Sources Sought Notice for Chemiluminescent immunoassay (CLIA) kits compatible with the government’s current CLIA instrumentation for the Brooke Army Medical Center (BAMC).

Active

Contract Opportunity

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 determine reportable range with data reduction in accordance with CLSI guidelines.

3. Precision study shall be performed utilizing normal and abnormal control material. This should consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal and abnormal controls.

4. Sensitivity: Sensitivity may be validated concurrently with the linearity verifications.

5. Specificity studies: Adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances including blood container are evaluated for interfering substances for each method performed.

6. Reference Range: Determine a reference range for each test following CLSI guideline C-23A. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols should be used:

a. If the suggested manufacturer's range is not appropriate for the patient population, a reference range must be established and may require additional reference individuals.

b. If a laboratory is currently using the proposed instrument/reagent system, the "in-use" reference range can be transferred to the "new" system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, then an alternate test must be provided.

7. Analytical Measurement range validation studies must be performed by vendor for applicable analytes,

8. All technical procedures must be provided electronically by vendor in CLSI format, using software compatible with each Laboratory's computer system, for local modification (editable) to meet CAP requirements.

9. Carryover studies must be performed, as applicable, as part of the initial evaluation of the instrument. Vendor shall provide interpretation of raw data for each instrument installed and validate no carryover exists within the test platforms.

10. Vendor must provide all reagents, calibrators, and controls needed along with technical assistance to perform correlation studies from a single lot at no additional cost for new test methods or changes in test menus. (i.e., vendor is to provide all manpower and reagents/supplies to do correlation studies).

11. Vendor must provide hands-on training to staff onsite prior to or during instrument integration at the facility. Expert/advanced user training should be offered at vendor/manufacturer site at a minimum of two (2) staff per instrument.

Analytical Systems:

• Not applicable. Vendor will not provide instrumentation. The government’s instrumentation will be used.

Reagents and Supplies:

1. Vendor must describe kit size options available for applicable tests.

2. Vendor reagents must be 99% liquid ready to use from storage, requiring no reconstitution or mixing. List all Reagents that are not liquid, ready to use.

3. Vendor calibrators must be at least 95% liquid ready to use from storage, requiring no reconstitution or mixing. List all assay calibrators that are not liquid, ready to use.

4. Quality of Reagents, Supplies and Disposables: The contractor shall assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality product. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission. In the event that supplies are found to be defective and unsuitable for use with the contractor's equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order.

5. Vendor must provide 5 years of FDA field action notifications.

TABLE 1. WORKLOAD DATA. All volumes are in tests per year included in the attached Chart on a different document.

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