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Cytomegalovirus nucleic acid kit

Performance and Clinical Performance Test Results

Clinical performance tests showed a high correlation with clinical diagnosis and real-time PCR method.

Table 1: Correlation with Clinical Diagnosis

Genelys CMV Total
Positive Negative
Clinical
Diagnosis
CMV infection Positive Group 32 0 32
CMV Non-infection Control Disease Group 0 107 107
Disease-free Group 0 41 41
Total 32 148 180

Overall concordance 100%(180/180)

Table2: Correlation with Real-Time PCR Method

Genelys CMV Total
Positive Negative
Real-Time PCR Positive 32 0 32
Negative 0 148 148
Total 32 148 180

Overall concordance 100%(180/180)