Basic Requirements - Table 1 - Workload Data.docx

Basic Requirements: The system must contain random access technologies that improve workflow and be approved by, and include molecular based test methods approved by, the Food and Drug Administration (FDA). The system must fit in the current space available which is approximately 5’ x 5’ per instrument.

Test Menu and Special Requirements: Listed testing requirements must be capable of completion in under 180 minutes from start time (time of loading onto instrument). All assays must be available on a single platform. Proposal should include automated, rapid, molecular based detection of all of most (>80%) of the following:

Gastrointestinal Panel (GI Panel) / Stool in Cary Blair medium

BACTERIA:

Campylobacter (C. jejuni / C. coli / C. upsaliensis) Clostridioides (Clostridium) difficile (toxin A/B) Plesiomonas shigelloides Salmonella Yersinia enterocolitica Vibrio (V. parahaemolyticus / V. vulnificus / V. cholerae)

· Vibrio cholerae DIARRHEAGENIC ESCHERICHIA COLI/SHIGELLA:

Enteroaggregative E. coli (EAEC) Enteropathogenic E. coli (EPEC) Enterotoxigenic E. coli (ETEC) lt/st Shiga-like toxin-producing E.

coli (STEC) stx1/stx2

· E. coli O157 Shigella/Enteroinvasive E. coli (EIEC) PARASITES:

Cryptosporidium Cyclospora cayetanensis Entamoeba histolytica Giardia lamblia VIRUSES:

Adenovirus F40/41 Astrovirus Norovirus GI/GII Rotavirus A Sapovirus (I, II, IV, and V)

BACTERIA:

Escherichia coli K1 Haemophilus influenzae Listeria monocytogenes Neisseria meningitidis Streptococcus agalactiae Streptococcus pneumoniae

Meningitis Panel (ME Panel) / cerebrospinal fluid

VIRUSES:

Cytomegalovirus (CMV) Enterovirus (EV) Herpes simplex virus 1 (HSV-1) Herpes simplex virus 2 (HSV-2) Human herpesvirus 6 (HHV-6) Human parechovirus (HPeV) Varicella zoster virus (VZV) YEAST:

Cryptococcus (C. neoformans/C. gattii)

Blood Culture Identification Panel (BCID) / positive blood culture

GRAM-NEGATIVE BACTERIA:

Acinetobacter calcoaceticus- baumannii complex Bacteroides fragilis Enterobacterales

· Enterobacter cloacae complex

· Escherichia coli

· Klebsiella aerogenes

· Klebsiella oxytoca

· Klebsiella pneumoniae group

· Proteus spp.

· Salmonella spp.

· Serratia marcescens Haemophilus influenzae Neisseria meningitidis Pseudomonas aeruginosa Stenotrophomonas maltophilia

GRAM-POSITIVE BACTERIA:

Enterococcus faecalis Enterococcus faecium Listeria monocytogenes Staphylococcus spp.

· Staphylococcus aureus

· Staphylococcus epidermidis

· Staphylococcus lugdunensis Streptococcus spp.

· Streptococcus agalactiae

· Streptococcus pneumoniae

· Streptococcus pyogenes

YEAST:

Candida albicans Candida auris Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis Cryptococcus (C. neoformans/C. gattii)

ANTIMICROBIAL RESISTANCE GENES:

Carbapenemases

· IMP

· KPC

· OXA-48-like

· NDM

· VIM

Colistin Resistance

· mcr-1

ESBL

· CTX-M

Methicillin Resistance

· mecA/C

· mecA/C and MREJ (MRSA) Vancomycin Resistance

· vanA/B

Respiratory Panel (RP) / nasopharyngeal swab in viral transport media

BACTERIA:

Bordetella parapertussis Bordetella pertussis Chlamydia pneumoniae Mycoplasma pneumoniae VIRUSES:

Adenovirus Coronavirus 229E Coronavirus HKU1 Coronavirus NL63 Coronavirus OC43 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Human Metapneumovirus Human Rhinovirus/Enterovirus Influenza A virus Influenza A virus A/H1 Influenza A virus A/H3 Influenza A virus A/H1-2009 Influenza B virus Parainfluenza virus 1 Parainfluenza virus 2 Parainfluenza virus 3 Parainfluenza virus 4 Respiratory syncytial virus

TABLE 1. WORKLOAD DATA. “Panels per year” in base year and all options years are listed as kits per year.

PERIOD