QUANTITATIVE PCR FOR DETECTION OF PML-RARA FUSION

FUSION TESTED: PML-RARα :bcr1 bcr2 bcr3 transcripts

INDICATIONS FOR ORDERING: Diagnostic in suspected cases of acute Promyelocytic leukemia (APL)

METHOD USED: Real time qualitative polymerase chain reaction kits provided by 3B Blackbio Biotech India Pvt Ltd for PML-RARA fusion transcript (TRUPCR PML-RARA KIT)

SPECIMENS – Type, storage and transport

• Type: Non-diluted peripheral blood sample/bone marrow aspirate in an EDTA (lavender) tube. PLEASE AVOID HEPARINATED BLOOD

Bone Marrow: Min. 3mL
Whole Blood: 3 mL

• Transport: Specimens must be received within 24 hours of collection due to lability of RNA. APPROPRIATE COLD CHAIN TO BE MAINTAINED AS RNA QUALITY WILL GET COMPROMISED
• Storage: Whole Blood or Bone Marrow: Separate specimens must be submitted when multiple tests are ordered.
• Unacceptable samples: Specimens collected in anticoagulants other than EDTA, haemolysed/clotted samples, extracted RNA

TEST DESCRIPTION: This is an RNA based real-time polymerase chain reaction which is run with adequate number of positive and negative controls for all the transcripts (bcr1,bcr2 and bcr3). This will yield a positive or a negative result only.

In case the ABL copy numbers are not adequate, a repeat sample is requested in view of degraded RNA.

ANALYTICAL SENSITIVITY: This is qualitative test, hence yields a positive or a negative result only.
Analytical sensitivity refers to the limit of detection of any assay and may not be applicable in this context.

TURNAROUND TIME: As soon as possible, atleast one working day

QUALITY ASSURANCE & COMPETENCY TESTING: Regular internal quality checks and intra-lab comparisons are performed to ensure accurate and precise results. Highly trained personnel performing this test undergo regular competency assessments and attend regular conferences and educational programs in order to stay upbeat with the newer advances in the biology and diagnostics of the disease in question.

ACCREDITATION: NABL

NOTE: Kindly note that this test does yield the copy numbers of the fusion transcript detected and hence is not recommended for monitoring of molecular residual disease.