1drop Inc.

Global Mobile Healthcare Leader, 1drop

BCR-ABL qPCR Kit?

Treatment of chronic myelogenous leukemia, finding the correct dose of the appropriate targeted agents after diagnosis is a condition for the best effect.
3/6/12 months after the first treatment started, a chromosome test via a bone marrow examination and quantitative BCR-ABL1 gene examination via blood will be performed.
The results of the genetic tests performed at each time point should show a gradual decrease of 10%, 1%, and 0.1%, and if the optimal curative effect is achieved, it will decrease to less than 0.1% within a year.
If treatment goes successful and a major Molecular Response is obtained, life expectancy is similar to a normal person. And if the treatment continues, the chances of obtaining less than 0.0032% of the BCR-ABL1 gene, the complete molecular response, are increased. Eventually, the chances of stopping targeted agents for a certain period will increase.

1drop's 1copy™ BCR-ABL qPCR Kit shows high precision and sensitivity in quanitative testing for CML. Capable of detecting BCR-ABL genes with high sensitivity - 0.0017% IS, the 1copy™ BCR-ABL qPCR Kit can stably detect and measure BCR-ABL1 levels at 0.0032% or lower (Complete Molecular Response). The 1copy™ BCR-ABL qPCR Kit has a short response time and is convenient,
due to its single-process reverse transcription and amplification response.

Fast and Convenient

The 1copy™ BCR-ABL qPCR Kit allows for fast and convenient use
by detecting multiple mRNA targets in a single step.

1copy™ BCR-ABL
(1step)
competitor
(2steps)
Turn-around Time 2hours 25minute 3hours 30minute
Hands-on time 20minutes 1hour

Product

Product Detection range based on K562 RNA/test Character
100pg 50pg 20pg 10pg 4pg 2pg 0.8pg 0.2pg 0pg(NTC)
1copy™ o(100%) o(100%) o(100%) o(100%) o(94%) o(88%) o(56%) △(13%) x 1 step qRT PCR Kit
A o(100%) o(100%) x x x x x x x 2 step qRT PCR Kit
B o(100%) o(100%) x x x x x x x Only for qPCR
(RT reaction is not included)
Product 1copyTM A B
Detection range based on K562 RNA/test 100pg o(100%) o(100%) o(100%)
50pg o(100%) o(100%) o(100%)
20pg o(100%) x x
10pg o(100%) x x
4pg o(94%) x x
2pg o(88%) x x
0.8pg o(56%) x x
0.2pg △(13%) x x
0pg(NTC) x x x
Character 1step qRT PCR Kit 2step qRT PCR Kit Only for qPCR
(RT reaction is not included)

Companion Diagnostics

The 1copy™ BCR-ABL qPCR Kit is highly sensitive, with CMR results above 0.0032% IS.

Category Period Criteria
Early Molecular Response
(EMR)
3months BCR-ABL ≤10%
Complete Cytogenetic Response
(CCyR)
6months BCR-ABL ≤1%
Major Molecular Response
(MMR)
12months BCR-ABL < 0.1%
Deep Molecular Response
(Deep Molecular Response)
OR
(Complete Molecular Response)
after 12months BCR-ABL < 0.0032%

Detection target regio(Genotype coverage)

1copy™ BCR-ABL kit can detect Major type (p210: e14a2, e13a2), Minor type (p190: e1a2), Micro type (p230: e19a2) genotype in a 1time test

Specification

Experimental step Single step
Limit of detection 4pg(~8copies, >95%,cl)
MR 4.77(MR value)
Target 4 Species fusion mRNA (b3a2, b2a2, e1a2, e19a2)
Time 2hours 25 minutes
Specimen (Collection Specimen) Total RNA(Blood, Marrow)
Internal Control Gene ABL1
Measurable disease CML(Chronic Myeloid Leukemia)
Catalog number M18MD100C

Contents

Kit contents Cap Volume(100 Test)
Master mix Red 2 x 1000 ㎕
Primer Probe mix Brown(Amber tube) 100㎕
BCR-ABL1 Standard1
(1Ⅹ10⁶ copy / 2 ㎕)
Green 50㎕
BCR-ABL1 Standard2
(1Ⅹ10⁵ copy / 2 ㎕)
Green 50㎕
BCR-ABL1 Standard3
(1Ⅹ10³ copy / 2 ㎕)
Green 50㎕
BCR-ABL1 Standard4
(1Ⅹ10² copy / 2 ㎕)
Green 50㎕
ABL1 Standard1
(1Ⅹ10⁶ copy / 2 ㎕)
Blue 50㎕
ABL1 Standard2
(1Ⅹ10⁵ copy / 2 ㎕)
Blue 50㎕
ABL1 Standard3
(1Ⅹ10⁴copy / 2 ㎕)
Blue 50㎕
Control1 Yellow 50㎕
Control2 Yellow 50㎕
DEPC Water Clear 1000㎕

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