LRN
Iterative Approaches to NA Test Validations:
Previous Validations
Sensitivity analysis:
Serial 100-fold dilutions (1ng/
l to 1 fg/
L) of DNA
Inclusivity panel –
Variola virus
DNA:
2 purified viral stocks
33 crude viral stocks
2 Human scab samples
Specificity analysis:
Serial 100-fold dilutions (1ng/
l to 1 fg/
L) of DNA
Exclusivity panel – near neighbor (
Orthopoxvirus
):
Eurasian: 1
Ectromelia virus
2
Monkeypox viruses
2
Camelpox viruses
1
Cowpox virus
1
Taterapox virus
5
Vaccinia viruses
North American: 1
Skunkpox virus
Exclusivity panel – other rash-causing illnesses:
1
Varicella Zoster virus
1
Herpes simplex virus
(type 1)
1 Rickettsia strain
Exclusivity panel – negatives:
Myxoma
& tissue culture (2)