Run 1x per week as needed, Monday or Wednesday, day shift only.
Methodology
PCR
Reported
7-10 days
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.
Reflex Testing
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).
Synonyms
Acute Promyelocytic leukemia
APL
AML-M3
t(15
17)
Retinoic acid receptor alpha
Sample Type
EDTA Whole blood, bone marrow
Collect
Lavender top
Amount to Collect
Blood: 5 mL
Bone marrow: 2 mL
Preferred Volume
Blood: 5 mL
?Bone marrow: 2 mL
Minimum Volume
Blood: 2 mL
?Bone marrow: 1 mL
Remarks
Due to limited stability samples for this test should not be collected the day before a holiday or 3-day weekend.
Do not collect sample in heparin. Keep sample refrigerated for overnight or longer storage.
Stability (from collection to initiation)
Refrigerated 3 days.
Test Code
PMLR
Performing Lab
Medical Genomics - Molecular Diagnostics
Specimen Preparation
Refrigerate sample. Send to China Basin refrigerated
Preferred Volume
Blood: 5 mL
?Bone marrow: 2 mL
Minimum Volume
Blood: 2 mL
?Bone marrow: 1 mL
Stability (from collection to initiation)
Refrigerated 3 days.
Reference Interval
No PML-RARA bcr1, bcr2 or bcr3 fusion transcripts
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 Codes
81315
LDT or Modified FDA
Yes
LOINC Codes
21551-7
Available Stat
No
Test Code
PMLR
Performing Lab
Medical Genomics - Molecular Diagnostics
Performed
Run 1x per week as needed, Monday or Wednesday, day shift only.
Methodology
PCR
Remarks
Due to limited stability samples for this test should not be collected the day before a holiday or 3-day weekend.
Do not collect sample in heparin. Keep sample refrigerated for overnight or longer storage.
Collect
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
Minimum Volume
Blood: 2 mL
?Bone marrow: 1 mL
Specimen Preparation
Refrigerate sample. Send to China Basin refrigerated
Reference Interval
No PML-RARA bcr1, bcr2 or bcr3 fusion transcripts
Synonyms
Acute Promyelocytic leukemia
APL
AML-M3
t(15
17)
Retinoic acid receptor alpha
Stability (from collection to initiation)
Refrigerated 3 days.
Reported
7-10 days
Reflex Testing
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 Codes
81315
LDT or Modified FDA
Yes
LOINC Codes
21551-7
Ordering
Available Stat
No
Performing Lab
Medical Genomics - Molecular Diagnostics
Performed
Run 1x per week as needed, Monday or Wednesday, day shift only.
Methodology
PCR
Reported
7-10 days
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.
Reflex Testing
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).
Synonyms
Acute Promyelocytic leukemia
APL
AML-M3
t(15
17)
Retinoic acid receptor alpha
Collection
Sample Type
EDTA Whole blood, bone marrow
Collect
Lavender top
Amount to Collect
Blood: 5 mL
Bone marrow: 2 mL
Preferred Volume
Blood: 5 mL
?Bone marrow: 2 mL
Minimum Volume
Blood: 2 mL
?Bone marrow: 1 mL
Remarks
Due to limited stability samples for this test should not be collected the day before a holiday or 3-day weekend.
Do not collect sample in heparin. Keep sample refrigerated for overnight or longer storage.
Stability (from collection to initiation)
Refrigerated 3 days.
Processing
Test Code
PMLR
Performing Lab
Medical Genomics - Molecular Diagnostics
Specimen Preparation
Refrigerate sample. Send to China Basin refrigerated
Preferred Volume
Blood: 5 mL
?Bone marrow: 2 mL
Minimum Volume
Blood: 2 mL
?Bone marrow: 1 mL
Stability (from collection to initiation)
Refrigerated 3 days.
Result Interpretation
Reference Interval
No PML-RARA bcr1, bcr2 or bcr3 fusion transcripts
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.
Administrative
CPT Codes
81315
LDT or Modified FDA
Yes
LOINC Codes
21551-7
Complete View
Available Stat
No
Test Code
PMLR
Performing Lab
Medical Genomics - Molecular Diagnostics
Performed
Run 1x per week as needed, Monday or Wednesday, day shift only.
Methodology
PCR
Remarks
Due to limited stability samples for this test should not be collected the day before a holiday or 3-day weekend.
Do not collect sample in heparin. Keep sample refrigerated for overnight or longer storage.
Collect
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
Minimum Volume
Blood: 2 mL
?Bone marrow: 1 mL
Specimen Preparation
Refrigerate sample. Send to China Basin refrigerated
Reference Interval
No PML-RARA bcr1, bcr2 or bcr3 fusion transcripts
Synonyms
Acute Promyelocytic leukemia
APL
AML-M3
t(15
17)
Retinoic acid receptor alpha
Stability (from collection to initiation)
Refrigerated 3 days.
Reported
7-10 days
Reflex Testing
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.
