IMED License

Acute Myeloid Leukemia Inv16/t(16;16) CBFB::MYH11 Detection Kit

Features:

  • Performed in a one-step reaction (no need for cDNA synthesis)

  • 100% diagnostic sensitivity and specificity

  • Contains internal, positive, and negative controls to confirm the extraction process and PCR test

  • Results obtained in the shortest possible time (90 minutes)

  • A Type, D Type, E Type

Description

Inv16/t(16;16) CBFB::MYH11 Detection rRT-PCR Kit | Inv16/t(16;16) CBFB::MYH11 rRT-PCR Detection Kit
A Type, D Type, E Type

This kit is a product of ap-rad and is designed and manufactured for the rapid, sensitive, and specific detection of common CBFB::MYH11 fusions.

Acute Myeloid Leukemia (AML) is a hematopoietic malignancy that originates from immature myeloid cells in the bone marrow. One of the important and relatively common subtypes of AML in both children and adults is leukemia associated with Core Binding Factor (CBF) gene abnormalities. This subtype accounts for approximately 5 to 15 percent of all AML cases.

Chromosome 16 abnormalities, including Inv(16) and t(16;16), are observed in about 5 to 8 percent of patients and are considered among the three major abnormalities defining the World Health Organization (WHO) classification.

Patients with this type of AML typically respond favorably to high-dose Cytarabine therapy and often achieve complete remission. However, despite being classified as a low-risk group, approximately two-thirds of adult patients are at risk of relapse, especially when they cannot receive high-dose treatment.

The Inv16/t(16;16) CBFB::MYH11 rRT-PCR Kit, with its high sensitivity and specificity, enables accurate detection of these fusions and is an important tool for the molecular diagnosis, prognosis determination, and selection of appropriate treatment for patients with CBF-related AML.

اطلاعات کیت
Description Real-Time Amplification Kit with Genomic RNA Extraction of Specimen
Method Real-Time
Type Qualitative
Regulatory Status RUO
Storage & Transfer Condition (˚C) 20-
Number of Reactions 25
Controls Positive & Negative
Applicable Instruments All Type of Real-Time PCR Machines with FAM and JOE Channels
Result Display Time 1.5hours
Validated Specimens Peripheral Blood
Bone Marrow Aspirate
Sample Volume 2µL
Analytical Sensitivity (Copy/µL)s 0.6Copy/µL
Analytical Specificity 100%
Clinical Sensitivity 100%
Clinical Specificity 100%
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