Diasorin Molecular IAM BCR ABL Kit

Iam BCR-ABL Kit

An ultra rapid molecular solution for one-step differential detection of BCR-ABL common and rare fusion transcripts

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KIT for Oncohematology

Overview

Background

The BCR-ABL fusion gene codes for an oncogenic protein with elevated tyrosine kinase activity, which is responsible for the neoplastic transformation. The timely and accurate molecular detection of the BCR-ABL transcripts is mandatory in order to diagnose Philadelphia Positive Leukemias allowing implementation of targeted therapies, which are able to selectively inactivate the BCR-ABL chimeric protein.

Why to choose it

A simplified, comprehensive and rapid solution for the reliable molecular identification of BCR-ABL translocations.

For use on

Benefits

Diasorin Molecular IAM BCR ABL Kit
Enhanced
formulation

Comprehensive detection of common and rare BCR-ABL isoforms

Clinical studies performed on the limited number of available samples (n=14) have demonstrated that the assay is capable of detecting the rarer isoforms of p190 and p210, and the p230 variant (μbcr).

DETECTABLE ISOFORMS
p210 b2a3
b2a2
b3a2
b3a3
p190 e1a2
e1a3
p230 e19a2
e19a3
Ultra rapid

Identification of the translocation within 20 minutes, starting form extracted RNA

Results within 20 minutes
Laboratory worker filing paperwork
One step
closed format

the assay works directly on 500 ng RNA with no need for multistep procedures: decreased risk of contamination and errors

Highly
reliable

Internal endogenous control and quality controls are included to allow validation of results.

Highly
specific

No false positive results and absence of primer dimers

Validated on 746 samples

Tested on 521 BCR-ABL negative cell lines RNA extracted by both Qiagen Rneasy kit and modified TRIzol and on 225 NTC, the assay shows >99.8% specificity

Extraction Method Total No. Replicates Sample Type % Analytical Specificity
Extraction MethodQiagen RNeasyTM Kit Total No. Replicates252 Sample TypeCell lines % Analytical Specificity99.6
Extraction MethodModified TRIzolTM Total No. Replicates269 Sample TypeCell lines % Analytical Specificity100
Extraction MethodN/A Total No. Replicates225 Sample TypeCell lines % Analytical Specificity100
Specialists are collaborating together in a laboratory
Highly
Sensitive

Sensitivity 100 folds higher than the one needed for Detection at the onset

One traslocated RNA in 1000 wild type is reproducible detected (>95% of cases).

K562 and TOM-1 10-4 dilutions were detected in ≥ 95% of replicates; K562 10-4 / TOM-1 10-4 dilutions extracted with Qiagen RNeasyTM Kit and modified TRIzolTM were detected 87.5%/90% and 88.4%/85% respectively.

EXTRACTION METHOD
Qiagen RNeasyTM Kit
Limit of Detection
Limit of DetectionK562 10-3
Limit of DetectionTOM-1 10-3
Modified TRIzolTM
Limit of Detection
Limit of DetectionK562 10-3
Limit of DetectionTOM-1 10-3
Clinically
validated

100% concordance with the traditional RT-PCR (Biomed Protocol*, by Van Dongen et al)
*Leukemia. 1999 Dec;13(12):1901-28.

200 clinical samples tested

One traslocated RNA in 1000 wild type is reproducible detected (>95% of cases)

Sample status Number of diagnostic results % Agreement with laboratory developed
PCR method (BIOMED protocol)
Sample statup190 Positive Number of diagnostic results30 % Agreement with laboratory developed
PCR method (BIOMED protocol)
100%
Sample statup210 Positive Number of diagnostic results30 % Agreement with laboratory developed
PCR method (BIOMED protocol)
100%
Sample statup190 or p210 Negative Number of diagnostic results140 % Agreement with laboratory developed
PCR method (BIOMED protocol)
100%
Young, microbiologist and his colleagues are sitting in a modern laboratory
Robust

Superior robustness to inhibitors, RNA degradation and suboptimal target quantities

The intrinsic robustness of the enzyme employed in Q-LAMP results in an enhanced robustness versus the classical inhibitor factors of PCR.

Superiority
vs. PCR

Q-LAMP is a very rapid, easy, accurate, convenient and robust method for differential detection of BCR-ABL translocations

Can be implemented even in not specialized laboratories for a timely Philadelphia Positive Leukemias diagnosis and as a screening for exclusion of Philadelphia Positive conditions.

Q-LAMP RT-PCR (Biomed)
SubjectRNA input Q-LAMP500 ng/rx robust down to 25 ng/rx RT-PCR (Biomed)1μg/rx
SubjectSteps Q-LAMP1 RT-PCR (Biomed)3
SubjectAssay format Q-LAMPMULTIPLEX RT-PCR (Biomed)SIMPLEX
SubjectControl of reaction Q-LAMPINTERNAL RT-PCR (Biomed)EXTERNAL
SubjectRobustness Q-LAMP– to chemical contamination
– to PCR inhibitors
– to degraded samples
RT-PCR (Biomed)To chemical contamination
SubjectResult interpretation Q-LAMPOBJECTIVE RT-PCR (Biomed)SUBJECTIVE
SubjectTime to result Q-LAMP60min RT-PCR (Biomed)3h 30min

Libraries


Ordering info

Product Code Reactions
Product

Iam BCR-ABL

Code V31BCR Reactions 24

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Our repository

All the answers you need.
Access our database to find:
instructions for use, safety data sheets,
assay protocols and more.

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