STATEMENT OF NEED REAGENTS to PERFORM RESPIRATORY PANELS AND PNEUMONIAE PANELS Purpose: The Wilke-Barre VA Medical Center (WBVAMC) has an emergent need for reagent panels that will be used on the BioFire Film Array Torch System. The reagent panels are to perform respiratory panels with and without COVID as well as the pneumonia panels all to confirm or rule out COVID-19 on patients. Reagents Required: The reagents required will be to perform the following panels: Respiratory Panel consisting of 21 tests Respiratory Panel consisting of 22 tests including SARS-CoV-2 Pneumonia Panel consisting of 33 tests All reagent Panels must be compatible to run on the BioFire Film Array Torch System. Respiratory Panel must be a single test that looks for respiratory pathogens that include viruses and bacteria by processing a nasopharyngeal swab. The following is a list of viruses and bacteria that the panel must include: Viruses Adenovirus Coronavirus HKU1 Coronavirus NL63 Coronavirus 229E Coronavirus OC43 Human Metapneumovirus Human Rhinovirus/Enterovirus Influenza A Influenza A/H1 Influenza A/H1-2009 Influenza A/H3 Influenza B Parainfluenza 1 Parainfluenza 2 Parainfluenza 3 Parainfluenza 4 Respiratory Syncytial Virus Bacteria Bordetella pertussis Bordetella paraperussis Chlamydophila pneumoniae Mycoplasma pneumoniae Respiratory Panel must be a single test that looks for respiratory pathogens that include viruses and bacteria by processing a nasopharyngeal swab. The following is a list of viruses and bacteria that the panel must include: Viruses Adenovirus Coronavirus HKU1 Coronavirus NL63 Coronavirus 229E Coronavirus OC43 Human Metapneumovirus Human Rhinovirus/Enterovirus Influenza A Influenza A/H1 Influenza A/H1-2009 Influenza A/H3 Influenza B Parainfluenza 1 Parainfluenza 2 Parainfluenza 3 Parainfluenza 4 Respiratory Syncytial Virus SARS-CoV-2 Bacteria Bordetella pertussis Bordetella paraperussis Chlamydophila pneumoniae Mycoplasma pneumoniae Pneumonia Panel must be a single test that looks for respiratory pathogens that can cause pneumonia that include viruses and bacteria by processing a sputum specimen (including endotracheal aspirate) or bronchoalveolar lavage (including mini-BAL). For 15 of the bacteria, the results are semi-quatitative results which can help in determining whether an organism is a colonizer or a pathogen. The following is a list of viruses and bacteria that the panel must include: Viruses Adenovirus Coronavirus Human Metapneumovirus Human rhinovirus/ Enterovirus Influenza A Influenza B Parainfluenza Virus Respiratory Syncytial Virus Antimicrobial Resistance Genes Methicillin resistance: mecA/C and MREJ Carbapenemases: KPC NDM Oxa-48-like VIM IMP ESBL: CTX-M Bacteria Semi-Quantitative Bacteria Acinetobacter calcoaceticus-baumannii complex Enterobacter cloacae complex Escherichia coli Haemophuilus influenzae Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae group Moraxella catarrhalis Proteus spp. Pseudomonas aeruginosa Serratia marcescens Staphylococcus aureus Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes Atypical Bacteria Qualitative Bacteria Chlamydia pneumoniae Legionella pneumophila Mycoplasma pneumoniae A verification kit is required for the Respiratory Panel as well as one for the Pneumonia Panel. Reagents should have an expiration date of at least 9 months from delivery date.

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