Revised SPADA EOP - 01-23-2017

72

2.3 73 74 Inclusion of all environmental panel organisms is not a requirement if a method developer provides 75 appropriate justification that the intended use of the assay permits the exclusion of specific panel 76 organisms. Justification for exclusion of any environmental panel organism(s) must be documented and 77 submitted. 78 79 If bioinformatic analysis is completed then DNA from Group 1 organisms should be tested. If 80 bioinformatic analysis is not completed then DNA from Group 1 and 2 organisms should be tested 81 82 Organisms and cell lines may be tested as isolated DNA, or as pools of isolated DNA. Isolated DNA may 83 be combined into pools of up to 10 panel organisms, with each panel organism represented at 10 times 84 the AMDL, where possible. The combined DNA pools are tested in the presence (at 2 times the AMDL) 85 and absence of the target gene or gene fragment. If an unexpected result occurs, each of the individual 86 environmental organisms from a failed pool must be individually re-tested at 10 times the AMDL with 87 and without the target gene or gene fragment at 2x the AMDL in the candidate method DNA elution 88 buffer. 89 90 DNA in this list that already appear in the inclusivity or exclusivity panel do not need to be tested again 91 as part of the environmental factors panel. Environmental Organisms

92 93 94 95 96 97 98 99

Group 1

Aedes aegypti (ATCC /CCL-125(tm) mosquito cell line)

Aedes albopictus (Mosquito C6/36 cell line)

Dermatophagoides pteronyssinus (Dust mite -commercial source)

Xenopsylla cheopis Flea (Rocky Mountain labs)

100 101 102

Drosophilia cell line

Musca domestica (housefly) ARS, USDA, Fargo, ND

Gypsy moth cell lines LED652Y cell line (baculovirus)– Invitrogen

Cockroach (commercial source) 103 Tick (Amblyomma and Dermacentor tick species for F. tularensis detection assays) 1 104 Mus musculus (ATCC/HB-123) mouse 105 Rattus norvegicus (ATCC/CRL-1896) rat 106 Homo sapiens (HeLa cell line ATCC/CCL-2) human

107 108 109 110