Page 26 - Brochure Hibergene
P. 26
Instructions for Use
Relative Sensitivity and Specificity Direct Format
A panel of 109 clinical specimens, comprising 69 negative and 40 positive nasopharyngeal swabs collected in 3ml of UTM, were independently characterised using a commercial PCR assay at a hospital laboratory. These samples were tested to demonstrate the clinical sensitivity and specificity of the direct format assay.
2 samples returned invalid results, resulting in an overall invalid rate of 1.8% (2/109) - both were valid when tested following RNA extraction. These 2 samples were excluded from further analysis of direct format assay performance.
Overall comparison to PCR for valid samples (n=107) was as follows:
Relative sensitivity and specificity, including the 95% confidence interval in relation to the sample size [16], is as follows:
These results indicate an overall relative sensitivity of 71.8% (28/39 samples) for samples across the viral load range (Ct 14.8 - 34.6) in a population which included samples taken from the day of onset of COVID-19 symptoms out to 28 days from onset.
PCR
Pos
Neg
HG COVID-19 Direct
Pos
28
0
Neg
11
68
IFU-024 Rev 03 Page 25 of 31
71.8% (28/39 samples)
95% CI
Relative Sensitivity
54.9 – 84.4%
Relative Specificity
100% (68/68 samples)
93.3 – 100%