CA2251785A1 - Non-invasive identification system - Google Patents

Non-invasive identification system Download PDF

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Publication number
CA2251785A1
CA2251785A1 CA 2251785 CA2251785A CA2251785A1 CA 2251785 A1 CA2251785 A1 CA 2251785A1 CA 2251785 CA2251785 CA 2251785 CA 2251785 A CA2251785 A CA 2251785A CA 2251785 A1 CA2251785 A1 CA 2251785A1
Authority
CA
Canada
Prior art keywords
dna
swabs
envelope
corpse
collected
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA 2251785
Other languages
French (fr)
Inventor
Edmund T. Delguercio
Robert P. Ricciardi
John Dephillipo
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
GeneLink Inc
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2251785A1 publication Critical patent/CA2251785A1/en
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • A61B10/0051Devices for taking samples of body liquids for taking saliva or sputum samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0096Casings for storing test samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B2017/320004Surgical cutting instruments abrasive
    • A61B2017/320012Brushes

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

A system and a kit for the non-invasive collection of DNA material from the inner cheeks of a living person or corpse. Included are swabs of high modulus fibers which scrape DNA material from the inner cheeks to obtain sufficient material for future identification.

Description

CA 022~178~ 1998-10-14 WO97/18009 PCT~B96/01440 NON-INVASIVE IDENTIFICATION SYSTEM
Field of the Invention The present invention provides an improved non-invasive system for generating a genetic file for identification and medical evaluation. More particularly, the present invention relates to the harvesting of cells for DNA isolation and genetic testing from the inner cheeks of individuals and corpses for the purpose of storage for later evaluation.
Backqround of the Invention The ability of diagnose genetic disease has developed rapidly over the last 20 years. There are tests today which could reveal to some the likelihood of suffering in later life diseases to which they have a propensity. Disease conditions with currently available tests include cystic fibrosis, Huntington's disease, Gaucher's disease, hemophilia, retardation, sickle cell anemia, Down's syndrome, and others.
While many gene-based applications are being used today in the diagnosis and prognosis of diseases, it is the area of predisposition testing that will provide the shift to disease prediction.
Information from parents and grandparents is seldom collected and preserved for use in genetic testing. DNA
(deoxyribonucleic acid) matching has been used to identify missing people both living and dead.
Therefore, there exists a need for an effective system of collecting and preserving vital identifying or hereditary information about cell bearing specimens from family members.
Such a system should be complete, convenient, easy to use at home CA 022~l78~ l998-l0-l4 WO97/18009 PCT~B96/01~0 without supervision and should be adapted to preserve cell bearing specimens for long periods of time without significant deterioration of the specimens.
U.S. Patent No. 5,101,970 to Turner discloses one system for collecting and storing DNA specimens from living persons which includes storage of the specimens together with information in a freezer. However, the information is collected only from living parties and blood samples are used.
DNA is responsible for transmitting a person's hereditary characteristics. PCR (Polymerase Chain Reaction) technology can amplify a genetic blueprint a million fold as tiny segments of the human genomic DNA. DNA samples can be obtained by swabbing or scraping the inside of a cheek with a sterile swab.
DNA samples taken from skin or hair may be tainted with chemicals from hair sprays or body lotions so as to obscure the DNA reading.
It is understood that the term "inner cheeks" which is used herein refers to the cheek area as well as the portion of the mouth about the lips and is referred to as the buccal mucosa.
Summary of the Invention The present invention provides a method of collecting and storing DNA bearing materials from living or deceased persons.
According to the present invention, a plurality of sterile swabs are used to collect the DNA bearing material from the inner cheeks of the person by stroking the inside of the cheeks at least about 10 times, preferably at least 20 times when unsupervised.

CA 022~178~ 1998-10-14 WO97/18009 PcT~s96/ol44o Advantageously, about 2250 nanograms of DNA bearing material is collected with each swab so as to obtain at least 4500 nanograms.
The DNA bearing swabs are then placed into an envelope which bears information regarding the donor of the DNA specimen. The specimens can then be sent for processing. The DNA inside of the cells on a swab are stable for over a month at room temperature and can experience extreme temperatures of 37cC and -20OC for 12 to 24 hour periods.
It is known that the presence of secretory leucocyte protease inhibitor in saliva reduces the chance of HIV infection so as to provide the use of inner cheek material as a safer method of evaluation for the technician than the use of blood samples.
Preferably, at least two or more, preferably 3-6 swabs of DNA material are collected for preservation or immediate processing. Advantageously, theenvelopes containingthe swabs with specimens are bar coded to preserve the confidentiality of the person and/or the party with whom the background information is applied.
In connection with the method of the present invention, there is provided a kit. The preferred kit contains an envelope with a data information sheet which identifies the party providing the specimens. A second envelope contains at least six sterile swabs. The swabs are of high modulus fibers. A third envelope or container is preaddressed to a depositary.
Advantageously, the envelopes are bar coded so as to be read by a computer. The kit is provided so that the DNA material can be CA 022~178~ 1998-10-14 WO97/18009 PCT~B96/01440 collected at home.
It is therefore an object of the invention to provide a more efficient non-invasive method for collecting DNA samples from living or deceased persons at the time of death.
It is another object of the invention to improve the method for identifying missing or lost people.
It is yet another object of the invention to provide a safer method of evaluation by a technician of DNA material.
It is still another object of the invention to provide a genetic record which is complete even after a relative dies.
These and other objects, features, and advantages will become more apparent upon review of the following detailed description.
Detailed Description of the Preferred Embodiments The present invention provides a non-invasive system for collecting and preserving data and physical evidence from a living or deceased individual for identification. More specifically, means is provided for collecting a DNA sample from the inner cheeks of an individual, identifying the person and then sending the sample to a depository where the information is collected and the DNA sample is dated, identified and/or stored in a frozen state for future use.
In the present system a sealable envelope is provided which contains a data collection sheet for recording information regarding the individual providing the samples. In a second envelope sterile swabs are provided for collecting specimens from the inner cheeks of the individual. The swabs comprise high modulus synthetic fibers such as polyamide, polyester, polyimide, CA 022~178~ 1998-10-14 W~97/18009 PCT~B96/01440 polyethylene, and the like. Most preferable are swabs comprising DACRON (trademark of E.I. DuPont). It is preferred to have a multiplicity of swabs, preferably about 6-l0 swabs so that sufficient material is available for multiple analysis over a period of time or generations of individuals. At least l0 strokes or rubbings are utilized to collect the samples so as to provide an average of at least about 4~00 nanograms of DNA
material for living persons or corpses. A further envelope is used for mailing the information sheet and swabs to a processing and storage facility.
The used swabs are returned into the envelope and placed together with the first envelope containing the data sheet into a third envelope which is then mailed for processing at a depository for a reading and/or storage in a conventional manner.

CA 022~l78~ l998-l0-l4 WO97/18009 PCT~B96/01440 The following chart represents a study performed on living individuals wherein the individuals were requested to stroke their inner cheeks with a DACRON swab so as to collect DNA
material.
CHART I

COMPARISON OF THE NUMBER OF SCRAPES/BUCCAL
SWAB DNA ISOLATION PROCEDURE
Individual1 ScraPe 10 Scrapes 20.

De 6100 7400 9100 p 5400 5200 5000 D'A 6500 7600 4800 Ka 4600 6700 8300 TOTAL . 58400 91000 101000 Conclusions 1 Scrape : 58400/15 = 3893 ng/2 swabs = 1946 ng/swab 10 Scrapes: 91000/15 = 6067 ng/2 swabs = 3033 ng/swab 20 Scrapes: 101000/15 = 6733 ng/2 swabs = 3367 ng/swab As seen in Chart I, one scrape of the swab yields on the average of about 2000 nanograms of DNA material. Ten scrapes result in the samples of DNA per swab of an average of about 3,000 nanograms of DNA samples. 20 scrapes did not improve the yield of collected DNA material. 10 scrapes has been found to consistently result in more than 4500 nanograms of DNA material from two swabs, even when performed by non-technicians.

CA 022~l78~ l998-l0-l4 WO97/18009 PCT~B96/01440 The following chart shows a study wherein DNA material was collected from the inner cheeks of corpses with ten scrapes. The study involved 22 corpses wherein 21 corpses were pre-embalmed and one was post-embalmed. All samples were collected 6-38 hours post mortem.
CHART II
POST-MORTEM SWAB SAMPLES
Sample Pre-embalmed: Post-~mh~lm~
2050 1500 1660 1665/3=588 ng Total35935 38495 39075 Average 113505/63-1800 ng/swab Because of the lack of moisture it has been found that at least three swabs are preferred to consistently obtain at least 4500 nanograms of DNA material. However, it was possible at times with only two swabs.

CA 022~178~ 1998-10-14 WO97/18009 PCT~96101440 The Kit The kit of the present invention is intended for use at home and by non-technicians. A container is provided which holds three envelopes. One envelope contains an information sheet or card which collects vital data used in identifying individuals such as name, address, place and date of birth, and relevant, medical history, etc. Such data can be used and is often valuable in identifying persons or relatives. If desired, means for fingerprinting and recording the fingerprints may be provided.
Another envelope is provided which contains the sterile swabs for obtaining the DNA material from the inner cheeks. The swabs can be in the form of a wrap of high modulus fibers on a stick that can be readily inserted to scrape the inner cheeks by the individual or other person. The used swabs can be reinserted into the envelope for proper identification and for sending up to storage facility.
The third envelope is a transporting or mailing envelope which preferably has the address of the storage facility. The identifying card in its envelope and the used swabs in their envelope can thereby be sent or mailed to the proper places.
Preferably, each of the envelopes is bar coded for easier identification that all of the envelopes are related. The envelopes should be of suitable material so as to permit writing and/or printing.
Sealable envelopes such as comprising TYVEK or plastic lined envelopes may be utilized.

.. _ . .. . _ . ..

CA 022~178~ 1998-10-14 WO97/18009 PCT~B96/01440 With the vital information, the sealed envelopes can be sent to a processing laboratory where the DNA is removed and stored within a family freezer. In the freezer, the samples are chilled to a temperature below the freezing point so that the useful life of the samples can be extended.
At the depository, the bar coding from the envelope is placed on a computer system. The swab heads are cut from the swab stems and placed in microcentrifuge tubes where the DNA
cells are lysed to extract DNA from the nuclei. The DNA is quantitated to assure a minimum amount of 4500 nanograms are present. This process insures the integrity of the DNA and that there is enough DNA for future testing. Preferably, the DNA
samples are split and stored in two separate freezers for safety and integrity.
The invention has been disclosed above in terms of a preferred embodiment. It will be obvious that many variations of the illustrated embodiment might well be contemplated. The types of envelopes, container and the form of swabs may be varied to be in the form of tubes or boxes which can be cellulosic or of plastic materials. These and other modifications and additions might well be made to the illustrated embodiment without departing from the spirit and the scope of the invention as claimed.

Claims (8)

1. A method for the non-invasive collection of DNA from a living person or a corpse for storage and identification which comprises the steps of swabbing or scraping about the inner cheek of said person or corpse with at least six swabs consisting of high modulus fibers, each of said swabs scraping the inner cheek at least about ten times.
2. The method of claim 1 wherein each swab collects at least about 4500 nanograms of DNA material is collected.
3. The method of claim 1 wherein at least about 4500 nanograms of DNA are collected swabs from a corpse.
4. The method of claim 1 wherein said high modulus fibers are selected from the group consisting of polyamide, polyethylene, terephthalate, polyimide and polyester.
5. The method of claim 1 including lysing of the DNA
material from the swabs and storage of the lysed material at low temperatures.
6. The method of claim 1 wherein the collected DNA material contains secretory leucocyte protease inhibitor.
7. A kit for use in the non-invasive collection of DNA

material from a living person or a corpse which comprises:
a first envelope suitable containing a data collection sheet;
a second envelope containing at least six swabs comprising high modulus fibers for collecting DNA material from inner cheeks;
a mailing envelope for mailing said data sheet and swabs to a storage facility, and a container for said envelopes.
8. The kit of claim 7 wherein said envelopes are bar-coded.
CA 2251785 1995-11-15 1996-11-15 Non-invasive identification system Abandoned CA2251785A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US55884095A 1995-11-15 1995-11-15
US08/558,840 1995-11-15

Publications (1)

Publication Number Publication Date
CA2251785A1 true CA2251785A1 (en) 1997-05-22

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA 2251785 Abandoned CA2251785A1 (en) 1995-11-15 1996-11-15 Non-invasive identification system

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EP (1) EP0956083A4 (en)
CA (1) CA2251785A1 (en)
WO (1) WO1997018009A1 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7054758B2 (en) * 2001-01-30 2006-05-30 Sciona Limited Computer-assisted means for assessing lifestyle risk factors
WO2003091940A1 (en) 2002-04-23 2003-11-06 Exegetics, Inc. System and method for collecting dna and fingerprints
BE1015794A6 (en) * 2003-11-19 2005-09-06 Faculte Univ Sciences Agronomiques Gembloux Analysis method by molecular hybridization nucleic acid and kit for implementing the method.

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5101970A (en) 1990-09-10 1992-04-07 Turner Mike L Personal identification system
EP0653920A1 (en) * 1992-08-07 1995-05-24 Genzyme Corporation Process for obtaining a non-liquid cell sample
US5411065A (en) * 1994-01-10 1995-05-02 Kvm Technologies, Inc. Liquid specimen transfer apparatus and method
AU1602295A (en) * 1994-01-14 1995-08-01 Jockey Club, The Non-invasive sampling method for nucleic acid analysis
ITBO940205A1 (en) * 1994-05-10 1995-11-10 Gd Spa CIGARETTE PACKAGE WITH EASY OPENING.

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Publication number Publication date
EP0956083A1 (en) 1999-11-17
EP0956083A4 (en) 2000-07-05
WO1997018009A1 (en) 1997-05-22

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