Specimen Source Identification
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Determining specimen origin when the patient identity of a specimen is in question
Genetics Test Information Provides information that may help with selection of the correct test or proper submission of the test request
A panel of 12 microsatellite markers that recognizes highly variable regions of human DNA is used in a PCR-based assay to compare the genotype for the specimen in question with that determined from DNA isolated from patient specimens of known identity.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Microsatellite markers are used to compare the genotype for the specimen in question with that from DNA isolated from patient specimens of known identity.
(Polymerase chain reaction [PCR] is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Specimen Source Identification
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Due to the complex nature of this test, direct communication (eg, pathologist to pathologist) is required to avoid delays in sample processing and ensure an understanding of relevant case details.
A brief letter that includes the following 4 pieces of information is required for all orders:
1. Reason for testing, including detailed information regarding what specific comparisons are requested.
2. Clear identification of the known and unknown specimens.
3. Copies of all existing pathology reports pertaining to submitted issue specimens.
4. Contact information for the ordering physician.
1. New York Clients-Informed consent is required. Please document on the request form or electronic order that a copy is on file. An Informed Consent for Genetic Testing (Supply T576) is available in Special Instructions.
2. If not ordering electronically, submit a Molecular Genetics Request Form (Supply T245) with the specimen.
Chain of custody documentation is not available. This test is not intended for medico-legal or forensic purposes.
Specimen must arrive within 96 hours of draw.
Specimen Type: Whole blood
Preferred: Lavender top (EDTA) or yellow top (ACD)
Acceptable: Any anticoagulant
Specimen Volume: 3 mL
1. Invert several times to mix blood.
2. Send specimen in original tube.
Specimen Stability Information: Ambient (preferred)/Refrigerated
Specimen Type: Tissue block or slide
1. Submit formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or 4 to 10 unstained sections (each 5 micron-thick) plus 1 slide stained with hematoxylin and eosin (H and E).
2. The number of unstained sections required depends on the amount of tissue that can be used for analysis.
3. For very small tissue fragments, 10 sections are recommended; for large tissue fragments, 4 sections are generally sufficient.
4. If known and unknown specimens are within the same block, include labeled H and E-stained slide identifying the known and unknown specimens.
5. Specimen ID tests involving very small fragments of tissue, including most floaters are performed at the discretion of the reviewing pathologist. Cases involving floaters are usually rejected due to an insufficient amount of the floater tissue.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Blood: 0.5 mL/Tissue: send paraffin-embedded whole tissue OR 4x5 micron-thick sections plus 1 H/E slide
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
For various reasons, the patient origin for a particular specimen may be questioned. This is especially true for paraffin-embedded material: labeling accuracy may be questioned or tissue from other sources may be included by mistake. Confirmation of the patient origin may be critical to the clinical work-up of that patient.
Molecular methods are now available to extract DNA from various sources, including paraffin-embedded material, and to compare the molecular fingerprint (genotype) of one specimen source with another one. Matching genotypes on multiple specimens suggest that they are derived from the same patient, whereas differences in genotype suggest different patient sources.
An interpretive report will be provided.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Errors in our interpretation of results may occur if information given is inaccurate or incomplete.
A previous bone marrow transplant from an allogenic donor will interfere with testing. Call Mayo Medical Laboratories for instructions for testing patients who have received a bone marrow transplant.
Chain-of-custody documentation is not available.
This test is not intended for use in forensic or medicolegal cases; the use of this assay for these purposes is strongly discouraged.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
Sano K, Takayanagi K, Kaneko T, et al: Application of short tandem repeat of genomic DNA and mitochondrial DNA for identification of mixed-up tissue specimens. Pathol Int 2000;50:1-6
Method Description Describes how the test is performed and provides a method-specific reference
A panel of microsatellite markers that recognize highly variable regions of human DNA is used in a PCR-based assay to compare the genotype for the specimen in question with that determined from DNA isolated from patient specimens of known identity. The 12 markers tested include D7S484, D13S158, D10S197, D14S70, mycl, D21S1252, D8S262, D17S250, D15S1002, D16S520, D2S2368, and D6S441.(Sano K, Takayanagi K, Kaneko T, et al: Application of short tandem repeat of genomic DNA and mitochondrial DNA for identification of mixed-up tissue specimens. Pathol Int 2000;50:1-6)
Supplemental Report Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday, Wednesday; 10 a.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Whole Blood: 2 weeks (if available) Extracted DNA: 3 months
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
81265-Comparative analysis using Short Tandem Repeat (STR) markers; patient and comparative specimen (eg, pre-transplant recipient and doner germline testing, post-transplant non-hematopoietic recipient germline [eg, buccal swab or other germline tissue sample] and donor testing, twin zygosity testing or maternal cell contamination of fetal cells
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|17284||Reason For Referral||42349-1|