Real Time PCR System

Trade Agreement: NAFTA/AIT/Canada FTAs with Peru/Colombia/Panama
Tendering Procedures: Generally only one firm has been invited
to bid
Attachment: None
Non-Competitive Procurement Strategy: Interchangeable Parts
Comprehensive Land Claim Agreement: No
Vendor Name and Address: 
Life Technologies Inc.
5250 Main Way
Burlington Ontario
Canada
L7L5Z1
Nature of Requirements: 
Marlene Hall
Supply Specialist
Telephone:  204 984-6423
E-mail:  marlene.hall@pwgsc-tpsgc.gc.ca

File No.: 6D063-132302/A



TITLE:	Real Time PCR System

Public Works and Government Services Canada (PWGSC), on behalf
of Public Health Agency Canada (PHAC), intends to negotiate with
Life Technologies Inc. for the provision of a Real Time PCR
System.


DEFINITION OF REQUIREMENT
The Public Health Agency of Canada has a requirement for the
supply and delivery of one (1) ViiA 7 Real Time PCR System.  

The National Laboratory for HIV Reference Services (NLHRS)
represents Canada's premier reference laboratory for HIV and
HTLV testing in support of testing programs conducted by
provincial ministries of health and the Canadian Blood Services.
Our role is to strengthen the country's capacity to diagnose,
detect and characterize HIV infection, which threatens the
public health system and blood supply. Our reference diagnostic
testing program and Reference Material, Proficiency testing and
External Quality Control program supports national and
international stakeholders. As well, our Surveillance program is
at the leading edge of new and novel HIV and Hepatitis C testing
due to its reference diagnostic and technical capacity and we
have the ability to rapidly 'alert' public health and blood
screening agencies of potential new threats. We have extensive
experience in molecular and serological testing, from a variety
of sample types, for HIV-1 and HIV-2 as well as other human
retroviruses (Human T-cell Leukemia Virus (HTLV-I, HTLV-II), SIV
and endogenous retroviruses (ERVs)). Our laboratory is also
actively involved in the development and optimization of new and
innovative technologies.  

The NLHRS also possesses an invaluable expertise in HIV
serological and molecular testing of challenging samples (whole
blood, cell pellets, plasma, formalin fixed and frozen tissue
and dried blood spots (DBS), etc.) for Canadian provinces and
the Canadian Blood Services. This requires us to deliver time
sensitive results in a timely manner in order to avoid
devastating consequences for patients across Canada.

The NLHRS has a need for a multi-functional thermal cycler that
has the capacity to perform high resolution melting (HRM). The
NLHRS currently borrows a Life Technologies ViiA™ 7 Real-Time
PCR System from a different lab.  HRM is used for the
determination of genetically diverse HIVs that are sent to us by
Canadian Public Health Labs. The method, chemistry and software
that have been part of the development of the standard operating
procedure (SOP) has taken considerable time to develop. Although
there are other vendors who may have the ability to perform HRM,
the ViiA7 technology has already been established and is already
part of our workflow. The justification for a second unit is to
enhance our productivity (increase through-put) without
disrupting the current workflow.

The Real Time PCR System must be compatible with running our
current diagnostic tests which are currently being performed
manually. Compatible means that migration from the current
platform to a new platform will be seamless. No other instrument
would be acceptable as it would not fall within our current
workflow or be able to be used interchangeably with the current
instrument the NLHRS borrows. 


SECURITY REQUIREMENT
There is a security requirement associated with this requirement.


Any interested supplier must demonstrate by way of a statement
of capabilities that its product meets the following mandatory
requirements:

PERFORMANCE/ CRITERIA/OBJECTIVES/SPECIFICATIONS
1.	The Real Time PCR HRM system must be compatible with the
current chemistry and workflow.
2.	The Real Time PCR HRM system must have the option of
user-interchangeable blocks to accommodate 96-well, Fast 96-well
low volume, 384-well plates or TaqMan® Array Cards. No service
visits or re-calibration are necessary after a block change. The
interchangeable blocks must be accessible from the front of the
instrument to help maximize bench space and provide tool-free
block exchange capability.

3.	The Real Time PCR system must have the capacity to perform
high resolution melting (HRM).
4.	The Real Time PCR system must have the option for automation
compatibility to maximize productivity.

5.	The Real Time PCR system must not be limited to needing
liquid-handling robots or complex pipetting to use the 384-well
plates. 

6.	The Real Time PCR system must have procedures in place for
data recovery capabilities.

7.	The Real Time PCR system must have a minimum of six decoupled
excitation and emission filter channels for multiplexing.

8.	The instrument includes a user-interchangeable light source
that is readily accessible and can be replaced from the front of
the instrument. The light source has a median lifetime of at
least 2000 hours.

9.	The Real Time PCR system must allow for flexible data
collection, including during temperature ramp stages.

10.	The Real Time PCR system must be able to detect target
quality changes as small as 1.5 fold in a singleplex reaction.

11.	The ability to monitor the progress of the PCR reaction as
it occurs in real-time.

12.	The ability to precisely measure the amount of amplicon at
each cycle.

13.	An increased dynamic range of detection compared to other
nucleic acid detection methods.

14.	The combination of amplification and detection in a single
tube, which eliminates post-PCR manipulations
.
15.	The instrument must have an on-board computer and can run in
standalone mode, without a computer attached. The on-board
computer must also have the ability to store protocols for quick
run starts without needing a separate computer. The instrument
must also allow for uploading of protocols or downloading of run
files using a USB interface.

16.	The instrument includes a license to software at no cost
that is designed to collect and analyze the fluorescence data
for the applications of absolute quantification, relative
quantification, presence/absence assays, and allelic
discrimination/SNP (Single Nucleotide Polymorphism) detection.
The instrument software must also provide raw fluorescent data
and multicomponent (segregated by dye type) data for
troubleshooting of experiment. Instrument software must also
include statistical analysis tools like Box-Whisker plots to
assess Ct distribution, scatter plots and heat maps to assess
sample correlation and quality.

17.	The Real Time PCR system, in addition to  high resolution
melting  (HRM) must support a variety of application including:
-	Mutation Scanning -	Gene expression
-	MicroRNA profiling
-	SNP genotyping
-	Copy number variation
-	Protein assays with proximity ligation assays
-	Non-coding and Pri-miRNA assays
-	Pathogen Detection, Strain Typing, and Viral Load
-	Methylation and other Epigenetic Applications

JUSTIFICATION FOR PRE-IDENTIFIED SUPPLIER
Life Technologies Inc. is the only known supplier that can
provide a Real Time PCR System that meets all of the mandatory
performance specifications.


TRADE AGREEMENTS
The following limited tendering reasons pertain to this
requirement:

Government Contract Regulations, Part 1, Section 6(d) only one
person is capable of performing the contract.

Government on Internal Trade (AIT), Article 506-12(a) to ensure
compatibility with existing products, to recognize exclusive
rights, such as exclusive licences, copywright and patent
rights, or to maintain specialized products that must be
maintained by the manufacturer or its prepresentative;

North American Free Trade Agreement (NAFTA), 1016.2(d) for
additonal deliveries by the original supplier that are intended
either as replacement parts or continuing services for existing
suppliers, services or installations, or as the extension of
existing suppliers, services or installations, where a change of
supplier would compel the entity to procure equipment or
services not meeting requirements of interchangeability with
already existing equipment or services, including software to
the extent that the initial procurement of the software was
covered by this Chapter;


DELIVERY DATE
The equipment must be delivered on or before March 31, 2014, FOB
destination.


PRE-IDENTIFIED SUPPLIER
Life Technologies Inc.
5250 Mainway
Burlington, Ontario
L7K 5Z1
Delivery Date: Above-mentioned

You are hereby notified that the government intends to negotiate
with one firm only as identified above. Should you have any
questions concerning this requirement, contact the contracting
officer identified above.

An Advance Contract Award Notice (ACAN) allows departments and
agencies to post a notice, for no less than fifteen (15)
calendar days, indicating to the supplier community that it
intends to award a good, service or construction contract to a
pre-identified contractor. If no other supplier submits, on or
before the closing date, a Statement of Capabilities that meets
the requirements set out in the ACAN, the contracting authority
may then proceed with the award.  However, should a Statement of
Capabilities be found to meet the requirements set out in the
ACAN, then the contracting authority will proceed to a full
tendering process.

Suppliers who consider themselves fully qualified and available
to provide the services/goods described herein, may submit a
statement of capabilities in writing to the contact person
identified in this Notice on or before the closing date of this
Notice. The statement of capabilities must clearly demonstrate
how the supplier meets the advertised requirements.

The PWGSC file number, the contracting officer's name and the
closing date of the ACAN must appear on the outside of the
envelope in block letters or, in the case of a facsimile
transmission, on the covering page.

The Crown retains the right to negotiate with suppliers on any
procurement.

Documents may be submitted in either official language of Canada.