DiaSorin Molecular Iam PML-RARA Kit

Iam PML-RARA Kit

An ultra rapid molecular solution for one-step differential detection of PML-RARA bcr1, bcr2, bcr3 fusion transcripts

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KIT for Oncohematology

Overview

Background

The PML-RARA t (15;17) translocation is associated with the Acute Promyelocytic Leukemia (APL), a potentially fatal subtype of Acute Myeloid Leukemia due to severe coagulopathy. Accuracy and speed of the diagnostic work-up are critical to allow timely initiation of efficient therapies that can convert APL from a highly fatal into a highly curable Leukemia. Iam PML-RARA detection bcr1,3 kit and Iam PML-RARA discrimination bcr2 kit are to be used in combination for accurate identification of bcr1/bcr2/bcr3 isoforms (100% specificity).

Why to choose it

A simplified, reliable and rapid solution: APL molecular diagnosis within 20 minutes is now possible.

For use on

Benefits

DiaSorin Molecular Iam PML-RARA Kit
Ultra Rapid

Identification of the translocation within 20 minutes, starting from extracted RNA.

VALIDATED ON 140 CLINICAL SAMPLES

The assay identifies a bcr1/bcr2/bcr3 positivity with an average threshold time of 16,52 ± 3,33 min. Amplification curves are visible in real time, to allow preliminary identification of positive urgent samples.

One step
closed format

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

100%
Specific

No false positive results and absence of primer dimers.

VALIDATED ON 600 SAMPLES

Tested on 400 PML-RARA negative cell lines RNA, extracted by both Qiagen RneasyTM kit and modified TRIzolTM, and on 200 NTC, the assay do not generate any aspecific signal.

PML-RARA Detection bcr1,3
Sample type Replicates % Analytical Specificity
Sample typeCell lines Replicates400 % Analytical Specificity100%
Sample typeNTC Replicates210 % Analytical Specificity100%
RNA was extracted from PML-RARA negative cell lnes by both Qiagen RNeasyTM kit and modified TRizolTM.
PML-RARA Discrimination bcr2
Sample type Replicates % Analytical Specificity
Sample typeCell lines Replicates400 % Analytical Specificity100%
Sample typeNTC Replicates210 % Analytical Specificity100%
RNA was extracted from PML-RARA negative cell lnes by both Qiagen RNeasyTM kit and modified TRizolTM.
Highly
Reliable

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

Clinically
Validated

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

VALIDATED ON 140 CLINICALLY ARCHIVED SAMPLES
IAM PML RARA DETECTION BCR1,3
Sample type Replicates % Analytical Specificity
Sample typebrc1 or brc3 positive Replicates54 % Analytical Specificity100%
Sample typebrc1 or brc3 negative Replicates30 % Analytical Specificity100%
All clinical analysis has been performed on RNA extracted by both Qiagen RNeasyTM and modified TRIzolTM.
IAM PML RARA DISCRIMINATION BCR2
Sample type Replicates % Analytical Specificity
Sample typebrc2 positive Replicates26 % Analytical Specificity100%
Sample typebrc2 negative Replicates30 % Analytical Specificity100%
All clinical analysis has been performed on RNA extracted by both Qiagen RNeasyTM and modified TRIzolTM.
Lab specialist holding a vial in his hand
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.

Superior Performance

Q-LAMP is a very rapid, easy, accurate, convenient and robust method for differential detection of PML-RARA translocation.

It can be implemented even in not specialized laboratories for a timely effective APL diagnosis, which is key for initiation of therapy.

Name Q-LAMP RT-PCR (Biomed)
NameRna Input Q-LAMP500 ng/rx
robust down to 25 ng/rx
RT-PCR (Biomed)1µg/rx
NameSteps Q-LAMP1 RT-PCR (Biomed)2
NameAssay format Q-LAMPMULTIPLEX RT-PCR (Biomed)SIMPLEX
NameControl of reaction Q-LAMPINTERNAL RT-PCR (Biomed)EXTERNAL
NameRobustness Q-LAMP– to chemical contamination
– to PCR inhibitors
– to degraded samples
RT-PCR (Biomed)100%
Name Result Interpretation Q-LAMP OBJECTIVE RT-PCR (Biomed) SUBJECTIVE
Name Time to result Q-LAMP 40 min RT-PCR (Biomed)3h 30min

Ordering info

Product Code Reactions
Product

Iam PML-RARA Detection bcr1,3

Code V32PML1/3 Reactions 30
Product

Iam PML-RARA Discrimination bcr2

Code V33PML2 Reactions 24
Product

Iam PML-RARA Detection bcr1,3 plus Iam PML-RARA Discrimination bcr2

Code V34PML Reactions -

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Our repository

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Access our database to find:
instructions for use, safety data sheets,
assay protocols and more.

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