Method of newborn identification and tracking

A method of ensuring that each newborn infant is identified at birth and maintaining the correct newborn and mother pairing at least until discharge of the mother and child. The method involves genotyping the infant and/or birth mother at one or more times.

SUMMARY OF THE INVENTION
 The present invention relates to a method of uniquely identifying a newborn
 and mother pair at the birth of a child in a hospital-like setting and
 ensuring that the newborn/mother pairing has been correctly maintained at
 least until discharge of the mother and child pair. The invention also
 provides a unique sample collection means that prevents samples from being
 mislabeled or incorrectly associated with a non-family member and can be
 permanently stored for future identification purposes.
 DESCRIPTION OF THE BACKGROUND
 Identification of infants at birth is a critical issue for hospitals,
 birthing centers and other institutions where multiple births occur. With
 approximately 300,000 infants born worldwide each day, a large hospital
 may experience over one hundred new births each day. A large hospital may
 see as many as a hundred new infants each day. Correct identification of
 infants is essential to ensure that each mother travels home with her own
 child.
 In the past infants have been identified by means of footprints. However,
 this is not a satisfactory method of identifying infants because there is
 no means of ensuring that a footprint is associated with a particular
 mother, other than placing a footprint in the mother's hospital records.
 Further, footprints of newborn infants are difficult to take and difficult
 to distinguish. Additionally, the footprints are useful for only a short
 period in identifying the infant and will not suffice as a permanent
 identification means.
 Current identification technologies generally consist of attaching an
 identification device to the newborn with a matching device for the
 mother. Before an infant can be moved from the hospital, the devices are
 compared to ensure that only the mother of that infant can leave with the
 child. Such devices include the typical wrist bands or bracelets, which
 today are often electronically readable (see e.g., WO98/18111). In another
 variation, the mother wears a wrist band, but the infant has an umbilical
 clamp (see e.g., U.S. Pat. No. 5,484,060 and U.S. Pat. No. 5,608,382) and
 in yet another variation, the infant is actually marked with a
 semi-permanent ink (see e.g., GB2,273,266 and U.S. Pat. No. 5,484,060).
 However, any device or external labeling means can be intentionally
 defeated, by changing the markings or electronic signature on the existing
 device, or by completely replacing the device with an appropriately marked
 device. Recently, it was discovered in the United States that two infants
 were switched at birth. Evidence strongly suggested that the switching was
 not accidental. Tragically, the switch was not discovered for several
 years and might not ever have been discovered absent a paternity contest
 involving one of the children. In its aftermath, the event leaves
 considerable consternation about how to cope with child custody issues,
 visitation rights, hospital liability, and an ongoing criminal
 investigation.
 Public concern over this issue is significant. A recent market survey
 created by an academic institution was conducted on 200 expectant mothers
 to assess their interest in a service that would assure them that their
 infants had not been switched at birth. An overwhelming 85% of the
 respondents wanted such a service and would be willing to pay for it.
 Public concern has also reached the U.S. Congress. Proposed legislation
 entitled "The Infant Protection and Baby Switching Prevention Act of 1998"
 (H.R. 4680) has been introduced into the House of Representatives in an
 effort to require hospitals to address this problem. Unfortunately, no
 specific solution was recommended in the Act.
 Therefore, although rare, infant switches do occur and with potentially
 devastating consequences. A failsafe method of uniquely identifying which
 infant belongs to which mother is urgently required. Such system should be
 tamper-proof, simple, easy, and cost effective. Furthermore, the ideal
 system would create a permanent record allowing for future identification
 of the child in the event of abduction or accident.
 Genotyping has been used to identify paternity, and occasionally maternity,
 where contested, usually in a child support context. Genotyping has also
 been suggested and used after the fact where it is suspected that infants
 have been switched. See e.g., de Pancorbo M. M., et al., Newborn
 Identification: A Protocol Using Microsatellite DNA as an alternative to
 Footprinting, CLIN. CHIM. ACTA (1997) 263(1): 3342. However, to date no
 one has applied genotyping technology to systematically identify infants
 at birth and again at discharge to ensure that no switching has occurred
 and that the infant has been correctly paired with its birth mother.
 Furthermore, no one has provided a permanent storage mechanism for future
 identification purposes.
 Such massive genotyping efforts have never been applied in a hospital
 setting and present significant logistical concerns. It would not suffice,
 for example, for a sample to be merely collected and later typed within
 the hospital environment because such a process is subject to the same
 labeling errors that currently exist with neonatal samples such as cord
 blood samples. See e.g., Heckman, Maria, et al., Quality Improvement
 Principles in Practice: The Reduction of Umbilical Cord-Blood Errors in
 the Labor and Delivery Suite; Interdisciplinary Performance Improvement,
 J. NURSING CARE QUALITY (1998) 3(12): 47 (noting that in the eight months
 prior to their process improvement efforts there were 18 mislabeled
 specimens out of 3,504 births--an error rate of 0.5%).
 SUMMARY OF THE INVENTION
 The only failsafe method of identifying correct infant/mother pairing is by
 genetic typing of the infant and/or the putative mother. However, prior to
 the present invention, no one has routinely employed genotyping for this
 purpose or devised a simple, inexpensive system that can be routinely
 performed at birth and/or at discharge. The method of the present
 invention has the benefit that even if the hospital records are incorrect
 or have been intentionally altered, such an event will be indicated and an
 infant/mother pairing can still be correctly determined.
 In one embodiment, the invention is a method for ensuring that a
 newborn/mother pairing is correct at discharge. The method comprises
 obtaining a first sample of newborn cells at the birth of a newborn. The
 sample is stored on a tamper-proof collection device, forwarding to a
 genotyping location, and examined to ensure that tampering has not
 occurred. The first sample is genotyped to provide a first newborn
 fingerprint. Likewise, a second sample of newborn cells is obtained and
 treated as the first sample. The first and second newborn fingerprints are
 compared, and substantial identity of the two fingerprints indicates that
 said newborn has not been switched prior to discharge.
 The tamper-proof collection device may also be stored in a dry, dark
 location for possible future use. Sample of newborn cells may be obtained
 from a buccal swab, blood, cord blood, amniotic fluid, embryonic tissue,
 hair, or fingernail clipping. Cells may be collected at birth or prior
 thereto.
 In an additional embodiment, at least one sample of maternal cells from a
 mother is collected as above. It is genotyped to provide a maternal
 fingerprint, and comparison of the maternal fingerprint and said first or
 second newborn fingerprints indicates maternity where there is evidence
 for transmittance of an allele from the mother to the infant at all marker
 loci studied (defined herein as "about 50% identity"). This result
 confirms that the newborn/mother pairing is correct.
 In all cases, a report summarizing the results of the genotyping comparison
 can be generated and forwarded to the parents or hospital.
 In another embodiment, the method comprises obtaining discharge-samples of
 newborn cells from a newborn and maternal cells from a mother prior to
 discharge, genotyping said discharge-samples to provide a discharge
 newborn fingerprint and a discharge maternal fingerprint and comparing the
 discharge newborn and maternal fingerprints. As above, where there is
 about 50% identity the newborn and mother are related, thus confirming
 that the newborn/mother pairing is correct.
 The method can be modified by also obtaining a birth-sample of newborn and
 maternal cells at the birth of said newborn; genotyping said birth-samples
 to provide a birth newborn fingerprint and a birth maternal fingerprint;
 and comparing all four fingerprints. Substantial identity between the two
 newborn fingerprints and substantial identity between the two maternal
 fingerprints confirms that the samples have not been tampered with. About
 50% identity between the newborn and the maternal fingerprints confirm
 that the newborn and mother are related.
 Samples may be handled as above and/or stored for future use. The sample of
 newborn cells can be obtained from a buccal swab, blood, cord blood,
 amniotic fluid, embryonic tissue, hair, or fingernail clipping, and the
 like and the sample of maternal cells can be obtained from blood, buccal
 swab, hair, skin or fingernail clippings, etc. In a preferred embodiment,
 buccal cells are used. Furthermore, the samples may be separate samples,
 mixed samples, or separate samples and a mixed sample. Reports can be
 generated as above.
 The invention also pertains to an improved sample collection device, the
 improvement comprising a location and label for a maternal cell sample, a
 location and label for a newborn cell sample and optionally, a location
 and label for a mixed newborn/mother cell sample or a paternal sample.

DETAILED DESCRIPTION OF THE INVENTION
 About 50% identity--Because a child inherits about half its DNA from its
 mother, an infant and mother should have about half identity in genotype,
 allowing however, for rare non-mendelian events and an acceptable rate of
 error in data collection (for example, where gel migration varies slightly
 due to temperature and other factors). Thus, about 50% identity in
 genotype between the infant and a putative mother indicates that the
 infant has inherited one allele (of two) at each marker from the putative
 mother and the mother and infant are related.
 Birth-sample--As used herein, the term "birth-sample" refers to a sample
 that is collected at birth, during, or prior thereto.
 Birth fingerprint--As used herein the term "birth newborn fingerprint" or
 "birth maternal fingerprint" refers to a DNA genotype that is ascertained
 from a birth-sample. Likewise a "discharge fingerprint" refers to
 genotypes determined from a discharge-sample.
 Collection device--Any device that can be used to collect and store
 samples, including Guthrie cards, tubes, swabs, papers, slides, containers
 and the like. Such devices can be made tamper-proof with the inclusion of
 seals and the like. In a preferred embodiment, collection devices are
 modified to allow for the collection and labeling of multiple samples.
 Discharge-sample--As used herein the phrase refers to a sample that is
 collected shortly before or during the discharge process.
 Genetic typing--Also genotyping, fingerprinting, DNA typing, or any similar
 phrase. The term includes the use of any means known to those skilled in
 the art for determining an individual's genotype. For example, techniques
 can be nucleic acid based including size fractionation, allele specific
 oligonucleotide (ASO) hybridization, sequencing, restriction fragment
 length polymorphism (RFLP) analysis, denaturation temperature analysis,
 mass spectrometry analysis, etc. The methodologies are numerous,
 continually developing, and cannot be detailed herein. The reader is
 referred to the references cited herein for details.
 Marker--Also polymorphism. Any sequence in the genome that is known to vary
 between individuals. For example, the IL-IRN gene has a marker that
 consists of a variable number of tandem repeats (VNTR). To date, this
 marker is thought to have five alleles. A single base polymorphism is also
 called an "SNP"--single nucleotide polymorphism. There are a variety of
 marker types, including VNTRs, simple tandem repeats (STRs), complex
 tandem repeats (CTRs), SNPs, microsatellites, etc.
 Newborn/mother pair--Also infant/mother pair or any similar phrase. Refers
 to a mother and her own newborn infant.
 Newborn/mother pairing--Refers to the assignment of a mother and infant to
 each other.
 Newborn fingerprint--A unique genetic fingerprint or genotype corresponding
 to a newborn.
 PCR--Polymerase chain reaction. A method of amplifying small amounts of DNA
 for ease of analysis. Many variations of the basic amplification protocol
 are well known to those of skill in the art.
 Substantial identity--As used herein, the term means that samples show the
 same genotypes, but nonetheless accommodates an acceptable rate of error
 in data collection.
 Generally speaking, the invention is directed to methods and devices
 associated with same for the failsafe identification of infants to ensure
 that the correct infant is sent home with a given mother. The invention
 involves genotyping the infant, and/or the mother, one or more times to
 ascertain that no switching has occurred.
 In its simplest embodiment, only the newborn's cells are sampled at birth.
 The sample is collected onto a tamper-proof card and placed into a lock
 box for routine transfer to an independent laboratory for subsequent
 testing. The sample is labeled with both mother and newborn names and
 preferably is initialed by a hospital witness to ensure that the sample on
 the card was collected from the newborn at birth. A similar sample is
 collected at discharge and both samples are sent to an independent
 laboratory for analysis. In this system, it is important that the sample
 cards are rendered tamper-proof to ensure that samples have not been
 compromised.
 In the independent test laboratory, all samples from a given institution
 are typed and for each pair of birth/discharge samples, a report is
 produced that can be provided to the parents which assures them that the
 infant birthed is the same child the parent brought home. If there is some
 discrepancy in the two samples, it may be possible to compare against all
 of the samples from a given institution and/or obtain additional maternal
 samples to ensure correct pairing. Thus, this system provides an
 important, yet cost effective back-up means of accurately identifying
 infants.
 This embodiment is particularly preferred where simple and fast genotyping
 technologies have not yet been established in a given hospital. In this
 way, the hospital gains the assurance that only a genotype can provide
 without having to implement a new series of process steps. However, this
 embodiment, although the simplest, is still subject to errors created by
 intentional mislabeling of samples. Thus, this embodiment is best suited
 as a backup system for the existing bracelet or cord clamp systems and not
 a replacement system. As indicated above, some 85% of expectant parents
 indicated they would be willing to pay for such a service and this simple
 embodiment is both cost effective and minimally intrusive. However, even
 in this embodiment, it may be preferred that both maternal and newborn
 cells are sampled in order to ensure that effects of intentional labeling
 errors are minimized, as described herein.
 In a second embodiment, newborn and maternal samples are collected prior to
 discharge, and as above, may be sent off-site for analysis. Both samples
 are collected onto a single card, thus minimizing the effects of
 mislabeling errors. This methodology ensures that the correct
 newborn/mother pairing occurred at discharge. As above, a report can be
 generated and sent to the anxious parent.
 These embodiments are simple embodiments and are cost effective with
 current technology. However, because there is the possibility of
 intentional mislabeling of samples, they are not appropriate as a system
 to replace existing infant identification means, but function rather as a
 safeguard to ensure that the existing methodology has not been tampered
 with. In order to use genotyping as a method in replacement of the
 existing bracelet/cord clamp identification technologies, it is felt that
 additional redundancies are required.
 Therefore, a more sophisticated embodiment, cells of both the mother and
 the child are sampled and typed to create a unique newborn/mother genetic
 fingerprint. This unique newborn/mother fingerprint can be electronically
 coded into the existing bracelet or cord clamp devices and/or merely
 stored under normal record keeping procedures. Prior to discharge of the
 pair, additional cell samples can be collected and retyped to ensure that
 the correct pairing has been maintained and that the child has not been
 switched with another. Variations between the initial and subsequent
 newborn/mother fingerprints indicate that switching, an error in data
 analysis, or an error in recordation may have occurred and suggest
 additional data analysis. If necessary, a more detailed genome analysis of
 the putative mother and child will conclusively establish correct pairing.
 This particular embodiment of the invention is technically feasible with
 current technology, but is not yet cost effective for routine screening.
 However, with the rapid development of existing genetic analysis
 technologies, it will soon be feasible to have an automated machine on
 site in every hospital which can rapidly take and confirm genotypes.
 In another embodiment, the method comprises of three types of DNA samples;
 a maternal sample; a newborn sample and a mixed sample. The mixed sample
 acts as an internal control to ensure that the maternal and newborn
 samples have been correctly assigned to each other upon typing. However, a
 single mixed sample or only the separate maternal and newborn samples may
 also be employed. Mixed DNA samples are readily obtainable form a variety
 of sources, including blood, cord blood, amniotic fluid or any other
 tissue which has a mixture of both fetal and maternal cells or genetic
 material. Alternatively, separate samples of each may be manually mixed.
 Of course, it is also possible to add paternal samples to the collection
 cards as well. However, because of the potential sensitivity of paternity,
 this may not be appropriate for routine use, but can be provided on
 request.
 The taking of samples at birth need not await complete delivery of the
 newborn. In fact, the genotyping analysis can begin prior to birth by
 sampling the amniotic fluid, or other maternal/embryonic tissues. This may
 even be preferred as the genotyping process itself can reasonably be
 expected to require at least an hour, even with the most sophisticated of
 current technologies. Thus, the taking of samples "at birth" expressly
 contemplates and includes fetal sampling. One particularly useful means of
 establishing a mother/child fingerprint is with the use of fetal cell
 sorting to separate the fetal cells that are found in the maternal
 bloodstream. With this technology, the pair can be safely typed before
 delivery without risk to the fetus. This procedure helps to eliminate the
 necessity of additional tests during delivery, at a time when the
 minimization of extraneous activities is desirable.
 All samples may be stored for future use. One easy reliable means of
 storing blood, for example, is on the Guthrie card generally used for
 newborn screening of inborn errors of metabolism. Whole blood is collected
 on filter paper, dried and stored at room temperature. The use of a single
 card, specially designed for collecting infant and mother blood samples
 will ensure that the samples are always associated and cannot be
 separated. Alternatively, blood samples may be mixed and contained in a
 single collection device or tube.
 A Guthrie-like card that contains separate sample collection spaces and
 labeling indicia so that maternal and newborn samples may be collected on
 the same card has been designed. If desired, a space can be included for
 paternal samples as well. The use of a single card for the collection of
 samples ensures that samples cannot be inadvertently associated with a
 non-family member and helps to eliminate at least one source of error.
 The multiple-use card especially helps to eliminate errors in those
 institutions where an infant record is not created until after the birth
 of the infant. Thus, upon sample collection there is a period of awaiting
 a hospital record number before a given sample can be correctly labeled
 and this is an important source of mislabeling errors in the process. In
 those hospitals where an infant record is created at the time of admitting
 the expectant mother, this is not an issue and the sample can be correctly
 labeled at the onset.
 It is strongly suggested that preprinted maternal and newborn labels, coded
 to show the relationship, be created on admittance of the expectant mother
 and used throughout the hospital stay. This additional level of automation
 will ensure that the sample collection card is correctly labeled. However,
 even in the event of labeling errors in those hospitals that lack such
 process measures, the presence of both samples on a single card is an
 improvement over separate samples because in the event of complete
 labeling or record failure, the samples on the cards can still be typed
 and infants matched to mothers on the basis of genotype. Further, the
 inclusion of a mixed sample provides an important internal positive
 control.
 Another preferred sample type is that obtained by a buccal swab. This may
 be preferred for pre-discharge sample collection because it is painless to
 collect. Additionally, protocols using these specimen types show
 superiority to those using blood specimens in the areas of collection,
 transport, storage and overall cost. Further, PCR amplifications of DNA
 collected by buccal swab are not subject to inhibition by heme. A dried
 buccal swab is amenable to subsequent DNA analysis for at least five years
 and it is expected that samples will be preserved for as long as they are
 kept dry and away from the light.
 Buccal samples are collected onto cotton or sponge swabs which can then be
 blotted onto FTA paper. Alternatively, the samples are stored on cardboard
 folders (see e.g., Hochmeister M, et al., A foldable cardboard box for
 drying and storage of by cotton swab collected biological samples, ARCH.
 KRIMINOL. (1997) 200(3-4):113-20) or on flat slide-like sheets which may
 or may not be provided with some type of protective covering. A hinged or
 bifold sheet has been designed which may be substantially flat on its top
 and bottom surfaces or may have depressions in the bottom surface into
 which the sample can be placed. The sheet can be made of paper or membrane
 if flat and may also be made of plastic where depressions are preferred,
 or may be any other material that does not interfere with subsequent
 sample extraction. The trifold paper collection card with a tab on one
 side that allows for vertical storage e.g., with the tab protruding up
 from the stacked cards to allow ease of identification, is preferred as
 both inexpensive and space conserving. Other sample collection and storage
 means are described in U.S. Pat. No. 5,756,126, Like the Guthrie card,
 these collection devices are modified to allow for multiple sample
 collection and labeling.
 The genetic typing may be performed on genomic DNA, mitochondrial DNA or
 may be based on typing the RNA present in a cell. See e.g., Zang Y. H. &
 McCabe E. R., RNA Analysis from Newborn Screening Dried Blood Specimens,
 HUM. GENET. (1992) 89(3): 311-4. Further, the typing methodology may be
 any that is currently used in the art, including techniques that are
 sequence based, size analysis based, hybridization based or a combination
 thereof. Generally, DNA samples may be amplified before analysis in a PCR
 or PCR-like reaction. Genetic typing methodologies are well known and need
 not be detailed herein.
 A particularly powerful means of analyzing genetic information is DNA chip
 technology. Generally speaking, DNA chips comprise an array of
 oligonucleotide probes. Conditions can be established such that nucleic
 acid will only hybridize to a given probe if a perfect match is found. The
 array can comprise thousands of oligonucleotides and the use of automated
 scoring techniques and sophisticated data analysis software allow the
 collection of large amounts of data very quickly. (see e.g., U.S. Pat. No.
 5,827,482; U.S. Pat. No. 5,821,060; U.S. Pat. No. 5,795,716; U.S. Pat. No.
 5,763,599; U.S. Pat. No. 5,741,644; U.S. Pat. No. 5,733,729; U.S. Pat. No.
 5,733,509; U.S. Pat. No. 5,731,152; U.S. Pat. No. 5,728,532; U.S. Pat. No.
 5,671,303; U.S. Pat. No. 5,632,957; U.S. Pat. No. 5,605,662; U.S. Pat. No.
 5,599,668; U.S. Pat. No. 5,593,839; U.S. Pat. No. 5,571,639; U.S. Pat. No.
 5,561,071; and U.S. Pat. No. 5,445,934; See also; Wang D. G., et al.,
 Large-scale identification, mapping, and genotyping of single-nucleotide
 polymorphisms in the human genome, SCIENCE (1998) 280 (5366): 1077-82;
 Hacia J. G., et al., Evolutionary sequence comparisons using high-density
 oligonucleotide arrays, NAT. GENET. (1998)18(2): 155-8; Livache T., et
 al., Polypyrrole DNA chip on a silicon device: example of hepatitis C
 virus genotyping, ANAL. BIOCHEM. (1998) 255 (2): 188-94; Pastinen T., et
 al., Minisequencing: a specific tool for DNA analysis and diagnostics on
 oligonucleotide arrays, GENOME RES. (1997) 7(6): 606-14; Wang J., et al.,
 Nucleic-acid immobilization, recognition and detection at
 chronopotentiometric DNA chips, BIOSENS. BIOELECTRON. (1997) 12 (7):
 587-99; Hacia J. G., et al., Detection of heterozygous mutations in BRCA1
 using high density oligonucleotide arrays and two-colour fluorescence
 analysis, NAT. GENET. (1996) 14(4): 441-7; Schena M., et al., Parallel
 human genome analysis: microarray-based expression monitoring of 1000
 genes, PROC. NATL. ACAD. SCI. USA (1996) 93(20): 10614-9; Southern E. M.,
 DNA chips: analysing sequence by hybridization to oligonucleotides on a
 large scale, TRENDS GENET. (1996) 12(3): 110-5; Stimpson D. I., et al.,
 Real-time detection of DNA hybridization and melting on oligonucleotide
 arrays by using optical wave guides, PROC. NATL. ACAD. SCI. USA (1995)
 92(14): 6379-83; Pease A. C., et al., Light-generated oligonucleotide
 arrays for rapid DNA sequence analysis, PROC. NATL. ACAD. SCI. USA (1994)
 91(11): 5022-6); Shumaker et al., Mutation Detection by Solid Phase Primer
 Extension, HUM. MUTATION (1996) 7:346-54.
 Another powerful means analyzing genetic information involves the use of
 mass spectrometers to identify small mass differences in PCR products that
 have single nucleotide polymorphisms (SNPs). Kirpekar F., et al., DNA
 sequence analysis by MALDI mass spectrometry, NUCLEIC ACIDS RES. (1998)
 26(11): 2554-9. Gene Trace Systems, Inc., for example, is able to analyze
 10,000 samples a day with an error rate of one in 10,000. With a large
 collection of SNPs in a multiplex PCR one can quickly and easily genotype
 an individual without the necessity for time consuming electrophoretic
 separation of samples.
 Yet another means of analyzing genetic information is "dynamic allele
 specific hybridization" or "DASH" for short. This technique uses labeled
 oligonucleotides in a multiwell format that will fluoresce when the
 oligonucleotide exists in a double-stranded form, but not when it is
 single-stranded. Adding a single strand of the DNA to be tested allows the
 strands to hybridize. The temperature at which the strands again denature
 will allow identification of the base at the SNP. This technique has the
 advantage that it is technically simple, not requiring expensive detection
 devices, such as mass spectrometers.
 Furthermore, it is expected that DNA sequencing and genotyping methodology
 will continue to evolve and will present additional viable means of
 quickly genotyping an individual. See e.g., Xu L., et al., Electrophore
 mass tag dideoxy DNA sequencing, ANAL. CHEM. (1997) 69(17): 3595-602, Haff
 L. A., Smirnov I. P., Single-nucleotide polymorphism identification assays
 using a thermostable DNA polymerase and delayed extraction MALDI-TOF mass
 spectrometry, GENOME RES. (1997) 7(4): 378-88; Taranenko N. I., et al.,
 Laser desorption mass spectrometry for point mutation detection, GENET.
 ANAL. (1996) 13(4): 87-94; Tang K., et al., Matrix-assisted laser
 desorption/ionization mass spectrometry ofimmobilized duplex DNA probes,
 NUCLEIC ACIDS RES. (1995) 23(16): 3126-31; Griffin H. G. & Griffin A. M.,
 DNA sequencing. Recent innovations and future trends, APPL. BIOCHEM.
 BIOTECHNOL. (1993) 38(1-2): 147-59; Fauser S. & Wissinger B., Simultaneous
 detection of multiple point mutations using fluorescence-coupled
 competitive primer extension, BIOTECHNIQUES (1997) 22(5): 964-8; Fox S.
 A., et al., Rapid genotyping of hepatitis C virus isolates by dideoxy
 fingerprinting, J. VIROL. METHODS (1995) 53(1): 1-9.
 Any array of markers with a reasonably high probability of
 individualization is sufficient for these purposes. The markers can be
 VNTRs, STR, CTRs, SNPs, microsatellites, etc. The number of markers that
 can be used herein is virtually limitless and the reader is referred to
 GENBANK and the literature for identification of markers and which have
 been successfully used in genotyping methodologies.
 This system is designed to identify one out of a hundred or at most one in
 one thousand infants. In consequence, the genotyping need not be to such
 exacting specifications as in a paternity suit or criminal context. Thus,
 while a 50 SNP set might be required for paternity testing in a legal
 context, a 24 SNP set would be sufficient for infant identification
 purposes. For example, a set of three multiplex amplifications as follows
 will suffice for these purposes: