Test Price
2,800 AED✅ Home Collection Available
B-Cell Gene Rearrangement Clonality Test in Dubai | 2,800 AED | DNA Labs UAE
ISO 9001:2015
Cert: INT/EGQ/2509DA/3139
DHA Licensed Facility 1143
Executive Summary & Core Metrics
- Diagnostic Accuracy: 99.9% sensitivity achieved through ISO‑accredited PCR Fragment Analysis strictly adhering to the BIOMED‑2 protocol for immunoglobulin heavy chain (IGH) gene rearrangements.
- Premium Logistics: VIP Mobile Phlebotomy and temperature-controlled cold-chain sample transport (2–8°C) for standard EDTA whole blood specimens, ensuring comprehensive pre-analytical integrity.
- Clinical Guidance: Post-test telephonic consultation is provided to contextualize molecular results within the broader clinical presentation.
- Insurance Verification: Direct billing facilitation; please verify coverage via WhatsApp at +971 54 548 8731.
Test Overview & Methodology
The B‑Cell Gene Rearrangement Clonality Assay is a high-precision molecular diagnostic test utilized to identify monoclonal B‑cell populations. The methodology focuses on the amplification and capillary electrophoresis analysis of immunoglobulin heavy chain (IGH) gene rearrangements. This approach is considered the gold standard for differentiating malignant lymphoid proliferations, such as leukemia and lymphoma, from reactive polyclonal lymphocytosis. It also serves as a critical tool for minimal residual disease (MRD) monitoring.
| Feature | Our ISO‑Certified Molecular Assay | Closest Alternative (Flow Cytometry) |
|---|---|---|
| Precision & Sensitivity | 99.9% Diagnostic Sensitivity via BIOMED‑2 multiplex PCR | ~95–98% sensitivity; limited by immunophenotypic marker overlap |
| Methodology | PCR Fragment Analysis (Capillary Electrophoresis) with GeneScan | Flow Cytometric light‑chain restriction analysis |
| Turnaround Time | 10–12 business days (comprehensive final report) | 3–5 days (screening-only preliminary result) |
* Comparison based on standard clinical laboratory practices within the GCC region.
Physician Insight & Safety Protocols
“Molecular clonality testing provides pivotal evidence in the diagnostic workup of suspected lymphoproliferative disorders. Identifying a monoclonal IGH rearrangement can strongly support a diagnosis of malignancy or assist in tracking residual disease. However, these results must be interpreted alongside clinical, morphological, and immunophenotypic data to ensure therapeutic decisions are precise and evidence-based.”
— Lina Osama Zaki Quteineh, Consultant Medical Genetics | DHA Registration ID: 9294403
⚠ Medication & Clinical Care Advisory
Do not discontinue, modify, or initiate any prescribed therapy solely based on this genetic test result without direct consultation with your treating hematologist or oncologist. This assay is an adjunctive diagnostic tool and does not replace comprehensive clinical care.
Sample Rejection Criteria & Emergency Indicators
- Sample Rejection: Hemolyzed, clotted, frozen, or improperly collected specimens (non‑EDTA tubes). Insufficient volume (<2 mL) or absence of the mandatory Genomics Clinical Information Requisition Form (Form 20) will also necessitate recollection.
- Urgent Clinical Referral: Sudden high fever (>38.5°C), unexplained bleeding or extensive bruising, severe bone pain, or progressive neurological changes (confusion, seizures) may indicate aggressive disease and require immediate hematological intervention.
All clinical procedures comply with Federal Decree-Law No. 4 of 2016 on Medical Liability.
Patient FAQ & Clinical Guidance
1. What exactly does the B‑Cell Gene Rearrangement Clonality Test detect?
Direct Answer: This test identifies whether a population of B‑cells is monoclonal (derived from a single parent cell) or polyclonal (derived from many cells). Monoclonality is a hallmark of B‑cell lymphomas and leukemias, while polyclonality indicates a benign, reactive condition such as an infection or autoimmune response.
It specifically targets the unique DNA sequences created when immunoglobulin heavy chain (IGH) genes rearrange during B‑cell development. If a large enough fraction of cells share the exact same rearrangement, a dominant clone is identified, providing strong evidence for a lymphoproliferative disorder.
2. How accurate is the test, and when is a positive result considered definitive for lymphoma?
Direct Answer: The assay offers 99.9% diagnostic sensitivity. A positive result indicates the presence of a clonal B‑cell population, which is highly suggestive of a malignancy such as Acute Lymphoblastic Leukemia (ICD‑10 C91.00) or Mantle Cell Lymphoma (ICD‑10 C83.10).
However, a positive result is not entirely exclusive for malignancy. Rare benign clonal expansions can occur, particularly in elderly or immunocompromised patients. Therefore, a definitive diagnosis requires integration with peripheral blood counts, flow cytometry, histopathology, and cytogenetic analysis for comprehensive clinical correlation.
3. What are the specific sample requirements and how is the logistics chain maintained?
Direct Answer: A 4 mL whole blood specimen collected in a Lavender‑top (EDTA) tube is required. The sample must be shipped under strictly controlled refrigerated conditions (2–8°C) and must never be frozen.
Our VIP Mobile Phlebotomy team collects the sample directly from your home, ensuring immediate temperature-controlled packaging and cold-chain transport to our Dubai Healthcare City laboratory. The Genomics Clinical Information Requisition Form (Form 20) must accompany the specimen for processing. The definitive molecular report is released within 10–12 business days of sample receipt.
UAE Regulatory & Data Privacy Adherence
DNA Labs UAE strictly complies with the UAE’s comprehensive data protection and healthcare regulatory frameworks. All personal data processing activities are governed by Federal Decree-Law No. 45 of 2021 on Personal Data Protection (PDPL) and Federal Law No. 2 of 2019 Concerning the Use of Information and Communication Technology in Health Fields.
Our clinical laboratory operations, including patient consent, specimen handling, and reporting, adhere to the standards set forth by Federal Decree-Law No. 4 of 2016 on Medical Liability, ensuring complete accountability and patient safety.
We are licensed by the Dubai Health Authority (DHA License 1143) and operate from our accredited facility in Dubai Healthcare City.
Clinical & Logistical Metadata
| Test Name | B-Cell Gene Rearrangement Detection (Clonality) |
| Price (AED) | 2,800 AED |
| Turnaround Time | 10–12 Business Days |
| Sample Type / Matrix | Whole Blood (4 mL in EDTA Lavender-Top Tube) |
| Methodology Used | PCR Fragment Analysis & Capillary Electrophoresis (BIOMED-2 Protocol) |
| ICD-10-CM Code | C91.00, C83.10 |
| LOINC Code | TBD – Assigned upon formal request |
| DHA Facility License & Address | 1143 | DNA Labs UAE, Premises 105, Floor 1, Building 33, Dubai Healthcare City, Dubai, UAE |
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