Production and Characterization of PEP Specimens | PEP Specimen QC |
• All specimens generated under strict conditions and rigorously characterized. | • Acceptance criteria: Pure and Potent |
• Infectious agents are obtained from known sources and sequenced to confirm identity. | • Immune serum |
− Seropositive to inoculated pathogen only | |
− Moderate to strong reaction by standard assays | |
• Experimental animals are inoculated, and the serum and relevant tissues are collected and aliquoted for use as standardized specimens. | • Infectious specimen |
− Free of extraneous pathogens | |
− Easily detectable concentration of pathogen | |
• Aliquoted specimens are evaluated by 2 laboratories to confirm quality |
Production and Characterization of PEP Specimens | PEP Specimen QC |
• All specimens generated under strict conditions and rigorously characterized. | • Acceptance criteria: Pure and Potent |
• Infectious agents are obtained from known sources and sequenced to confirm identity. | • Immune serum |
− Seropositive to inoculated pathogen only | |
− Moderate to strong reaction by standard assays | |
• Experimental animals are inoculated, and the serum and relevant tissues are collected and aliquoted for use as standardized specimens. | • Infectious specimen |
− Free of extraneous pathogens | |
− Easily detectable concentration of pathogen | |
• Aliquoted specimens are evaluated by 2 laboratories to confirm quality |
PEP, Performance Evaluation Program; QC, quality control.
Production and Characterization of PEP Specimens | PEP Specimen QC |
• All specimens generated under strict conditions and rigorously characterized. | • Acceptance criteria: Pure and Potent |
• Infectious agents are obtained from known sources and sequenced to confirm identity. | • Immune serum |
− Seropositive to inoculated pathogen only | |
− Moderate to strong reaction by standard assays | |
• Experimental animals are inoculated, and the serum and relevant tissues are collected and aliquoted for use as standardized specimens. | • Infectious specimen |
− Free of extraneous pathogens | |
− Easily detectable concentration of pathogen | |
• Aliquoted specimens are evaluated by 2 laboratories to confirm quality |
Production and Characterization of PEP Specimens | PEP Specimen QC |
• All specimens generated under strict conditions and rigorously characterized. | • Acceptance criteria: Pure and Potent |
• Infectious agents are obtained from known sources and sequenced to confirm identity. | • Immune serum |
− Seropositive to inoculated pathogen only | |
− Moderate to strong reaction by standard assays | |
• Experimental animals are inoculated, and the serum and relevant tissues are collected and aliquoted for use as standardized specimens. | • Infectious specimen |
− Free of extraneous pathogens | |
− Easily detectable concentration of pathogen | |
• Aliquoted specimens are evaluated by 2 laboratories to confirm quality |
PEP, Performance Evaluation Program; QC, quality control.
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