Boditech Med has been conducting the performance evaluations in several geographically different areas. We would like to share the clinical evaluation data from the Unite States, Republic of Korea, and Netherlands.
The prospective clinical performance evaluation study was conducted by testing 181 suspected COVID-19 patients and asymptomatic persons (41 positive and 140 negative) enrolled at three point-of-care sites in the US. The overall sensitivity and specificity are 85.4% and 99.3% respectively.
|AFIAS COVID-19 Ag||Comparative RT-PCR test results|
Sensitivity = 85.26%
Specificity = 99.28%
Republic of Korea
The prospective clinical performance evaluation study was conducted by testing 290 samples (133 positive and 157 negative) at three different sites in Republic of Korea. Sensitivity was 91.5% for samples collected with patients within 7 days of symptom onset and 92.3% for samples collected from patients 8 days or more after symptom onset. The overall specificity is 98.7%.
|Comparative RT-PCR test results|
|Sample collection date from onset of symptom||Positive||Negative|
|0~7 days||8 days~||Total|
|AFIAS COVID-19 Ag||Positive||97||24||121||2|
Sensitivity = 91.7%
(Sensitivity for Sample collection date from onset of symptom 0-7 days = 91.5%)
(Sensitivity for Sample collection date from onset of symptom over 8 days = 92.3%)
|Specificity = 98.7%|
The prospective clinical performance evaluation study was conducted by testing 427 people (106 positive and 321 negative) with mild symptoms. In the case of the patients who are classified as a group of early infections (Ct<30), the sensitivity is 96.4% and overall specificity is 100%, respectively.
|Sensitivity||Specificity||Number of Samples|
|AFIAS COVID-19 Ag||
81.1% (72.5 – 87.4%)
Ct < 32: 89,.4%
Ct < 30: 96.4%
(98.8 – 100%)
(106 positive and 321 negative)