The *FIND evaluation of ichroma™ COVID-19 Ag had been posted. The evaluation had been performed at Swiss with 241 candidates.
Estimate of Clinical Performance
|Clinical Sensitivity (95% Cl), N||73.2% (58.1, 84.3), 41|
|Clinical Sensitivity days ≤ 7, N||83.9% (67.4, 92.9), 31|
|Clinical Sensitivity Ct ≤ 33, N||83.3% (68.1, 92.1), 36|
|Clinical Sensitivity Ct ≤ 25, N||95.5% (78.2, 99.2), 22|
|Clinical Specificity (95%, Cl), N||100% (98, 100), 191|
|Invalid rate (%, n/N)||0% (232/232)|
The general sensitivity and specificity of ichroma™ COVID-19 was 73.2%, 100 % respectively. The sensitivity of within seven days of symptom onset is 83.9.% and Ct value 25 or less is 95.5%. Specificity of ichroma™ COVID-19 is 100% and it is important that for screening COVID-19, since 100% specificity means that there will be far less false-positive (normal person is not resulted with patient).
*FIND (Foundation for Innovative New Diagnostics) is a global non-profit organization driving innovation in the development and delivery of diagnostics to combat major diseases affecting the world’s poorest populations. FIND is a WHO Collaborating Centre for Laboratory Strengthening and Diagnostic Technology Evaluation.
Ref.) FIND Evaluation of Boditech Medical, Inc. ichroma ™ COVID-19 Ag Test External Report Version 1.0, 23 February 2021.iChroma_Ag-Public-Report_v1_20210223.pdf