QUANTIFERON-TB GOLD IN-TUBE (QFT-GIT) ASSAY VOLUME STUDY

QUANTIFERON-TB GOLD IN-TUBE (QFT-GIT) ASSAY VOLUME STUDY. The 311 Human Systems Wing/PKAH, Brooks City-Base TX, intends to award a SOLE SORCE Purchase Order to the National Foundation Center for Disease Control and Prevention, 50 Hurt Plaza Ste.765, Atlanta, GA 30303. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. The Reference Number is F1JEAC9065B001 is issued for the purpose of entering into a Firm-Fixed price contract for services in accordance with the Performance Work Statement. This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular 2005-30. The associated NAICS code is 621511, and the size standard is $12.5 M. The Government intends to award a Sole Source Purchase Order to assess the reproducibility of QFT-GIT results when the volume of the blood specimen used is both within- and out-of-range per the FDA approved package insert which allows a specimen range of 1.0 ml - 0.2ml. The specimen volumes to be used per test subject collected at a single point in time are 0.5ml, 0.8ml, 1.0ml, 1.0ml, 1.0ml, 1.2ml, and 1.5ml. The objective is to assess the degree of discordance in QFT-GIT results across specimen volumes and to identify conditions under which discordance may be expected. The contractor shall also measure inter-assay agreement in QFT-GIT results when the test antigens are mixed with the whole blood specimens using two different mixing conditions: a. Whole blood specimens shall be mixed with the antigens by shaking to the point at which the blood begins to froth - this procedure is recommended by the QFT-GIT manufacturer and has been FDA approved. b. Whole blood specimens shall be mixed with the antigens by rolling on a mixing platform (concurrently rocks and rolls tubes to assure full surface coverage) - this procedure is more consistent with the way phlebotomists are taught to handle blood specimens. The provisions at FAR Part 52.212-1, Instructions to Offerors - Commercial, applies to this solicitation. The clause at 52.212-4, Contract Terms and Conditions, Commercial Items, applies to this acquisition. (xii) The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items, applies to this acquisition. The following FAR clauses identified at paragraph b. of FAR 52.212-5 are considered checked and are applicable to this acquisition: (b)1, 14-22, 24, 36, (c) 1, 2, and 4. 252.201-7000 Contracting Officer's Representative , 252.204-7003 Control of Government Personnel Work Product, 252.204-7004 Alternate A Central Contractor Registration, DFAR 252.212-7001 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items, 252.232-7003 Electronic Submission of Payment Requests, 252.232-7010 Levies on Contract Payments.