J and A for Contract to Develop and Evaluate prototype dengue point- of -care immunchromatographic strip assays.

Justification and Approval

For Other Than Full and Open Competition



1. Contracting Activity



Naval Medical Logistics Command, Acquisition Management Directorate, Code02, 693 Neiman Street Fort Detrick, MD 21702-9203

a.Requesting Activity: Naval Medical Research Center, Admin Directorate/Contracting Division, 503 Robert Grant Avenue, Silver Spring, MD 20910 USA

b.Document Number: N3239809RCCH023

c.Shipped To: 503 Robert Grant Avenue, Silver Spring, MD 20910 USA



2.Description of Action: Approval is requested to support the mission of the Military Infectious Diseases Research Program Area L- Diagnostic Systems for Infectious Disease by developing a Reverse Transcriptase Loop-mediated Isothermal Amplification (RT-LAMP) assay for dengue virus detection on the basis of other than full and open competition.



3. Description of Supplies/Services:

Contractor responsibilities include:

a.Optimize prototype RT-LAMP assay using replaced reagents

ii.Obtain prototype RT-LAMP assay and stock dengue RNA extracts from NMRC

iii.Replace the dTTP in the reaction with a mixture of Biotin-11-dUTP, digoxigenin-11-dUTP, and dTTP

iv.Perform and optimize the RT-LAMP reaction using stock dengue RNA extracts so that the biotin and digoxigenin will be incorporated into the nucleic acid reaction products

b.Transitioning the optimized RT-LAMP assay developed by NMRC into an Immunochromatographic (ICT) strip format including:

ii.Capture the biotin and digoxigenin-containing RT-LAMP products on the ICT strips to be visualized by the naked eye

iii.Manufacture ICT assays using Contractor SOPs

c.Evaluate the prototype ICT assay using patient RNA extracts to obtain clinical sensitivity, specificity, and cross reactivity for other flaviviruses.

ii.Obtain patient RNA extracts from NMRC

iii.Perform preliminary evaluation using patient RNA to obtain clinical sensitivity, specificity, and cross reactivity for other flaviviruses

iv.Troubleshoot to meet performance standards



4. Statutory Authority Permitting Other than Full and Open Competition: The authority cited is 10.U.S.C. 2304 (1), as implemented by FAR 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirement.



5. Rational Justifying Use of Cited Statutory Authority: No other contractor provides successful transition of the prototype dengue RT-LAMP diagnostic assays to an ICT strip format to make the dengue diagnostic easier to read and interpret in a field setting. The process for transitioning and evaluating the ICT assay involves multiple steps: optimizing the ICT assay, incorporating the labeling proteins, striping ICT strips, performing specificity analyses with patient serum samples. National Chung Hsing University in Taiwan has successfully produced the prototype ICT, and in their preliminary testing, it shows that the prototype ICT can detect the nucleic acid amplification products. The contractor has successfully manufactured ICT strips that contain a nano-gold streptavidin conjugate and a line of anti-digoxigenin to capture amplification products.

6. Description of Efforts Made to Solicit Offers from as Many Offers Practicable: Market research was conducted and found that only one responsible source will meet the governments need. A notice of intent will be posted in order to locate more potential sources.



7. Determine of Fair and Reasonable Cost: The Contracting Officer will determine that the anticipated cost to the Government will be fair and reasonable prior to award.



8. Action to Remove Barriers to Future Competition: A notice of intent to sole source will be posted to FBO.gov in accordance with FAR 5.201.



9. Interested Sources: Please see 6.



10. Other Facts

a. Procurement history:

i. Contract numbers and dates of the last several awards: N/A

ii. Competitive status of these actions:

b. Acquisition Data Availability:

c. Unusual and Compelling Urgency: N/A

d. Subcontracting Competition: N/A

e. Follow on Contracts: N/A