Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving nucleic acid
Reexamination Certificate
1999-04-30
2001-09-18
Jones, W. Gary (Department: 1656)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving nucleic acid
C435S091200, C206S223000, C206S232000, C206S438000, C206S549000, C206S570000, C206S572000, C206S803000
Reexamination Certificate
active
06291171
ABSTRACT:
FIELD OF THE INVENTION
The present invention provides a kit for use in the home or by professionals for generating a genetic file for identification and medical evaluation. More particularly, the present invention relates to a kit for use in the harvesting of cells for DNA isolation and genetic testing from the mouths of individuals and corpses for the purpose of storage for later evaluation.
BACKGROUND OF THE INVENTION
The ability to 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.
The article of Richards et al. entitled, “Multiplex PCR Amplification From The CFTR Gene using DNA Prepared From Buccal Brushes/Swabs”
Human Molecular Genetics
, Vol. 2, No. 2, pps. 159-163 teaches the use of only two swabs in a professional atmosphere for screening genetic diseases and reports a failure rate of 5% in testing for the CFTR gene even when performed by health care professionals.
In many diseases, for example, prostatic cancers, it is recognized that there are three genes involved. Alzheimer testing involves at least four genes. It is further known that specific disease characteristics may be common for more than one disease. Therefore it is essential that a multiplicity of DNA samples are available in order to identify a disease. It is further essential that a large amount of DNA bearing material be stored because of degradation which can occur shortly before cryogenic storage. This is especially important since it may be impossible to obtain additional samples after the host has either disappeared or has been deceased for a long period of time.
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 without supervision and should be adapted to preserve cell bearing specimens for long periods of time without significant deterioration of the specimens.
U.S. Pat. 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 kit for collecting and storing DNA bearing materials from living or deceased persons. According to the present invention, a plurality of sterile swabs are provided 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.
Advantageously, about 2250 nanograms of DNA bearing material is collected with each swab so as to obtain at least 4500 nanograms for preserving or testing.
The kit comprises a compartmented base member and a pair of hinged members which contain a client data information form and at least one mailing envelope having a bar code. A folded stand is formed in the kit, and a compartment for holding swabs for collecting oral buccal mucosa. The other compartments can also be provided to contain at least one mailing envelope and a client data sheet.
Advantageously, for use with corpses, there is provided means for detecting the presence of DNA on the swabs to ensure that a specimen has been obtained.
Also, for use with corpses, the swabs may comprise PCR so as to assure the fixing of the DNA.
It is thus an object of the invention to provide a convenient and non-invasive method of collecting DNA bearing specimens for identification.
It is another object to provide a kit for collecting DNA bearing specimens at home by non-professionals.
It is a further object of the invention to provide a kit for identification of persons killed in a common disaster such as a plane crash or during a war.
A further object of the invention is to provide loved ones with the peace of mind in knowing that should one of them become missing, a complete record for use in location and identification is readily available.
These and other objects, features, and advantages of the invention will become more apparent upon review of the following detailed description when taken in conjunction with the accompanying drawings.
REFERENCES:
patent: 5101970 (1992-04-01), Turner
De Phillipo John R.
Ricciardi Robert P.
Jones W. Gary
Tung Joyce
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