Attachment 3 Sample Special Study Statement of Work.doc

CLIN 0008 SPECIAL STUDIES AND SERVICES

DEMONSTRATION OF CAPABILITY: ABI 7900 FASTBLOCK

STATEMENT OF WORK

BACKGROUND: PFPA needs to transition to a new polymerase chain reaction (PCR) platform. This new platform is the ABI Prism® 7900 HT instrument from Applied Biosciences. Before operational samples may be run with the contractor produced reagents on this new instrument, a demonstration of capability must be performed to ensure the new methods will meet or exceed the current standards presently exemplified in our routine sample analysis. The Joint Program Executive Office (JPEO) Quality Assurance program mandates that this preliminary testing take place.

SCOPE: In accordance with the JPEO QA Program document #QC-002 New Methods Acceptance Requirements, the lab shall test cocktails prepared and verified at NSWC (using the ABI 7900HT platform). Samples have been spiked and shipped to the PFPA CBRNE laboratory. Forty-five samples shall be created for laboratory analysis.

TECHNICAL REQUIREMENTS:

Sample Analysis

1. Upon receipt by the laboratory, the samples shall be stored at 4°C until analysis activities begin.

2. Extraction shall be performed using the manual concentration bead-beating (MCBR) extraction protocol.

3. The contractor shall prepare and transport the Fastblock master mix reagents to be used throughout this study.

4. PCR analyses shall be performed in singlet using the ABI 7900HT platform and shall utilize Fastblock reagents provided by the contractor for targets N1 and N2, OS1, UL1, LE1 and LE4 and CRP FastBlock-optimized reagents for UL3 and UL4 (provided by the government)

5. Inhibition testing shall be performed for each sample.

6. All standard extraction and quality control samples shall also be included.

7. Analyses of the 45 filters shall be distributed across at least two instruments (as indicated by the sample ID). In addition, the analyses should cover at least two analysts and at least two analysis days. The distribution across days and analysts is left to the discretion of the laboratory.

Additional Support

1. As the testing for each sample is completed, results shall be recorded and reported to Signature Science (SSLLC). Results for all associated QC data (both positive and negative controls) shall also be reported.

2. Prepare and upgrade the Laboratory Information Management System (LIMS) at the PFPA Lab to permit data importing, data compilation and result reporting for the ABI instrument.

3. Provide onsite training to the PFPA personnel in the use and maintenance procedures for the ABI 7900 Fastblock.

4. Provide the capability of preparing pdf data files suitable for emailing to government personnel to maintain ability to review data from home.

5. Assist with the development of the Laboratory SOPs for ABI FastBlock sample analysis, reagent preparation and instrument maintenance.

Deliverables

1. Compilation of test results for the 45 samples associated with the DOC, presented to both SSLLC and PFPA Lab.

2. Demonstrated ability to produce pdf files detailing test results in a format suitable for electronic transmission.