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T-Spot TB Testing Diagnostic Services


California, United States
Government : Federal
RFP
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The VA Palo Alto Health Care System (VAPAHCS) intends to negotiate a sole source contract with Oxford Diagnostic Laboratories/Immunotec Ltd. The proposed contract action is for a one (1) year order with a one (1) year option for Interferon Gamma Release Assay (IGRA) with sensitivity and specificity greater than 95% to diagnose tuberculosis in patients with other diseases that compromise their immune system or as a secondary/confirmatory test when indeterminate results are obtained with the primary testing method. Oxford Diagnostics is the only provider in the United States to provide this type of testing service.

Only two IGRAs have been approved by the U.S. Food and Drug Administration (FDA) and are
commercially available in the United States:

1) QuantiFERON TB Gold In-Tube Test (QFT-GIT) and
2) T-Spot.TB test (T-spot.)

The VAPAHCS currently uses QuantiFERON TB test as a primary test and uses T-Spot to diagnose
tuberculosis disease in patients with other diseases that compromise their immune system and as a
second/confirmation test when indeterminate results are obtained through the primary test method.
Oxford Immunotec, Inc. is the only source for T-Spot.TB test kits. The T-Spot test is the only
commercially available, FDA approved interferon-gamma release assay (IGRA) that utilizes the ELISPOT
technology.

This sole source action is in accordance with FAR 8.405-6(a)(1)(i)(B). Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. THIS IS NOT A REQUEST FOR COMPETITIVE QUOTES and no competitive solicitation will be issued; however, any firm that believes it can meet these requirements or provide an equal product may give written notification to the Contracting Specialist for consideration. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the requirements. Responses are due by February 21, 2019 at 4:00 PM PST. A determination by the Government not to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

Responses must be e-mailed to charles.simon@va.gov . No telephone responses will be accepted. No reimbursement for any costs associated with providing capability statements will be provided by the Government.

Charles Simon

Contract Specialist

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