Samples for Urinalysis and Related Procedures ( 2026 - UWMSN - 01304 - RFB )

2026-11-03

The University of Wisconsin - Madison , hereinafter referred to as the “ University ”, through its Purchasing Services Department , hereinafter referred to as “ Purchasing ”, on behalf of the Wisconsin State Laboratory of Hygiene Proficiency Testing Department , hereinafter referred to as “ Department ” or “ WSLH - PT ”, requests bids for the purchase of Samples for Urinalysis and Related Procedures . GENERAL SPECIFICATIONS MEET SPECIFICATIONS A . Sample Specifications YES NO A . 1 Samples must be human based , unless otherwise specified . A . 2 Vendors must manufacture product ( s ) in conformance with the current Good Manufacturing Practices ( cGMP ) as defined by the Food and Drug Administration ( FDA ). A . 3 Vendor must be International Standardization Organization ( ISO ) certified and provide documentation of certification . A . 4 Vendor must provide a Certificate of Analysis ( COA ) for every sample with each shipment . For purposes of this specification , production or internal quality control data are also acceptable . This will be for WSLH PT internal use only and is not considered to be a claimed performance characteristic of the product . A . 5 COAs must include expiration dates and sample storage requirements . A . 6 COAs must be provided to WSLH PT by mail or electronically at least one week prior to WSLH PT scheduled ship date . A . 7 Sample performance documented on each COA must be from the final product shipped to WSLH PT . A . 8 Analyzer ( s ) mfg / model ( s ) used in testing for COA documentation must be recorded on COA . A . 9 Samples must test non - reactive for Human Immunodeficiency Virus ( HIV ), Hepatitis B and Hepatitis C . Documentation of testing by techniques approved by the FDA must be provided on the COA . A . 10 Samples must be free of microbial contaminants that could damage the product . A . 11 Microbial incidence must be reported on the COA . A . 12 Vendor must be capable of providing samples specified in this contract on a regular basis beginning no later than March 2027 . A . 13 Upon request , vendors must supply a representative test sample and / or COA prior to acceptance of the bid . A . 14 Vendor , at no cost to WSLH PT , must replace any samples found not suitable for analysis . A . 15 The vendor must provide safety data sheets ( SDS ) for all applicable samples . A . 16 Vendor must disclose all methods with which the samples offered are known to be incompatible . A . 17 Samples must be of different levels ( normal and abnormal ) which span the analytical range for most instrument / kits , representative of clinical human samples . A . 18 Upon request , vendor must provide WSLH PT the product name ( s ), number of levels available , projected annual production schedule ( s ), product insert ( s ) and assay sheet ( s ). A . 19 For each non - custom product , the vendor must submit a product insert and potential analyte concentrations from which to choose . A . 20 Samples supplied must be free from known interferences and suitable for use on the most common instruments / kits currently on the market . Written documentation of compatibility tests must be available to WSLH PT upon request . A . 21 Vendor must notify WSLH PT of any changes to additives and / or preservatives made to the product after the original bid acceptance . A . 22 Samples must be free from fibrin and other particulate matter which might interfere with sample processing or analysis . These specifications are in addition to the General Bid Specifications . MEET SPECIFICATIONS ITEM SAMPLE SPECIFIC SPECIFICATIONS YES NO 1 . Samples must be at least 10 mL liquid human urine matrix with human source material . 2 . Samples must be suitable to test for qualitative and semi - quantitative biochemical components of human urine . 3 . Vendor must provide six sample formulations to accommodate a three - sample program that ships two times a year . 4 . WSLH PT will have the ability to select from the levels of material offered and will determine the labeling order for each sample . 5 . Samples must contain the following analytes : bilirubin , glucose , blood / hemoglobin , ketones , leukocyte esterase , nitrite , pH , protein , specific gravity , urobilinogen , and qualitative urine hCG . 6 . Samples may contain the following additional analytes : Microalbumin , Creatinine If present , please list on the COA . 7 . Samples must be compatible with visually read urine reagent strips as well as automated and semi - automated urinalysis instruments . Strips and instruments include , but are not limited to , Siemens reagent strips and CLINITEK analyzers ; Roche reagent strips and analyzers ( cobas u and Urisys ); Aution Max AX - 4030 ; McKesson Consult reagent strips and analyzers ; and other urine reagent strips on the market . Vendor must disclose any analyte / instrument compatibility issues below . ___________________________________________________________ 8 . Samples may be suitable for use with urine confirmatory tests for bilirubin , ketones and reducing substances ( example : AimTab ). 9 . Samples may be suitable for use with Sulfosalicylic Acid test for total protein . 10 . Samples must be compatible with qualitative urine hCG kits . 11 . Samples must be free from interfering substances that may cause invalid urine hCG results . 12 . The sample vial must have enough depth to allow common urinalysis reagent dipsticks to be totally submerged in the sample . 13 . Samples must have a minimum closed vial refrigerator or room temperature stability that extends the duration of the WSLH PT event testing period . The WSLH PT event testing periods end 4 - 5 weeks after the WSLH PT event ship date . 14 . Vendor must disclose approximate open vial stability below : Refrigerator open vial stability ( if applicable ): _____________________ Room temperature open vial stability ( if applicable ): _________________ 15 . Sample stability and integrity must be maintainable during the WSLH PT 2 - day shipping to participants ( samples must not be labile under normal shipping conditions ).

Wisconsin

2026-05-06