SARS-COV-2 Cartridge-based PCR

EVALUATION OF CARTRIDGE-BASED 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.

Results
# Kit Name Sensitivity Specificity Date Performed
1 BioFire Respiratory Panel 2.1 100%
(88.4-100% CI)
100%
(88.4-100% CI)
August 17-21

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.