Innovative qPCR Solutions for Advanced Molecular Diagnostics

The future of clinical diagnostics lies in molecular testing, with molecular diagnostics playing a crucial role in infectious disease, oncology and other critical areas. As molecular testing evolves, assay developers face complex challenges, necessitating flexible, efficient solutions that ensure high-quality results. 

This eBook explores real-time qPCR in vitro diagnostic (IVD) solutions that are designed to address these needs, offering a complete and innovative workflow for assay development and commercialization. 

Download this eBook to discover how to:

• Choose the system and consumables which fit your needs
• Take command of assay design 
• Streamline your lab workflow

Empower your molecular
diagnostics: The future is here
Innovative qPCR solutions for molecular diagnostics
For In Vitro Diagnostic Use.
qPCR
Putting you in control of molecular diagnostics 3
Which system fits your needs? 6
QuantStudio 7 Pro Dx Real-Time PCR System (CE-IVD, IVDR) 7
QuantStudio 5 Dx Real-Time PCR System (CE-IVD, IVDR) 9
Diomni Enterprise Software (CE-IVD, IVDR) 11
Services and support 13
TaqPath master mixes for real-time PCR 15
MicroAmp qPCR plastics 17
Commercial supply partnerships for MDx assay developers 19
Contents
For In Vitro Diagnostic Use.
For In Vitro Diagnostic Use.
At Thermo Fisher Scientific, we understand that the future of clinical diagnostics is
molecular testing. Molecular diagnostics (MDx) tests have become indispensable
tools, and the use of molecular-based assays will continue to grow in number
and importance for infectious disease, oncology, and other vitally important
diagnostic tests.
Assay developers face many complex challenges as molecular testing continues
to rapidly evolve. The need for solutions that are flexible and efficient, and that
support the delivery of high-quality results, is paramount.
We designed real-time PCR (qPCR) in vitro diagnostic (IVD) solutions with you in
mind. Our innovative and complete workflow enables you to effectively respond
to the assay design challenges you face in developing and commercializing
products. Since 2008, we have been supporting your qPCR needs with a full
workflow for assay developers. We now offer a comprehensive qPCR diagnostics
portfolio, including instruments, master mixes and consumables, primers and
probes, software solutions, and service and support.
Instruments: Powered by proven technology, the Applied Biosystems
QuantStudio 7 Pro Dx Real-Time PCR System is an advanced, stand-alone
qPCR platform that is versatile, highly expandable, and easy to use for a smart,
assay-driven qPCR workflow, from setup to report.
The compact and flexible Applied Biosystems QuantStudio 5 Dx Real-Time
PCR System is designed to streamline workflows and minimize training needs so
you can get clinical answers quickly.
Putting you in control
of molecular diagnostics
Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics 33
Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics
All high-quality Applied Biosystems QuantStudio IVD real-time PCR systems
offer a small footprint, simple workflow and software, and world-class service and
support plans
Software solution: Designed to improve your lab’s efficiency,
Applied Biosystems Diomni Enterprise Software is an
enterprise workflow solution that reduces time-to-results
with interpretation, automated quality control, and
configurable reporting.
Diomni software also provides a scalable solution by connecting
to multiple instruments and supporting multiple concurrent users
with centralized data management. In addition to integrating with
QuantStudio real-time PCR systems, Diomni software reduces
manual steps through integration with your laboratory information
system (LIS)/laboratory information management system
(LIMS), and the Thermo Scientific KingFisher Apex Dx sample
prep instrument.
Diomni software is a flexible solution to support a variety
of testing needs with traceability to help you meet
compliance standards.
Service and support: We enable peace of mind with the
assurance that our diagnostic solutions are all backed
by a proven, global leader in molecular testing; a reliable,
single-source supplier with a robust supply chain; and
exceptional service and support.
For In Vitro Diagnostic Use.
Discover how we can put you in
control of molecular diagnostics.
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Applied Biosystems TaqPath real-time PCR master mixes deliver confidence
and reliability for your most demanding molecular diagnostic development and
testing needs
Master mixes and consumables: Thermo Fisher Scientific is
your trusted partner, from assay development, through validation
and testing, to ultimate production. We offer a complete qPCR
ecosystem that includes a broad range of custom primers and
probes, GPR and GMP Applied Biosystems TaqPath master
mixes, and PCR plastics.
Optimized to work synergistically, our flexible, high-performance
solutions enable optimal PCR performance, giving you complete
control and accelerating assay development, so you can bring
high-quality diagnostic tests to market faster.
TaqPath master mixes are designed to meet the needs of clinical
diagnostic testing and are available for qPCR and one-step
reverse transcription qPCR (RT-qPCR) in singleplex and
multiplex formats.
Each reagent is manufactured in an ISO 13485–registered facility
and rigorously tested to help ensure lot-to-lot reproducibility for
Cq consistency and wide dynamic range.
Applied Biosystems MicroAmp PCR plastics are engineered to
reduce cross-contamination and promote optimal heat transfer.
Applied Biosystems MicroAmp General Purpose Laboratory
Equipment (GPLE) reaction plates are ideal for use in diagnostic
procedures and certified in an ISO 13485–registered facility to be
free of DNA, RNase, and PCR inhibitors.
For Laboratory Use.
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Which system fits your needs?
QuantStudio IVD real-time PCR systems
For In Vitro Diagnostic Use.
QuantStudio 7
Pro Dx system
QuantStudio 5
Dx system
Formats
96-well, 0.2 mL
96-well, 0.2 mL
384-well
User-interchangeable blocks Yes No
Colors Up to 6 colors
(21 filter combinations)
Up to 6 colors
(21 filter combinations)
Touchscreen 21.5 cm 21.5 cm
Applied Biosystems VeriFlex Blocks
temperature control Yes, 6 zones* Yes, 6 zones
Security, auditing, electronic
signature (SAE) Yes Yes
Dimensions (H x W x D) 55 x 34 x 53 cm 40 x 27 x 50 cm
Weight 38 kg 26 kg
Regulatory status CE-IVD, IVDR; US-IVD CE-IVD, IVDR; US-IVD
Block format Customer-interchangeable
384-well and 96-well, 0.2 mL Fixed 96-well, 0.2 mL
Software Diomni software solution
RUO, IUO, and IVD modes
Diomni software solution
RUO, IUO, and IVD modes
Integration APIs for hardware integration
Diomni software for LIMS compatibility Diomni software for LIMS compatibility
Footprint Benchtop (55 x 34 x 53 cm); stand-alone Benchtop (40 x 27 x 50 cm);
computer required
Performance
Up to 6 colors, 21 filter combinations;
6-zone VeriFlex Block
temperature control*
Up to 6 colors, 21 filter combinations;
6-zone VeriFlex Block temperature control
Standardization and security Security, auditing, electronic signature Security, auditing, electronic signature
* 96-well block only .
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The QuantStudio 7 Pro Dx Real-Time PCR System is an In Vitro Diagnostic Regulation
(IVDR)–compliant qPCR platform that combines modern hardware and software in a
compact footprint, enabling assay developers and molecular diagnostics labs to achieve
exceptional efficiency, smarter productivity, and higher accuracy from their workflow.
The system enables flexible throughput with interchangeable 96-well and 384-well
blocks, and it features an RUO mode for development and an IVD mode for routine
diagnostics.
Smart instrument, smart features, and smart
productivity enabled by connectivity
• IVDR—meets IVDR requirements and technical
documentation requirements
• Results you can trust—detect diff erences in target quantity as
small as 1.5-fold in singleplex reactions, and obtain 10 orders
of magnitude of linear dynamic range
• Simple, powerful software—users can set up a run, lay out
assays, control the instrument, and analyze plates within
a single, easy-to-use touchscreen interface; no computer
is needed
• Proven performance—over 10 years of clinical real-time PCR
instrument manufacturing
• Effi cient—shorter run times compared to those with previous
QuantStudio Dx systems, minimal maintenance, and
compatibility with existing plastic consumables
• Enhanced security—SAE functionalities that assist with
compliance and have the ability to support multiple clients;
maintain centralized SAE settings that can be applied to
multiple instruments on the same network, allowing better
control for your IT department
• Instrument monitoring—use a mobile app to check
instrument availability and monitor run progress
• Voice command—enables selected hands-free operation by
voice control (Alexa services)
• Smart Help and Remote Support—Smart Help enables
you to report issues or request instrument services to reduce
downtime; remote access to device for troubleshooting
Take command of assay design
QuantStudio 7 Pro Dx Real-Time PCR
System (CE-IVD, IVDR)
Automatable
The application programming interface (API) enables
integration with a robotic plate mover, a liquid handler, and a
third-party system.
The QuantStudio 7 Pro Dx instrument is a
stand-alone system
The graphical user interface (GUI) enables an end-to-end
IVD workflow, offering the following features:
• Run setup with predefi ned assays
• Instrument controls
• Run monitoring
• Post-run data analysis, exporting, and reporting
• Maintenance and support
• SAE features to assist with 21 CFR Part 11 requirement
The instrument is Internet of Things (IoT)—enabled
(Thermo Fisher Connect Platform)
• Voice-activated controls
• Smart support
• Remote run monitoring
Routine testing at scale
Diomni software supports the use of multiple instruments and
users with centralized data management.
Take command of assay design
For In Vitro Diagnostic Use.
Learn more at thermofi sher.com/quantstudio7prodx
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E-signature and data approval
SAE software records test events, dates, user
names, and user roles and activity performed, for
documentation and archiving purposes.
Test results
Report records details for documentation, archiving,
and review-at-a-glance needs, including experiment
name, barcode, file name, time stamps (creation, run start, run
finish, duration, and modifications), instrument name, serial
number, experiment type, results summary, plate layout image,
standard curves, results table, and QC summary.
Cybersecurity
The system has passed penetration testing that fulfills
cybersecurity guidance from US regulatory bodies.
Features to maintain data quality and integrity
Specifications
QuantStudio 7 Pro Dx system
Sample capacity 96-well, 384-well
Reaction volume 96-well, 0.2 mL block: 10–100 μL; 384-well block: 5–20 µL
Excitation source Bright white LED
Filter or color combinations 6 decoupled filters, CMOS camera
Excitation/detection range 450–680 nm/500–730 nm
Multiplexing 5-plex with 1 passive reference; 6-plex with no passive reference
Maximum block ramp rate 6.5°C/sec
Average sample ramp rate 3.66°C/sec
Temperature uniformity ±0.5°C
Temperature range 4–99.9°C
Heating and cooling method Peltier
Independent temperature zones 6 VeriFlex Blocks zones (5°C zone-to-zone)*
Chemistries Fast and standard
Run time <30 min (fast mode)
Compatible dyes Applied Biosystems FAM, SYBR Green, VIC, ABY, NED, TAMRA, JUN, ROX,
Mustang Purple, and cyanine 5 dyes
SAE features Included
Automation-compatible Yes
Footprint (H x W x D) 55 x 34 x 53 cm
Weight 38 kg
* VeriFlex Block zones are only applicable for the 96-well, 0.2 mL block.
Automated quality control
Run data are systematically analyzed based on
predefined settings pertaining to each test, such as
validity of internal positive and negative controls. Assessment for
failed samples can be configured based on assay characteristics.
Reagent tracking
The system stores and archives information about
reagents used with each test, including lot number
and expiration date, with each run. Archived files can be retrieved
when required to track samples that were tested with a given set
of reagents.
Sample tracking
The system tracks sample name and type; captures
critical sample data, with parameters customizable
to fit the laboratory’s needs; and enables laboratories to more
easily track samples associated with a particular plate, a set of
reagents, a run date and time, and data files.
For In Vitro Diagnostic Use.
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An easy-to-use, reliable, IVD qPCR
system to put you in control
QuantStudio 5 Dx Real-Time
PCR System (CE-IVD, IVDR)
An instrument with premium performance at an aff ordable price
• IVDR—updated to meet IVDR requirements and technical
documentation requirements
• Results you can trust—detect diff erences in target quantity
as small as 1.5-fold in singleplex reactions, and obtain
10 logarithmic units of linear dynamic range
• Simple, powerful software—allows users to set up
a run, lay out assays, control the instrument, and conduct plate
analysis within a single, easy-to-use software interface
• Designed with the clinic in mind—an interactive diagnostic
instrument, with short run times and minimal maintenance, that
uses existing plastic consumables
• Security—SAE functionalities and the ability to support
multiple clients, plus centralized SAE settings that can be
applied to multiple instruments on the same network, allowing
better control for your IT department
• Peace of mind—the IVD test menu allows only authorized
tests to be run through IVD mode, helping to reduce the risk of
unauthorized use and accidental or intentional misuse
* Test development mode is for Research Use Only.
Designed to simplify workfl ows and minimize training needs,
the QuantStudio 5 Dx Real-Time PCR System can help you
get to your clinical answers quickly by fi tting seamlessly into
your established workfl ow. This compact, fl exible system
provides confi dence in performance and supports both
development and IVD modes.
For In Vitro Diagnostic Use.
• Flexibility you need—diagnose or develop, the choice is yours
with software options that guide you through every step of test
development* and IVD modes
• Maximize benchtop space—a compact instrument footprint
and a plate loading drawer at the front
• Superior support—services and support are available globally
by highly skilled, customer-focused staff
• QuantStudio system performance—the reliability, sensitivity,
and accuracy you expect, coupled with an intuitive and
simple-to-use interface that allows users of any experience
level to easily operate the system
Learn more at thermofi sher.com/quantstudio5dx
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Specifications
QuantStudio 5 Dx system
Sample capacity 96-well
Reaction volume 96-well, 0.2 mL block: 10–100 μL
Excitation source Bright white LED
Filter or color combinations 6 decoupled filters, CMOS camera
Excitation/detection range 450–680 nm/500–730 nm
Multiplexing 5-plex with 1 passive reference; 6-plex with no passive reference
Maximum block ramp rate 6.5°C/sec
Average sample ramp rate 3.66°C/sec
Temperature uniformity ±0.4°C
Temperature range 4–99.9°C
Heating and cooling method Peltier
Independent temperature zones 6 VeriFlex Blocks zones (5°C zone-to-zone)
Chemistries Fast and standard
Run time <30 min
Compatible dyes FAM, SYBR Green, VIC, ABY, NED, TAMRA, JUN, ROX, Mustang Purple, and cyanine 5 dyes
SAE features Included
Automation-compatible No
Footprint (H x W x D) 40 x 27 x 50 cm
Weight 26 kg
Features to help maintain quality and security
Maintenance and calibration reports
Records are updated automatically with maintenance
and calibration events and can be printed on demand,
documenting that the system has been maintained and calibrated
to vendor specifications.
Reagent tracking
The system stores and archives information about
reagents used with each test, including lot number
and expiration date, with each run. Archived files can be retrieved
when required to track samples that were tested with a given set
of reagents.
Sample tracking
The system tracks sample name and type; captures
critical sample data, with parameters customizable
to fit the laboratory’s needs; and enables laboratories to more
easily track samples associated with a particular plate, a set of
reagents, a run date and time, and data files.
E-signature history
SAE software records test events, dates, user
names, and user roles and activity performed, for
documentation and archiving purposes.
Experimental results
Report output records details for documentation,
archiving, and review-at-a-glance needs, including
experiment name, barcode, file name, time stamps (creation, run
start, run finish, duration, and modifications), instrument name,
serial number, experiment type, results summary, plate layout
image, standard curves, results table, QC summary plate, set of
reagents, run date and time, and data files.
For In Vitro Diagnostic Use.
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Streamline your lab workflow
Diomni Enterprise Software
Single encapsulation for assay workflow into one
setup file:
• Define the assay-specific run protocol, QC parameters,
analysis settings, and result interpretation in one
place—start in development phase, iteratively adjust for
verification and validation, and submit your validation evidence
with your assay submission
• Choose the workspace designed specifically for your
assay stage—each assay has a development status that
can be used as your assay moves through the development
process by choosing the RUO/IUO/IVD workspace that
corresponds to each stage; functionalities in each workspace
are optimized to support the matching objectives
– RUO workspace—support iterative changes to the assay
definition during the assay development phase; routine
RUO tests
– IUO workspace—support verification and validation runs
for product development
– IVD workspace—support routine testing for IVD tests
• Expand test menu with speed—assays may be added to the
system without requiring a software upgrade
Assay-driven runs:
• Use of predefined protocols to reduce time and error in
run setup
• Result interpretation according to your assay and automated
QC saves time and effort for data review
• Problematic data callout and QC tools make data review
quicker and easier
Easily integrated into development workflows:
• Self-certify—assays can be published in Diomni software to
lock down parameters and prevent user error when ready for
routine testing and clinical trials, and after regulatory approval
• Customized data input and output—make data transfer
between LIS simple and flexible
• Configurable reporting—tailor the PDF report to your needs
• Integrate with LIS/LIMS—reduce manual steps to transfer
data through configurable and automated sharing of results;
additional traceability through ASTM communication to receive
sample and test information available with full integration
• IT friendly—the client server deployment model will enable
your lab to maintain the software with ease and manage your
lab in a secured, centralized location
Specifications:
• Microsoft Windows 10 or Windows 11 operating system
• Supported browsers: Google Chrome, Microsoft Edge,
Apple Safari (OS X), and Mozilla Firefox
• Client server model designed for setup on local network
• SAE Administrator Console Dx Software v1.2
• Instrument compatibility: Applied Biosystems QuantStudio
7 Pro series and QuantStudio 5 series real-time PCR systems
Diomni software makes assay design on QuantStudio instruments more efficient,
from development and verification to validation and launch.
For In Vitro Diagnostic Use.
Learn more at thermofisher.com/diomni
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Develop your assay, then run it with ease using the Diomni software workspaces
Reduce time-to-market with the assay developer workflow
in Diomni software
Development Sample-to-report workflows
Assay definition
management
IUO
Investigational*
RUO
Research
IVD
In vitro diagnostic
Feasibility Early to
mid-development Validation Late-development
verification Submission Launch
Develop ADF Validate ADF Release ADF
ADF Lock down ADF Obtain approval
For In Vitro Diagnostic Use.
* Investigational use only. Performance evaluation is only available upon request.
Each instrument is equipped with a security, audit, and electronic signature
(SAE) module to assist in compliance with regulatory requirements that involve
a quality management system (QMS), GMPs, cybersecurity, and electronic
records and signatures.
• Secure access to instruments and data
• Role-based permissions for different lab personnel
You’re in control of assay design with the Diomni software self-certifying process to seamlessly
transition through the test development stages. Once your assay has obtained approval for
IVD use, the ADF can be locked and distributed as a final product for easy plug-and-play use.
Your customers will reduce setup time and reduce error using your supplied IVD-labeled ADF.
Security features fit
for molecular diagnostics
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For In Vitro Diagnostic Use.
Get started with our global customer
concierge services*
Count on our dedicated customer concierge services for
an exceptional and seamless experience implementing your
QuantStudio real-time PCR IVD systems. From order placement
through installation and training, our team is here to streamline
and simplify the process by:
• Preparing your laboratory space for a successful installation by
providing critical documentation and checklists
• Connecting your IT department with our IT specialists to
help ensure an easy and secure network connection, so you
can take advantage of cutting-edge features and advanced
digital support
• Coordinating instrument installation with a highly skilled field
service engineer (FSE)
• Scheduling interactive SmartStart Orientation training with an
experienced field application scientist (FAS)
* Concierge services are available in certain geographies.
A standard of support that’s a cut above
Thermo Fisher Scientific offers a comprehensive range of services and support to keep your
QuantStudio real-time PCR IVD systems performing at peak level. Your instrument purchase
comes with a standard 1-year factory warranty, customer concierge services, SmartStart
Orientation, and an advanced digital service ecosystem built right into the instrument.
Extended warranty coverage is also available at the time of purchase for total peace of mind.
SmartStart Orientation enables your success
Both QuantStudio 5 Dx and QuantStudio 7 Pro Dx Real-Time
PCR Systems come with SmartStart Orientation to help your
team quickly become proficient using the new software features
and instrumentation. Led by an experienced FAS, this interactive
course is a 1-day instrument- and software-based training that
covers the principles of quantitative real-time PCR and how to
use the QuantStudio instrument, Diomni software, and SAE
features. The course will cover the following topics:
• Proper experimental technique
• Basic workflow
• Software features and data analysis features
• Discussion of instrument maintenance
• Certificate of Training Completion for up to three users
Keep advancing with
new technology.
We’ve got your back.
Get superior service and support to maximize
your investment
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For In Vitro Diagnostic Use.
Digital services and support ecosystem and
on-demand support at your fi ngertips
Your new QuantStudio 7 Pro Dx Real-Time PCR System is
equipped with a state-of-the-art ecosystem of digital services
and support so you can access our network of over 2,000 trained
professionals at the touch of a button. With Smart Help you can
easily share log and run files to speed up service troubleshooting
and, if needed, request a service visit. Remote Support
features enable our technical team to see your instrument in real
time and interact with you on the instrument screen to resolve
issues virtually.
Find out how our digital support helps resolve up
to 70% of cases in minutes, not days, enabling
you to focus on your next scientific breakthrough.
thermofisher.com/digitalserviceecosystem
Comprehensive warranty and service plans to protect
your investment
Choose from a range of extended-coverage service plans to
meet your budget and needs. In addition to the standard 1-year
warranty, these plans offer:
• Preventive maintenance
• Access to advanced troubleshooting features, including
Smart Help and Remote Support
• Prioritized response time
To build your personalized service quote, go to
thermofisher.com/serviceselector
Enjoy premium coverage with our premier service plan
The Applied Biosystems AB Platinum plan is our top-tier total
solution designed not only to optimize instrument performance
and uptime, but also to provide a seamless experience and
prompt resolutions.
Key features of the AB Platinum plan include:
• 98% uptime guarantee*
• Comprehensive repair coverage
• Rapid-response on-site support**
• Priority Technical Support†
• Qualifi cation services
• Digital remote support
• Additional FAS training (2-hour virtual consultation)
Find out more about the AB Platinum service plan at
thermofisher.com/abplatinum
* Terms and conditions apply. For complete details, go to AB Platinum terms and conditions.
** Rapid-response on-site support within the next business day is subject to regional availability.
† Priority Technical Support is available in the English language only.
98% uptime
guarantee
with the AB Platinum service plan*
70% remote
resolution
using Smart Help and Remote
Support features
Learn more at thermofi sher.com/instrumentservices
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TaqPath master mixes for real-time PCR
Delivering confidence and performance
TaqPath master mixes are designed to deliver confidence and
performance for even your most demanding clinical applications.
With over 15 years of leadership in clinical real-time PCR, we are
committed to providing trusted, versatile, and innovative tools.
All TaqPath qPCR master mixes are:
• Designed using fluorogenic 5´ nuclease chemistry
• General purpose reagents (GPRs) registered with the US FDA
• Manufactured in ISO 13485–certified facilities under CGMP
• Supported by a comprehensive compliance
document package
• Labeled “For Laboratory Use” applications
• Quality controlled to help ensure lot-to-lot consistency
• Ready for IVD assay development and regulatory
body submission
TaqPath DuraPlex 1-Step RT-qPCR Master Mix
Applied Biosystems TaqPath DuraPlex 1-Step RT-qPCR
Master Mix is a benchtop-stable reagent optimized for rapid,
sensitive, and reproducible detection of viral and bacterial
pathogens, even in the presence of PCR inhibitors. The
automation-ready master mix comes in a 4X concentrated
formulation that is capable of multiplexing up to 6 targets in a
single well. Formulations are available with and without ROX
passive reference dye (Figure 1).
TaqPath BactoPure Microbial Detection Master Mix
Applied Biosystems TaqPath BactoPure Microbial Detection
Master Mix is for clinical customers who need a rapid method
for low-level DNA pathogen detection on a variety of targets
using complex samples. We offer the TaqPath BactoPure
master mix which—unlike competitors’ mixes—offers the lowest
limit of detection across common microbial targets of interest
(e.g., bacteria, as demonstrated by a 16S rRNA assay). TaqPath
BactoPure master mix is available with or without ROX dye to be
compatible with higher-order multiplexed assays.
TaqPath ProAmp Master Mix
Applied Biosystems TaqPath ProAmp Master Mix is for
high-throughput genotyping and copy number variation protocols
requiring uncompromising reliability and accuracy, even in the
presence of inhibitors commonly found in clinical samples. It is
designed to deliver sensitive and confident results from genomic
DNA targets on a broad range of qPCR instrument platforms.
TaqPath ProAmp Master Mix is manufactured under a strong
ISO 13485 quality management system and is designed to
produce consistent product performance, lot after lot.
TaqPath qPCR Master Mix, CG
Applied Biosystems TaqPath qPCR Master Mix, CG, is a
2X formulation designed for gene expression and miRNA
analysis, containing a thermostable fast DNA polymerase and
dNTPs in an optimized buffer solution for maximum robustness
and reproducibility.
For Laboratory Use.
Learn more at thermofisher.com/qpcr-taqpathmastermix
30
25
20
15
10
5
0
Lot
Cq
Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3
B2M
FN1
FZD1
GAPDH
RNase P
TFRC
Target
RNase P 30
25
20
15
10
5
0
Lot
Cq
Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3
B2M
FN1
FZD1
RNase P
RNase P
TFRC
Target
Figure 1. Three unique lots of TaqPath DuraPlex 1-Step RT-qPCR Master Mix were tested for consistency in performance. (A) Cq values for
all 6 gene targets are similar in a multiplex reaction tested with the version of the product with no passive reference dye. (B) Cq values for all 5 gene
targets are similar in a multiplex reaction tested with the ROX version of the product.
A B
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For Laboratory Use.
TaqPath DuraPlex
1-Step RT-qPCR
Master Mix
TaqPath BactoPure
Microbial Detection
Master Mix
TaqPath ProAmp Master Mix TaqPath qPCR
Master Mix, CG
Check price or order now Check price or order now Check price or order now Check price or order now
Recommended
applications
Pathogen detection,
gene expression Microbial detection SNP genotyping,
copy number variation
Gene expression,
microRNA analysis
Target RNA DNA gDNA cDNA
Multiplexing
and passive
reference dye
With ROX dye
(up to 5 targets)
No ROX dye
(up to 6 targets)
With ROX dye
(up to 3 targets)
No ROX dye
(>3 targets)
With ROX dye
(up to 3 targets)
With Mustang Purple dye
(>3 targets)
With ROX dye
(up to 3 targets)
Assay
recommendation Applied Biosystems TaqPath qPCR assays
Request a sample* Request a sample* Request a sample* Request a sample*
* No purchase necessary to receive evaluation sample. Participation is open only to life science professionals in the US (excluding Puerto Rico) and Canada who are 21 years or older. Completed evaluation
sample request forms must be received no later than December 31, 2024, at 6:00 p.m. PT, or until evaluation samples are depleted, whichever comes first. Limit one evaluation sample per lab. By submitting
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Applied Biosystems MicroAmp PCR plastics have been designed and tested to
work with our instruments and enable optimal performance.
MicroAmp qPCR plastics are:
• Verifi ed on Applied Biosystems thermal cyclers for optimal fi t and performance
• Designed to perform on all Applied Biosystems IVD qPCR instruments
• Designed for optimal heat transfer, with thin-walled polypropylene wells
• Designed to reduce cross-contamination, with raised well rims for
eff ective sealing
High-performance PCR plastics
for optimal qPCR results
MicroAmp qPCR plastics
Applied Biosystems MicroAmp EnduraPlate optical microplates, GPLE
Formats
96-well
96-well Fast
384-well
DNA-, RNase-, and PCR inhibitor–free Yes
ANSI/SBS standard dimension color Clear
Instrument compatibility Use our plastics selection tool
Barcode Yes (3 sides)
Multiple applications Yes
Optical compatibility Yes
Which qPCR plastic is right for you?
Find the plastic format with the throughput and features for your application
For Laboratory Use.
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Find the plastics and accessories you need for your
instrument quickly
Product
QuantStudio 7 Pro
Dx system
QuantStudio 5
Dx system Cat. No.
96-well, 0.2 mL reaction plates
MicroAmp Optical 96-Well GPLE Reaction Plates (10 plates) • • 4481191
MicroAmp Optical 96-Well GPLE Reaction Plates with Barcode
(10 plates) • • 4481192
MicroAmp EnduraPlate Optical 96-Well GPLE Clear Reaction
Plates with Barcode (20 plates) • • 4483348
MicroAmp EnduraPlate Optical 96-Well GPLE Clear Reaction
Plates with Barcode (500 plates) • • 4483351
384-well reaction plates
MicroAmp Optical 384-Well GPLE Reaction Plates with Barcode
(50 plates) • 4481195
MicroAmp EnduraPlate Optical 384-Well GPLE Clear Reaction
Plates with Barcode (20 plates) • 4483319
Seals and covers
MicroAmp Optical Adhesive Covers GPLE (25 films) • • A49767
Accessories
Splash-Free 96-Well Base • • 4312063
96-Well Support Base • • 4379590
For Laboratory Use. In Vitro Diagnostic Use.
18
Empower your molecular diagnostics: The future is here thermofisher.com/qpcr-molecular-diagnostics
Leveraging our state-of-the-art genetic sciences tools and solutions, the Licensing and Commercial Supply
(LCS) team helps our partners commercialize assays within a wide range of applications, including infectious
disease and oncology. Our team is aligned to help you navigate potential speed bumps on your path to
commercialization by providing you value beyond just products in our partnerships. Our team also specializes in
providing support for those in the ideation and feasibility phases.
We bring the right mix of solutions you need to help you on your path and combine these solutions with the
quality you can expect from Thermo Fisher Scientific.
Evaluate options to
build in-house or partner
Partner/
build
decision
Functional
and business
requirements
Development
and optimization
Initial trial Pilot of clinical studies Design transfer
through regulatory
clearance
Product launch
and maintenance
Supply
chain
setup
Regulatory
documentation
and support
Design
lock
Feasibility Development Verification Validation Regulatory
clearance
On the
market
• Commercial use rights
• Compliance documentation support
• Custom assay development
• Custom manufacturing
• Globalized footprint
• High-efficiency technology transfer
• Novel content and technology
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• Quality products and services
• Security of supply
As part of Thermo Fisher, our global regulatory team with expertise in established quality management systems;
FDA-, NMPA-, CE-IVD (including IVDR)–compliant facilities; manufacturing quality standards; and global trade
compliance can support your business, allowing you the freedom to focus on your priorities.
Commercial supply partnerships
for MDx assay developers
Example client assay development process
We begin working with your leadership team in the development of a value proposition to identify the solution
best suited for your success. Your innovation can receive the highest benefit from partnering during the
feasibility and development stages, prior to locking in your design.
Our support varies depending on where you are in your development process and includes:
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Further explore our molecular diagnostic offerings at
thermofisher.com/qpcr-molecular-diagnostics
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