Question 04.docx
DOCX document 12 KB Posted
- Attached to
- Rapid PCR / NAAT Analyzer Federal contract opportunity
- Solicitation number
- W81K02-21-Q-0193
- Issued by
- Department of the Army Medical Command
About this file
This document contains a solicitation for a Rapid (~20 minute) CLIA waived Polymerase Chain Reaction (PCR)/Nucleic Acid Amplification Test (NAAT) analyzer(s) along with related questions and responses. The Madigan Army Medical Center, Department of Pathology is seeking an equipment purchase and supply contract for analyzer(s) that can rapidly identify Influenza A & B, SARS-CoV-2, Respiratory Syncytial Virus (RSV), and Streptococcus Group A. The analyzer(s) must be CLIA waived or have received an FDA Emergency Use Authorization for SARS-CoV-2 detection, and the contractor must provide scheduled maintenance and hardware/software upgrades to maintain system integrity. The contract period is one base year with four option years, and performance will take place at Madigan Army Medical Center in Tacoma, Washington. Total analysis time for the assays should be approximately 20-30 minutes.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| QUESTION 03.docx | DOCX document | |
| QUESTION 02.docx | DOCX document | |
| QUESTION 01.docx | DOCX document | |
| W81K0221Q0193 0001.pdf | ||
| W81K0221Q0193.pdf |
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Text version
Question 04 QUESTION 1. Are the kits CLIA certified?
RESPONSE: See Statement Of Work (SOW), Description of Service and Specific Tasks, the reagents/analyzers must be CLIA waived (moderate or highly complex can be submitted for evaluation) and FDA approved In-Vitro Diagnostic (IVD) or Emergency Use Authorization (EUA) for the SARS-CoV-2 analyte.
QUESTION 2. Are the kits 20 minutes (last time I checked no, but they are constantly improving their kits so I need an update).
RESPONSE: See Statement Of Work (SOW), Description of Service ~ 20 minutes, the high end of that would be 30 minutes.
QUESTION 3. Is the kit is under 2 hours instead of 20 minutes?
RESPONSE: See Statement Of Work (SOW), Description of Service ~ 20 minutes, the high end of that would be 30 minutes.
QUESTION 4. Do you need 20 minutes of HANDS-ON TIME or 20 minutes of TOTAL time?
RESPONSE: See Statement Of Work (SOW), Description of Service ~ 20 minutes, the high end of that would be 30 minutes. Total time (both hands on and analyzing time.)
QUESTION 5. Is the CLIA certification a must?
RESPONSE: See Statement Of Work (SOW), Description of Service and Specific Tasks, the reagents/analyzers should be CLIA waived (moderate or highly complex can be submitted for evaluation) and FDA approved In-Vitro Diagnostic (IVD) or Emergency Use Authorization (EUA) for the SARS-CoV-2 analyte
File details come from the government source that posted it. Updated .