WO1997043453A1

WO1997043453A1 - Method and apparatus for ascertaining medical conditions

Info

Publication number: WO1997043453A1
Application number: PCT/US1997/008015
Authority: WO
Inventors: James E. Beecham
Original assignee: Beecham James E
Priority date: 1996-05-13
Filing date: 1997-05-09
Publication date: 1997-11-20
Also published as: EP0904413A1; EP0904413A4; AU3004297A; EA199800989A1; JP2000510975A; CA2254962A1

Abstract

A method and apparatus for collecting medical data from a test subject while preserving anonymity for the test subject. The method includes steps of collecting a sample from the test subject and taking biometric data from the test subject. The biometric data permit a high order of probability of correlation of the test subject with the sample and with test results derived from the sample. The method desirably further includes a step of providing the test subject with a unique correlating code also for permitting unique correlation of the test subject with the sample and with test results derived from the sample, and further desirably includes a step of labeling the sample with information including the biometric data.

Description

METHODANDAPPARATUS FOR ASCERTAINING MEDICALCONDITIONS

BACKGROUND OF THE INVENTION

Field of the Invention

This invention relates to a method, apparatus and system for anonymously providing medical data for humans including infectious status.

More particularly, the present invention relates to anonymously providing infectious status data for humans via unforgeable correlation characteristics.

In a further and more specific aspect, the instant invention concerns a method and apparatus for voluntarily and anonymously providing infectious status data for humans and allowing the subject to share that information with a chosen associate or associates.

Prior Art

Medical data collection, storage and display systems of great variety in construction and purpose are often employed for medical and non-medical purposes. Examples include the systems described in U.S. Patent No.

4,737,912 entitled "Medical Image Filing Apparatus", issued to Ichikawa, hereby incorporated herein by reference, directed to a medical image filing and display system and the like. Another example is described in U.S. Patent No.

5,193,541 entitled "Health Examination Method And System Using Plural Self-Test Stations And A Magnetic Card", issued to Hatsuwi, hereby incorporated herein by reference. This patent is directed to a system for storing medical data on magnetic media contained on a card, wherein the patient provides samples and the like to a variety of testing stations that also record the self-test data on the card.

A further example is taught in U.S. Patent No. 5,325,294 entitled "Medical Privacy System", issued to Keene, hereby incorporated herein by reference. This patent describes a system and method for retrieving medical data from a database and sharing these medical data voluntarily with another party while protecting against unauthorized access by unauthorized parties. A feature common to such systems is a means for identifying a particular patient or client and the associated, relevant medical records.

Human disease status is highly confidential information subject to misuse by any of a variety of agencies or individuals. For example, many doctors will advise patients not to seek human immunodeficiency virus (HIV) testing via the doctor because the records generated in the process of testing for HIV may be used by insurance companies to deny insurance coverage to the individual requesting the test results.

The reasoning seems to be that if the individual sought to ascertain HIV status information, the individual must have reason to suspect a positive HIV status. The individual therefore is adjudged likely (i) to have engaged in high-risk behavior, (ii) to continue to engage in high-risk behavior and (iii) to have an enhanced probability (compared to other population segments) of developing (a) HIV-positive status and (b) later, acquired immune deficiency syndrome (AIDS) , presently an almost invariably fatal condition. People may well be denied employment if it is suspected that they are at risk of developing an HIV-positive status or of contracting AIDS subsequent to infection by HIV. Accordingly, it is desirable, particularly with respect to HIV testing, to be tested in a way that completely protects the individual identity of the test subject. One such system is provided in some states through Planned Parenthood, which (i) collects a blood sample from the test subject and (ii) collects whatever identifying indicia the test subject cares to provide, such as a pseudonym. The agency typically then (iii) links the identifying indicia, the test sample and a unique identifying code or serial number in a computer database or other log and (iv) informs the test subject that test results are to be expected to be available following a set interval of one to two weeks, which interval is for shipping the test sample to a suitable laboratory or other testing facility and receiving the results of the analysis therefrom.

The test sample and code or serial number are then (v) sent to a remote site for testing and analysis. Results are then (vi) sent back to the test site (or any other designated place) . The test subject (vii) returns to the test site or goes to a designated office and (viii) is advised of the test results. If warranted, (ix) appropriate counseling is provided along with follow-up services. Additionally, (x) a paper record is often provided with an indication of the test results. Unfortunately, because the test subject often provides a pseudonym, a third party has no way of knowing that a particular record is actually the product of a test conducted on samples provided by the individual presenting such a record. Moreover, the paper record is easily forged or mutilated to alter the information contained thereon, in part because there is no standard or unforgeable format for such records. In short, this system affords an individual test subject great confidence in both the anonymity and the trustworthiness of the test result, but this system does not provide the test subject with any verifiable way of providing the test results to a third party. Additionally, recent multiple-drug therapies can reduce presence of HIV and indicia of HIV to immeasurably low levels but these therapies introduce detectable levels of drugs into the bloodstream of the test subject.

Further, the situations in which people might meet and desire to know or communicate to each other the status of one another do not lend themselves to accessing of data during the course of normal business hours. Social settings in which persons might meet and form a mutual desire for sexual activity tend to be focused on hours other than normal business hours, for example, m the evening at a nightclub. If there were a method for reliably and anonymously exchanging information such as indicia of HIV-negative status and the date on which the sample providing this result was collected, it would need to be useful in such settings or in conjunction therewith in order to be effective m controlling the spread of this deadly disease.

Accordingly, it is desirable to provide reliable data on health and/or infectious status in an anonymous fashion whereby the person viewing the data has some assurance that the data correspond to the individual with whom they are considering carrying out such activities. However, this alone is not necessarily sufficient because it is desirable to be able to have access to the data on a twenty-four-hour-a-day basis, and also because identification cards and the like may not correspond to the bearer thereof. Therefore, it is appropriate and useful to base the correlation process on parameters unique to the individual whilst continuing to ensure anonymity of the test subject, the test results and the fact that the test subject had the testing performed. In order to combat these varied problems, some form of correlation that is unique to the individual, that is not based on a photograph or the like of the individual and that does not employ a transferable or forgeable identity device (such as an identity card) is required. The form of correlation needs to be highly reliable and also must operate rapidly m real time to provide "go-no go" identification in a short period of time (e.g., a minute or less) . While the various mentioned prior art devices function as apparatus for collecting, storing and retrieving human medical data, certain inherent deficiencies preclude adequate, satisfactory performance of the purpose of reducing risk of exposure of the individual identities of persons using the system.

SUMMARY OF THE INVENTION

Briefly, to achieve the desired objects of the instant invention in accordance with a preferred embodiment thereof, provided is a method of ascertaining the medical condition of a subject. The method includes collecting a sample from said subject and taking biometric data from said subject. The sample is analyzed to derive a result indicative of a medical condition of the subject. The result is linked to the biometric data to form a single record. This record is stored in a database.

Also provided is a system for carrying out the steps provided.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and further and more specific objects and advantages of the instant invention will become readily apparent to those skilled in the art from the following detailed description of preferred embodiments thereof taken in conjunction with the drawings in which: FIG. 1 is a schematic illustration of a collecting station for taking (i) a biological sample from a test subject and (ii) collecting correlating data pertinent to the test subject in accordance with the teachings of the instant invention;

FIG. 2 is a schematic illustration of a collecting station for contemporaneously taking (l) a biological sample from a test subject and (ii) collecting correlating data pertinent to the test subject in accordance with the teachings of the instant invention; FIG. 3 is a schematic illustration of a biological sample analysis laboratory and computer data entry station of the instant invention;

FIG. 4 is a schematic illustration of an embodiment of the data retrieval station of the instant invention; FIG. 5 is a flowchart describing steps involved in collecting (i) a biological sample from a test subject and (ii) collecting correlating data pertinent to the test subject in accordance with the teachings of the instant invention;

FIG. 6 is a flowchart describing steps involved in biological sample analysis laboratory and computer data entry in accordance with the teachings of the instant invention; and

FIG. 7 is a flowchart describing steps involved in secure data retrieval m accordance with the teachings of the instant invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Turning now to the drawings, in which like reference characters indicate corresponding elements throughout the several views, attention is first directed to FIGs. 1 and 2, illustrating a data collection station, generally designated by the reference character 11, for taking (1) a biological sample from a voluntary test subject and (ii) collecting correlating biometric data pertinent to the test subject, and provided with biometric scanner or correlation device 18 in accordance with the teachings of the instant invention. The arrangement of FIG. 2 provides a single apparatus 12' for contemporaneously (and preferably simultaneously) taking (l) a biological sample from a test subject and (ii) collecting correlating data pertinent to the test subject in accordance with the teachings of the instant invention. This arrangement is preferred for sample collection stations 11 operating without a human caretaker and for maintaining the integrity of the biometric data and sample collection process as is described in more detail below.

It will be appreciated that many different types of biometric scanners 18 could conceivably be employed to realize the desired function for biometric scanner 18.

For example, human fingerprints provide unique indicia of identity, while automatic scanning of hand geometry may also be employed for attempting to identify specific individuals. Techniques for automatically scanning fingerprints are described in U.S. Patent No. 5,465,303, "Automated Fingerprint Classification/Identification System And Method", Levison et al. and U.S. Patent No. 5,222,152, entitled "Portable Fingerprint Scanning Apparatus For Identification Verification", issued to Fishbme et al . , which patents are hereby incorporated herein by reference.

While such systems are readily used and do not require removal of clothing etc. in most climates, one disadvantage of these types of systems is that certain classes of persons may already have their fingerprints on file. These classes of persons include but are not limited to law enforcement officials, persons holding governmental security clearances, persons holding certain types of permits or personal property for which fingerprints are required and other people. These persons may not feel that a system based on fingerprinting as a means of access provides a degree of anonymity sufficient to promote use of the system. Other possible methods of correlation might include toeprints, which are not usually on file, but this would require a person to remove their footgear in order to use the system and also might lend itself to the spread of annoying conditions such as athlete's foot. Other types of biometric data successfully used for positive identification or correlation of an individual include dental records, anatomical geometries, retinal patterns, speech recognition or, for that matter, gene sequences or other chemical biodata that uniquely identify a particular individual with a high degree of confidence in the accuracy of the identification.

It will be appreciated that positive correlation of biometric data need not necessarily provide unique identification of a particular individual when a second technique for associating a specific test subject with a specific test result is employed. For example, when a unique serial number known to the test subject is coupled with biometric indicia for providing positive correlation of the test subject and sample, the degree of confidence a third party might have that the test results correspond to the individual could be quite high (even approaching certainty) if the biometric data alone would only provide, for example, a positive correlation carrying at least 95% confidence that the subject was correctly identified (as used herein, the term "positive correlation" means "a high order of probability of identification", i.e., a 95% certainty or better of identification) . This means that the biometric data need not be exhaustive and that reduced datasets may be employed for the purpose of reducing the amount of biometric data that must be collected, transmitted and correlated.

Feature recognition based on face geometry is described in U.S. Patent No. 4,975,969 entitled "Method And Apparatus For Uniquely Identifying Individuals By

Particular Physical Characteristics And Security System Utilizing Same", issued to Tal, and in U.S. Patent No. 5,012,522 entitled "Autonomous Face Recognition Machine", issued to Lambert, which patents are hereby incorporated herein by reference.

Identification techniques based on retinal patterns are described, for example, in U.S. Patent No. 5,369,415 entitled "Direct Retinal Scan Display With Planar Imager", issued to Richard et al., and in U.S. Patent No. 5,359,669 entitled "Remote Retinal Scan Identifier", issued to Shanley et al., which patents are hereby incorporated herein by reference. Identification based on speech recognition is described, for example, in U.S. Patent No. 4,961,229 entitled "Speech Recognition System Utilizing IC Cards For Storing Unique Voice Patterns", issued to Takahashi, which patent is hereby incorporated herein by reference.

Identification based on gene sequences or other chemical biodata that uniquely identify a particular individual with a high degree of confidence in the accuracy of the identification is described in U.S. Patent No. 5,270,167 entitled "Methods Of Identification Employing Antibody Profiles", and in U.S. Patent No. 4,880,750 entitled "Individual-Specific Antibody Identification Methods", both issued to Francoeur, which patents are hereby incorporated herein by reference.

An algorithm suitable for searching a database of entries for a match for any of the above-noted biometric classification techniques is described in U.S. Patent No. 5,479,523, entitled "Constructing Classification Weights Matrices For Pattern Recognition Systems Using Reduced Element Feature Subsets", issued to Gaborski et al.

A preferred form of biometric classification for use with the present invention is automated scanning of hand geometry. Hand geometry scanners are described in, for example, U.S. Patent No. 5,483,601, entitled "Apparatus And Method For Biometric Identification Using Silhouette And Displacement Images Of A Portion Of A Person's Hand", U.S. Patent No. 5,335,288, entitled "Apparatus And Method For Biometric Identification", both issued to Faulkner; U.S. Patent No. 5,073,950, entitled "Finger Profile Identification System", issued to Colbert et al.; U.S. Patent No. 5,073,949, entitled "Personal Verification Apparatus", issued to Takeda et al. ; and U.S. Patent No. 3,648,240, entitled "Personnel Identification Apparatus", issued to Jacoby et al.

Data collection station 11 also includes sample collection device or station 12 for collecting sample 14. In a preferred embodiment of data collection station 11, collection device 12 is a blood sample collection station. Other types of bodily fluids (semen, saliva etc.) could be employed, however, at the present time, blood samples are preferred for testing uniformity and accuracy. Additionally, it will be appreciated that sample collection station 12 may be employed, if desired, for conducting additional tests (e.g., for pubic lice, herpes, and/or antigens or antibodies associated with infectious diseases and any other infectious or communicable conditions of the test subject, including those previously successfully treated but identifiable by remaining antibodies or other indicia in samples from the test subject, drugs used to treat sexually transmissible diseases and/or "recreational" drug use, especially that associated with risk of acquiring communicable diseases, for example, via sharing of hypodermic needles) as desired or required. Sample collection station 12 yields sample 14 and sample 14 is then labeled by labeling device 24. Labeling device 24 includes optional input port 26, whereby additional data may be entered (e.g., via a keyboard by medical personnel) for inclusion on the label of sample 14 and/or included with biometric correlation data and test date from biometric correlation device 18. Labeling device 24 may be a laser printer, bar code printer or other printing or labeling device as is well known m the art. Biometric correlation data from biometric correlation device 18, a serial number or other correlating indicia, the date of the test and any other desired data are then linked together and supplied via external link 20 for shipment to database 39 (FIG. 3) via electronic link 20.

In a preferred embodiment of the instant invention, electronic link 20 is an encrypted digital link and may be effected via telephone line, for example. In a preferred embodiment of the instant invention, computer 13 supplies the serial number via link 15 to printer 19, which prints out slip 21 bearing the serial number for later use by the test subject. The system of FIG. 2, wherein biometric scanner 18 is integrally combined with sample collection device 12 to provide combined scanner/sample collection device 12', is a preferred arrangement for the practice of the instant invention. By collecting sample 14 contemporaneously (and preferably simultaneously) with biometric indicia, assurance that sample 14 and the labeling biometric indicia correspond to one and the same person is provided without requiring the presence of a human monitor in order to ensure compliance. For example, a small blood sample is taken from the tip of one finger (e.g., the middle finger) during the scanning of biometric data from the test subject's hand or at least during a single insertion of the test subject's hand into combined scanner/sample collection device 12' . This arrangement avoids a situation that could occur if the test subject were allowed to simply volunteer a previously-collected sample when having biometric data collected. In the latter scenario, there is no assurance that the sample actually came from the test subject, rather than the test subject's friend, child or pet. Apparatus for collection of small blood samples are well known in the medical industry where such procedures have been employed for decades for testing for, for example, phenylketonuria in newborns.

Labeled sample 14 is transferred via link 16 to sample analysis station 35 of FIG. 3. Transfer via link 16 may be by common carrier to a remote site (e.g., a central testing facility) or to another room in the same facility. This could be effected via the Confide HIV

Testing Service™ provided via Direct Access Diagnostics, a subsidiary of Johnson and Johnson, Inc. Direct Access Diagnostics has obtained FDA approval for an over-the- counter blood sample collection kit and testing procedure similar to the testing approach used by Planned Parenthood, i.e., providing the tested individual with great confidence m the accuracy of the test results but not providing a third party with any assurance that the test result corresponds to the presenting individual. By taking the test sample either under supervision of a neutral medical person or in conjunction with the collection of correlating biometric data, this assurance can be provided to third parties. An additional advantage is realized in that the test subject needn't reveal a personal address or telephone number to an agency such as Direct Access Diagnostics, where this information might be discoverable by others. A further advantage accrues if the test subject can only activate access to the test results by first reviewing the test result with a trained counselor; m-person, face-to-face counseling with appropriate compassion and concern is then available to the test subject in the unfortunate event of a positive test result for HIV or other curable or incurable conditions. Other methods for providing link 16 and suitable testing facilities are available as well .

FIG. 3 is a schematic illustration of biological sample analysis laboratory and computer data entry/storage station 35 of the instant invention. Incoming samples 14 arrive via link 16 and are identified by label reader 17 to determine the serial number or other correlating indicia associated with the biometric data and to be associated with the results of analysis of sample 14. Sample 14 is supplied to sample analyzer 37 via link 16 and an analysis of the contents of sample 14 is performed and communicated to computer/database 39 via link 38. The results of the analysis of sample 14 are coupled to the biometric correlation data and to the serial number by computer and database 39. FIG. 4 is a schematic illustration of an embodiment of data retrieval station 43 of the instant invention. Data retrieval station 43 includes biometric correlation device 18 coupled to database 39 of computer data entry station 35 (FIG. 3) via link 20. Data retrieval station 43 also includes display 45 and desirably includes data entry device 47. Data entry device 47 comprises a keyboard in a preferred embodiment of the instant invention. Data entry device 47 and display 45 are coupled to computer data entry station 35 (FIG. 3) and database 39 via link 20.

FIG. 5 is a flowchart describing steps involved in process 49 for collecting (I) biological sample 14 from a test subject and (ii) collecting correlating data pertinent to the test subject in accordance with the teachings of the instant invention. Process 49 begins (block 50) by taking a biometric correlation reading (block 52) which is digitized for further processing by computer/database 39 (FIG. 3) . Phlebotomy sample 14 is collected (block 54), preferably under the supervision of one or more witnesses to both sample collection and the taking of the biometric correlation reading (block 52) in order to ensure the integrity of the data collection and collation process. Alternatively, sample collection (block 54) may be automated by, for example, combining a retinal scan with an expectorate collection device or blood sample collection device such that sample 14 could only have come from the individual test subject from whom biometric correlation data were collected. Similarly, a fmgerstick blood sample collected simultaneously with a finger print by drawing sample 14 from the finger from which the fingerprint is being taken and at the same time as the fingerprint is taken provides similar assurances. These methods have the advantage of allowing the sample collection station to operate without requiring human operators while still protecting the integrity of the system, i.e., a third party could still reasonably have great confidence that the medical information derived from sample 14 corresponds to the individual providing matching biometric data.

A numeric correlation number or serial number is assigned (block 56) and this may be effected via either computer 13 within station 11 (FIGs. 1, 2) or by computer/database 39 of computer data entry station 35

(FIG. 3), with the latter being a preferred arrangement. The serial number, biometric data, test date and sample are linked (block 58) by (i) printing an correlating label on sample 14 via labeling device 24 (FIGs. 1, 2) and (ii) transmission of the serial number, test date and biometric data via link 20 to computer/database 39 (FIG. 3) . The serial number is desirably but optionally made available to the test subject (block 59) via slip 21 from printer 19 (FIGs. 1, 2) . Labeled sample 14 is then transported (block 60) via link 16 (FIGs. 1, 2) to biological sample analysis laboratory and computer data entry station 35 (FIG. 3) . The data collection process then ends (block 62) .

FIG. 6 is a flowchart describing steps involved in biological sample analysis and computer data entry in biological sample analysis laboratory and computer data entry station 35 (FIG. 3) in accordance with the teachings of the instant invention. Process 69 begins (block 70) when incoming samples 14 are transported via link 16 to label reader 17 (FIG. 3) and the serial number and/or biodata and test date on the label of sample 14 are read (block 72) by label reader 17 (FIG. 3) . Sample 14 is analyzed (block 74) to determine infectious status, presence of antigens or antibodies associated with past or present infectious disease of the test subject and/or presence of therapeutic or "recreational" drugs. The results of the analysis are linked to the serial number, sample collection date and biometric correlation data (block 76) and are stored (block 78) in database 39 (FIG. 3) . Analysis process 69 then ends (block 80) .

FIG. 7 is a flowchart describing steps involved in secure data retrieval process 90 in accordance with the teachings of the instant invention. Data retrieval process 90 begins (block 92) with at least two parties (herein designated "A" and "B") who approach data retrieval station 43 (FIG. 4) . "A" and "B" could, for example, be a couple who have recently met at a nightclub and who may have expressed mutual interest in sexual activity but who may also have concerns about the infectious status and/or drug treatment status of each other. "A" enters a serial number SN (block 94) via data entry device 47 (FIG. 4) and also accesses (block 96) biometric correlation device 18 (FIG. 4) . Results are transmitted (block 98) to computer/database 39 (FIG. 3) via link 20. When a match is achieved between the serial number and biometric correlation (collectively referred to as "ID") sent from data retrieval station 43 (FIG. 4) with those data stored in biological sample analysis laboratory and computer data entry station 35 (FIG. 3) , the test results and date of the test are transmitted back via link 20 and are received (block 100) by data retrieval station 43 (FIG. 4) . These results and the date of sample collection are then displayed (block 102) on display 45 (FIG. 4), where "A" and/or "B" may view them.

Data retrieval station 43, after a suitable interval or in response to signals from data entry device 47 (FIG. 4), then determines if a second set of data (corresponding to "B" in this example) are desired. When a second set of data are desired, process 90 loops back to entry of a second serial number (block 94) via data entry device 47 (FIG. 4) followed by "B's" accessing (block 96) biometric correlation device 18 (FIG. 4) . Results corresponding to "B" are transmitted (block 98) to computer/database 39 (FIG. 3) via link 20. When a match is achieved between the serial number and biometric correlation (collectively referred to as "ID") sent from data retrieval station 43 (FIG. 4) with those data stored m biological sample analysis laboratory and computer data entry station 35 (FIG. 3), the test results and date of sample collection are transmitted back via link 20 and are received (block 100) by data retrieval station 43 (FIG. 4) . These results and the date of the sample collection are then displayed (block 102) on display 45 (FIG. 4), where "A" and/or "B" may view them. When another set of data are not desired, the display is blanked (erased) and process 90 ends.

It will be appreciated that it is not to A' s or B's advantage to present themselves in the above-described setting in order to learn the status of the test results for the first time. Additionally, it is desirable to provide counseling for persons who test positive, particularly for HIV, and for test results where there is a possibility of an indeterminate test result or of a false positive. Suitable compassion and counseling can be guaranteed if access to the system is only activated by mandatorily requiring the individual to present him- or her-self at a data retrieval station 43 where the individual and the counselor play the roles of "A" and "B" and review A's or B's test results together in a private setting.

The foregoing detailed description of the instant invention for the purposes of explanation have been particularly directed toward separate facilities for data storage and data retrieval. It will be appreciated that the invention is equally useful for systems where data storage is also performed at each data retrieval station, for example.

It will be appreciated that a system for anonymously testing for infectious disease and/or associated antigens or antibodies and/or other therapeutic or "recreational" drugs has been described that does not require the test subject to carry any identification card or to provide any photograph or home address to the system has been described. The system permits twenty-four hour access to the data in a fashion that (i) provides high credibility to the user as to the accuracy of the test result and the applicability of the test result to the user and (ii) provides high credibility to another person that the test results and test sample collection date correspond to the observable user and accurately reflect the infectious/communicable status of the test subject and/or presence of associated antigens or antibodies and/or other therapeutic or "recreational" drugs as of the date of sample collection, without compromise of the identity of the user or of the another.

It will be appreciated that need for a serial number or at least need for the test subject to have any knowledge of a serial number could be eliminated by employing the biometric data alone as means for accessing the system. However, use of a serial number does require that the parties employing data retrieval station 43 (FIG. 4) both be conscious and also requires voluntary compliance with the data retrieval process. Use of "stress codes" (i.e., codes which inactivate the opening of a closed area and also silently notify authorities) in security systems is widespread and similar procedures may be incorporated into the system of the instant invention in order to obviate abuse of the system or of users of the system. Accordingly, use of a serial number in data retrieval is desirable.

Various changes and modifications to the embodiment herein chosen for purposes of illustration will readily occur to those skilled in the art. For example, other types of diseases may be tested for, to effectuate a combination of capabilities as may be desired for a specific application. To the extent that such modifications and variations do not depart from the spirit of the invention, they are intended to be included within the scope thereof which is assessed only by a fair interpretation of the following claims.

Having fully described the invention in such clear and concise terms as to enable those skilled in the art to understand and practice the same, the invention claimed is:

Claims

1. A method of ascertaining the medical condition of a subject comprising steps of: collecting a sample from said subject; taking biometric data from said subject; analyzing said sample to derive a result indicative of a medical condition of said subject; linking said biometric data and said result to form a single record; and storing said single record.

2. A method as claimed in claim 1, further including a step of labeling said sample with information including said biometric data.

3. A method as claimed in claim 2 wherein the steps of collecting a sample and taking biometric data occur contemporaneously.

4. A method as claimed in claim 1, further including forming a data base of a plurality of said single records.

5. A method as claimed in claim 4 further including retrieving a stored result comprising steps of: providing a biometric reading by a user; and receiving the result from a database when said biometric reading positively correlates with the biometric data linked to said record stored in said database.

6. A method of ascertaining the medical condition of a subject comprising steps of: providing a biometric reading by a user; and receiving medical records from said database when said biometric reading positively correlates with a biometric reading associated with said medical records stored in said database.

7. A method as claimed in claim 6 wherein the step of providing a database comprising steps of: collecting a sample from said subject; taking biometric readings from said subject; analyzing said sample to derive a result indicative of a medical condition of said subject; linking said biometric reading and said result to form a medical record; and storing said medical record in the database.

8. A method as claimed in claim 7, further including a step of labeling said sample with information including said biometric reading.

9. A method as claimed in claim 8 wherein the steps of collecting a sample and taking biometric readings occur contemporaneously.

10. A system for ascertaining the medical condition of a subject comprising: a sample collection apparatus for collecting a biological sample from said subject; a biometric data collection device, said biometric data collection device for collecting biometric data permitting a high order of probability of positive correlation of said biological sample with said subject; an apparatus for labeling said biological sample with said biometric data; a label reader for reading biometric data and a date of collection of a biological test sample from the label on said biological test sample from said subject; an analyzer for analyzing said biological test sample to provide a test result including evidence of infectious status of said voluntary test subject and/or presence of antigens or antibodies associated with infectious disease and/or presence of therapeutic or "recreational" drugs, said analyzer coupled to said label reader; and a computer coupled to said label reader and to said analyzer, said computer for linking said biometric data from said label reader, said date and said test result to provide a single record and for storing said single record in a database.