Abstract
The method of detection and identification of Variola virus DNA in aerosol collection filters and/or liquids is discussed. The analytical technique used is polymerase chain reaction (PCR) methods. The predetermined minimum level of an analyte, as specified by an expert committee, which must be detected by the candidate method at a specified probability of detection (POD) is necessary. The inclusivity panel shall include sequences from at least two representative strains from each major clade of Variola virus Any other strain with differences in the assay primer and/or probe target sequences based on bioinformatic analysis. Inclusion of all environmental panel organisms is not a requirement if a method developer provides appropriate justification that the intended use of the assay permits the exclusion of specific panel organisms. Justification for exclusion of any environmental panel organism(s) must be documented and submitted.
Original language | English (US) |
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Pages (from-to) | 1046-1049 |
Number of pages | 4 |
Journal | Journal of AOAC International |
Volume | 98 |
Issue number | 4 |
DOIs | |
State | Published - Jul 1 2015 |
ASJC Scopus subject areas
- General Medicine