Salient Characteristics Rapid PCR.doc
DOC document 49 KB Posted
- Attached to
- Rapid PCR / NAAT Analyzer Federal contract opportunity
- Solicitation number
- PANHCA-21-P-007893
- Issued by
- Department of the Army Medical Command
About this file
This document outlines a sources sought synopsis for a rapid PCR/NAAT analyzer rental and supply contract. The Regional Health Contracting Office-Pacific is seeking information on potential sources that can provide an FDA-cleared or EUA-authorized benchtop PCR/NAAT analyzer for rapid identification of influenza A & B, SARS-CoV-2, RSV, and streptococcus group A. The analyzer must be CLIA-waived and provide results in approximately 20 minutes. The contract would support the Department of Pathology at Madigan Army Medical Center in Tacoma, Washington. Interested parties should submit a capabilities statement no more than ten pages by August 6th, 2021 to the listed contracting officer. The base period of performance is one year from October 1, 2021 through September 30, 2022 with two optional one-year extensions.
View the file
Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| SOW Rapid PCR.doc | DOC document |
On GovTribe
Work with this file on GovTribe
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
Rapid PCR (Influenza, RSV, SARS, and Streptococcus Testing)
SALIENT CHARACTERISTICS
1. Characteristics:
A. FDA clearance (or EUA clearance for SARS-CoV-2) and CLIA waived.
B. PCR system with high quality reagents and supplies
C. Special connectivity method for interfacing with LIS.
D. Benchtop model.
E. Performs one test at a time per unit or module, and is random access.
F. Specificity for Influenza A/B greater than 92% G. Sensitivity for influenza A/B greater than 98% H. Sensitivity for SARS-CoV-2 greater than 98%
I. Specificity for SARS-CoV-2 greater than 98%
J. Positive percent agreement and negative percent agreement for RSV greater than 97% when compared to other NAAT based testing methods.
K. Streptococcus Group A assay Level of Detection (LOD) is comparable to culture.
L. Must be able to provide complete system validation and provide enough reageants free of charge to do so.
M. Must be able to provide training for staff how to use and troubleshoot the system.
N. Fully automated walk-away system.
O. Automatic Start/Stop feature included.
P. Onboard quality control (QC) record keeping.
Q. Safety considerations that provide minimal exposure to hazardous reagents and pathogens.
R. Additional safety features, such as run stops when door is opened.
S. Operate within the existing environmental conditions of 15-35 °C and 15-75% relative humidity.
T. 120 Voltage U. Vendor must invoice using Wide Area Workflow (WAWF) or software utilized by Defense Finance Accounting Service (DFAS) within one month of delivery of supplies.
V. Supplies and reagents must have an expiration date of 6 months or later when compaired to delivery date.
File details come from the government source that posted it. Updated .