B-26027 ELFA Bid Specs.docx

BID SPECIFICATIONS

For Automatic Enzyme-Linked Fluorescent Immunoassay

The Illinois Department of Public Health, Division of Laboratories intends to procure an automated Enzyme-Linked Fluorescent Assay (ELFA) system to rapidly and accurately detect the most common pathogens in food including but not limited to E. coli O157:H7, Salmonella species, Campylobacter, Listeria including Listeria monocytogenes and Staph Enterotoxins.

A. THE VENDOR’S RESPONSE TO THE BID SOLICITATION MUST CONTAIN:

1.) Instrument Cost including warranty details.

2.) Instrument maintenance and repair coverage for 4 years including 1-year warranty and 3 additional years of service coverage. Include service plan details in the bid.

3.) Price per test for all testing reagents to identify: E. coli 057:H7, Salmonella species, Campylobactor, Listeria sp. (including L. monocytogenes), and Staph Enterotoxin. Base pricing on an estimated _____ tests per year.

**Bid can be submitted with this table as a separate document or using the Items Tab.

ELFA Instrument (including 1 year warranty)

1 Instrument

Per Test Cost for Commodities

1,600 Tests

Repair and Maintenance for ELFA Instrumentation for Years 2-4

3 Years

TOTAL QUOTE (Add 3 rows from above)

B. KIT MATERIALS (QC AND REAGENTS):

1. The test kits must be internationally validated and approved Enzyme-Linked Fluorescent Assay (ELFA) methodology for detection of the most common food pathogens. Kits must be validated for detection of Salmonella species, Listeria species, E. coli O157:H7, Campylobacter, and Staph enterotoxin.

2. The Enzyme-Linked Fluorescent Assay (ELFA) method and kit must:

a. Be a rapid qualitative assay capable of detecting target food pathogen with the highest level of specificity and accuracy

b. Be fully automated

c. Include all applicable assay Quality Control (QC) materials (positive and negative controls) Calibrators, and any other reagents required to perform the validated methodology.

3. All reagents, commodities, incidental laboratory supplies, and controls must minimum of six months expiration at receipt. Kits in each delivery must be of the same lot number to maximize quality control testing. Delivery of test kits, controls, calibrators, and other consumable testing supplies will be at no charge to the state and shipped upon receipt of order.

C. EQUIPMENT SPECIFICATIONS:

1. The instrument system must be a fully validated system for performing the assays to qualitatively detect targeted foodborne pathogens including but not limited to Salmonella species, Listeria species, E. coli O157:H7, Campylobacter, and Staph enterotoxin.

2. The vendor must supply all necessary instrumentation to automate the entire assay system (including computers, printers, software, cables and any other items necessary for proper operation) at the Springfield Public Health Laboratory.

3. The vendor must provide regular and routine required preventive maintenance for instrumentation under the 1-year warranty and an additional 3-year maintenance agreement.

4. The vendor must provide service, repair, or replacement for all instrumentation within 24 hours of notification under the 1-year warranty and an additional 3-year maintenance agreement. (NOTE: IDPH Laboratories function Monday through Friday from 8:00 am to 4:30 pm, only.)

5. The vendor must supply all replacement parts, preventative maintenance parts, and software upgrades.

D. LABORATORY INFORMATION SYSTEM REQUIREMENTS

1. The instrumentation for this system must be compatible with the Illinois Department of Public Health (IDPH), Division of Laboratories, laboratory information management system (LIMS). Any hardware, software, technical expertise, or labor required to interface the vendor’s instruments with the LIMS system will be provided by the vendor at no additional cost.

a. The instruments must have software allowing for the following:

i. Bi-directional interface to exchange information with the LIMS.

ii. Remote connection available for troubleshooting.

iii. Instrument automated capability to read and accession standard code 39 barcodes. 2D barcode capability is preferred.

2. The State of Illinois requires one (1) automated instrument capable of testing approximately 50 samples/day based on a 7.5-hour day. The testing system will be delivered to and operated at IDPH Springfield, 825 N Rutledge, Springfield, IL 62702.

E. VENDOR SUPPORT:

1. For the installation and verification of the test kits and equipment, the vendor will provide the following support at no additional cost:

a. Training at the IDPH laboratory for initial on-site installation of the assay system (instrumentation, computers, software, etc.) for technical and managerial staff. This training will be provided by a product specialist and include reagent use, assay protocols, and instrumentation operation.

b. All test kits, QC materials, and consumables required to train the technical and managerial staff will be provided by vendor and included in the purchase of the instrumentation.

c. All test kits, QC materials and consumables required to perform on-site verification study at the Springfield IDPH lab prior to “going live” with testing.

2. The vendor will provide the following support in their service plan:

a. Any service, repair, or replacement for all vendor supplied instrumentation within 48 hours of notification. NOTE: IDPH Laboratories’ business hours are Monday through Friday from 8:00 AM to 4:30 PM, only. The 24-48 hour turn around expectation does not include weekends and state holidays.

b. A toll-free telephone number for 24/7 technical support for both the automated system and assay performance.

c. All replacement parts, preventive maintenance parts and any parts to repair instrument malfunction. Delivery of parts will be at no charge to the state and shipped upon receipt of order.

d. Regular preventive maintenance and quality control testing for vendor supplied instrumentation, or the vendor must supply the agency all of the necessary materials to perform preventive maintenance and quality control testing within ISO 17025 standard.

e. Any manufacturer software upgrades.