B-27232 ELFA Bid Specs.docx
DOCX document 31 KB Posted
- Attached to
- Food Analyzer Lab Purchase - SP
- Solicitation number
- 22-482DPH-HLTHP-B-27232
- Issued by
- St. Clair County, Illinois
About this file
This document is a set of bid specifications from the Illinois Department of Public Health, Division of Laboratories for the procurement of an automated Enzyme-Linked Fluorescent Assay (ELFA) system. The system must be capable of rapidly and accurately detecting the most common foodborne pathogens, including E. coli O157:H7, Salmonella species, Campylobacter, Listeria including Listeria monocytogenes, and Staphylococcal enterotoxins. The vendor's response must include the instrument cost, maintenance and repair coverage details, and completed pricing tables for the instrument and testing reagents. The ELFA system must be fully automated, validated for the target pathogens, and compatible with the state's laboratory information management system.
The vendor must provide on-site installation, training, and verification support at no additional cost. The service plan must include 24/7 technical support, preventive maintenance, software upgrades, and timely repair or replacement of any malfunctioning equipment. The bid price submission requires vendors to complete detailed cost tables for the instrument, maintenance, quality control testing, and individual testing reagents for Listeria, Salmonella, Campylobacter, E. coli O157, and Staphylococcal enterotoxin. The vendor must certify their ability to meet all the specified requirements.
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Text version
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. 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. Completed Price table Section F: Instrument Acquisition Table and Testing Reagents Table that identifies:
E. coli 057:H7, Salmonella species, Campylobacter, Listeria sp. (including L. monocytogenes), and Staph Enterotoxin.
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 three (3) business days 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 systems (LIMS). The IDPH Labs currently utilize StarLIMS, but is in the process of transitioning to Horizon. 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.
2. The instruments must have software allowing for the following:
a. Bi-directional interface to exchange information with the LIMS.
b. Remote connection available for troubleshooting.
c. Instrument automated capability to read and accession standard code 39 barcodes. 2D barcode capability is preferred.
3. 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 three (3) business days of notification. NOTE: IDPH Laboratories’ business hours are Monday through Friday from 8:00 AM to 4:30 PM, only.
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 with the necessary materials to perform preventive maintenance and quality control testing within ISO 17025 standard.
e. Any manufacturer software upgrades.
F: BID PRICE SUBMISSION TABLES: Vendors must complete all information in the tables below for price submission.
Price Chart 1 – Instrument Acquisition and Care
ELFA Price Chart 1 - Instrument Acquisition and Care
| Item |
| Annual Estimated Quantity |
| Firm Price |
| Annual Total Estimated Cost |
| Initial Three-Year Term Estimated Cost |
| ELFA Instrument One Time Purchase (including one-year warranty) |
| 1 |
| $ - |
| $ - |
| Repair and Maintenance for ELFA Instrument |
| 1 |
| $ - |
| $ - |
| $ - |
| Monthly Instrument Quality Control Test |
| 12 |
| $ - |
| $ - |
| $ - |
One-Time Cost ELFA Instrument
Total Initial Term Estimated Cost
Price Chart 2: Testing Reagent Chart. Vendors must enter the external and internal controls per sample for accurate calculation of price comparison.
ELFA Price Chart 2 – Testing Reagents
| Item |
| Number of External Controls per Sample |
| Number of Internal Controls per Sample |
| Number of Tests per Box |
| Annual Estimated Quantity Individual Tests |
| Firm Price per Individual Test |
| Annual Estimated Cost (test quantity X individual test price) |
| Estimated Initial Term Cost (Annual cost X 4 years) |
Listeria Test
| 400 |
| $ - |
| $ - |
| $ - |
Salmonella Test
| 400 |
| $ - |
| $ - |
| $ - |
| Salmonella Enrichment Broth Vial |
| N/A |
| 400 |
| $ - |
| $ - |
| $ - |
Campylobacter Test
| 400 |
| $ - |
| $ - |
| $ - |
E. Coli 0157 Test
| 400 |
| $ - |
| $ - |
| $ - |
Staph Enterotoxin Test
| 400 |
| $ - |
| $ - |
| $ - |
TOTAL INITIAL TERM ESTIMATED COST
Total Estimated Costs Chart 1 and Chart 2:
Total Initial Term Estimated Costs
| Total Estimated Cost |
| Price Chart 1 |
| Price Chart 2 |
| Grand Total Initial Term Estimated Cost |
| $ - |
| $ - |
| $ - |
G. VENDOR CERTIFICATION OF ABILITY TO MEET THE ABOVE REQUIREMENTS:
Bidder agrees Bidder can and will comply with all specifications and requirements in section A – F of this bid.
Yes No
| Authorized |
| Representative |
| Signature: ______________________________________ |
Printed Name___________________________________ Date___________________________________________
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