Test Details
Methodology
Total RNA is isolated from the sample and subject to a real-time, reverse transcriptase polymerase chain reaction (RT-PCR). The PCR primers and probes are specific for BCR-ABL1 e13a2, e14a2 and e1a2 fusion transcripts. The ABL1 transcript is amplified as the control for cDNA quantity and quality. Serial dilutions of a validated positive control RNA with known t(9;22) BCR-ABL1 are used as reference for quantification of BCR-ABL1 relative to ABL1. The numeric BCR-ABL1 level is reported as % BCR-ABL1/ABL1 and the detection sensitivity is 4.5 log below the standard baseline (<0.0032%).
Result Turnaround Time
5 - 7 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
This assay can detect three different types of BCR-ABL1 fusion transcripts associated with CML, ALL, and AML:e13a2 (previously b2a2) and e14a2 (previously b3a2) (major breakpoint, p210), as well as e1a2 (minor breakpoint, p190). The e13a2 and e14a2 transcript values are titrated to the current International Scale (IS). The standardized baseline is 100% BCR-ABL1 (IS) and major molecular response (MMR) is equivalent to 0.1% BCR-ABL1 (IS) corresponding to a 3-log reduction. Results should be correlated with appropriate clinical and laboratory information as indicated.
Special Instructions
Please direct any questions regarding this test to oncology customer service at 800-345-4363.
Limitations
In vitro studies have indicated that this assay has an analytical detection sensitivity of 4.5 log below the standard baseline (<0.0032%). A negative result does not rule out the presence of low levels of BCR-ABL1 transcript below the level of detection of this assay, or the presence of rare BCR-ABL1 transcripts not detected by the assay.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
References
Specimen Requirements
Specimen
Whole blood, bone marrow, or cell pellet
Volume
3 to 5 mL whole blood or 1 to 2 mL bone marrow
Minimum Volume
1 mL bone marrow or 3 mL whole blood (Note: This volume does not allow for repeat testing.)
Container
Lavender-top (EDTA) tube, green-top (sodium heparin) tube, yellow-top (ACD-A) tube, tan-top (K2-EDTA) tube or pink-top (K2-EDTA) tube
Collection Instructions
Submit at room temperature. Specimens should arrive in the laboratory within 48 hours of collection. Indicate date and time of collection on test request form.
Storage Instructions
Submit at room temperature. If specimen has to be stored more than 48 hours, refrigerate at 2°C to 8°C.
Causes for Rejection
Specimen does not meet collection criteria; frozen whole blood or marrow; leaking tube; clotted blood or marrow; grossly hemolyzed; otherwise visibly degraded; contamination by another specimen; containing suspicious foreign material
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 480481 | BCR-ABL1, CML/ALL, PCR, Quant | 52135-1 | 481509 | e13a2 (b2a2) transcript | % | 52130-2 |
| 480481 | BCR-ABL1, CML/ALL, PCR, Quant | 52135-1 | 481510 | e14a2 (b3a2) transcript | % | 52131-0 |
| 480481 | BCR-ABL1, CML/ALL, PCR, Quant | 52135-1 | 481516 | e1a2 transcript | % | 52132-8 |
| 480481 | BCR-ABL1, CML/ALL, PCR, Quant | 52135-1 | 480488 | Interpretation: | 93479-4 | |
| 480481 | BCR-ABL1, CML/ALL, PCR, Quant | 52135-1 | 489031 | Director Review | 72486-4 | |
| 480481 | BCR-ABL1, CML/ALL, PCR, Quant | 52135-1 | 481507 | Background | 77202-0 | |
| 480481 | BCR-ABL1, CML/ALL, PCR, Quant | 52135-1 | 481508 | Methodology | 49549-9 | |
| 480481 | BCR-ABL1, CML/ALL, PCR, Quant | 52135-1 | 484516 | References | 52132-8 | |
| 480481 | BCR-ABL1, CML/ALL, PCR, Quant | 52135-1 | 511958 | 80563-0 | ||
| Order Code | 480481 | |||||
| Order Code Name | BCR-ABL1, CML/ALL, PCR, Quant | |||||
| Order Loinc | 52135-1 | |||||
| Result Code | 481509 | |||||
| Result Code Name | e13a2 (b2a2) transcript | |||||
| UofM | % | |||||
| Result LOINC | 52130-2 | |||||
| Order Code | 480481 | |||||
| Order Code Name | BCR-ABL1, CML/ALL, PCR, Quant | |||||
| Order Loinc | 52135-1 | |||||
| Result Code | 481510 | |||||
| Result Code Name | e14a2 (b3a2) transcript | |||||
| UofM | % | |||||
| Result LOINC | 52131-0 | |||||
| Order Code | 480481 | |||||
| Order Code Name | BCR-ABL1, CML/ALL, PCR, Quant | |||||
| Order Loinc | 52135-1 | |||||
| Result Code | 481516 | |||||
| Result Code Name | e1a2 transcript | |||||
| UofM | % | |||||
| Result LOINC | 52132-8 | |||||
| Order Code | 480481 | |||||
| Order Code Name | BCR-ABL1, CML/ALL, PCR, Quant | |||||
| Order Loinc | 52135-1 | |||||
| Result Code | 480488 | |||||
| Result Code Name | Interpretation: | |||||
| UofM | ||||||
| Result LOINC | 93479-4 | |||||
| Order Code | 480481 | |||||
| Order Code Name | BCR-ABL1, CML/ALL, PCR, Quant | |||||
| Order Loinc | 52135-1 | |||||
| Result Code | 489031 | |||||
| Result Code Name | Director Review | |||||
| UofM | ||||||
| Result LOINC | 72486-4 | |||||
| Order Code | 480481 | |||||
| Order Code Name | BCR-ABL1, CML/ALL, PCR, Quant | |||||
| Order Loinc | 52135-1 | |||||
| Result Code | 481507 | |||||
| Result Code Name | Background | |||||
| UofM | ||||||
| Result LOINC | 77202-0 | |||||
| Order Code | 480481 | |||||
| Order Code Name | BCR-ABL1, CML/ALL, PCR, Quant | |||||
| Order Loinc | 52135-1 | |||||
| Result Code | 481508 | |||||
| Result Code Name | Methodology | |||||
| UofM | ||||||
| Result LOINC | 49549-9 | |||||
| Order Code | 480481 | |||||
| Order Code Name | BCR-ABL1, CML/ALL, PCR, Quant | |||||
| Order Loinc | 52135-1 | |||||
| Result Code | 484516 | |||||
| Result Code Name | References | |||||
| UofM | ||||||
| Result LOINC | 52132-8 | |||||
| Order Code | 480481 | |||||
| Order Code Name | BCR-ABL1, CML/ALL, PCR, Quant | |||||
| Order Loinc | 52135-1 | |||||
| Result Code | 511958 | |||||
| Result Code Name | ||||||
| UofM | ||||||
| Result LOINC | 80563-0 |