Intent to sole source

This is NOT a request for quote-

USDA-ARS, Pullman, WA intends to award a sole source purchase order to Colorado State University Diagnostics Laboratory for A1 target Coxiella burnetiid quantitative Polymerase Chane Reaction Testing.

The qPCR test provides data not only on presence or absence of C. burnetii shedding, but also quantitative information on the amount of shedding from various veterinary sources. The goal of the research is to find ways to reduce not only the probability of shedding (presence or absence data), but also to reduce the quantitative amount of C. burnetii shedding that can contribute to transmission. To achieve this end, a quantitative measure is required, and the qPCR is the only such test advertised commercially. Taken together, the qPCR provides maximal sensitivity and interpretability of quantitative C. burnetii data from veterinary samples.

Market research included internet searches for terms including C. bu rnetii , Q fever, PCR, quantitative, and diagnostic . We also directly searched veterinary diagnostic lab websites for available C. burnetii testing services.

Texas A & M recently added the qPCR test to their sampling which includes 1-2 ml of vaginal fluids. Our samples are vaginal swabs which do not meet the sample volume requirement for this sample type. Texas would possibly be able to test our placental samples. Afte r speaking directly with the lab manager we have learned that Texas is not Select Agent Approved to work directly with C. burnetii, and they are also not equipped to test the number of samples we would like to send for testing. We know from previous testing of a subset of these samples that some serology came back positive for Q-fever, and some vaginal swabs came back positive for Q-fever DNA. To be clear, this is not a definitive diagnosis of Q-fever for these samples, but it does indicate that they are highly likely to test positive for the agent (C. burnetii) that is responsible for Q-fever. If a sample tests positive for Q-fever Texas A & M is required by law to destroy the samples.

We require that remaining samples that we collected are shipped to us. CSU is SRA approved and would be able to ship their extracted DNA and remaining placental tissues back to our BL3 lab in order to do further testing and research for publication. We would lose valuable unit time and money previously invested in the collection and testing of irreplaceable research samples if they were destroyed at Texas A & M. We have an in house BL3 and SRA approval in order to study these further.

We have already completed some sample testing through CSU that has been published. We require comparable data for our current samples in order to reference our previous publication and continue our research.

Other veterinary diagnostic laboratories offer C. burnetii serologic tests, but these only reflect an animal's history of C. burnetii exposure, not its current shedding status. A small number of veterinary diagnostic laboratories offer simple PCR testing for C. burnetii, but this test only provides data on the presence or absence of C. burnetii shedding, not the quantitative data needed to evaluate amounts of shedding. Since our research concerns the amounts of shedding that may contribute to transmission, the quantitative data are required.

Our justification to award is in accordance with Federal Acquisition Regulation (FAR) 6.302-1 - Only one responsible source and no other supplies or services will satisfy agency requirements.

All inquiries on this action can be submitted in writing via email to Brian.Fien@ars.usda.gov NO LATER THAN 11 June 2019 @ 12:00PM PST. All information shall be furnished at no cost or obligation to the Government.

Notice of Intent to Sole Source

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