EXP2630 Chembio PUR7776 Final.pdf

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Attached to
SURE CHECK HIV ½ Assay State and local contract opportunity
Solicitation number
SS-12046
Issued by
Leon County, Florida

About this file

This document is a Description of Intended Single Source Purchase (PUR 7776) from the Florida Department of Health (FDOH), specifically for the Bureau of Communicable Disease, HIV/AIDS Section. The agency seeks to purchase Chembio SURE CHECK HIV ½ Assay, an FDA-approved, single-use immunochromatographic test for detecting antibodies to Human Immunodeficiency Virus Type 1 and Type 2, for a three-year term. The solicitation was posted on 3/21/2025 with a last day for receipt of information on 4/11/2025, targeting a contract with Chembio Diagnostics Systems, Inc. as the sole manufacturer and distributor.

The total estimated dollar amount for this single-source procurement is $3,000,000.00. The unique justification for this single-source acquisition is that the Chembio SURE CHECK HIV 1/2 Assay is the only FDA-approved testing kit requiring only 2.5 microliters of finger-stick whole blood, which allows HIV testers to reach more people with less resistance and anxiety. The procurement is intended to support HIV testing in at-risk communities by providing a testing method that may be less intimidating and invasive compared to traditional testing approaches.

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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):

Three Years

Requestor (division, bureau, office, individual, as appropriate):

FDOH, Bureau of Communicable Disease, 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 FDOH, Bureau of Communicable Disease, HIV/AIDS Section has a need to purchase FDA approved HIV test kits to be used for at-risk communities. These kits increase the opportunity in the non-traditional rapid point of care diagnostic method by using the least amount of finger-stick whole blood, which encourages those who may have an aversion to needles or blood to get tested.

This allows HIV testers to reach more people with less resistance and anxiety.

In accordance with Chapter 60A-1.045, Florida Administrative Code, the FDOH, Bureau of Communicable Disease, HIV/AIDS Section requests authorization to purchase a single source the

AGENCY: Florida Department of Health (FDOH)

TITLE: SURE CHECK HIV ½ Assay Short description of the commodity or services desired: Chembio SURE CHECK HIV ½ Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2.

CONTACT

Name: Bill Zimmerman Address: 4052 Bald Cypress Way, Tallahassee, FL, 32399 Telephone: (850) 617-5894 Email: bill.zimmerman@flhealth.gov

Internal tracking number, if any: EXP2630

Date posted: 3/21/2025 Last day for receipt of information: 4/11/2025

PUR 7776 (Revised 07/2022) Page 2 of 2 Incorporated by Reference: Rule 60A-1.045, F.A.C.

Chembio SURE CHECK HIV ½ Assay, a single-use immunochromatographic test for detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2.

Intended Single Source:

Chembio Diagnostics Systems, Inc.

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 Chembio SURE CHECK HIV 1/2 Assay is the only FDA approved testing kit which requires 2.5 microliters of finger stick whole blood, thus requiring the least amount of whole blood for testing and allowing HIV testers to reach more people with less resistance and anxiety.

• Chembio Diagnostics Systems, Inc. is the sole manufacturer and distributer of the Chembio SURE CHECK HIV 1/2 Assay.

Approved By (names & titles, as appropriate, e.g., requestor, requestor management, information systems, budget, purchasing):

Allegra Small, 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 .