1drop Inc.

Global Mobile Healthcare Leader, 1drop

1copy™

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.

Sensitive
1Molecule qPCR

Limit of Detection

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(95%) o(88%) o(56%) △(13%) x 1 step qRT PCR Kit
Competitor A o(100%) o(100%) x x x x x x x 2 step qRT PCR Kit
Competitor B o(100%) o(100%) x x x x x x x Only for qPCR
(RT(Reverse transctiption))
Product 1copy™ 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)

Convenient

Use only single tube for RT and real-time PCR

RNA
+
Primer&Probe Mix
Master Mix

Real-time RT-PCR
Completed

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

1copy™
(1step)
Competitor
(2steps)
Total measurement time 2hours 25minute 3hours 30minute
Hands-on time 20minute 1hour

Highly
Sensitive

1Molecule qPCR

Our BCR-ABL qPCR Kit uses 1copy™
probes to ensure safe and accurate results.

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%

Contents

Master Mix

Primer Probe Mix

Standard(ABL)

Standard(BCR-ABL)

Control

DEPC DW

User Manual

Specification

1copy™
Experimental step Single step
Limit of Detection 4pg
(~ 8copies)
MR 4.77(MR value)
Target 4Species fusion mRNA
(b3a2, b2a2, e1a2, e19a2)
Time 2hour 25minute

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