Sex Chromosome Determination, FISH, Tissue
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Identifying the sex chromosome complement in paraffin-embedded tissues
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
This test does not include a pathology consultation. If a pathology consultation is requested, Surgical Pathology Consultation (test code: 5439) should be ordered and the appropriate FISH test will be ordered and performed at an additional charge.
Fluorescence In Situ Hybridization (FISH)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Sex Chromosome, FISH, Ts
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.
Please provide a pathology report with each tissue specimen. The laboratory will not reject a specimen that arrives without this information but will hold the specimen until a pathology report is received.
Preferred: Formalin-fixed, paraffin-embedded tumor tissue block and 1 hematoxylin and eosin slide
Acceptable: Four consecutive unstained 5-micron-thick sections placed on positive-charged slides and 1 hematoxylin and eosin slide
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, complete and submit a Hematopathology/Molecular Oncology Request Form (Supply T241) with the specimen.
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.
2 unstained slides and 1 hematoxylin-and-eosin (H and 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
Genotypically normal females possess 2 X chromosomes; genotypically normal males possess 1 X chromosome and 1 Y chromosome. Determining the sex chromosome complement in a tissue specimen can be used to:
-Identify opposite sex-donor cells post-transplant
-Help resolve cases of suspected sample mix-up
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
An interpretive report will be provided.
An interpretive report is provided.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test is not approved by the FDA and it is best used as an adjunct to existing clinical and pathologic information.
For testing of bone marrow samples from patients who have undergone an opposite sex transplant, order FBMT / XX/XY in Opposite Sex Bone Marrow Transplantation, FISH.
FISH analysis was performed on a series of patient specimens and results were compared to cytogenetic analyses. Using X and Y centromere probes, FISH analysis of interphase nuclei identified the correct chromosome complement. Specimens with known sex chromosome aneusomy were correctly identified.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Nakhleh RE, Zarbo RJ: Surgical pathology specimen identification and accessioning: A College of American Pathologists Q-Probes study of 1,004,115 cases from 417 institutions. Arch Pathol Lab Med 1996;120:227-233
2. Riopel MA, Yu IT, Hruban RH, et al: Whose tumor is this: FISHing for the answer. Mod Pathol 1995;8:456-457
3. Valenstein PN, Raab SS, Walsh MK: Identification Errors Involving Clinical Laboratories: A College of American Pathologists Q-Probes Study of Patient and Specimen Identification Errors at 120 Institutions. Arch Pathol Lab Med 2006;130:1106-1113
Method Description Describes how the test is performed and provides a method-specific reference
The test uses a commercially available X centromere probe (DXZ1) and Y centromere probe (DYZ3) set. Formalin-fixed, paraffin-embedded tissues are cut at 5 microns and mounted on positively charged glass slides. The selection of tissue and the target areas on the hematoxylin and eosin-stained slide is performed by a pathologist. Using the hematoxylin and eosin slide as a reference, target areas are etched with a diamond-tipped etcher on the back of the unstained slide to be assayed. The probe set is hybridized to the appropriate target areas and 2 technologists each analyze 50 interphase nuclei each (100 total) with the results expressed as percent of XX (female) or XY (male) nuclei.(Unpublished Mayo method)
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 through Friday; 6 a.m.-9 p.m., Saturday, Sunday; 6 a.m.-4 p.m.
Test reported Monday through Friday: 8 a.m.-5 p.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
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 using an analyte specific reagent. Its performance characteristics were 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.
88271 x 2-Molecular cytogenetics (eg, FISH), each probe
88275-Interphase in situ hybridization (100-300 cells)
88291-Cytogenetics and molecular cytogenetics, interpretation and report
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|
|CG639||Reason For Referral||42349-1|