Test ID: 19988
Pulmonary Cytology with FISH for the Detection of Lung Cancer on Bronchial Brushing
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Detection of lung cancer in bronchial brushing specimens collected during bronchoscopy
This test is most useful when used on specimens from peripheral lung lesions, especially those <2 cm in size
Additional Tests Lists test(s) that are always performed, at an additional charge, with the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| 88526 | Pulmonary Cytology, Bronchial Brush | No | Yes |
| 88665 | FISH, Bronchial Brush | No | Yes |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
When this test is ordered, pulmonary cytology and bronchial brushing FISH tests will always be performed at an additional charge.
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
Method Name A short description of the method used to perform the test
88526: Light Microscopy
88665: Fluorescence In Situ Hybridization (FISH)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
FISH
FISH for bronchial carcinoma
FISH for bronchial malignancy
FISH for lung carcinoma
FISH for pulmonary carcinoma
FISH for pulmonary malignancy
Lung Cancer Brushing
Lung Carcinoma
BBCWF
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.
Specimen Type: Bronchial brushing
Container/Tube:
Preferred: ThinPrep vial containing CytoLyt solution (Supply T564)
Acceptable: PreservCyt solution (Supply T536)
Specimen Volume: Entire collection
Collection Instructions:
1. Place bronchial brush in CytoLyt from each unique brushing site.
2. Specimen must be labeled with site where brushing was collected (eg, "right upper lobe" for peripheral lesions or "right mainstem" for central lesions).
Forms: If not ordering electronically, submit a Pathology/Cytology Request Form (Supply T246) with the specimen.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | Brushing specimen generally labeled (eg, "lung brushing," "right lung," or "brushing"), fine-needle aspirate (FNA), or washing specimen |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Varies | Ambient (preferred) | |
| Refrigerated | ||
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
The National Cancer Institute estimates that more than 219,000 men and women in the United States will be diagnosed with cancer of the lung and bronchus in 2009. The dismal 5-year survival of 15% for all patients diagnosed with lung cancer has been attributed to the fact that more than 80% have advanced disease at the time of diagnosis. Cytologic analysis of brushing specimens collected during bronchoscopy is widely used to help diagnose malignancy in patients suspected of having lung cancer. Previous studies have shown that in centrally located tumors, the diagnostic sensitivity of bronchial brushing cytology ranges from 23% to 93% (mean 61%).(1) However, the sensitivity is considerably lower in peripheral tumors ranging from 15% to 84% (mean 54%), and even lower in those patients with nodules <2 cm in size (5%-76%; mean 34%).(1) These data illustrate the need for improved clinical or laboratory tests to accurately detect early stage disease, especially in small, peripherally located tumors.
FISH is a technique that utilized fluorescently labeled DNA probes to examine cells for chromosomal alterations. FISH can be used to detect cells with chromosomal changes (eg, aneusomy) that are indicative of malignancy. The FISH for lung cancer assay utilizes a multicolor, multitarget probe mixture (Abbott Molecular, Inc.), which contains locus-specific probes to 5p15 (TERT), 7p12 (EGFR), 8q24 (c-Myc), and a centromeric probe to chromosome 6, to detect malignant cells in bronchoscopically obtained brushing specimens. Studies in our laboratory and other laboratories indicate that the sensitivity of FISH for the detection of lung cancer is superior to that of conventional cytology.(2-3)
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.
Interpretation Provides information to assist in interpretation of the test results
An interpretive report is provided, based on the combination of routine cytology and FISH results.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
An abnormal FISH result does not indicate the histologic subtype, stage, grade, or location of the tumor.
Supportive Data
A study of 312 patients with bronchoscopically obtained bronchial brushings from central and peripheral lung lesions compared the relative sensitivities and specificities of cytology alone and cytology with FISH for detecting primary lung carcinoma.(2) Bronchoscopic biopsy, surgical resection, needle aspirate results and/or clinical indication of lung cancer was used as the gold standard. Any mucosal abnormalities visualized during the bronchoscopic procedure were brushed and designated as central lesions. Peripheral lesions were defined as lesions beyond the segmental bronchi that required fluoroscopic guidance for visualization.
For peripheral lung lesions, the sensitivity of cytology with FISH for lung cancer (n=110) was significantly higher than cytology alone for peripheral lesions <2 cm (46% vs. 4%; P <0.001) and >2 cm (61% vs. 31%; P <0.001). There was no significant difference in specificity between cytology with FISH and cytology alone in lesions <2 cm
(87% vs. 100%; P=0.062) and >2 cm (98% vs. 100%; P=1.00) among patients without evidence of cancer (n=109).
For central lung lesions, sensitivity of cytology alone and cytology with FISH was 48% (23/48) and 81% (39/48) (P <0.001), respectively. However, there was a significant difference observed in the specificity of cytology alone and cytology with FISH (100% vs. 78%; P <0.001) among patients without evidence of cancer (n=45).
Lung cancer detection of cytology with FISH and cytology alone were compared for patients with non-small cell carcinoma at early (stages IIb and lower; n=38) and advanced (stage IIIa and higher; n=77) stage disease. The sensitivity of cytology with FISH was significantly higher than cytology alone for early (58% vs. 32%; P=0.002) and advanced (65% vs. 36%; P <0.001) stage disease.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Rivera MP, Mehta AC; Initial diagnosis of lung cancer: Accp evidence-based clinical practice guidelines (2nd edition). Chest 2007;132:131S-148S
2. Voss JS, Kipp BR, Halling KC, et al: Fluorescence in situ Hybridization Reflex Algorithm Improves Lung Cancer Detection in Bronchial Brushing Specimens. (Unpublished data/under review)
3. Halling KC, Rickman OB, Kipp BR, et al: A comparison of cytology and fluorescence in situ hybridization for the detection of lung cancer in bronchoscopic specimens. Chest 2006;130:694-701
4. Jett JR, Midthun DE: Screening for lung cancer: current status and future directions: Thomas A. Neff lecture. Chest 2004 May:125:158S-162S
5. Mazzone P, Jain P, Arroliga AC, et al: Bronchoscopy and needle biopsy techniques for diagnosis and staging of lung cancer. Clin Chest Med 2002:23:137-158
Method Description Describes how the test is performed and provides a method-specific reference
For cytology analysis, brushing specimens are processed and slides are prepared using the ThinPrep 2000 processor. Specimens are then stained using a Papanicolaou stain and analyzed microscopically by a cytotechnologist and pathologist.
For FISH analysis, slides prepared from bronchial brushing specimens are assessed by FISH for the presence of cells that have chromosomal abnormalities.
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; Varies
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.
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.
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.
88112–Cytology, bronchial brush
88368 x 4–Morphometric analysis, manual, FISH
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 |
|---|---|---|
| 20310 | Accession Number | N/A |
| 20311 | Referring Pathologist/Physician | 46608-6 |
| 20312 | Ref Path/Phys Address | In Process |
| 20313 | Material: | In Process |
| 20314 | Final Diagnosis: | 34574-4 |
| 20315 | Comment: | 22638-1 |
| 20316 | Revision Description: | In Process |
| 20317 | Signing Pathologist: | 19139-5 |
| 20318 | Specimen Description: | 33511-7 |
| 20319 | Special Procedures: | N/A |
| 20320 | SP Signing Pathologist: | N/A |
| 20321 | *Previous Report Follows* | N/A |
| 20322 | Addendum: | 35265-8 |
| 20323 | Addendum Comment: | 22638-1 |
| 20324 | Addendum Pathologist: | 19139-5 |
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