CHLAMYDIA/GONORRHEA TEST KITS

WSLH is a public health entity.  If public health pricing is available, Contractor is expected to honor that pricing structure. 

“D” F.O.B. DESTINATION, FREIGHT PREPAID AND ALLOWED
“I” F.O.B. DESTINATION FREIGHT PREPAID INCLUDED AND INSTALLED
“V” F.O.B. SERVICE/MAINTENANCE
If any State of Wisconsin Agencies, Wisconsin Municipalities, Other CIC member institutions or Non-Profit Organizations specifically linked by their mission to the University of Wisconsin Madison perform CT-GC testing, each location would need to acquire an instrument list price.

Supplies:  10 days ARO
Instruments:  60 days ARO

Instruments are currently on site and past their warranty period.  Consumables are as stated on the label.

INDIVIDUAL COMPONENTS

SPECIFICATIONS

NOTE:  In order to evaluate and confirm that the Products/ Instrumentation being bid meets WSLH protocol and State/Federal regulations, Contractor  must agree to provide at no cost or obligation to the University:

a)     An instrument for an evaluation period of at least one month
b)     Accessories necessary for operation (i.e. computer, automatic pipettors, etc.)
c)     Reagents, calibrators, controls necessary for evaluation and comparison studies
d)     On-site training provided before start of evaluation period

2.         Chlamydia-only test must be available.                                                                          

3.         Instrument and assay kits must be FDA cleared.                                                            

4.         The method of analysis must be nucleic acid amplification (NAA).                                              

5.         Calibrators, kits and controls must be stable for a minimum of 3 months.                                   

6.         Required throughput of the instrument(s) must be at least 400 patient specimens consisting of 200 CCT-GC combination tests and 200 CT-only tests (i.e. 400 CT results and 200 GC results on 400 specimens) in an 8 hour shift using no more  than 2 instruments, and including time for specimen processing and any required maintenance.                            

Number of specimen throughput in an 8-hour shift per instrument: 384 Specimens / 768 Tests

7.         Instrument must have interface capabilities.        Interface type: UPLOAD ONLY

8.         Is there a method to detect amplification inhibition?                    NO
           Is the Amplification Control required with all specimens?             NO

9.         Assay and instrumentation must be FDA cleared for use with cervical swabs, male  urethral swabs and urine from males and females for both Chlamydia and  Gonorrhea tests.

Other anatomical sites, specimen types and appropriate gender cleared for  testing by the FDA. 

The following specimen types are FDA cleared for testing:

II.      INSTRUMENTATION REQUIREMENTS
1.         Contractor must provide all instrumentation, software, accessories and on-going support,   and maintenance/ repair necessary to perform clinical assay and manage data sufficient for volume indicated. 

2.         Contractor must include at least two (2) training slots for each piece of instrumentation.  

3.         Instrument(s) provided must interface with an existing EPIC Laboratory Information  Management System (LIMS).

4.         Used or demonstrator equipment must be less than 10 years old and had been used in a laboratory setting.  Upon request Contractor must be able to provide a record of all preventive maintenance, repairs and upgrades that have been done to the instrument(s).  The laboratory user will determine the acceptability of the instrument(s).

5.         During the contract period any alternative or replacement instrumentation offered if used or a demonstrator must meet the #4 requirements.

6.         Must provide 24 hour, Monday through Friday, excluding holidays trouble-shooting consultation.

7.         On-site service must be performed within 24 hours of reporting the problem       

            Acceptance testing will occur after the Contractor states the Instrument is installed and ready to perform in compliance with specifications.  Acceptance of product and instrument is contingent on demonstration of equivalent or superior performance in WSLH laboratory.   Performance characteristics to be considered include clinical and analytical sensitivity and  specificity, and positive/ negative predictive values as compared to the method currently in use.

            If the system does not meet standard performance expectations, Contractor will have 30 days to meet standards or remove the System from the department.  If the System is brought into compliance within 30 days, department will have another full 30 days testing  period.  If the System still does not perform to specifications, Contractor agrees to remove the system and return all payments that have been made.

Revision History