Iam BCR-ABL

A one-step, rapid molecular assay for qualitative differential detection of BCR-ABL fusion transcripts.

 

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 (1-4). 

Iam BCR-ABL Qualitative MAIN FEATURES:

  • A simplified and reliable solution: from 500ng RNA to results in ONE STEP
  • Simultaneous detection and discrimination of the common isoforms p190 and p210
  • Ultra Rapid: first results visible in real-time within 20 minutes
  • Internal control to validate BCR-ABL negative results
  • Easy set-up

 

Specific and sensitive

Total No. Replicates

Sample Type

% Analytical Specificity

Qiagen RNeasy Kit

cell lines

99.6

Modified TRIzol®

cell lines

100

N/A

NTC

100

Detection of rare isoforms

e6a2

e8a2

e19a2

e18a2

Extraction Method

Limit of Detection

Qiagen RNeasy Kit

K562 10-3

TOM1 10-3

Modified TRIzol®

K562 10-3

TOM1 10-3

 

K562 10-4 and TOM 1 10-4 dilutions extracted with Qiagen RNeasy Kit and TRIzol® were detected 87.5%/92.5% and 72.5%/92.5% respectively.

Robust

Iam BCR-ABL is resistant to the common PCR inhibitors. During field evaluations the assay also returned accurate results for samples in which a partial degradation of RNA had occurred.

Clinically Validated

Sample status

% Agreement with laboratory developed

PCR method (BIOMED protocol)

p210 positive

100% (N=40)

p190 positive

100% (N=40)

p210 negative

99% (N=100)*

p190 negative

99% (N=100)

* 1 sample was defined as negative by the laboratory developed PCR method (BIOMED protocol) however was subsequently defined as p210 positive with a CE marked commercial quantitative PCR kit.