AML1 Fusion Real-Time PCR Kit

Product Overview


The TEL-AML1 fusion gene results from a chromosomal translocation t(12;21)(p13;q22), which is one of the most frequently observed genetic abnormalities in childhood B-lineage Acute Lymphoblastic Leukemia (ALL). Identifying this fusion gene not only confirms the diagnosis but also provides valuable prognostic information, helping clinicians tailor treatment strategies to individual patients. Accurate detection of the TEL-AML1 fusion gene supports early diagnosis and improved clinical evaluation, enabling faster, evidence-based clinical decisions and better long-term outcomes for patients.

To address this important clinical need, Genes2Me introduces the AML1 Fusion Real-Time PCR Kit — an advanced in vitro diagnostic solution designed for the rapid and accurate detection of the TEL-AML1 fusion gene in clinical samples. Built on highly sensitive Real-Time PCR technology, the assay enables reliable molecular detection to support leukemia diagnosis, prognosis, and patient management.

Targets:
TEL-AML1 Fusion Gene
Technology:
Multiplex Real-Time PCR (TaqMan)
Detection:
Qualitative (Detected / Not Detected)
Sample Type:
Whole Blood, Bone Marrow
Certification:
IVD
AML1-Fusion gene

How the Assay Works


The AML1 Fusion Kit utilises a multiplex Real-Time PCR system incorporating custom primers and fluorescent probes targeting TEL-AML1 fusion sequences. FAM-labeled probes enable detection of the TEL-AML1 fusion gene, while HEX-labeled probes simultaneously detect an internal control (RNase P) within a separate channel. This built-in control validates both sample quality and workflow accuracy, minimising the risk of false-negative results and enhancing overall test reliability. The multiplexing capability enables simultaneous detection of multiple targets within a single reaction, making the process more efficient and resource-friendly.

Clinical Relevance


TEL-AML1 fusion gene testing plays a vital role in the early diagnosis and prognosis of Acute Lymphoblastic Leukemia (ALL), making it particularly significant in pediatric oncology where timely intervention can greatly improve patient outcomes. Early and accurate detection helps clinicians not only confirm the diagnosis but also assess prognosis and guide treatment planning. With detection at Ct ≤ 35, the AML1 Fusion Kit provides laboratories with dependable molecular diagnostic performance for leukemia detection and disease management.

Sample Type & Reporting Output


Sample Type:
Whole Blood, Bone Marrow
Reporting Output:
Qualitative detection of TEL-AML1 fusion gene (Detected / Not Detected)
Targets Detected:
TEL-AML1 fusion gene sequences

Key Features & Benefits


Accurate TEL-AML1 Detection

Specifically detects TEL-AML1 fusion gene sequences associated with childhood B-lineage ALL.

High Diagnostic Performance

Reliable detection at Ct ≤ 35, ensuring confident and reproducible results.

Multiplex Assay Design

Simultaneous detection of TEL-AML1 fusion gene and internal control (RNase P) for enhanced assay reliability.

Flexible Compatibility

Validated on leading Real-Time PCR platforms including Thermo Fisher QuantStudio™ 5, Bio-Rad CFX96, Roche LightCycler® 480, and Genes2Me RapiCycler 96.

Reliable & Reproducible

Rapid turnaround provides timely and reproducible data for critical decision-making.

Fast & Streamlined Workflow

Easy reaction setup and optimised amplification protocol for efficient laboratory testing.

Applications


  • Clinical & Hospital Laboratories: Enables rapid, sensitive detection of TEL-AML1 across multiple sample types, supporting accurate differential diagnosis and timely clinical decisions for patients presenting with febrile illness or neurological complications in endemic areas.
  • Maternal & Reproductive Health: Critical for screening during pregnancy, given the well-documented association between Zika virus infection and congenital defects including microcephaly and other neurological abnormalities in newborns.
  • Paediatric & Neonatal Care: Supports confirmatory testing in neonates with suspected congenital TEL-AML1 syndrome, where early identification guides clinical management and long-term follow-up planning.
  • Outbreak Surveillance: Rapid molecular detection supports real-time monitoring of TEL-AML1 transmission in human populations, enabling targeted public health responses during outbreak periods.
  • Differential Diagnosis: Particularly valuable in settings where Dengue, Chikungunya, and Zika co-circulate, enabling definitive pathogen identification and avoiding the clinical and therapeutic consequences of misdiagnosis.
  • Travel & Occupational Health: Reliable TEL-AML1 screening for travel medicine clinics and occupational health programmes serving individuals returning from or working in endemic tropical and subtropical regions.

Analytical Performance


  • Detection of TEL-AML1 fusion gene at Ct ≤ 35 for reliable molecular identification.
  • Multiplex design with FAM channel (TEL-AML1) and HEX channel (RNase P internal control) validates sample quality and PCR efficiency in every run.
  • Rapid turnaround with consistent, reproducible performance across runs and operators.
  • 12-month shelf life with stable performance under recommended storage conditions.
  • Compatible with QuantStudio™ 5, CFX96, LightCycler® 480, and RapiCycler 96 platforms

With the AML1 Fusion Real-Time PCR Kit, laboratories can achieve highly sensitive, reproducible, and clinically meaningful detection of the TEL-AML1 fusion gene. By supporting early diagnosis and improved clinical evaluation of leukemia, the kit helps clinicians make informed decisions for patient care and disease management. Empower your laboratory with the AML1 Fusion Real-Time PCR Kit — because timely molecular insights can make a lasting difference in patient outcomes.

Data Analysis and Report


AML1 Fusion

AML1 Fusion Real Time PCR specific amplification plot of Treponema pallidum Positive Control (HEX Channel) along with Internal Control (Cy5 Channel)

Ordering Information


Commercial Name Old Cat No. New Cat No. Pack Size
AML1 Fusion Real-Time PCR Kit G610047-1 G610032-1 50 Tests

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Since its inception in 2016, Genes2me has been constantly striving towards setting a benchmark in the diagnostics space by introducing premium quality (Made in India) diagnostic kits which are CE-IVD, ISO-13485:2016, and ISO 9001:2015 certified, assuring our clients of unparalleled quality and compliance with international standards.


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