kit from a distribution outlet; using said kit to self-obtain a sample of cells from said individual's cervicovaginal tract; submitting said sample for analysis; and receiving results of said analysis.

In one embodiment, the distribution outlet is a publicly accessible venue such as a pharmacy or other retail outlet. Such an outlet does not require professional medical assistance and as such, the sample kit may be obtained by the user in a confidential manner at a time and place convenient to the user.

The step of obtaining the sample kit may further comprise a step of capturing the individual's details for establishing a link between said sample kit and said individual. The individual's details may include any one or more of the individual's name and/or a number associated with the individual's social security or medical health care program. The individual may provide their details at the time of obtaining the sample kit, either by entering their details into a computer provided at the distribution outlet, and/or by swiping a card associated with their social security or medical health care program in a card reader. In this regard, the sample kit may be provided with an identification tag which may also be captured at the time of obtaining the sample kit. The identification tag may be in the form of a unique bar-code or number which identifies the sample kit from other sample kits. Following capturing of the individual's details and the identification tag of the sample kit, the data may be stored in a database.

In one embodiment, the sample kit comprises a collection device for collecting cells from the individual's cervicovaginal tract. The collection device may be in the form of a conventional tampon, swab or elongated brush that the individual can insert into the cervicovaginal tract to collect exfoliated cells therefrom. The step of using the sample kit may comprise the individual inserting the collection device into their cervicovaginal tract such that the device contacts the walls of the cervicovaginal tract to absorb or otherwise collect exfoliated cells present therein. The exfoliated cells may be entrained in vaginal fluid which collects on the collection device. In this regard, the step of self obtaining the, sample may be performed in the privacy of the individual's home or a public convenience, such as a toilet or women's test τoom without requiring the individual to undergo a medical procedure.

The self-obtained sample may be sealed prior to submitting the sample for analysis. In one form, the sample kit may comprise a capsule for receiving the collection device following obtaining the sample. The capsule may seal the sample thereby preventing contamination of the sample. The capsule may comprise an identification tag corresponding to the identification tag of the sample kit, such that the sample can. be readily identified to the individual.

In one embodiment, the sample is submitted for analysis by depositing the sample at a collection centre. The collection centre may be a publicly accessible venue such as a pharmacy or other retail outlet, and may be the same venue as the distribution outlet for obtaining the sample kit. The collection point may comprise a depository into which the sample is received. The depository may comprise a reader unit for registering the submission of the sample. The reader unit may be an electronic reader unit, such as a scanner or the like, which reads the identification tag of the capsule upon receipt of the capsule. The reader unit may then initiate a signal to facilitate delivery of the sample to a laboratory or similar analysis facility for analysis of the sample.

In an embodiment, the step of submitting the sample for analysis further comprises delivering the sample to a laboratory. The laboratory may then detach the cells from the sample for testing. Following detaching of the cells, DNA may be extracted from the cells. The DNA may be extracted by a proteinase K digestion technique or by a phenol chloroform extraction technique. The extracted DNA may then be tested by a polymerase chain reaction (PCR) test, or the like, to identify the presence of a variety of viruses or organisms in the sample. In one form, the PCR test identifies the presence of human papillomavirus (HPV). In another form, the PCR test may identify the presence of human immunodeficiency virus (HIV), hepatitis, chlamydia, candidiasis, chancroid, cytomegalovirus, granuloma inguinale, gonorrhea, herpes, syphilis and/or trichomoniasis.

In another embodiment, the analysis of the sample may be performed by the depository following submission of the sample for analysis. The depository may detach the cells from the sample for testing upon receipt of the sample. Following detaching of the cells, DMA may be extracted from the cells. The DNA may be extracted by a proteinase K digestion technique or by a phenol chloroform extraction technique. The extracted DNA may then be tested by a polymerase chain reaction (PCR) test, or the like, to. identify the presence of a variety of viruses or organisms in the sample. Tn one form, the PCR test identifies the presence of human papillomavirus (HPV). Tn another form, the PCR test may identify the presence of human immunodeficiency virus (HIV), hepatitis, chlamydia, candidiasis, chancroid, cytomegalovirus, granuloma inguinale, gonorrhea, herpes, syphilis and/or trichomoniasis.

During analysis of the sample by the laboratory or the depository, the results of the analysis are recorded against the individual's details. In this regard, the results of the analysis may be received directly by the individual in accordance with the individual's preferred options. Tn this regard, the individual may directly receive the results in electronic form, by way of an email or the like, or the results may be posted on a readily accessible internet site which the individual can access through the use of a password or the like to ensure anonymity. In another embodiment, the results may be received by the individual through the mail or similar postal service. Where indicated, the results of the analysis may also be forwarded to a medical professional nominated by the individual for further analysis or recording against the individual's medical history.

According to a second aspect, the present invention is a system for screening for abnormalities present in cervical cells of individuals, comprising: a register for recording users of the system, said register accessible by said users; a sample kit available to said users for facilitating self-collection of a sample of cervical cells by an individual user; and an analysis facility for receiving and screening said sample for abnormalities, said analysis facility providing results of said screening to the register for access by the individual user.

In one embodiment of this aspect of the invention, the register is a database.

The database may be accessible by the users through the internet. The register may record a profile for each user which is accessible by the user through entry of a password. The profile may comprise the user's name and contact details together with the user's Medicare or social security identification code.

The sample kit may be available to the users for purchase and/or collection through a publicly accessible venue such as a pharmacy or other retail outlet. Such an arrangement does not require the user of the system to seek professional medical assistance to participate in the screening program, as the sample kit may be obtained by the user in a confidential manner at a time and place convenient to the user.

Upon purchase and/or collection of the sample kit by a user, the sample kit may be identified in the register against the user's profile. In this regard, the sample kit may be provided with an identification tag to facilitate identification of the kit and enable tracking of the kit and subsequent sample throughout the screening process. The identification tag may be in the form of a unique bar-code or number which identifies the sample kit from other sample kits.

In one embodiment, the sample kit comprises a collection device for collecting cells from, the individual's cervicovaginal tract. The collection device may be in the form of a conventional tampon, swab or elongated brush that the individual can insert into the cervicovaginal tract to collect exfoliated cells therefrom. Upon inserting the collection device into the cervicovaginal tract the device may be arranged such that it contacts the walls of the cervicovaginal tract to absorb or otherwise collect exfoliated cells present therein. The exfoliated cells may be entrained in vaginal fluid which collects on the surface of the collection device. In this regard, the sample may be collected in the privacy of the individual's home or a public convenience, such as a toilet or women's rest room without requiring the individual to undergo a medical procedure, The sample may be sealed prior to submitting the sample to the analysis facility for screening. In one form, the sample kit may comprise a capsule for receiving the collection device following collection. The capsule may seal the sample thereby preventing contamination of the sample. The capsule may comprise an identification tag corresponding to the identification tag of the sample kit, such that the sample can be readily identified to the individual.

In one embodiment, the analysis facility may comprise a depository for receiving the sample. The depository may comprise a reader unit for registering the submission of the sample and recording the submission of the sample against the user's profile on the register. The reader unit may be an electronic reader unit, such as a scanner or the like, which reads the identification tag of the capsule upon receipt of the capsule.

The analysis facility may be a laboratory. The laboratory may detach the cells from the sample for testing. Following detaching of the cells, DNA may be extracted from the cells. The DNA may be extracted by a proteinase K digestion technique or by a phenol chloroform extraction technique. The extracted DNA may then be tested by a polymerase chain reaction (PCR) test, or the like, to identify the presence of a variety of viruses or organisms in title sample. In one form, the PCR test identifies the presence of human papillomavirus (HPV). In another form, the PCR test may identify the presence of human, immunodeficiency virus (HlV), hepatitis, Chlamydia, candidiasis, chancroid, cytomegalovirus, granuloma inguinale, gonorrhea, herpes, syphilis and/or trichomoniasis.

Following screening of the sample, the results may be recorded against the user's individual profile in the register, In this regard, the results of the screening may be handled in accordance with any preferred options stored against the user's individual profile. In one form, the user may request that the analysis be forwarded to a nominated medical professional, for further analysis or recording against the individual's medical history. In another form, the individual may directly Teceive the results in electronic form, by way of an email or the like. In yet another form, the individual may directly access the results through directly accessing their individual profile on the register.

Brief Description of the Drawings By way of example only, preferred embodiments of the invention are now described with, reference to the accompanying drawings, in which:

Fig. 1 is a flow chart of the method of self-obtaining a cervical sample according to one embodiment of the present invention;

Fig. 2 is a front view of a cervical sample collection device according to one embodiment of the present invention;

Fig. 3 A is view of the cervical sample collection device of Fig. 1 in combination with a receptacle prior to assembly; and

Fig. 3B is a front view of the cervical sample collection device and receptacle of Fig, 2 A in sealing assembly.

Detailed Description of Exemplary Embodiments

The present invention provides a system for monitoring and screening a variety of conditions which may be present in the genital tract of most females. The system is readily accessible by a woman without requiring any specific contact with a clinic or medical service provider, and as such is relatively confidential and can be employed by women to monitor their health at regular intervals such that should the need arise, the individual can seek immediate medical attention to address any potential health issues that may have been detected. The present system will be described in relation to its use in the screening of cervical cancer. It will be appreciated, however, that the present system could equally be employed by individuals to monitor the presence of a variety of viral , parasitical or bacterial infections associated with sexually transmitted infections, such as candidiasis, chancroid, chlamydia, cytomegalovirus, granuloma inguinale, gonorrhea, hepatitis, herpes, human immunodeficiency virus (HIV), human papillomavirus (HPV), syphilis and/or trichomoniasis.

As will become evident, the present invention essentially resides in an overall distribution and information management system which enables individuals to self collect a cervical/vaginal sample and have the sample analysed and the results returned to them without the specific need for the individual to visit a clinic or medical specialist. The system captures the individual's details and preferences and tracks the sample results in a manner that ensures confidentiality and integrity of the results.

The system 20 of the present invention will now be described in relation to Fig.

1.

As alluded to above, in order to improve the participation rate of women in cervical screening programmes, the system 20 provides a self-collection sample kit readily available for purchase by the individual at step 22. In this regard, a pharmacy or other suitable retail outlet functions as a distribution point, whereby the individual can collect/purchase a self-collection sample kit together with other regularly purchased products at a time and place that is convenient to the individual and relatively non-confrontational.

As will be discussed in more detail below, at the time of purchasing the kit the user may submit their personal details, which can be captured and stored in an appropriate database which stores the personal details of the individual together with an identification, tag of the purchased kit. The identification tag of the purchased kit may be a unique serial number or bar code mat identifies the individual kit from other such kits. Similarly, the personal details of the individual may be captured through the swiping of an appropriate card such as a Medicare card or Health Benefit card which identifies the individual and may also capture the relevant personal details of the individual, such that the test kit can be initially linked to the individual for all future transactions.

The self-collection sample kit essentially contains a device for collecting a cellular sample from the cervicovaginal canal of the individual. A variety of devices have been proposed for self-collection of cellular samples from the cervicovaginal canal. One such device 10 is shown generally in relation to Fig. 2. The collection, device 10 generally consists of an elongate portion 12 having a domed distal end which is made from an absorptive material that resembles a tampon, but which is greater in length than a regular tampon so as to permit sampling of as much of the cervicovaginal canal fluids as would be possible using a regular tampon. The width of the elongate portion 12 is also variable to accord with variations in the size of the vaginal canal of different women, as well as to provide a preference to the woman for a size that she finds easiest for her to use. The absorptive material of Hie collection device 10 is also typically treated prior to use to ensure sterility of the device, such that the integrity of the sample taken is maintained. In this regard, in order to differentiate the collection device 10 from a regular tampon that may be used during a woman's menstrual period, the depicted elongate portion 12 is made of a distinctive colour.

To ensure that the sterility of the device 10 is maintained during use and not pre- contaminated during handling prior to use, a handle 14 is provided to aid in the insertion procedure. Tt will be appreciated that the construction and form of the device 10 can vary and still fail within the scope of the present invention. In this regard, the device 10 can be in a variety of forms and shapes which enables collection of exfoliated cells from the cervicovaginal canal in a relatively routine and relatively comfortable manner without the need for assistance. Alternatively, a conventional tampon can equally well be used as the collection device.

Once the kit has been purchased/obtained by the individual, the individual can then collect the sample in comfort and privacy, such as in the comfort of their own home. In this regard, with the embodiment of the device 10 as shown in Fig. 2, the individual grips the handle 14 and inserts the elongate portion 12 into the vaginal canal in much the same way as she would normally insert a tampon during her menstrual period. In doing so, the collection device 10 is able to obtain a sample of the vaginal fluid which contains the exfoliated cells that harbour HPV as well as the other constituents of the vaginal fluid such as viruses, bacteria, fungi, yeasts etc, which may be used to detect whether the individual is infected with said microorganisms, thus assisting in diagnosis of a medical condition or risk of future development of a medical condition. Rather than requiring a medical procedure where sections of the cervicovaginal tissue are taken for testing, the device 10 enables the samples to be taken relatively conveniently and in the privacy of the individual's own home or public convenience such as a women's rest room.

Following insertion, the collection device 10 is then removed and placed within the receptacle 16 to prevent the sample from becoming contaminated, in the manner as shown in Figs. 3A and 3B. The receptacle 16 may be in the form of a smooth plastic tube that is shaped to enclose the elongate portion 12 of the collection device such any contact of the sample contained on the elongate portion 12 with the receptacle 16 is prevented. The receptacle 16 may be provided with an internal screw thread 17 at its open end which can. engage with a corresponding external screw thread 18 provided on the handle 14 to secure the receptacle in position and seal the sample following collection thereof. Alternatively, a screw cap may be applied to the receptacle which fulIy encloses the device 10 to provide a tight seal about the device 10. A clip seal is another alternative. As discussed above, it will be appreciated that a variety of sealing/encapsulating means may be employed to seal the sample following the self- sampling procedure.

Referring to Fig. 1, following the self-sampling procedure 24, the sample is submitted for analysis by the individual at step 26 in a discrete and simple manner. In this regard, the kit may include a capsule (not shown) into which the device 10 is securely placed for deposit at a prcdesignated pick-up point. The capsule may be marked with an identification tag which corresponds with the identification tag of the originally purchased kit. In this regard, the individual can merely deposit the capsule at the pick-up point without requiring completion of any deposit forms etc, as the capsule will be identified as belonging to the individual through the associated database records.

The pick-up point may be a pharmacy or similar retail outlet which may also function as a distribution point for collecting/obtaining the original kit. The pick-up point may have a designated drop-in box where the deposited capsules arc temporarily stored prior to delivery to the laboratory for testing. In this regard, upon depositing the capsule, a bar code reader may detect the presence of the capsule and an appropriate register of this event may be made on the central database indicating a deposit awaiting collection and delivery to a laboratory for further analysis. Registration of such an event in the database may then trigger a signal to be sent to an appropriate courier or transport service to collect the deposited sample and deliver it to a laboratory fox analysis. The transport service may be a dedicated courier service which routinely visits each pick-up point at regular intervals to deliver deposited samples to the laboratory, or may be a collcction-on-demand service that awaits notification of the presence of a deposited capsule via the database, and initiates collection and delivery of the capsule to the laboratory upon notification. Alternatively, the box may be designed to detect a change in the weight of its contents, triggering a message, such as via a computer, to .he pick-up service to notify that there arc samples to collect. This change in weight of contents may be quantitative, so that the number of samples contained within the drop-off, box can be estimated and relayed to the courier or other relevant party.

As shown as step 28 of Fig, 1, the manner in which the laboratory analyses the sample can vary, depending on the type of analysis technique required. In one embodiment, upon delivery of the sample to the clinical pathology laboratory, the cells attached to the collection device 10 are dislodged from the elongate portion 12 by soaking then squeezing (using conventional microbiological sterile technique) in 10 ml of a suitable solution, such as standard laboratory Tris-HCl-salme buffer, pH 7.5, containing EDTA. After the cells are sedimented from this solution using a centrifuge, the DNA is extracted by a conventional technique, which may involve, but is not restricted to, proteinase K digestion and phenol chloroform extraction. A commercially available kit, such as, but not restricted to, those manufactured and distributed by Qiagen, may be employed to perform this function. The HPV PCR test is then undertaken, the protocol for which is described in the above referenced United States of America patents. It will be appreciated by those skilled in the art that the analysis need not be restricted to that which is described in these patents, nor indeed to PCR itself, should a different test emerge in the future. The HPV test will also involve a kit, where kits for testing of viruses such as HIV, HcpB, HPV, chlamydia, etc, as well as other micro-organisms are currently marketed, by Roche Diagnostics. The HPV PCR kit contains the specific primers needed for detection of relevant types of HPV by a PCR protocol. It should also be noted that, as alluded to, the analysis may include testing for the presence of other micro-organisms or constituents in the sample. Following testing and analysis, the sample is then destroyed appropriately.

During the laboratory analysis, the individual's personal details and preferences are captured together with the sample such that as the sample is analysed in accordance with the individual's preferences and as the results of the analysis materialize, they are stored with the individual's contact and personal details. In this regard, the individual may only be identifiable through their Medicare number and/or Health Care and/or Private Insurance number thereby ensuring total anonymity throughout the process.

At step 30, the results of the analysis are provided to the individual. This can be done in accordance with the individual's preferences and may be in the form of an e- mail notification or by way of a conventional posted letter. In this regard, should the individual require, the results of the analysis may be forwarded to the individual's medical practitioner in accordance with their stored preferences, such that the results of the analysis can be stored on the individual's medical records. In this arrangement, should the results indicate a positive detection of HPV the individual would be contacted by the medical practitioner and asked to make an appointment to attend for further clinical evaluation and counselling, together with any treatment that may be required.

It will be appreciated that with technological advances in the widespread use of PCR in the clinical pathology setting, testing will eventually be fully automated and access to testing will be expanded so as to allow a pharmacist or designated qualified technician to be able to perform the test using a simple, reasonably-priced machine that takes the sample and carries out the test automatically. In this regard, step 28 could be performed substantially simultaneously with the submission of the sample in step 26 to provide relatively immediate results to the individual. This would, for example, incorporate automated removal of cells from the collection device, extraction of DNA, addition of HPV PCR primers, dinucleotides, thermostable polymerase, buffer and other constituents that made up the PCR mix, then multiple rounds of amplification of HPV DNA through the various temperature steps common to a PCR procedure. This device would thus incorporate the automated thermal cycler and the other steps in an automated fashion, generating at the end a print-out of the result, which may also be linked to a computer that can forward the result to the nominated medical, practitioner electronically.

The monitoring and screening system 20 of the present invention provides a system that is more accessible to a large number of women and enables women to take a more active and personal role in monitoring their own health needs and performing self sampling for cervical screening to reduce the incidence of cervical cancer and the costs associated with traditional screening processes.

The system 20 removes much of the anxiety and discomfort typically associated with routine cervical screening routines and provides a degree of anonymity not previously possible with conventional screening techniques .

By providing a central and dedicated database to capture and control the overall distribution of the system, each individual, can submit a sample for analysis at a time and regularity that suits them and can be assured that the integrity of their results are maintained throughout the process. Similarly, such a dedicated database ensures that the individual can readily monitor and access their own medical history to take a more active role in their own health, such that problems can be identified early to ensure appropriate action can be initiated.

Whilst the method described above is the preferred embodiment, it is envisaged that from time to time variations of this method under various circumstances could take place, such as collection and dispatch within, the setting of a medical practice under the supervision of a medical practitioner.

It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

Claims

CLAIMS:

1. A method for -monitoring cells taken from an individual's cervicovaginal tract for the presence of abnormalities, comprising: obtaining a sample kit from a distribution outlet; using said kit to self-obtain a sample of cells from said individual's cervicovaginal tract; submitting said sample for analysis; and receiving results of said analysis.

2. A method according to claim 1, wherein the distribution outlet is a publicly accessible venue.

3. A method according to claim 2, wherein the publicly accessible venue is a pharmacy or retail outlet.

4. A method according to claim 1, wherein the sample kit comprises a collection device for collecting cells from the individual's cervicovaginal tract.

5. A method according to claim 4, wherein the collection device is a tampon.

6. A method according to claim 4, wherein the collection device is a swab or elongated brush.

7. A method according to claim 4, wherein the step of using the kit to self-obtain a sample of cells from, the individual's cervicovaginal tract comprises inserting the collection device into the cervicovaginal tract to collect exfoliated cells therefrom.

8. A method according to claim 7, wherein following collection of said sample, the sample is placed in a container.

9. A method according to claim 8, wherein the container seals the sample.

10. A method according to claim 8, wherein the step of submitting the sample for analysis comprises depositing the container at a collection centre.

11. A method according to claim 10, wherein, the collection centre is a pharmacy or other retail outlet.

12. A method according to claim 11 , wherein, the collection centre is the same venue as the distribution outlet for obtaining the sample kit.

13. A method according to claim 10, wherein the collection centre comprises a depository into which the sample is received.

14. A method according to claim 13, wherein following receipt of said sample in said depository, the sample undergoes analysis.

15. A method according to claim 14, wherein the analysis comprises detaching the cells from the sample.

16. A method according to claim 15, wherein DNA is extracted from the detached cells.

17 A method according to claim 16, wherein the DNA is extracted from the cells by proteinase K digestion or phenol chloroform extraction.

18. A method according to claim 17, wherein the extracted DNA undergoes a polymerase chain reaction (PCR) test to identify the presence of a variety of viruses or organisms in the sample.

19. A method according to claim 18, wherein the PCR test identifies the presence of human papillomavirus (HPV) in the sample.

20. A method according to claim 18, wherein the PCR test identifies the presence of human immunodeficiency virus (HIV), hepatitis, chlamydia, candidiasis, chancroid, cytomegalovirus, granuloma inguinale, gonorrhea, herpes, syphilis and/or trichomoniasis in the sample.

21. A method according to claim 19 or 20, wherein the analysis is performed in a laboratory.

22. A method according to claim 19 or 20, wherein the analysis is performed by the depository upon submitting the sample for analysis.

23. A method according to any one of the preceding claims, wherein the step or receiving the results of the analysis comprises directly sending the results to the individual.

24. A method according to claim.23, wherein the results are sent to the individual in accordance with the individual's preferred options.

25. A method according to claim 24, wherein the individual receives the results in electronic form by way of an email.

26. A method according to claim 24, wherein the results of the analysis are posted on a secure internet site, accessible by the individual .

27. A method according to claim 24, wherein the results of the analysis are received by the individual through the mail or similar postal service.

28. A system for screening for abnormalities present in cervical cells of individual users, comprising: a register for recording said users of the system, said register accessible by said users; a sample kit available to said users for facilitating self-collection, of a sample of cervical cells by an individual user; and an analysis facility for receiving and screening said sample for abnormalities, said analysis facility providing results of said screening to the register for access by the individual user.

29. A system according to claim 28, wherein the register is a database.

30. A system according to claim 29, wherein tlie database contains an individual profile for each user.

31. A system according to claim 28, wherein the sample kit is available to the users for purchase and/or collection through a publicly accessible venue.

32. A system according to claim 28, wherein the sample kit comprises a collection device for collecting said cells from the individual's cervicovaginal tract.

33. A system according to claim 32, wherein the analysis facility is a laboratory.

34. A system according to claim 33, wherein the laboratory screens the sample by extracting DNA from the cells and performing a polymerase chain reaction (PCR) test on the cells to identify the presence of a variety of viruses or organisms in the sample.

35. A system according to claim 34. wherein the PCR test identifies the presence of human papillomavirus (HPV) in the sample.

36. A system according to claim 34, wherein the PCR test identifies the presence of human immunodeficiency virus (HIV), hepatitis, chlamydia, candidiasis, chancroid, cytomegalovirus, granuloma inguinale, gonorrhea, herpes, syphilis and/or trichomoniasis in the sample.

37. A system according to claim 35 or claim 36, wherein the results of the PCR test are recorded against the user's individual profile in the register.