Reagents for detection of Mycobacterium Tuberculosis: Liaison QuantiFERON TB Gold Plus and LIAISON Control QuantiFERON TB Gold Plus

The Medical Readiness Contracting Office – Pacific, Joint Base Lewis McChord Health Contracting Branch is issuing this sources sought notice for informational purposes only. The notice is a means of conducting market research to identify industry’s capabilities.

The Madigan Army Medical Center (MAMC) Department of Pathology requires reagents for the detection of Mycobacterium tuberculosis (TB), a QuantiFERON TB Gold-Plus assay.

This sources sought notice is not a solicitation for quotations, proposals nor invitation for bids. Any information submitted by respondents to this notice is strictly voluntary and will not be compensated. Telephonic inquiries will not be accepted or acknowledged. The Government will not evaluate the information received nor provide comments or feedback.

Your response to the information requested will assist the Government in determining the appropriate acquisition method. Businesses of all sizes are encouraged to respond; however, each respondent must clearly identify their business size in their capabilities and qualifications statement. A determination by the Government not to compete this proposed effort based upon responses to this notice is solely within the discretion of the Government. The Government is not obligated to issue a solicitation nor award a contract under this announcement. If a solicitation is released, it will be synopsized on the Government-Wide Point of Entry (GPE). It is the responsibility of potential offerors to monitor the GPE for additional information pertaining to this requirement.

Project Background

The MAMC Department of Pathology currently uses QuantiFERON TB Gold-Plus assay to detect TB using the LIAISON XL System. Qiagen QFT Gold Plus is a testing method that aids in the detection of Mycobacterium tuberculosis, the bacteria which causes tuberculosis (TB). Qiagen is the only FDA approved source available for in house latent TB testing from blood samples using InterFeron Gamma Release. Not using Qiagen would require testing be sent to a commercial reference laboratory.

Required Capabilities

Salient Characteristics of LIAISON QuantiFERON TB Gold-Plus and LIAISON QuantiFERON TB Gold-Plus Control:

• Bar-coded data entry capabilities.


• FDA-approved assays for: QuantiFERON TB Gold Plus


• Preference will be given to platforms that have FDA-approved assays for the additional analytes specified.


• Ready-to-use reagents, bar-coded cassettes.


• Must be able to provide complete system validation (or assist facility with validation, as needed).


• Vendor will provide sufficient kits, at no cost to the Government, for verification of each assay as described in the verification plan signed by the Medical Director, Department of Pathology, Madigan Army Medical Center.


• Operate within the existing environmental conditions of 15-35 °C and 15-75% relative humidity.


• Pipette tip locking and monitoring technology, including anti-droplet control (ADC) for reliable sample transfer. Disposable tips preferred. If system uses fixed tips, manufacturer must have completed a robust carry-over study or assist facility with design and completion of study.


• If available, external controls and/or calibrators for each assay should be included as part testing from the same manufacturer. Preference will be given to test assays that include external controls to meet requirements of Clinical Laboratory Improvements Acts of 1988.


• Any calculations for results interpretation for QuantiFERON TB Gold PLUS and other serological assays indicated are automatic (i.e. no manual manipulation of data or additional system hardware requirements) with direct reporting of results to LIS.

Eligibility

The applicable NAICS code for this requirement is 325413 – In-Vitro Diagnostic Substance Manufacturing with a small business size standard of 1,250 employees. The product service code is 6550 in vitro diagnostic substances, reagents, test kits and sets. Businesses of all sizes are encouraged to respond.

Submission Details

Interested parties are requested to submit responses via email. The interested party are encouraged to submit a capability statement that clearly demonstrates their provided reagents for the detection of Mycobacterium tuberculosis (TB), a QuantiFERON TB Gold-Plus assay that meet all the salient characteristics. The email subject line should be “Sources Sought Response for W81K0225QA100.” Capability Statements may be in either Microsoft Word, Portable Document Format (PDF), and shall be addressed to brittany.n.chartier.civ@health.mil. Proprietary, classified, confidential, or sensitive information should not be included in your response.