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  Instructions for Use
11. Performance Characteristics 11.1 Analytical Performance
The analytical sensitivity of the HG COVID-19 reaction mix (COVID-RX) was determined by testing inactivated viral particles in transport medium. Specificity was determined by testing a panel of potential cross-reactive organisms.
Analytical Sensitivity
The Limit of Detection (LOD), defined as the lowest concentration of viral DNA that is detected in at least 95% of replicates, was determined using quantified cellular material (Strain USA-WA1/2020, Bei Resources Cat. No. NR-52286, lot# 70033548) spiked into specimen transport buffer (VCM, Medical Wire, UK).
Direct Format
Samples were prepared at a concentration of 1 TCID50/ml and treated per the direct format protocol described above. 30 replicates were tested across 3 batches of HG COVID-19 product. 97% of replicates (29/30) were detected, demonstrating that the LOD is ≤ 1 TCID50/ml 1. As the post-inactivation viral genome copy number of this material is quoted as 1.16 x 109 cps/ml, the equivalent LOD in terms of SARS-CoV-2 genome copies is 7.25cps/μl.
1 TCID50 = Median tissue culture infectious dose. This is the quantity of virus which produces a cytopathic effect in 50% of inoculated cultures.
Extracted Format
Samples were prepared at 0.5 TCID50/ml and treated per the Extracted format protocol described above. 30 replicates were tested across 3 batches of HG COVID-19 product. 97% of replicates (29/30) were detected, demonstrating that the LOD is ≤ 0.5 TCID50/ml, equivalent to 3.63 cps/μl.
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