Materials Distribution Services

ITEM

DESCRIPTION

UNIT PRICE

PACKAGING

CATALOG NUMBER

1

HPV REAGENTS - cobas® 4800 HPV Amplification/ Detection Kit

$3,318.34

240

O5235880190

2

HPV HR KIT - cobas® 4800 HPV Controls Kit

$360.00

10 sets of 24

O5235855190

3

HPV HR COCKTAIL PROBES  - cobas® 4800 System Sample Preparation Kit   

$144.00

240

O5235782190

4

HPV 16 PROBE - cobas® 4800 System Liquid Cytology Preparation Kit

$144.00

240

O5235812190

5

HPV 18 PROBE   - cobas® 4800 System Wash Buffer Kit   

$72.00

240

O5235863190

6

POSITIVE CONTROLS - CO-RE Tips, 100 µl

$285.60

3,840

O4639642001

7

NEGATIVE CONTROLS - cobas® 4800 System Extraction Plat      

$624.40

50

O5232716001

8

HOUSEKEEPER OR HUMAN DNA CONTROL   - Reagent Reservoir, 50mL      

$720.30

200

O5232732001

9

DISPOSABLE KIT - Reagent Reservoir, 200mL

$768.60

100

O5232759001

10

PIPETTES - Sarstedt Tubes

$110.60

500

O6395023001

11

WELL PLATE KIT - Sarstedt Caps

$200.20

5,000

O6395015001

12

cobas z 480 Microwell Plate and Sealing Film

$960.40

50

O5232724001

13

cobas® 4800 CT/NG Amp/Detection Kit

$1,017.98

1 (240)

05235936190

14

cobas® 4800 CT/NG Controls Kit

$210.00

10 sets (240)

05235928190

15

cobas® PCR Urine Kit

$75.00

1 (100)

05170486190

16

cobas® PCR Female Swab Kit

$75.00

1 (100)

05170516190

ITEM #

CATALOG OR 
MODEL #

DESCRIPTION

1.

0520089001

cobas x 480 Instrument

2.

05200881001

cobas z 480 Analyzer

Reagents

$4.46

Consumables

$3.04

Total

$7.50

I.

HPV Automated Testing Instrumentation and Reagents Specifications

1.

The HPV Automated Testing Instrumentation must provide amplification and detection of high risk HPV through other methods that have been FDA approved

2.

The HPV Automated Testing Instrumentation must  test for 14 High Risk types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, plus additional HR types.

3.

HPV types 16 and 18 are reported separately from the 14 type cocktail in one run.

4.

The HPV Automated Testing Instrumentation must include a house keeper control in order to provide documentation that each test has adequate amount of human DNA.

5.

The HPV Automated Testing Instrumentation must include positive and negative controls that are run with each sample.

6.

The HPV Automated Testing Instrumentation must have FDA approval for Hologic ThinPrep collection using PreservCyt.

7.

The HPV Automated Testing Instrumentation must provide a minimum of 84 patient results in eight hour period, and the department would prefer up to 200 patient results in an eight hour period.

Number of patient results your equipment will provide in 8 hour period:  Minimum 84 / Maximum 188

8.

The HPV Automated Testing Instrumentation must require only 2mL of sample to be used for testing.

9.

Aliquot must be able to be performed before or after Pap test processing.

10.

All equipment required for the automated HPV platform test is provided by the Contractor and must be part of the reagent rental price.

11.

All disposable products (pipette tips, well plates, etc) should be part of the reagent rental price.

12.

Equivocal or suboptimal testing results are kept at a minimum and staff are able to troubleshoot cut off points to determine whether or not specimen has a high likelihood of being successful in a subsequent run.

Equivocal or suboptimal result findings:  NONE  No manual adjustment is required.

13.

Automated platform should also be able to test CT/NG tests along with other oncologic molecular tests.

14.

HPV testing platform must be able to be used for research purposes and validate non-FDA approved products.

15.

Provide reagent supplies for student education and training. The WSLH Cytotechnology school would like to be able to train and allow each student (up to 12/year) to process at least one full patient run.  One extra kit is provided by the Contractor each year for special student training.

Contractor is willing to provide extra kits/year:  This request will need to be considered under a separate product donation process.  Roche is unable to include a product donation in an RFP.

16.

Contractor should provide a schematic or drawing of instrument  footprint along with requirements for electrical outlets.

17.

Contractor must provide on-site warranty for repairs within 24 hours, and to fix the problem within 4 working days. 

18.

If the equipment is down for 5 days or more, the Contractor must provide loaner equipment.

II.

Installation and Training

1.

The system must include unit installation and training for at least one technologist.

2.

The training should be a minimum of 2 to 3 days, and preferably should be off-site.

Training will occur:  Indiana

3.

Delivery and set up of equipment should be done by the Contractor, and is expected to take 1-3 days.  It can be done at the same time as off-site training.

4.

Implementation of initial training to be done on-site should take approximately 1 day.

5.

Method verification is expected to take 5 days and start after implementation methods are complete and signed off.  It is expected that all testing personnel will go through  the verification process.  WSLH expects the Contractor to be present for at least one staff member to verify the system, and be available by phone for the rest of the personnel to verify the system.  This may take longer than one week depending on verification findings.

6.

Building modifications may be necessary.  Upon award, the WSLH and Contractor will work together to ensure the best place for the equipment in the lab along with additional requirements.  It is expected the equipment will require special electrical outlets and that the Contractor will cover the cost for the outlets.  UW facilities management will be responsible for putting in the additional electrical outlets.  This may take two or more weeks depending on WSLH, Contractor and UW Facilities current plans.

7.

Reagents used during implementation and verification should be provided at no additional charge.  This will include side by side testing of both the old and new methods along with result comparisons by all three testing personnel.

8.

Contractor must provide equipment/operation manuals and special software for instrumentation at time of delivery and installation.

9.

Contractor must provide all supplies related to installation, implementation and verification and running of patient results.  This might include:  cabling, piping, computer, monitor, consumable supplies and reagents and safety equipment.