Test Details
Methodology
Fluorescence in situ hybridization (including diagnostic interpretation by MD pathologist)
Result Turnaround Time
4 - 5 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
The assay is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from subjects with transitional cell carcinoma of the bladder. This assay does not detect other chromosomal or genetic alterations. Results are intended for use as a noninvasive method of monitoring for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. The clinical interpretation of test results should be evaluated within the context of the patient's medical history and other diagnostic laboratory test results.
Special Instructions
Specimens should be received at the laboratory within 72 hours postcollection for optimal testing. Specimens older than 72 hours will not be rejected; however, results not guaranteed. In these instances, clients should consider recollection if possible.
Limitations
Positive FISH results in the absence of other signs or symptoms of bladder cancer recurrence may be evidence of other urinary tract-related cancers (eg, ureter, urethra, renal, and/or prostate in males), and further patient follow-up may be helpful. Negative FISH results in the presence of other signs and symptoms of bladder cancer recurrence may need to be regarded as suspicious false-negative results; repeat testing may be indicated. Although the assay was designed to detect chromosome changes associated with most bladder cancers, there are some bladder cancers whose genetic changes are not targeted by this test.
Specimen Requirements
Specimen
Urine
Volume
50 mL urine mixed with preservative in TCC Monitoring kit
Minimum Volume
33 mL urine mixed with preservative in TCC Monitoring kit
Container
TCC Monitoring kit (PeopleSoft item N° 44921). Other containers that are accepted, but not recommended: PreservCyt® vial, Cytology Special Studies Kit (PeopleSoft item N° 3203), or sterile urine container with Carbowax® fixative (two parts urine; one part fixative).
Collection Instructions
Step 1: Use the large, open cup in the kit to collect the urine specimen. First void of the day is preferred. Ensure that the urine specimen reaches the minimum fill line of 33 mL.
Step 2: Slowly pour urine into the smaller container to the maximum fill line of 90 mL.
Step 3: Tighten the lid until you hear a click in order to prevent leakage.
Storage Instructions
Specimen should be refrigerated at 2°C to 8°C and shipped on cool packs. Do not freeze.
Causes for Rejection
Incorrect fixative; significant contamination with blood obscuring bacterial overgrowth; inadequate specimen cellularity
References
LOINC® Map
Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
---|---|---|---|---|---|---|
130080 | Bladder Cancer FISH, MD Review | 56030-0 | 130018 | Bladder Cancer FISH Findings: | 56030-0 | |
130080 | Bladder Cancer FISH, MD Review | 56030-0 | 130019 | Specimen Type: | 31208-2 | |
130080 | Bladder Cancer FISH, MD Review | 56030-0 | 130034 | Specimen Description: | 33511-7 | |
130080 | Bladder Cancer FISH, MD Review | 56030-0 | 130035 | Case Comment: | 48767-8 | |
130080 | Bladder Cancer FISH, MD Review | 56030-0 | 130036 | Specimen Comment: | 8251-1 | |
130080 | Bladder Cancer FISH, MD Review | 56030-0 | 130059 | Electronically signed: | 19139-5 | |
130080 | Bladder Cancer FISH, MD Review | 56030-0 | 130043 | Clinician provided ICD-9: | 52797-8 | |
130080 | Bladder Cancer FISH, MD Review | 56030-0 | 130289 | Clinician provided ICD-10: | 52797-8 | |
130080 | Bladder Cancer FISH, MD Review | 56030-0 | 130044 | Pathologist provided ICD-9: | 52797-8 | |
130080 | Bladder Cancer FISH, MD Review | 56030-0 | 130290 | Pathologist provided ICD-10: | 52797-8 | |
130080 | Bladder Cancer FISH, MD Review | 56030-0 | 130045 | Clinical Data: | 55752-0 | |
130080 | Bladder Cancer FISH, MD Review | 56030-0 | 130046 | CPT Codes: | N/A | |
130080 | Bladder Cancer FISH, MD Review | 56030-0 | 130222 | Disclaimer: | N/A | |
130080 | Bladder Cancer FISH, MD Review | 56030-0 | 130042 | Resulting PhD Name: | 72486-4 | |
130080 | Bladder Cancer FISH, MD Review | 56030-0 | 130279 | 11502-2 | ||
Order Code | 130080 | |||||
Order Code Name | Bladder Cancer FISH, MD Review | |||||
Order Loinc | 56030-0 | |||||
Result Code | 130018 | |||||
Result Code Name | Bladder Cancer FISH Findings: | |||||
UofM | ||||||
Result LOINC | 56030-0 | |||||
Order Code | 130080 | |||||
Order Code Name | Bladder Cancer FISH, MD Review | |||||
Order Loinc | 56030-0 | |||||
Result Code | 130019 | |||||
Result Code Name | Specimen Type: | |||||
UofM | ||||||
Result LOINC | 31208-2 | |||||
Order Code | 130080 | |||||
Order Code Name | Bladder Cancer FISH, MD Review | |||||
Order Loinc | 56030-0 | |||||
Result Code | 130034 | |||||
Result Code Name | Specimen Description: | |||||
UofM | ||||||
Result LOINC | 33511-7 | |||||
Order Code | 130080 | |||||
Order Code Name | Bladder Cancer FISH, MD Review | |||||
Order Loinc | 56030-0 | |||||
Result Code | 130035 | |||||
Result Code Name | Case Comment: | |||||
UofM | ||||||
Result LOINC | 48767-8 | |||||
Order Code | 130080 | |||||
Order Code Name | Bladder Cancer FISH, MD Review | |||||
Order Loinc | 56030-0 | |||||
Result Code | 130036 | |||||
Result Code Name | Specimen Comment: | |||||
UofM | ||||||
Result LOINC | 8251-1 | |||||
Order Code | 130080 | |||||
Order Code Name | Bladder Cancer FISH, MD Review | |||||
Order Loinc | 56030-0 | |||||
Result Code | 130059 | |||||
Result Code Name | Electronically signed: | |||||
UofM | ||||||
Result LOINC | 19139-5 | |||||
Order Code | 130080 | |||||
Order Code Name | Bladder Cancer FISH, MD Review | |||||
Order Loinc | 56030-0 | |||||
Result Code | 130043 | |||||
Result Code Name | Clinician provided ICD-9: | |||||
UofM | ||||||
Result LOINC | 52797-8 | |||||
Order Code | 130080 | |||||
Order Code Name | Bladder Cancer FISH, MD Review | |||||
Order Loinc | 56030-0 | |||||
Result Code | 130289 | |||||
Result Code Name | Clinician provided ICD-10: | |||||
UofM | ||||||
Result LOINC | 52797-8 | |||||
Order Code | 130080 | |||||
Order Code Name | Bladder Cancer FISH, MD Review | |||||
Order Loinc | 56030-0 | |||||
Result Code | 130044 | |||||
Result Code Name | Pathologist provided ICD-9: | |||||
UofM | ||||||
Result LOINC | 52797-8 | |||||
Order Code | 130080 | |||||
Order Code Name | Bladder Cancer FISH, MD Review | |||||
Order Loinc | 56030-0 | |||||
Result Code | 130290 | |||||
Result Code Name | Pathologist provided ICD-10: | |||||
UofM | ||||||
Result LOINC | 52797-8 | |||||
Order Code | 130080 | |||||
Order Code Name | Bladder Cancer FISH, MD Review | |||||
Order Loinc | 56030-0 | |||||
Result Code | 130045 | |||||
Result Code Name | Clinical Data: | |||||
UofM | ||||||
Result LOINC | 55752-0 | |||||
Order Code | 130080 | |||||
Order Code Name | Bladder Cancer FISH, MD Review | |||||
Order Loinc | 56030-0 | |||||
Result Code | 130046 | |||||
Result Code Name | CPT Codes: | |||||
UofM | ||||||
Result LOINC | N/A | |||||
Order Code | 130080 | |||||
Order Code Name | Bladder Cancer FISH, MD Review | |||||
Order Loinc | 56030-0 | |||||
Result Code | 130222 | |||||
Result Code Name | Disclaimer: | |||||
UofM | ||||||
Result LOINC | N/A | |||||
Order Code | 130080 | |||||
Order Code Name | Bladder Cancer FISH, MD Review | |||||
Order Loinc | 56030-0 | |||||
Result Code | 130042 | |||||
Result Code Name | Resulting PhD Name: | |||||
UofM | ||||||
Result LOINC | 72486-4 | |||||
Order Code | 130080 | |||||
Order Code Name | Bladder Cancer FISH, MD Review | |||||
Order Loinc | 56030-0 | |||||
Result Code | 130279 | |||||
Result Code Name | ||||||
UofM | ||||||
Result LOINC | 11502-2 |