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Opportunity Details

Solicitation Number: 162025

Date Added: January 07, 2025

Description:

The Medical Readiness Contracting Office West (MRCO) is issuing this Sources Sought Notice to find potential sources to provide Chemiluminescent immunoassay (CLIA) kits compatible with the government’s current CLIA instrumentation for the Brooke Army Medical Center (BAMC) Department of Pathology and Area Laboratory Services – Immunology Laboratory, Fort Sam Houston, Texas. Required assays are listed below. A base period of performance from 01 October 2025 through 30 September 2030 will be required for this action.


THIS IS NOT A SOLICITATION ANNOUNCEMENT – This is a Sources Sought Notice and is issued solely for information and planning purposes – it does not constitute a Request for Quote (RFQ) or a promise to issue an RFQ in the future. Solicitations are not available at this time and requests for a solicitation will not receive a response. This notice does not constitute a commitment by the United States Government to contract for any supply or service whatsoever. All information submitted in response to this announcement is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government. Not responding to this Sources Sought Notice does not preclude participation in any future RFQ, should one be issued. It is the responsibility 
of the potential offerors to monitor this site for additional information pertaining to this requirement.

The Government will use responses to this notice in formulating its acquisition strategy. If the Government does not receive sufficient information in response to this notice to verify the potential for competition exists, it is possible that a sole- source contract, supported by a Justification and Approval document, will be issued to support the Government's requirement. MRCO-W 
is seeking the following information (please answer paragraph below with your response):

1. Company name, CAGE code, and point of contact information (including phone number and email address), and socio-economic category(ies) as related to NAICS 325413 (In-Vitro Diagnostic Substance Manufacturing), such as 8(a), HUBZone, Women-Owned, Service-Disabled Veteran-Owned, Small, or Other-than-Small.

2. Capability Statement (limited to ten pages), describing how your company meets the below objectives, providing additional proof (such as FDA approval) where appropriate:

Requirements of Services to be provided:

Basic Requirements: Chemiluminescent immunoassay applicable kits must be FDA-approved and compatible with the government’s current CLIA instrumentation. Training must be provided for reagent kits/assay kits provided.  Test Menu and Special Requirements for Awarded Contractor: Vendor must meet, or improve, each Laboratory's existing turn-around times as a minimum, by any change in instrumentation. Listed testing requirements must be capable of completion in under 60 minutes from start time (time of loading onto instrument). 

Proposal should include automated CLIA processing for:

•  Calprotectin (fecal)
•  Cytomegalovirus IgG
•  Cytomegalovirus IgM
•  Epstein-Barr Virus
o EBV IgM
o VCA IgG
o EBNA IgG
o EA IgG
•  Herpes Simplex Virus ½, type specific IgG for each
•  Measles IgG
•  Mumps IgG
•  Rubella IgG
•  Rubella IgM
•  Toxoplasma gondii IgM
•  Toxoplasma gondii IgG
•  Treponema pallidum (IgG/IgM)
•  Varicella Zoster Virus IgG
•  Zika virus IgM
•  Lyme
o Lyme total antibody
o Lyme IgG
o Lyme IgM
•  MeMed BV (or similar structure)
o Immune system-based protein signature to differentiate between bacterial and viral infections Method Performance/Comparison shall be at the expense of the Vendor, shall include linearity material and reagents, and be consistent with current CLSI Standards and related documents, CAP Standards and Federal Regulations, for the following:

1.  Correlation studies for each analyte. A minimum of 20 samples, spanning the reportable range, shall be run by the present and the new contracted method. Vendor shall analyze numbers and provide statistical data to accept the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, and meet current standards defined by CLSI.

2.  Linearity analysis shall be performed on new contracted instrument(s) for each analyte to&nb

Set-Aside: N/A (N/A)

Place of Performance: Fort Cavazos, Texas, UNITED STATES

NAICS Codes:
325413

Files:

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