Amendment Testing Required.docx

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Q301--|554 | New Base +4 RTPCR GI & Respiratory Testing
Solicitation number
36C25925Q0385
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This document is an Amendment specifying detailed testing requirements for a Department of Veterans Affairs laboratory contract. The amendment outlines two comprehensive testing panels: a Gastrointestinal (GI) Panel RT-PCR and a Respiratory Panel, each with specific FDA-approved targets. The GI Panel includes testing for multiple bacterial species (such as Campylobacter, Salmonella, and various E. coli strains) and parasites (including Cryptosporidium and Giardia), while the Respiratory Panel covers a wide range of viruses and bacteria, including SARS-CoV-2, various influenza strains, coronaviruses, and respiratory syncytial viruses.

The related federal contract opportunity is a pre-solicitation Sources Sought Notice for RT-PCR GI and Respiratory Testing at the Rocky Mountain Regional VA Medical Center in Aurora, CO. The procurement seeks a contractor to provide equipment, reagents, and testing services for the Pathology and Laboratory Medicine department, with testing priced on a cost per reportable result (CPRR) basis. The solicitation (Number 36C25925Q0385) is open to various business sizes, potentially set aside for small businesses, with responses due by May 12, 2025. Interested vendors must submit a capability statement to the VA's Network Contracting Office 19, including contact information, business size status, and supporting documentation.

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Testing Required:

Laboratory assays performed, and organisms tested within, shall include but may not be limited to the following:

a. Gastrointestinal Panel RT-PCR

1. FDA-Approved assay for bacteria and parasite targets

2. Targets: bacterial and parasites

ii. Bacterial:

i. Campylobacter (C. jejuni, C. coli and C. upsaliensis)

ii. Shigella/Enteroinvasive Escherichia coli (EIEC)

iii. Enteropathogenic Escherichia coli (EPEC)

iv. Enterotoxigenic Escherichia coli (ETEC) It/st

v. Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 (including specific identification of E. coli O157 serogroup within STEC)

vi. Salmonella

vii. Plesiomonas shigelloides

viii. Yersinia enterocolitica

iii. Parasite:

i. Cryptosporidium

ii. Cyclospora cayetanensis

iii. Entamoeba histolytica

iv. Giardia lamblia** (Giardia intestinalis and Giardia duodenalis)

b. Respiratory panel

1. FDA-Approved SARS-CoV-2

2. Targets: Bacterial and Viral:

ii. Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

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