Page 27 - Brochure Hibergene
P. 27
Instructions for Use
When the results for positive samples are analysed with reference to the Ct values obtained from PCR analysis, the relative sensitivity of the assay for samples with high to moderate viral loads (Ct < 28) is shown to be 96%:
When the results for positive samples are correlated to date of onset of symptoms, the detection rate of the assay in individuals up to 2 days post onset is shown to be 95%:
Ct value
Number of Samples
Detection Rate
≤ 26
25
100%
≤ 28
28
96%
≤ 30
33
82%
Days from onset
Number of Samples
Detection Rate
≤2
19
95%
≤4
26
88%
≤7
29
86%
≤ 14
31
84%
Extracted Format
A subset of 67 clinical specimens, comprising 40 negative and 27 positive samples were extracted and tested. The results can be summarised as follows:
PCR
Pos
Neg
HG COVID-19 Extracted
Pos
27
0
Neg
0
40
Relative sensitivity and specificity, including the 95% confidence interval in relation to the sample size, is as follows:
Relative Sensitivity
IFU-024 Rev 03 Page 26 of 31
100% (27/27 samples)
95% CI
84.5 – 100%
Relative Specificity
100% (40/40 samples)
89.1 – 100%
