Attachment B-Salient Characteristics.docx
DOCX document 16 KB Posted
- Attached to
- 6550--Molecular Diagnostic Tests for SARS-CoV-2 Federal contract opportunity
- Solicitation number
- 36C26224Q0704
About this file
This document outlines salient characteristics for molecular diagnostic tests for the SARS-CoV-2 virus. The Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 22 seeks FDA-approved assays that can detect SARS-CoV-2 as well as SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus from nasopharyngeal, anterior nasal, or nasal samples. Assays must be compatible with Cepheid GenXpert systems without requiring alterations and must not negatively impact system performance, results, safety, or equipment lifespan. Pricing provided by offerors must incorporate all applicable handling, hazardous materials, dry ice, and shipping fees.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| Amendment 0001 doc.pdf | ||
| SOW.docx | DOCX document | |
| 36C26224Q0704.docx | DOCX document | |
| Attachment A doc.xlsx | XLSX spreadsheet | |
| RFQ.docx | DOCX document |
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Text version
Attachment B Salient Characteristics
· SARS-CoV-2 Assay and SARS-CoV-2/Influenza/RSV must be 100% compatible with all features, must physically fit without alteration, and not void the preventive maintenance and service or warranty of the current VA-owned and leased Cepheid GenXpert systems:
· GENEXPERT XVI Dx R1
· GENEXPERT XVI Dx R2
· GenXpert Infinity
· SARS-CoV-2 Assay must be EUA FDA approved for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab or anterior nasal swab specimen obtained from individuals meeting COVID-19 clinical and/or epidemiological criteria, as well as individuals without symptoms or other reasons to suspect COVID-19 infection.
· SARS-CoV-2/Flu/RSV plus must be EUA FDA approved for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A, influenza B, and/or respiratory syncytial virus (RSV) in either nasopharyngeal swab, anterior nasal swab or nasal wash/ aspirate specimens collected from individuals suspected of respiratory viral infection, consistent with COVID-19, by their healthcare provider.
· SARS-CoV-2 Assay and SARS-CoV-2/Influenza/RSV must not negatively impact system performance, assay results, safety, and equipment life cycle of the current VA-owned and leased Cepheid GenXpert systems.
· Ambient temperature transport system and storage of reagents.
· Pricing must include all handling, HAZMAT, dry-ice and shipping fees when applicable.
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