Iam BCR-ABL Kit

Iam BCR-ABL Kit

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.

Benefits

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

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 Specific 

No false positive results and absence of primer dimers

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 MethodTotal No. ReplicatesSample Type% Analytical Specificity
Qiagen RNeasyTM Kit
252Cell lines99.6
Modified TRIzolTM
269Cell lines
100
N/A225Cell lines
100


Highly Sensitive

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 RNeasy Kit and modified TRIzolTM were detected 87.5%/90% and 88.4%/85% respectively.

EXTRACTION METHOD

QIAGEN RNEASY KIT
MODIFIED TRIZOL
Limit of DetectionLimit of Detection
K562 10-3K562 10-3
TOM-1 10-3
TOM-1 10-3

Clinically Validated

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

Sample statusNumber of diagnostic results% Agreement with laboratory developed PCR method (BIOMED protocol)
p190 Positive 30100%
p210 Positive30100%
p190 or p210 Negative140100%

Robust

Superior robustness to inhibitors, RNA degradation and suboptimal target quantities.

The intrinsic robustness of the enzyme employed in Q-LAMP results in a 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 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-LAMPRT-PCR (Biomed)
RNA input
500 ng/rx robust down to 25 ng/rx
1μg/rx
Steps13
Assay formatMULTIPLEXSIMPLEX
Control of reactionINTERNALEXTERNAL
Robustness– to chemical contamination
– to PCR inhibitors
– to degraded samples
To chemical contamination
Result interpretationOBJECTIVESUBJECTIVE
Time to result60min

3h 30min


For use on

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PRODUCTCODEREACTIONS
Iam BCR-ABLV31BCR24

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