EXP2666 PUR7776_Final.pdf
PDF 121 KB Posted
- Attached to
- bioLytical INSTI HIV – 1/HIV-2 Antibody Test
- Solicitation number
- SS-15549
- Issued by
- Leon County, Florida
About this file
This is a purchase authorization document from the Florida Department of Health's Bureau of Communicable Disease, HIV/AIDS Section, requesting approval to procure bioLytical INSTI HIV-1/HIV-2 antibody testing devices as a single-source purchase. The Florida Department of Health seeks to acquire FDA-approved, third-generation INSTI HIV IgG/IgM testing devices that deliver results within 60 seconds for use in at-risk communities, along with associated testing kit training. The procurement is being pursued as a single-source purchase in accordance with Chapter 60A-1.045 of the Florida Administrative Code, indicating that bioLytical has been identified as the sole qualified vendor capable of meeting the Department's specific testing requirements.
The document establishes the justification and authorization framework for the purchase of these specialized rapid HIV testing devices from bioLytical without competitive bidding. The single-source procurement approach reflects the specialized nature of the INSTI technology and its suitability for rapid point-of-care testing in community health settings. No specific contract term, renewal options, pricing details, quantities, or funding amounts are detailed in the authorization document itself, as this serves as the foundational approval to proceed with the purchase rather than the final procurement contract.
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Text version
PUR 7776 (Revised 07/2022) Page 1 of 2
Incorporated by Reference: Rule 60A-1.045, F.A.C.
DESCRIPTION OF INTENDED
SINGLE SOURCE PURCHASE
(PUR 7776)
This description of commodities or contractual services intended for purchase from a single source is posted in accordance with Sections 120.57(3) and 287.057(3), Florida Statutes (F.S.), and will remain posted for a period of at least 15 business days.
Commodity or Contractual Service Required (commodity or United National Standard Products and Services Code (NSPSC), manufacturer, model, and description, as appropriate):
41113000 Chemical Evaluation instruments and supplies
Quantity or Term (as appropriate):
3 Year Term
Requestor (division, bureau, office, individual, as appropriate):
Florida Department of Health, Bureau of Communicable Diseases (BCD), HIV/AIDS Section
Performance and/or Design Requirements (e.g. intended use, function or application, compatibility, requirements; reference to policy, rule, statute or other act of the Legislature, etc., as appropriate):
The Florida Department of Health’s Bureau of Communicable Disease, HIV/AIDS Section has a need to purchase FDA approved, INSTI HIV – ½, IgG/IgM, 3r d generation testing devices, which provide results in 60 seconds for at-risk communities and testing kit training. In accordance with
Chapter 60A-1.045, Florida Administrative Code, the Florida Department of Health’s (BCD), HIV/AIDS Section, requests authorization to purchase as a single source, the INSTI HIV – ½, IgG/IgM, 3rd generation testing devices from bioLytical.
AGENCY: Florida Department of Health
TITLE: bioLytical INSTI HIV – 1/HIV-2 Antibody Test
Short description of the commodity or services desired: bioLytical INSTI HIV-1/HIV-2 Antibody Test is a 3rd Generation HIV rapid point of care test which provides a result in 60 seconds.
CONTACT
Name: Keshauna Johnson
Address: 4052 Bald Cypress Way, Tallahassee, FL 32399
Telephone: (850) 558-9723
Email: Keshauna.Johnson@flhealth.gov
Internal tracking number, if any: EXP2666
Date posted: 4/2/2026 @ 11:00AM Last day for receipt of information: 4/23/2026 @ 11:00AM mailto:Keshauna.Johnson@flhealth.gov
PUR 7776 (Revised 07/2022) Page 2 of 2
Incorporated by Reference: Rule 60A-1.045, F.A.C.
Intended Single Source:
bioLytical
Estimated Dollar Amount:
$3,000,000.00
Justification for single source acquisition (what is necessary and unique about the product, services or source; steps taken to confirm unavailability of competition, as appropriate):
• The bioLytical INSTI HIV-1/HIV-2 Antibody, 3rd Generation HIV rapid point of care test is the only FDA-approved, Clinical Laboratory Improvement Amendment (CLIA) waived rapid device providing a test result in 60 seconds.
• bioLytical is the sole approved provider for HIV-1/HIV-2 Antibody, 3rd Generation HIV rapid point of care test devices providing a result of 60 seconds and training for Public
Health, Governmental entities, and the ability to offer HIV testing to more individuals.
Approved By (names & titles, as appropriate, e.g., requestor, requestor management, information systems, budget, purchasing):
Sonja German, Purchasing Director
Prospective vendors are requested to provide information regarding their ability to supply the commodities or contractual services described. If it is determined in writing by the agency, after reviewing any information received from prospective vendors, that the commodities or contractual services are available only from a single source, the agency shall provide notice of its intended decision to enter a single-source purchase contract in the manner specified in Rule 60A-1.045, Florida Administrative Code, and section 120.57(3), F.S.
File details come from the government source that posted it. Updated .