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24998 PML/RARA Quantitative, PCR (PMLR)

PML/RARA Quantitative, PCR (PMLR)
Test Code: PMLSO
Synonyms/Keywords
​Lab Ref Code:  84114, (15;17)(q22;q12), Acute myeloid leukemia (AML), Acute promyelocytic leukemia (APL), AML (acute myeloid leukemia), AMPL, APL minimum residual disease, PCR, PML/RARA
Useful For
Diagnosis of acute promyelocytic leukemia (APL)
Detection of residual or recurrent APL
Monitoring the level of promyelocytic leukemia/retinoic acid receptor alpha (PML/RARA) in APL patients
 
This assay DOES NOT qualifiy as COG approved for the AAML0631 study.  See MISC test to ARUP 2002871. 
Specimen Requirements

Specimen Type

Varies (submit only one)

 Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Whole Blood​ ​EDTA Lavender Top Tube (LTT) ​  10 mL​ 4 mL​ ​
​Bone Marrow EDTA Lavender Top Tube (LTT)​ ​  ​4 mL​ ​2 mL ​
Collection Processing Instructions

Submit only 1 of the following specimens: whole  blood or bone marrow.

Refrigerated specimen must arrive within 5 days (120 hours of draw), and room temperature specimens must arrive within 3 days (72 hours) of draw.

The following information is required:
1. Pertinent clinical history-include if this is to be considered a diagnostic specimen for the purposes of future monitoring
2. Clinical or morphologic suspicion
3. Date and time of collection       
4. Note sample type on label.​
Specimen Stability Information
Specimen Type Temperature Time
​Varies   Refrigerated (preferred)​ ​ 5 days​
​  Room Temperature ​72 hours
Rejection Criteria
Hemolysis
Mild OK; Gross reject
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Mayo Medical Laboratories​​
Monday through Friday; 12 p.m.
​
4 days
​
Quantitative, Real-Time Polymerase Chain Reaction (PCR)
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)         
Reference Lab
Mayo Clinic Laboratories
Test Information
Acute promyelocytic leukemia (APL) accounts for 5% to 10% of acute myeloid leukemia, and generally has a good prognosis with current treatment protocols. APL cells contain a fusion gene comprised of the downstream sequences of the retinoic acid receptor alpha gene (RARA) fused to the promoter region and upstream sequences of one of several genes, the most common (>80%) being the promyelocytic leukemia gene (PML). The fusion gene is designated PML/RARA and may be seen in a karyotype as t(15;17)(q22;q12). Messenger RNA (PML/RARA) produced from the fusion gene can be detected using a PCR-based assay, and indicates the presence of neoplastic cells. The PCR-based assay has greater sensitivity than standard methods such as morphology review, karyotyping, or FISH.
Recent studies have indicated that sensitive monitoring is important because the majority of patients who remain PCR-positive, or become PCR-positive again following treatment, will relapse and likely benefit from early intervention for residual/recurrent disease. This quantitative assay allows PML/RARA levels to be monitored rather than simply detecting the presence or absence of disease. ​
Reference Range Information
Performing Location Reference Range
Mayo Medical Laboratories​​ Interpretive report​
Interpretation
The assay is reported in the form of a normalized ratio, which is an estimate of the level of promyelocytic leukemia/retinoic acid receptor alpha (PML/RARA) RNA present in the specimen, expressed in relation to the level of RNA from an internal control gene (beta glucuronidase, designated GUSB). The normalized ratio has no units but is directly related to the level of PML/RARA detected (ie, larger numbers indicate higher levels of PML/RARA and smaller numbers indicate lower levels). A relative expression value minimizes variability in the RNA levels measured in separate specimens tested at different times. Although a quantitative PCR assay is performed, the precision of the assay is such that results must be considered semiquantitative, and it is recommended that only log changes be considered significant. Critical results, such as a change in the status of positivity, should be repeated on a separate specimen to verify the result​
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​81315 ​ ​ ​ ​
Synonyms/Keywords
​Lab Ref Code:  84114, (15;17)(q22;q12), Acute myeloid leukemia (AML), Acute promyelocytic leukemia (APL), AML (acute myeloid leukemia), AMPL, APL minimum residual disease, PCR, PML/RARA
Ordering Applications
Ordering Application Description
​Centricity ​PML/RARA Quantitative, PCR (84114)
​Cerner Acute Myeloid Leukemia PML/RARA​
​COM ​PML/RARA Qnt, PCR
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements

Specimen Type

Varies (submit only one)

 Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Whole Blood​ ​EDTA Lavender Top Tube (LTT) ​  10 mL​ 4 mL​ ​
​Bone Marrow EDTA Lavender Top Tube (LTT)​ ​  ​4 mL​ ​2 mL ​
Collection Processing

Submit only 1 of the following specimens: whole  blood or bone marrow.

Refrigerated specimen must arrive within 5 days (120 hours of draw), and room temperature specimens must arrive within 3 days (72 hours) of draw.

The following information is required:
1. Pertinent clinical history-include if this is to be considered a diagnostic specimen for the purposes of future monitoring
2. Clinical or morphologic suspicion
3. Date and time of collection       
4. Note sample type on label.​
Specimen Stability Information
Specimen Type Temperature Time
​Varies   Refrigerated (preferred)​ ​ 5 days​
​  Room Temperature ​72 hours
Rejection Criteria
Hemolysis
Mild OK; Gross reject
Useful For
Diagnosis of acute promyelocytic leukemia (APL)
Detection of residual or recurrent APL
Monitoring the level of promyelocytic leukemia/retinoic acid receptor alpha (PML/RARA) in APL patients
 
This assay DOES NOT qualifiy as COG approved for the AAML0631 study.  See MISC test to ARUP 2002871. 
Reference Range Information
Performing Location Reference Range
Mayo Medical Laboratories​​ Interpretive report​
Interpretation
The assay is reported in the form of a normalized ratio, which is an estimate of the level of promyelocytic leukemia/retinoic acid receptor alpha (PML/RARA) RNA present in the specimen, expressed in relation to the level of RNA from an internal control gene (beta glucuronidase, designated GUSB). The normalized ratio has no units but is directly related to the level of PML/RARA detected (ie, larger numbers indicate higher levels of PML/RARA and smaller numbers indicate lower levels). A relative expression value minimizes variability in the RNA levels measured in separate specimens tested at different times. Although a quantitative PCR assay is performed, the precision of the assay is such that results must be considered semiquantitative, and it is recommended that only log changes be considered significant. Critical results, such as a change in the status of positivity, should be repeated on a separate specimen to verify the result​
For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Mayo Medical Laboratories​​
Monday through Friday; 12 p.m.
​
4 days
​
Quantitative, Real-Time Polymerase Chain Reaction (PCR)
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)         
Reference Lab
Mayo Clinic Laboratories
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​81315 ​ ​ ​ ​
For most current information refer to the Marshfield Laboratory online reference manual.