Salient Characteristics.pdf

36C25720Q1137 Salient Characteristics Page 1 of 2

EQUIPMENT REQUIREMENTS

A. The vendor shall be required to furnish/provide all the necessary equipment/tools for the installation of the processor.

B. The PCR analyzer shall provide the following to meet the needs of the customer:

1. Desktop instrument that takes up no more than 3-4 feet of countertop space.

2. Has a high throughput

3. It is random access instrument

4. Ability to upgrade analyzer if needed when testing volume increases.

5. Must allow rapid identification of pathogens from laboratory samples from critically ill patients with a turnaround time 60 minutes or less.

6. This instrument allows rapid identification of pathogens allows improved clinical decisions and may contribute to better patient outcomes and reduced bed days of care.

7. Easy to clean and disinfect

8. Low maintenance

9. All bar code readers must be capable of reading and decoding any label when manually applied to a specimen tube in accordance with the guidelines described in the Clinical and Laboratory Standards Institute (CLSI) standard, Laboratory Automation: Bar Codes for Specimen Container Identification, CLSI Document Auto2- A, Approved Guideline, Vol. 20, No. 19, October 2005.

10. Fully automated self-contained closed and walk away PCR system multiplexed nucleic acid test.

11. The analyzer must be easy-to-use multiplex PCR system that can be used in complex diagnostic situations that require multiple answers in a critically short period of time.

12. Fully automated self-contained closed and walk away PCR system multiplexed nucleic acid test.

C. Multiplex PCR Panels

1. The Respiratory Panel 2.1 shall be able to identify 21 targets, both viral and bacterial common pathogens in one test. The Respiratory panel 2.1 shall be approved for nasopharyngeal samples in transport media.

2. As needed: The Gastrointestinal Panel shall be able to identify common gastrointestinal pathogens including 27 targets such as viruses, bacteria, and parasites that cause infectious diarrhea in one test. The panel shall be

36C25720Q1137 Salient Characteristics Page 2 of 2 approved for stool specimens.

3. As needed: The Blood Culture Identification Panel shall be able to identify 27 targets including 24 pathogens (bacterial and fungal), and 3 antibiotics resistance genes associated with bloodstream infections in one test. The panels shall be approved for positive blood culture broth.

4. As needed: The meningitis/Encephalitis Panels shall be able to identify 14 targets including bacteria, viruses and fungi. The test shall be approved for Cerebral Spinal Fluid samples.

5. As needed: the pneumonia Panel shall be able to identify 33 targets including bacteria, atypical bacteria, viruses, and antimicrobial Resistance Genes associated with sputum, bronchoalveolar lavage samples.

6. The panels requested or as needed shall not require the use of any sharps for sample/reagent transfer.

D. Data Management System.

1. Shall be able to analyze and report results in a simple and easy to read format

2. Shall provide automated qualitative data analysis in Windows-based software.

3. Shall be capable of maintaining all data for up to 1 hour in the event of normal Electrical power interruptions via battery backup.

4. Shall have a built-in comprehensive quality control program to regularly monitor performance of vital components. including Troubleshooting or System Validation QC material. The system must have quality control data storage and reporting capabilities, the ability to view and print daily and monthly cumulative QC results, troubleshoot unsatisfactory results and system errors validate archive data document all information.

5. Shall have an external printer.