Table 3.

Production, Characterization, and QC of PEP Specimens

Production and Characterization of PEP SpecimensPEP 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 SpecimensPEP 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.

Table 3.

Production, Characterization, and QC of PEP Specimens

Production and Characterization of PEP SpecimensPEP 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 SpecimensPEP 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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