Verification of Microbiology Tests - SWACM
Verification of Microbiology Tests - SWACM
Verification of Microbiology Tests - SWACM
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<strong>Verification</strong> vs. Establishment <strong>of</strong><br />
Performance Characteristics<br />
• Under CLIA, labs must establish performance<br />
characteristics <strong>of</strong> modified tests or LDTs<br />
– Requires more analyses and more rigorous studies<br />
• CLIA: verification studies, plus analytical sensitivity,<br />
analytical specificity/interfering substances, others as<br />
applicable (e.g. for quantitative methods)<br />
Source: CLIA Subpart K, 493:1253<br />
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