Salient Characteristics UA Analyzer FY21.docx

Brand Name or Equal Worksheet (“Salient Characteristics”) May 12,2020 Brand Name Item: Urinalysis Automated Analyzer

1) Essential/significant physical, functional, or performance characteristics.

Compatibility –Model must: Technology that assays urine chemistry and urine microscopic testing with Flourescent Flow cytometry technology and digital imaging and a reliable chemistry back up analyzer.

· Bench top analyzer 110 volts /220 volts

· Urinalysis analyzer with alternate back up chemistry analyzer which ensures standardized test results and excellent correlation

· Backup instrument should be a walkaway with autosampler and high throughput

· Both primary and secondary (back-up)instrument should be validated to demonstrate that chlorhexidine present in our current BD VACUTAINER PLUS UA Preservative tubes will not have any adverse effect on the routine urinalysis parameters. Both instrument should have an excellent agreement.

· UA analyzer with digital imaging which yields microscope- quality images with accurate sediment classification and cell identification for fewer screen review

· Decreased need to do manual microscopy for confirmation of formed elements.i.e. presence of bacteria, yeast cells and crystals

· Random access with walkaway shutdown, restart capabilities and continuous analyses

· Utilize Flourescent Flow Cytometry methodology in identifying and quantifying cells.

· Reduced carryover with adjustable carryover rinse cycle settings to eliminate interference.

· No dilution required. No special handling requirements for particle analysis.

· ON Board Warmer that dissipates urates and phosphate material thus eliminating an additional steps to reduce amorphous interference. This will help tremendously in analysing samples from CBOCs.

· Provide calibration and assisted calibration verification and set up reference ranges.

· Ready to use reagents with good stability upto 14 days.

· Easily standardized with accurate particle differentiation, bacteria quantification and enhanced detection down to <0.5 um.

· Minimal maintenance <30 minutes with walkaway capability and minimize staff hands-on and free technologists for more critical tasks.

· Be able to print results and/or interface to Vista LIS system.

· Data Innovations interface compatible

· Cost effective, Safe , Easy to use and labor saving

· Assays FDA approved

· Precision when compared with other laboratory performances on proficiency surveys

2) Complete generic identification – Urinalysis Chemistry and Microscopic Analyzer

3) Applicable model/make/catalog number – UN2000(UF-5000+UD-10), Siemens CLINITEK NOVUS

4) Manufacturer name – SYSMEX and Siemens Healthineers

Per VAAR 811.104 and 811.105, I certify the following regarding the above information:

· The salient characteristics listed above are essential to the Government’s requirements.

· To my knowledge, the restrictions listed above will not limit the acquisition to an item peculiar to one manufacture.

Name: Cleofe J. Reed, Lead Technologist -Urinalysis and Coagulation VASNHCS-Reno, Nevada 89502