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Reference Materials
•
Any material being used to qualify the “assay(s)”
•
Filters or liquid from liquid samplers (if not standardized)
•
Soils used to challenge prospective “assay(s)”
•
Other matrices identified as a matrix for which the assay will be validated
•
Cultures used to challenge the assay(s)
•
Certified or Noncertified Reference Materials
•
What should be a reference material
•
Key organisms in the inclusivity panel and exclusivity panel
•
Matrices of interest (air samples or air sample equivalents)
•
SuggestedReference Material for Air sample testing‐
•
Dust from air conditioners, air conditioner chases, filters from commercial and residential buildings in multiple locations. Dust should be tested by existing test methods to determine
cross reactivity for any
B. anthracis
targets
•
Accepted dust was sieved to get multiple samples of dust from distinct origins
•
Each was tested by culture and PCR currently being used for BA detection (3 distinct reactions)
•
Equalvolumes of each dust were homogenized for 72 hours in a rolling drum
•
Homogenized dust was tested using PCR and culture for BA
•
Homogenized dust was placed in 100 ml serum bottles, frozen and lyophilized
•
The dust was characterized for particle size and background organisms
•
This SMPR had
•
15B.anthracis reference cultures (1certified)
•
20otherBacillus cultures (1certified)
•
87environmental biological sampleDNAs (0certified)
•
25soils (0certified)
•
22powdersand chemicals (0certified)
Bacillus anthracis
Inclusivity Strains
Number
Strain
Characteristics
BA1
Canadian bison
pXO1+ , pXO2+, VNTR genotype group A1a
BA2
V770‐NP‐1R
pXO1+ , pXO2‐, VNTR genotype group A1b
BA3
PAK‐1
pXO1+ , pXO2+, VNTR genotype group A2
BA4
BA1015
pXO1+ , pXO2+, VNTR genotype group A3a
BA5
Ames
pXO1+ , pXO2+, VNTR genotype group A3b
BA6
K3
pXO1+, pXO2+, VNTR genotype group A3c
BA7
Ohio ACB
pXO1+, pXO2+, VNTR genotype group A3d
BA8
SK‐102
(Pakistan)
pXO1+ , pXO2+, VNTR genotype group A4
BA9
Vollum 1B
pXO1+ , pXO2+, VNTR genotype group A4
•
The study included DNA from 15
B. anthracis
strains tested at the
AMDL (2000 genome
equivalents/mL or 11 pg/mL) or
lower and DNA from 20 near
i hb
i
t t d t 10
BA10
BA1035
pXO1+ , pXO2+, VNTR genotype group B1
BA11
RA3
pXO1+, pXO2+, VNTR genotype group B2
BA12
2002013094
(240)
pXO1+, pXO2+, VNTR genotype group C
BA13
Pasteur
pXO1‐ , pXO2+; VNTR genotype group A1a
BA14
Sterne
pXO1+ , pXO2‐, VNTR genotype group A3b
BA15
Turkey #32 pXO1+, pXO2+, VNTR genotype group A1b
ne g or organ sms es e a
times the AMDL, or 110 pg/mL