AOAC ISPAM Meeting eBook, March 17 2015

Draft, Do Not Distribute

System False-Negative Rate

42 43 44 45 46 47 48 49 50

Proportion of test results that are negative contained within a population of known

positives.

System False-Positive Rate

Proportion of test results that are positive contained within a population of known

negatives.

Variola virus

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 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. 54

63 64 65 66 67 68

2 Approved Variola SMPR v7.5