Background Image
Table of Contents Table of Contents
Previous Page  24 / 134 Next Page
Information
Show Menu
Previous Page 24 / 134 Next Page
Page Background

Draft, Do Not Distribute

6 Draft SMPR Coxiella burnetii V3

Table IV: Environmental Factors Panel For Validating PCR Detectors For Biothreat

79

Agents

80

81

[Adapted from the Environmental Factors Panel approved by SPADA on June 10, 2010.]

82

83

The Environmental Factors Panel is intended to supplement the biothreat agent near- neighbor

84

exclusivity testing panel, and it should be applicable to all PCR biothreat agent detection assays.

85

The panel criteria are divided into two main groups – the matrix panel of unknown

86

environmental samples (Part 1); and the environmental panel of identified environmental

87

organisms (Part 2). This panel will test for potential cross-reactive amplification and/or PCR

88

inhibitors.

89

90

Part 1:

91

92

Environmental Matrix Samples - Aerosol Environmental Matrices

93

94

o

The aerosol environmental matrix pools should be used to confirm that there is no

95

detection with the method used i.e. there is no cross reactivity of the target assay

96

with unknown environmental organisms.

97

o

The aerosol environmental matrix pools should also be tested with the target

98

fragment at the AMDL to confirm the filter pool does not interfere with detection by

99

the method used.

100

101

·

Method developers should obtain environmental matrix samples that are representative

102

and consistent with the collection method that is anticipated to be utilized in generating the

103

sample being analyzed. This includes considerations that may be encountered when the

104

collection system is deployed operationally such as collection medium, duration of

105

collection, diversity of geographical areas that will be sampled, climatic/environmental

106

conditions that may be encountered and seasonal changes in the regions of deployment.

107

Justifications for the selected conditions that were used to generate the environmental

108

matrix and limitations of the validation based on those criteria must be documented.

109

110

o

Method developers will test the environmental matrix for interference with

111

sufficient samples to achieve 95% probability of detection.

112

o

Cross-reactivity testing will include sufficient samples and replicates to ensure each

113

environmental condition is adequately represented

.

114

115

116