75 / 120
Draft, Do Not Distribute
System False-Negative Rate
42
Proportion of test results that are negative contained within a population of known
43
positives.
44
45
System False-Positive Rate
46
Proportion of test results that are positive contained within a population of known
47
negatives.
48
49
Variola virus
50
A member of t
he genus
Orthopoxvirus
and the causative agent of smallpox.
51
52
5.
System suitability tests and/or analytical quality control:
53
The controls listed in Annex I shall be embedded in assays as appropriate. Manufacturer
54
must provide written justification if controls are not embedded in the assay.
55
56
6.
Validation Guidance:
AOAC INTERNATIONAL Methods Committee Guidelines for Validation
57
of Biological Threat Agent Methods and/or Procedures (AOAC INTERNATIONAL Official
58
Methods of Analysis, 2012, Appendix I).
59
60
7.
Other Requirements:
Method developer must present the positive predictive value in their
61
submission since Smallpox
is an eradicated disease. The positive predictive value must be
62
based on data generated within the environmental matrix.
63
64
65
66
67
68
2 Approved
Variola
SMPR v7.5