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**Overview**: FISH t(14;18) IGH BCL2 Panel**Introduction**: The FISH t(14;18) IGH BCL2 Panel is a diagnostic tool designed to detect t(14;18) in lymphoma using whole blood or bone marrow samples. In India, t(14;18)(q32;q21) IGH/BCL2 translocation occurs in ~85-90 percent of follicular lymphoma (FL) and ~20-30 percent of DLBCL, associated with BCL2 overexpression and favorable prognosis in FL but variable in DLBCL. High morbidity from under-testing in rural/low-SES lymphoma patients, limited FISH labs, delayed rituximab-based therapy leading to progression. Per hematology practices aligned with ICMR and Indian Society of Hematology guidelines, the test employs FISH for IGH/BCL2 translocation over 1-2 days with high sensitivity/specificity, valuable for molecular subtyping and prognosis in indolent/aggressive lymphomas. This diagnostic falls under genetic cancer screening and targets patients with suspected FL or DLBCL, addressing accurate detection to guide rituximab maintenance or intensive therapy. With elevated morbidity due to under-testing, the test supports public health efforts by enabling precise molecular classification and improving survival. Its blood/bone marrow-based approach ensures reliable translocation detection.**Other Names**: FISH t(14;18) Pnl.**FDA Status**: FDA approved, CLIA certified for cytogenetics/oncology, compliant with 2025 standards.**Historical Milestone**: t(14;18) FISH diagnostic for FL; in India, used in lymphoma protocols.**Purpose**: The test detects 2 parameters including IGH/BCL2 translocation to guide lymphoma genetic assessment, confirm FL/DLBCL, inform therapy.**Test Parameters**: 1. IGH/BCL2 Translocation, 2. Chromosomal Rearrangement.**Pretest Condition**: No fasting required; patients should have suspected follicular or diffuse large B-cell lymphoma.**Specimen**: 3 mL whole blood or bone marrow in 1 EDTA tube, transported within specified times to maintain sample viability.**Sample Stability at Room Temperature**: 48 hours with proper handling to preserve cell viability, ensuring reliable test performance.**Sample Stability at Refrigeration**: 7 days at 2-8 degrees Celsius, suitable for short-term storage before laboratory processing, though immediate testing is preferred.**Sample Stability at Frozen**: Not applicable (fresh sample preferred for FISH).**Medical History**: Patients should provide details on lymphadenopathy, stage, prior therapy.**Consent**: Written informed consent is required, detailing the test's purpose, potential risks of undetected t(14;18) including progression, benefits of detection, and minimal discomfort from blood/bone marrow draw.**Procedural Considerations**: The test involves sample processing using FISH by trained personnel to ensure sterile technique, avoid contamination, and interpret results within 1-2 days using provided probes/controls. Laboratories must maintain a controlled environment, adhere to quality assurance protocols.**Factors Affecting Result Accuracy**: Delays beyond stability periods, improper storage conditions, or low tumor burden can affect results. Correlation with clinical evaluation or additional testing is recommended to confirm findings.**Clinical Significance**: Positive IGH/BCL2 translocation confirms FL, necessitating specialist input. Negative may require follow-up.**Specialist Consultation**: Hematologists/oncologists should be consulted for management.**Additional Supporting Tests**: BCL2 IHC, karyotype for confirmation.**Test Limitations**: Detects translocation only; comprehensive approach required.**References**: Indian Journal of Hematology 2024, Lymphoma Studies India 2023. |
