Test Catalog

Test Id : FBILM

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Biliary Tract Malignancy-Cytology, FISH, Varies

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Assessing bile duct brushing or hepatobiliary brushing specimens for bile tract malignancy

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
BILMB Biliary Tract Malignancy, FISH No No
BILMC Biliary Tract Malignancy, FISH No No
BILMD Biliary Tract Malignancy, FISH No No
BILME Biliary Tract Malignancy, FISH No No
BILMF Biliary Tract Malignancy, FISH No No

Additional Tests
Lists tests that are always performed, at an additional charge, with the initial tests.

Test Id Reporting Name Available Separately Always Performed
BILMA Biliary Tract Malignancy, FISH No Yes

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

When this test is ordered, fluorescence in situ hybridization testing will be performed. When additional specimens are received, the laboratory will add BILMA to the first specimen, BILMB to the second specimen, BILMC to the third specimen, and so on.

Method Name
A short description of the method used to perform the test

Cytology Light Microscopy and Fluorescence In Situ Hybridization (FISH)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Biliary Tract Malignancy-Cyto/FISH

Aliases
Lists additional common names for a test, as an aid in searching

Bile Duct Cancer, FISH

Bile Duct Cytology

Bile Duct Stricture Malignancy, FISH

BILEM

Cholangiocarcinoma, FISH

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

When this test is ordered, fluorescence in situ hybridization testing will be performed. When additional specimens are received, the laboratory will add BILMA to the first specimen, BILMB to the second specimen, BILMC to the third specimen, and so on.

Specimen Type
Describes the specimen type validated for testing

Varies

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
CY070 Collection Procedure
CY042 Source
CY043 Clinical History
CY044 Fixative

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies:

PreservCyt Vial (T536)

CytoLyt Solution (T564)

Specimen Type: Bile duct brushing, bile duct aspirate, hepatobiliary brushing, or hepatobiliary aspirate

Container/Tube: Separate ThinPrep vial containing 20 mL PreservCyt or CytoLyt solution for each specimen

Specimen Volume: Entire collection

Collection Instructions: Label with site specimen was collected from (eg, right hepatic duct or common bile duct).

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Pancreatic mass
Pancreatic cyst
Pancreatic fine-needle aspiration (FNA) 		Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred)
Ambient

Useful For
Suggests clinical disorders or settings where the test may be helpful

Assessing bile duct brushing or hepatobiliary brushing specimens for bile tract malignancy

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

When this test is ordered, fluorescence in situ hybridization testing will be performed. When additional specimens are received, the laboratory will add BILMA to the first specimen, BILMB to the second specimen, BILMC to the third specimen, and so on.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Endoscopic retrograde cholangiopancreatography (ERCP) is used to examine patients with biliary tract obstruction or stricture for possible malignancy. Biopsies and cytologic specimens are obtained at the time of ERCP. Cytologic analysis complements biopsy by sometimes detecting malignancy in patients with a negative biopsy. Nonetheless, a number of studies suggest that the overall sensitivity of bile duct brushing and bile aspirate cytology is quite low.

 

Fluorescence in situ hybridization (FISH) is a technique that utilizes fluorescently labeled DNA probes to examine cells for chromosomal alterations. FISH can be used to detect cells with chromosomal changes (eg, aneuploidy) that are indicative of malignancy. Studies in our laboratory indicate that the sensitivity of FISH to detect malignant cells in biliary brush specimens is superior to that of conventional cytology.

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.

Negative for malignancy.

Interpretation
Provides information to assist in interpretation of the test results

An interpretive report will be provided.

 

A positive cytology diagnosis is normally definitive for the presence of malignancy.

 

Suspicious or atypical results need further confirmation by clinical observation, repeat cytology, or perhaps appropriate biopsy.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

A positive FISH result does not identify location or type of malignancy. FISH abnormalities may be associated with high-grade dysplasia or carcinoma in situ. Cytology and biopsy may help clarify such situations.

Supportive Data

Cell counts using the biliary FISH probe set on pancreatobiliary brushings were compared between 49 patients with malignancy and 41 patients without malignancy to determine normal value cutoffs for this assay. The cutoff values were independently validated in a blinded study from brushing samples collected from 112 patients at the time of endoscopic retrograde cholangiopancreatography (ERCP). Among patients with malignancy on follow-up, the sensitivity of a polysomy FISH result was significantly superior to cytology (74% vs. 28%, P<0.001). The specificity of FISH and cytology were similar (96% vs. 100%).

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Barr Fritcher EG, Voss JS, Brankley SM, et al. An optimized set of fluorescence in situ hybridization probes for detection of pancreatobiliary tract cancer in cytology brush samples. Gastroenterology. 2015;149(7):1813-1824

2. Barr Fritcher EG, Kipp BR, Voss JS, et al. The development of a tailored pancreatobiliary fluorescence in situ hybridization (FISH) assay to improve detection of malignancy in pancreatobiliary brushings. J Mol Diagn. 2013;15(6):909

3. Barr Fritcher EG, Kipp BR, Halling KC, et al. A multivariable model using advanced cytologic methods for the evaluation of indeterminate pancreatobiliary strictures. Gastroenterology. 2009;136(7):2180-2186

Method Description
Describes how the test is performed and provides a method-specific reference

Standard brush cytology sampling is performed on patients undergoing endoscopic retrograde cholangiopancreatography for suspicious biliary tract strictures. Brushes are placed in a ThinPrep vial containing PreservCyt or CytoLyt solution. The specimen is sent in a single vial with or without the brush. If brush is present, it is removed, and cells are collected from it by scraping them into a single vial containing 20 mL of PreservCyt solution. Two aliquots are prepared and used for each portion of the test. The cytology specimen is processed using the ThinPrep processor. Specimens are stained using a Papanicolaou stain and analyzed microscopically by a cytotechnologist and pathologist.

 

Biliary cells are harvested, fixed, and placed on a slide. Fluorescently labeled DNA probes to 1q21 (MCL1), 7p12 (EGFR), 8q24 (MYC), and 9p21 (CDKN2A) (Abbott Molecular Inc) are hybridized to the cells on the slide. The slide is then washed and stained with DAPI (a nuclear counterstain). Fluorescence microscopy with unique band filters is used to assess 100 consecutive epithelial cells for gains and losses of probe signals (ie, chromosomal loci). Specimens are considered abnormal if cell counts exceed predetermined cutoff values for one or more of the following abnormalities: polysomy, homozygous 9p21 loss, single locus gain, single locus gain with 9p21 loss in the same cells, and/or tetrasomy. If the cutoff for polysomy is not attained in the 100-cell enumeration, then the remainder of the slide is assessed for polysomy until the cutoff is reached or the slide is exhausted.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

7 to 10 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Up to 1 week depending on the results

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) 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 US 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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

88112

88377 (if appropriate)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
FBILM Biliary Tract Malignancy-Cyto/FISH 95230-9
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
CY070 Collection Procedure 33724-6
CY042 Source 22633-2
CY043 Clinical History 22636-5
CY044 Fixative 8100-0
71816 Case Number 80398-1
71291 Interpretation 69965-2
71292 Participated in the Interpretation No LOINC Needed
71293 Report electronically signed by 19139-5
71294 Addendum 35265-8
71295 Gross Description 22634-0
71570 Disclaimer 62364-5

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
Test Status - Test Resumed 2023-10-13
Test Status - Test Down 2023-09-07