Attachment B - Specifications - Pages 1-2.docx
DOCX document 16 KB Posted
- Attached to
- Molecular Diagnostics Analyzer - LDH-OPH Bid Cancelled: 05/22/2025 - Addendum No. 1 – CANCELLATION Date Issued: 05/22/2025 Your reference State and local contract opportunity
- Solicitation number
- 3000024682
- Issued by
- East Baton Rouge Parish, Baton Rouge City, Louisiana
About this file
This document is a specifications attachment for a Molecular Diagnostic Analyzer solicitation (RFx No.: 3000024682) issued by Louisiana Department of Health (LDH) Office of Public Health (OPH). The specifications outline requirements for a molecular-based medical testing equipment system capable of performing multiplex tests for COVID-19, Influenza A, Influenza B, and potentially RSV. The anticipated annual testing volume is 1,250 tests, which will be reserved and made available to the LDH OPH Lab on an as-needed basis. The analyzer must be FDA approved or emergency use authorized, capable of providing first results within 115 minutes, and able to detect various virus strains including emerging COVID-19 variants and avian/swine influenza variants.
The equipment must meet specific technical specifications, including a built-in barcode scanner, touchscreen computer, printer, and the ability to accommodate multiple tube types. Critical performance requirements include differentiating between flu strains and COVID-19, having sensitivity and specificity comparable to current in-house testing methods, and supporting nasal and nasopharyngeal swab samples in viral transport media. The system should minimize human error through features like reagent bottle design, operator lockouts, and the ability to change waste during processing without requiring daily maintenance. No specific pricing details are provided in this specifications document, which appears to be part of a competitive solicitation process for diagnostic testing equipment and supplies.
View the file
Other files for this state and local contract opportunity
| File | Type | Posted |
|---|---|---|
| 3000024682-1.pdf | ||
| Attachment C - Online Bidding Instructions - Pages 1-10.pdf | ||
| Attachment A - Special Terms and Conditions - Pages 1-7.pdf | ||
| Attachment B - Specifications - Pages 1-2.docx | DOCX document | |
| Attachment C - Online Bidding Instructions - Pages 1-10.pdf | ||
| 3000024682.pdf | ||
| Attachment A - Special Terms and Conditions - Pages 1-7.pdf |
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Text version
Attachment B – Specifications
RFx No.: 3000024682 Title: Molecular Diagnostic Analyzer – LDH-OPH
I. Molecular Based Medical Testing Equipment A. Shall have reagent bottles designed to help minimize human error when loading.
B. Shall not require off-board reagent reconstitution.
C. Shall have operator and QC lockout.
D. Shall have a built-in barcode scanner, built-in or included computer with touchscreen and a printer.
E. Shall have the ability to change waste while processing.
F. Shall not require daily maintenance.
G. Shall accommodate multiple tube types, widths, and heights all in the same sample rack.
H. Shall have documentation detailing cross contamination checks and aerosol safety within the processing room.
II. Testing Supplies A. General
1. Pricing shall include Multiplex Test Kits for COVID-19, FLU-A, FLU-B, and, if included RSV
2. Assay shall have an internal (specimen quality) QC and external (assay quality) QC
3. Shall be able to provide first results in 115 minutes or less
4. Shall be FDA approved or emergency use authorized for diagnostic result reporting
5. Shall be able to detect Influenza A, including avian and swine variants
6. Shall be able to detect SARS-CoV-2, including emerging variants
7. Shall be able to differentiate FLU-A, FLU-B, RSV (if applicable), and SARS-CoV-2 and potential co-infections
8. Shall not require removing swab and cap from tube for testing such as utilizing pierceable caps
9. Shall have SARS-CoV sensitivity and specificity comparable to current in house methods, Thermo TaqPath with Kingfisher extraction and Hologic SARS-CoV-2 on Panther.
10. Shall have Influenza A and Influenza B sensitivity and specificity comparable to current in house methods, BioFire RP 2.1 and CDC Influenza A/B Screen.
B. Types
1. Sample type shall include nasal swab and nasopharyngeal swab
2. Transport shall be in VTM and UTM but can include others C. Quantities
1. Testing supplies to be utilized per annum are as follows: Covid-19/FluA/FluB/RSV: 1250
2. Please note that the tests indicated above shall be the estimated number of tests that shall be reserved and made available to LDH OPH Lab on an as needed basis.
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