6515--Purchase of a Molecular PCR Analyzer for Detection of Pathogen's related to Women's Health and Sexual Health

Closed Solicitation Posted

Solicitation number
36C26026Q0844
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Veterans Affairs, Veterans Integrated Service Network 20, Network Contracting Office 20, is conducting market research on behalf of Jonathan M. Wainwright Memorial VA Medical Center to identify potential contractors capable of providing a molecular PCR analyzer for detection of pathogens related to women's health and sexual health, with capabilities statements due July 21 by 10:00 AM PST. This is a sources-sought notice only; no formal solicitation is currently available, and the Government may or may not issue a subsequent solicitation.

Place of performance includes Jonathan M. Wainwright Memorial VA Medical Center, La Grande VA Clinic, Lewiston VA Clinic, Morrow County VA Clinic, Richland VA Clinic, and Yakima Valley VA Clinic across Oregon and Washington.

The analyzer must perform rapid in-house molecular testing with turnaround times of 1.0 to 1.5 hours and support simultaneous execution of Multiplex Vaginal Panel (results within 60 minutes) and Chlamydia trachomatis/Neisseria gonorrhoeae panels (results within 90 minutes) on a single platform. The system must accommodate self-collected specimens including endocervical, vaginal, pharyngeal, rectal, and urine samples with FDA approval for patient self-collection. Additional requirements include capability to support COVID-19, influenza, RSV, MRSA, and Group A Streptococcus testing; minimum simultaneous capacity of 16 test modules; on-demand random access functionality; closed-cartridge configuration with internal controls; benchtop design with maximum dimensions of 21 inches width by 26 inches height by 14 inches depth and weight under 175 pounds; bidirectional LIS interface; and UPS backup with printer.

Interested parties must submit a capabilities statement including business name, address, point of contact, phone, email, business size and type, SAM Unique Identifier, and affirmation of capability compliance to Hector Gonzalez at hector.gonzalez1@va.gov. The NAICS code is 334516, Analytical Laboratory Instrument Manufacturing. PSC is 6515, Medical and Surgical Instruments, Equipment, and Supplies. All questions must be submitted in writing only.

Notice text

The Department of Veterans Affairs (VA), Network Contracting Office 20 (NCO 20), is conducting market research on behalf of the Jonathan M. Wainwright Memorial VA Medical Center to identify potential contractors capable of providing reagents and consumables for laboratory tests for the VA medical facilities and clinics.

The Jonathan M. Wainwright Memorial VA Medical Center is comprised of:

Jonathan M. Wainwright Memorial VA Medical Center.

La Grande VA Clinic.

Lewiston VA Clinic.

Morrow County VA Clinic.

Richland VA Clinic

Yakima Valley VA Clinic

To be considered a responsive and potential source, interested parties shall provide a capabilities statement containing the following information:

Business name, address, point of contact, phone number and email address.

Business size, type, and SAM Unique Identifier Number

Affirmation that the vendor can provide the supplies in accordance with the attached Salient Characteristics.

Additionally, contractors can provide feedback on the attached Requirements Description, which may be considered if a solicitation is posted.

Provide the requested information to Hector Gonzalez at hector.gonzalez1@va.gov before 10:00 AM PST on July 21st, 2026. All questions must be submitted in writing, no telephonic inquiries will be accepted.

This is a sources-sought notice only. The purpose of this notice is to obtain information regarding the availability and capability of verified sources to include qualified SDVOSB/VOSB to perform this potential requirement. Responses received will assist the Government in determining the appropriate acquisition strategy. The Government may or may not issue a solicitation as a result of this notice. There is no solicitation available at this time, and this is not a request for quotes.

Salient Characteristics

Molecular PCR Analyzer for Detection of Pathogen s related to

Women s Health and Sexual Health

Overview:

The Women s Health Innovation and Staffing Enhancements (WHISE) initiative awarded funding to the Jonathan M. Wainwright Memorial VA Medical Center (VAWW) Laboratory to support implementation of in-house molecular testing capability during Fiscal Year 2026 for prompt detection and reporting of pathogens related to veteran women s health and sexual health.

Scope Required for Women s Health and Sexual Health Testing:

The analyzer must allow for rapid in-house molecular testing with significantly improved turnaround times of 1.0 -1.5 hours (or less) for women s health and sexual health to support same-day diagnosis and treatment workflows when clinically appropriate. Must have the ability to perform Multiplex Vaginal Panel and Chlamydia trachomatis/Neisseria gonorrhoeae on a single platform (instrument) simultaneously. These two panels include:

Multiplex Vaginal Panel (results in 60 minutes or less)

Bacterial vaginosis

Atopobium spp.

Bacterial Vaginosis-Associated Bacterium (BVAB2)

Megasphaera-1

Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis

Candida glabrata/Candida krusei

Trichomonas vaginalis

CT/NG Panel (results in 90 minutes or less) for both males and females. Cartridge must also include sample adequacy controls to confirm the presence of human DNA.

Chlamydia trachomatis (CT) - both males and females

Neisseria gonorrhoeae (NG) two independent targets required for accuracy

Test Collection Requirements:

Specimen collection kits must be available for the following samples and FDA approved for patient self-collection in a clinical setting:

Endocervical

Vaginal

Pharyngeal

Rectal

Urine

Analyzer must be capable of performing qualitative PCR tests on self-collected samples for detection and differentiation of these DNA targets with testing multiplexed efficiently to include all analytes in the least amount of test panels.

Scope Required for Additional Testing:

Compatibility with future decentralized and waived molecular testing workflows within the same manufacturer ecosystem represents a significant operational advantage for future outpatient and CBOC expansion strategies. Ability to consolidate all the laboratory molecular testing workflows onto one integrated platform will improve, turnaround times, operational standardization, continuity of operations, staffing efficiency, and future scalability.

Therefore, the requested platform must support broader rapid molecular diagnostic testing needs including:

COVID-19;

combined COVID-19/Influenza A/B/RSV testing;

FDA-cleared asymptomatic COVID-19 testing;

MRSA;

Group A Streptococcus (Strep A);

Influenza A/B;

RSV;

and additional molecular diagnostic assays.

Fast Turn Around Times (TAT) vs. High Throughput:

As an ambulatory care facility, the emphasis is on quick result turnaround times and not high throughput. This instrumentation must provide prompt results (within 1.5 hours) for same day diagnosis and treatment. Analyzers designed for high throughput such as those used in reference laboratories do not meet the turnaround time requirements as they process large amounts of specimens at once but take longer overall to produce test results (3 to 4 hours).

Specifications:

Optimized workflow with multi-test capacity.

Must have the ability to run a minimum of 16 test modules simultaneously.

Must be able to run multiple assay types and test for multiple diseases at the same time using individual cartridges.

Workflow simplicity and minimal hands-on time that utilize efficient user guided software with touchscreen and barcode reader.

Pre analytical workflows suited for CBOC and outpatient transport demands.

Fast throughput with test results within 1 1.5 hours.

Requires on demand random access to allow real time testing (not batches).

Test cartridges:

Must be closed configuration to reduce the risk of contamination with all steps of PCR testing occurring within the cartridge (extraction, amplification and detection.

Must include internal controls to monitor/confirm PCR reaction and verify reagent integrity.

CT/NG Panel cartridge must also include:

Sample Adequacy Control to confirm the presence of human DNA.

Two independent targets required for accuracy

FDA approved and validated for self-collected samples.

On board quality controls to determine run accuracy, probe function and sample adequacy.

Stability at room temperature for reagents that require significant space.

Instrument must be able to bidirectionally interface with an LIS.

UPS backup storage.

Printer

Instrument must be benchtop with compact design with dimensions adequate for countertop space and weight limitations:

21 width x 26 height x 14 depth

Less than 175 lbs.

Installation included in quote.

One year service agreement included in quote and 24/7 technical support

Files

File Type Posted
36C26026Q0844_1.docx DOCX document

Notice history

Notice Type Posted
This notice Latest solicitation Solicitation
6515--Purchase of a Molecular PCR Analyzer for Detection of Pathogen's related to Women's Health and Sexual Health Original Pre-Solicitation

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