Enhanced Diagnostic Tools
Pathological Specimen DNA identification to determine relationship between patient specimens, tissues, or tissue fragment for quality assurance is vital to pathological review or medical procedure. Without verification, potential sources of error in pathological labs include specimen mix-up or cross-contamination from “floaters.” Tissue samples taken for pathologic analysis can be inadvertently mislabeled during sample collection or the time of pathology review. Misidentifying patients' samples can have serious consequences for patient management, as well as the treatment plan.
Bio-Synthesis offers Tissue DNA Identification and Testing Services for hospitals that are seeking to eliminate ID errors which compromise a patient’s well-being. Eliminating these errors will also help prevent hospitals from potential legal issues. Our services are performed at our accredited human tissue DNA fingerprinting/Genotyping facilities led by a team of scientists with extensive experience in multiplex STR to confirm tissue DNA identity. Bio-Synthesis also offers customized bioinformatics data analysis to differentiate tested specimens with sample pools specified by our clients.
Our commitment to total quality management (TQM) assures that our customers receive only the most highly discriminating methods for the confirmation of specimen identity and detection of patient sample cross-contamination and misidentification. All of our testing services are in compliance with current good tissue practices (CGTP) to validate your tissue banks.
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Bio-Synthesis offers the most comprehensive STR DNA testing available by examining of a panel of 15 highly polymorphic genetic markers plus one gender marker (amelogenin), to generate an STR DNA profile that uniquely identifies a patient sample. The results are reported as the number of identical or nonidentical alleles between the known and unknown samples. If the suspected source tissue is provided, an interpretation as to the identity of the unknown specimens also is given. If the suspected contaminant and patient’s known sample derived from unrelated individuals, there is a > 99.9999%
likelihood that one or more loci will be different.
DNA fingerprinting analysis by PCR is a highly accurate technique for determining the patient identity of a tissue
sample. This assay uses PCR amplification of short tandem repeats (STRs) with number of highly polymorphic unlinked loci.
Each STR locus has two alleles, and each allele has a specific length that is stably inherited. PCR amplification of 15 highly polymorphic STR loci [D3S1358, THO1, D21S11, PentaE, D5S818, D13S317, D7S820, D16S539, CSF1PO, PentaD, vWA, D8S1179, TPOX, D18S51, FGA] and a sex chromosome specific locus (amelogenin) is performed. The loci used for patient sample identification are utilized for human sample identity, and are not designed to detect non-human DNA.
DNA STR analysis can be performed on formalin-fixed, paraffin-embedded tissue, blood in EDTA, or fresh/frozen tissue. The submitting pathologist must designate the suspected contaminant/mix-up as well as the patient’s known sample with which to compare. It is optional to include the suspected source tissue.
For DNA testing, we can utilize paraffin-embedded tissue or sections prepared on glass slides. If paraffin material is used for testing, specific requirement will be required.
Slide sample requirement:
In the event that deeper levels have exhausted the tissue from the sample block and the only sample remaining for testing is tissue on the original stained slides, we will attempt to remove the coverslip and use the stained tissues for DNA testing.We will attempt analysis from any fragment size, but success rates are not guaranteed for samples <2 mm.
Select your desired Tissue Specimen DNA Testing Services below. Also you have the option to create your own customized services package by contacting us at 800.220.0627 or Contact us now!