Evolis Twin Plus

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: Exclusive Rights
Comprehensive Land Claim Agreement: No
Vendor Name and Address: 
BIO-RAD LABORATORIES (CANADA) LIMITED
2403 Guénette
Montréal Quebec
Canada
H4R2E9
Nature of Requirements: 
Marlene Hall
Supply Specialist
Telephone:  204 984-6423
E-mail:  marlene.hall@pwgsc-tpsgc.gc.ca

File No.: 6D063-132296/A



TITLE:	EVOLIS Twin Plus
Public Works and Government Services Canada (PWGSC), on behalf
of Public Health Agency Canada (PHAC), intends to negotiate with
Bio-Rad Laboratories (Canada) Ltd. for the provision of an
EVOLIS Twin Plus System.


DEFINITION OF REQUIREMENT
The Public Health Agency of Canada has a requirement for the
supply, delivery, installation and training of one (1) EVOLIS
Twin Plus 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 (HCV)
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. The
surveillance studies focus on a number of various risk groups
which include, intravenous drug users, men who have sex with
men, street youth, aboriginal and people from endemic countries.
These surveillance studies are critical in tracking the spread
of the virus. This allows epidemiologists to see which groups
are at higher risk, where prevention programs are needed and
which prevention programs are working successfully, resulting in
more efficient use of funding. 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)). Sample types can include but
are not restricted to whole blood, cell pellets, plasma,
formalin fixed and frozen tissue and dried blood spots (DBS).
Our laboratory is also actively involved in the development and
optimization of new and innovative technologies.  

The NLHRS has a need for a fully automated enzyme immunoassay
(EIA) processor, specifically the EvolisTM Twin Plus System from
Bio-Rad to improve efficiency and reduce variability in sample
testing. 
Current diagnostic testing and projects testing samples from
national surveillance studies require the manual application of
tests with the number of samples ranging from hundreds to
thousands which must be tested in a timely manner. These assays
have numerous steps and involve incubations of various times,
some ranging from 5 minutes to 60 minutes. Due to the strict
time requirements and hands-on work, a technician is limited
both in the number of samples they can run in a day and the
amount of other work they can accomplish. The variation between
runs is also increased because of differences in technicians and
technique. In the current absence of an automated system this
requirement addresses the ability to perform these tests as
close to an automated fashion as possible.  The ability of this
instrument to: support different functions such as aliquoting,
diluting and archiving; running  many samples from primary
containers; run multiple assays at the same time; and
automatically recording and monitoring Quality Control
functions, will increase the through-put and efficiency of the
lab, reduce worker fatigue and injury, and aid in meeting ISO
15189 accreditation requirements.

The EVOLIS Twin Plus system from Bio-Rad Laboratories is the
only system on the market that can meet the mandatory
specifications This system has obtained Class IV Medical Device
licensing from Health Canada for In Vitro Diagnostic Devices
(IVDD) which allows it to be used for automated processing of
tests that diagnose transmissable blood born pathogens in blood
and blood products for transfusions or tissues for
transplantation.

To change the workflow in order to accommodate for the
automation of another instrument would be costly and time
consuming. It would also require the use of HIV and HCV positive
samples for validation which are precious and hard to come by in
sufficient volumes. We found no other Health Canada approved
Class IV medical device on the market with automation from
sample input to result in a closed system that can accommodate
the throughput needed by the NLHRS that also allows for complete
traceability for our ISO 15189 accreditation requirements.


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


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

1.	Due to the pathogenicity of HIV this instrument must be a
Health Canada approved Class IV
	medical device
	a.	An excerpt from Medical Devices Regulations (SOR/98-282)
PART 2 IN VITRO 
		DIAGNOSTIC DEVICES (IVDD): Use with respect to Transmissible
Agents 
		(http://lois-laws.justice.gc.ca/eng/regulations/SOR-98-282/page
-23.html#h-68):
		An IVDD that is intended to be used to detect the presence of,
or exposure to, a 
		transmissible agent in blood, blood components, blood
derivatives, tissues or organs to 
		assess their suitability for transfusion or transplantation is
classified as Class IV.

2.	The instrument must have an integrated QC program to monitor
reagent lot numbers and to trace 	
	events (monitor for errors in process), this complete
traceability is required to comply with our 
	lab's ISO 15189 accreditation requirements.

3.	The Instrument must have a compact design (must be small
enough to fit on lab bench) 

4.	The instrument must be a closed system and must not be
required to be placed in a biological 
	safety cabinet.

5.	The Instrument must be fully automated, from the beginning of
the process (direct sample input) 
	to the end result. The instrument must be able to perform a
pre-dilution step automatically without 	
	any manual manipulation beforehand.

6.	The instrument must be able to load up to 144 samples.

7.	The instrument must be able to run 3 full 96-well plates in a
day.

8.	The Instrument must have the capacity to incubate at
different temperatures (RT, 37°C, 40°C) 
	with shaking capacity.  Incubation times must be programmable.

9.	The instrument must have greater than one (>1) incubator to
allow for different temperature and 
	shaking options.

10.	The Instrument must have a  washer manifold capable of
washing flat, U and V-shaped plates

11.	The Instrument must have a sample dispenser with a minimum
volume of 10uL up to 1,000uL. 
	This minimum volume is critical considering that limited
volumes of samples will be used.

12.	The instrument must be able to verify pipetting accuracy
with different methods (Capacitive, and 
	Barometric) to alert when potential mishandling of samples
and/or reagents has occurred.

13.	The instrument must use disposable tips to eliminate
carryover contamination. 

14.	The Instrument must have an absorbance reader for single or
dual wavelength and have a filter 
	wheel with 450, 492 and 620 filters

15.	The Instrument must have the capability to:
	a.	perform plate dilutions 
	b.	distribute primary samples and reagents directly from
original containers 
	c.	accept a wide range of primary tube sizes

16.	The instrument must be able to archive samples to
microplates and be able to link with sample 
	storage inventory.


JUSTIFICATION FOR PRE-IDENTIFIED SUPPLIER
Bio-Rad Laboratories (Canada) Ltd. is the only known supplier
that can provide an EVOLIS Twin Plus 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(b) where
there is an absence of competition for technical reasons and the
goods or services can be supplied only by a particular supplier
and no alternative or substitute exists;

North American Free Trade Agreement (NAFTA), 1016.2(b) where,
for works of art, or for reasons connected with the protection
of patents, copyrights or other exclusive rights, or proprietary
information or where there is an absence of competition for
technical reasons, the goods or services can be supplied only by
a particular supplier and no reasonable alternative or
substitute exists;


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


PRE-IDENTIFIED SUPPLIER
Bio-Rad Laboratories Ltd.
2403 Guénette
Montréal, Quebec
H4R 2E9
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.