EVALUATION OF RAPID Ag TEST KITS
Last updated: 28 December 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 Antigen Test Kits to be used in COVID-19 testing, HTAC recommends a minimum sensitivity and specificity of 80% and 97%, respectively. This standard metric is explained in depth in the Guidance Document on the Technical Requirements for SARS-COV-2 Rapid Antigen Tests published by HTAC in September 2020.
|#||Kit Name||Manufacturer||Overall Clinical Sensitivity (95% CI)||Overall Clinical Specificity (95% CI)||CT Value ≤30||Date Performed|
|1||SD Biosensor Inc.||Sandard Q COVID-19 Ag Test (SD Biosensor Inc.)||71.43% (55.42 to 84.28)||100% (91.96 to 100)||93.10% (77.23 to 99.15)||August 11-September 9, 2020|
|2||Lumiquick Diagnostics Inc.||Quickprofile COVID-19 Ag Test Strip -(Lumiquick Diagnostics Inc.)||27.78% (14.20 to 45.19)||98.10% (93.29 to 99.77)||100% (59.04 to 100)||September 21-October 13, 2020|
|3||Biocredit Covid-19 Ag||Rapigen, Inc.||70% (55.39-82.14)||100% (97.62 to 100)||97.06% (84.67 to 99.93)||November 17 – March 19, 2021|
|4||COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)||Lansion Biotechnology Co., Ltd.||91.43% (76.94 to 98.97)||95.08% (86.29 to 98.97)||100% (88.78 to 100)||January 22 – March 8, 2021|
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.