NOI Sole Source_biorad.pdf

THIS IS A NOTICE OF INTENT TO AWARD A SOLE-SOURCE CONTRACT

AND IS NOT A REQUEST FOR COMPETITIVE PROPOSALS.

The United Stated Army Medical Research Acquisition Activity (USAMRAA) intends to negotiate on a sole source basis, IAW FAR 13.5, with Bio Rad Laboratories 1000 Alfred Nobel

Drive, Hercules, California 94547, USA,as the only responsible source that can provide Serology

Analyzers, Consumables, and Reagents for HIV Diagnostic Testing. This acquisition is being conducted under FAR Part 12 Acquisition of Commercial Items. Provisions and clauses in effect through Federal Acquisition Circular 2020-06 are incorporated.

The Walter Reed Army Institute of Research (WRAIR) intends to procure a firm-fixed-price

Indefinite Delivery Indefinite Quantity (IDIQ) with a Five (5) Year Ordering Period for the leasing/purchase, installation, and validation of serological automated analyzers with UPS backup systems. The Contractor shall also provide all reagents, consumables, and instrument maintenance/re-calibration related to the screening and confirmation of the HIV virus in patient specimens. The contractor shall provide the following leased analyzers:

Eleven (11) BioRad EVOLIS Analyzer, Catalog Number 1314.

Six (6) Geenius Confirmatory Analyzers, Catalog Number 92052.

The contractor shall provide the following reagents:

Product Name Catalog Number

Western Blot (40 tests/kit) #32508

HIV Combo Ag/Ab EIA

(96/kit)

#26218

Geenius, HIV1-2 (20 tests/kit)

#72461

Evolis Sample Rack #90433

Geenius HIV1-2 Controls

(1Pos,1Neg)

#72339

Ortho HCV, 4N Sulfuric

Acid Solution

#933040

HBs Ag Confirmation

Testing

#32594

Western Blot Buffer #32574

GS HIV Combo Ag/Ab

EIA 4800

#12003863

MONOLISA Anti-HBc

EIA (192 tests/box)

#26186

MONOLIS Anti-HBs

EIA (192 tests/box)

#25220

GS HBs Ag EIA 3.0 (48 tests/box)

#32591

Ortho HCV EIA v 3.0

(480 tests/box)

#930740

Ortho HCV Wash

Solution

#933730

GS HIV-1/HIV-2 Plus O

EIA (480 tests/box)

#32588

The maximum contract ceiling for the duration of the contract is $6,950,000.00.

The US Army HIV diagnostic algorithm is unique in that is uses a single clinical specimen to determine the HIV infection status of each Service Member. This approach is unique to the US

Army and is not employed in any known US or international clinical diagnostic laboratory. This test strategy was developed to eliminate the requirement for a second blood draw for molecular testing to detect genetic material of the virus during Acute or Early HIC infection when antibody responses to HIV are absent or not mature. Most importantly, the test strategy permits rapid identification and notification of acutely infected Soldiers when their potential to transmit HIV is highest and works to facilitate their rapid referral to clinical care. The single specimen virus testing procedures are a mandated process as defined in USA regulation, AR600-110, April 22, 2014, Identification, Surveillance, and Administration of Personnel Infected with Human

Immunodeficiency Virus, Section H Human Immunodeficiency Virus Testing Procedures.

The Bio-Rad EVOLIS System is the only serological analyzer that meets the stringent requirements for HIV infection status determination from a single specimen with highest fidelity.

Test fidelity is a measure of precision and accuracy without cross-contamination of the specimen.

High fidelity testing of a single specimen without cross-contamination minimizes false positive test results, the need to re-draw a specimen from the patient, and duplicative cost to the

Government as required in USA Regulation AR600-110. The Bio-Rad Geenius Analyzer is the only FDA Approved Analyzer for confirmatory testing. Bio-Rad Laboratories is the sole manufacturer of the FDA Approved supplemental confirmatory assays for HIV-1 and HIV-2

(HIV-1/2 Rapid Test, HIV-1 Western Blot, and the Geenius Analyzer) and the serological analyzer (model EVOLIS).

The intended procurement will be classified under North American Industry Classification

System (NAICS) 334516 with a Small Business Size Standard of 1000 employees. This notice of intent is not a request for competitive proposals and no solicitation document will be posted for this requirement. However, parties interested in responding to this notice shall submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by closing of this notification of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

Submit email capabilities statements (using PDF, MS Word, Excel attachments) to Kasey Carroll at kasey.l.carroll.civ@mail.mil. Statements are due no later than 1:00 P.M. EST on 17 July 2020.

Late responses will not be reviewed.

mailto:kasey.l.carroll.civ@mail.mil