III._SOW_Final.docx

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ISAV TESTING SERVICES
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AG-6395-S-17-0088
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III. STATEMENT OF WORK

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IV._Clauses_and_Provisions.docx DOCX document
Appendix_1._ISA_standards.pdf PDF

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III. PERFORMANCE WORK STATEMENT (PWS)

VETERINARY DIAGNOSTIC LABORATORIES TO PERFORM POLYMERASE CHAIN REACTION, INDIERCT FLUORESCENT ANTIBODY TEST, VIRUS ISOLATION (VI), AND SEQUENCING FOR THE DETCTION OF INFECTIOUS SALMON ANEMIA VIRUS

A. BACKGROUND

A fixed price Indefinite Delivery Indefinite Quantity (IDIQ) contract shall be established for reverse transcription polymerase chain reaction (both real-time (rRT-PCR) and conventional (RT-PCR)), indirect fluorescent antibody test (IFAT), and virus isolation (VI). All laboratories shall follow the testing algorithm set forth by APHIS. All PCR assays and VI shall be performed according to standard operating procedures (SOPs) set forth by the National Veterinary Services Laboratories (NVSL). Sequencing of the hemagglutinin-esterase (HE), matrix (M), or fusion (F) genes must be performed according to the participating laboratory’s SOP. These tests are performed under the USDA APHIS VS Infectious Salmon Anemia Virus (ISAV) Control Program in cooperation with the State of Maine Department of Marine Resources (DMR).

B. STATEMENT OF WORK

Work Requirements:

Laboratories are required to provide diagnostic testing services for USDA APHIS VS ISAV Control Program as required by the current Program Standards. Screening tests are RT-PCR (real-time or conventional) and IFAT. PCR is run immediately upon receipt of samples and IFAT is archived and run only to corroborate a positive PCR. VI is only run for follow-up sample collections on suspect/positive net-pens, until the net-pen is again classified as negative. Sequences are run on all initial positive PCR results in a net-pen (other sequences may be requested by the Program Manager) as part of confirmation by NVSL. Generally, 5-10 samples are collected monthly for each active marine site and sent directly from the site veterinarian to the laboratory. Additional samples may be collected as a result of suspect or positive results. Only laboratories meeting the approval requirement of the USDA, APHIS (VS Memo 567.2) to conduct official diagnostics tests for ISAV shall be considered; this includes laboratories approved to test for export purposes, or NAHLN laboratories, and those approved for both the real-time and conventional molecular assays. All laboratories must follow the established testing algorithm and utilize specific testing protocols approved by APHIS. All initial positive results for a specific net-pen will be sent to NVSL for confirmation.

Specific tests required

1. ISAV rRT-PCR Test

0. run on every sample

0. One RNA extraction with duplicate amplification- each RNA is tested twice

1. ISAV RT-PCR Test

1. run on up to three rRT-PCR positive sample from a cage or site

1. amplification from original extraction each RNA tested in duplicate with up to three different primer sets

1. ISAV IFAT

2. archive samples and run only to corroborate positive PCR results

1. Isolation of ISAV virus in cell culture

3. Run only on samples form suspect follow-up collections

3. Two cell lines: ASK and CHSE-214, or ASK and SHK

3. Individual fish or single cage pool of tissues from up to five fish

2. ≤30 fish (6 pools or less)

2. 60 fish (12 pools)

1. Environmental Water/Surfaces PCR

4. Testing when requested by ISA Program Manager and approved by the contracting officer.

Delivery Location:

All initial positive results for a specific net-pen will go to:

National Veterinary Services Laboratories 1920 Dayton Avenue Ames, IA 50010 Phone: (515) 337-7514

Instructions for Submitting diagnostic test samples to the NVSL and Quality Assurance at the NVSL (also include timeline for requesting testing protocols from NVSL)

See Appendix 1 for Infectious Salmon Anemia Program Standards.

C. WAGE DETERMINATION

This contract is subject to the Service Contract Labor Standards statute. Wage Determinations based on the contractors location will be enforced at contract award.

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