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PML-RARA PCR, Qualitative

Item Value
Available Stat? No
Utilization Guidelines Tests with long turn-around times (ie. Molecular based tests and Microarrays) should only be requested on an inpatient if the result is going to affect the inpatient management.

If the patient will likely be discharged before the result will be available, the test should be requested after discharge. (NOTE: UCSF Medical Center is not reimbursed for inpatient testing).

An exception to the above may be appropriate if there is a possibility the patient will not survive to be discharged and the information is important for diagnosis and/or family decisions/management (ie. recurrence risk).
Test code PMLR
Performed by Medical Genomics - Molecular Diagnostics
In House Availability Run 1x per week as needed, Monday or Wednesday, day shift only.
Method PCR
Collection Instructions Do not collect sample in heparin. Keep sample refrigerated for overnight or longer storage.

For UCSF Samples (from remote sites) Click here for sample collection instructions

For NON-UCSF Samples Click here for Requisition form & Account set-up instructions. Note we only do institutional billing.
Container type Lavender top
Amount to Collect
Blood 5 mL
Bone marrow 2 mL
Sample type EDTA Whole blood, bone marrow
Preferred volume
Blood 5 mL
Bone marrow 2 mL
Min. Volume
Blood 2 mL
Bone marrow 1 mL
Normal range No PML-RARA bcr1, bcr2 or bcr3 fusion transcripts
Synonyms Acute Promyelocytic leukemia; APL; AML-M3; t(15;17); Retinoic acid receptor alpha
Stability Refrigerated 3 days.
Turn around times 7-10 days
Reflex? If a translocation is detected the quantitative assay (PMLQNT) will be performed at an additional charge.

Note: If the patient has a prior positive qualitative test (PMLR), the order will be changed to the quantitative test (PMLQNT).
Additional information An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.

More than 98% of acute promyelocytic leukemia (APL) cases are caused by three translocations, termed bcr1 (long form), bcr2 (variable form) and bcr3 (short form), which fuse the promyelocytic leukemia (PML) gene on chromosome 15q22 to the retinoic acid receptor alpha (RARA) gene on chromosome 17q21. This assay will detect all three translocations. Each translocation results in the expression of a chimeric PML-RARA protein that suppresses the maturation of myeloid cells at the promyelocytic stage.

If this assay is positive, the follow-up quantitative assay (PMLQNT) will be performed to determine relative mRNA levels of PML-RARA fusion transcripts for the purpose of monitoring therapeutic response in minimal residual disease. The qualitative assay has a sensitivity of 1 in 100,000 cells and an analytical detection sensitivity of 10 PML-RARA copies.

Qualitative results are reported either as negative or positive. Quantitative results are reported with a percent ratio consisting of PML-RARA transcripts normalized to the internal control ABL. Samples that fall outside the standard curve range, but are clearly positive will be reported as weak positive, without a PML-RARA ratio.

NOTE: The quantitative PML-RARA assay is best interpreted by periodic evaluations of PML-RARA transcript levels in the same laboratory. Quantitative values among different laboratories do not necessarily correlate together.

This test was developed and its performance characteristics determined by the Clinical Laboratories at the Medical Center at UC San Francisco. It has not been cleared or approved by the U.S. Food and Drug Administration.
CPT coding 81315
LOINC code 21551-7
LDT or Mod FDA? Yes
Last Updated 1/22/2014 8:59:54 AM
Entry Number 1182

If you have additional questions regarding this test, please call: 415-353-1667

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