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
Identification of the translocation within 20 minutes, starting from extracted RNA.
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.
closed format
The assay works directly on 500 ng RNA with no need for multistep procedures: decreased risk of contamination and errors.
Specific
No false positive results and absence of primer dimers.
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% | |
| Total replicates | Replicates610 | % 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% | |
| Total replicates | Replicates610 | % Analytical Specificity100% | |
| RNA was extracted from PML-RARA negative cell lnes by both Qiagen RNeasyTM kit and modified TRizolTM. | |||
Reliable
Internal endogenous control and quality controls are included to allow validation of results.
Validated
100% concordance with the traditional RT-PCR (Biomed Protocol*, by Van Dongen et al).
*Leukemia. 1999 Dec;13(12):1901-28.
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% | |
| Total replicates | Replicates84 | % 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% | |
| Total replicates | Replicates56 | % Analytical Specificity100% | |
| All clinical analysis has been performed on RNA extracted by both Qiagen RNeasyTM and modified TRIzolTM. | |||
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.
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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