EVALUATION OF RAPID Ab TEST KITS
Last updated: 16 October 2020
The Research Institute for Tropical Medicine (RITM), as the National Reference Laboratory, is mandated to perform the evaluation of commercially-manufactured in vitro diagnostic medical devices, in collaboration with the Philippine Food and Drug Administration (FDA).
In support of the national COVID-19 response, the Institute has undertaken evaluation of laboratory test kits (PCR, rapid antibody, rapid antigen kits), nucleic acid extraction kits, as well as virus transport media and swabs.
Read more about the guidelines on the evaluation of in vitro diagnostic medical devices and other related laboratory diagnostic supplies for COVID-19 here.
The Health Technology Assessment Council (HTAC) is an independent advisory body with the overall role of providing guidance to the Department of Health (DOH) and the Philippine Health Insurance Corporation (PhilHealth) on the coverage of health interventions and technologies to be funded by the government.
For Rapid Antibody Test Kits to be used in COVID-19 testing, HTAC recommends a minimum sensitivity and specificity of 98% (CI: 96-100%) for specimens collected 20 days or more after the appearance of first symptoms. This standard metric is explained in depth in the Guidance Document on the Technical Requirements for SARS-COV-2 Rapid Antibody Test Kits as an adjunct test for COVID-19 published by HTAC in July 2020.
|#||Rapid Antibody Test Kits||Sensitivity||Specificity||Date Performed|
|1||SARS-COV-2 Antibody Test (Lateral Flow Method) – Guangzhou Wondfo Biotech Co. Ltd)||77.8%
|2||Rapid 2019-nCOV IgM/IgG Combo Test Card (Xiamen Boson Biotech)||IgM
8-14 days: 41.67%
15-35 days: 66.67%
8-14 days: 66.67%
15-35 days: 88.89%
Results of RITM evaluations do not, in any way or form, represent a Certificate of Product Registration or Certificate of Authorization issued by the Philippine Food and Drug Administration (FDA).
The Institute is making this information available for public good and does not serve to endorse companies, manufacturers, or product brands for commercial purposes.