SPECIFICATIONS
I. GENERAL REQUIREMENTS OF SUPPLIES
1. Vendor must provide Polymerase Chain Reaction (PCR) supplies for the detection of Hepatitis C Virus (HCV) that are Food and Drug Administration (FDA) licensed or under FDA review.
2. Must come with UNG (uracil n glycosylase) as a means to prevent amplicon contamination.
3. Must have incorporated one positive and one negative RNA control. Additionally an internal control to check for inhibition/efficiency of sample preparation must be an option.
4. Must utilize the same methodological principles; PCR target amplification, hybridization of the amplified products to a specific nucleic acid probe and detection of the amplified product by color formation.
5. Vendor must replace any incomplete or unsatisfactory supplies at no additional charge to the WSLH.
II. INSTRUMENTATION REQUIREMENTS
1. Instrumentation must be capable of interfacing with an existing EPIC Laboratory Information Management System (LIMS).
2. Instrumentation must include integrated walk-away amplification, dilution and detection.
3. Instrumentation must have a throughput of at least 48 specimens (22 samples plus 2 controls for amplification and detection, plus 22 samples, plus 2 controls for detection only) per day.
4. Instrumentation must utilize barcode scanner technology .
5. Used or demonstrator instrumentation being offered must be is less than 10 years old and has been used in a laboratory setting. Vendor must be able to provide a record of all preventive maintenance, repairs and upgrades that have been done to the instrument(s) they are proposing to provide. The laboratory user will determine the acceptability of the instrument(s).
6. Must provide at no charge technical service and training to laboratory staff for each piece of instrumentation being provided upon request by the Department.
7. Vendor must provide trouble-shooting consultation within 8 hours of initial call. |
