Significance, Detection and Elimination of ... - Minerva Biolabs
Significance, Detection and Elimination of ... - Minerva Biolabs
Significance, Detection and Elimination of ... - Minerva Biolabs
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NAT method<br />
• Nucleic acid amplication test with<br />
primers <strong>and</strong> commercial kits free <strong>of</strong><br />
choice<br />
• Eur. Ph. 2.6.7, v 5.8, valid since 01.<br />
July 2007<br />
• Validation must show equality to<br />
established methods according<br />
sensitivity, specificity, <strong>and</strong> robustness<br />
• Can replace indicator methods if<br />
sensitivity below 100 cfu/ml<br />
• Can replace culture method if<br />
sensitivity is below 10 CFU/ml<br />
• Can replace both methods if results<br />
are required quickly<br />
• Cell culture enrichement possible to<br />
increase sensitivity<br />
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