EVALUATION OF RAPID Ag TEST KITS
Last updated: 9 April 2021
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.
Performance evaluation involves comparison of the assay under evaluation and a reference assay. For Rapid Antigen test kit evaluation, the reference assay is RT-PCR.
The evaluation consists of fresh collection of nasopharyngeal swabs from cohorts of symptomatic and asymptomatic subjects, and testing these on the rapid antigen test being evaluated onsite. An additional nasopharygneal swab is taken and tested in parallel with RT-PCR. A minimum of 30 positives and 30 negatives are typically included per kit evaluated.
For Rapid Antigen Test Kits to be used in COVID-19 testing, the World Health Organization recommends a minimum sensitivity and specificity of 80% and 97%, respectively.
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.
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.
|No.||Kit Name||Manufacturer||Clinical Sensitivity at CT Value < 30 (95% CI)||Overall Clinical Sensitivity (95% CI)||Overall Clinical Specificity (95% CI)||Date Submitted||Date Performed|
|1||Sandard Q COVID-19 Ag Test||SD Biosensor Inc.||93.10% (77.23 to 99.15)||71.43% (55.42 to 84.28)||100% (91.96 to 100)||June 5, 2020||August 11-September 9, 2020|
|2||Quickprofile COVID-19 Ag Test Strip||Lumiquick Diagnostics Inc.||100% (59.04 to 100)||27.78% (14.20 to 45.19)||98.10% (93.29 to 99.77)||September 19, 2020||September 21-October 13, 2020|
|3||Biocredit Covid-19 Ag||Rapigen, Inc.||97.06% (84.67 to 99.93)||70% (55.39-82.14)||100% (97.62 to 100)||September 19, 2020||November 17 - March 19, 2021|
|4||COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)||Lansion Biotechnology Co., Ltd.||100% (88.78 to 100)||91.43% (76.94 to 98.97)||95.08% (86.29 to 98.97)||November 26, 2020||January 22 - March 8, 2021|
|5||Sofia 2 SARS Antigen FIA||Quidel Corporation||92.86% (76.50 to 99.12)||81.08% (64.84 to 92.04)||95.83% (85.75 to 99.49)||September 22, 2020||November 19 - March 15, 2021|
|6||FaStep COVID-19 Antigen Rapid Test Device (NPS/ OPS Swab)||Assure Tech (Hangzhou) Co. Ltd||81.48% (61.92 to 93.70)||57.41% (43.21 to 70.77)||96.43% (87.69 to 99.56)||November 16, 2020||November 23 - March 23, 2021|
|7||PanbioTM COVID-19 Ag Rapid Test Device (nasopharyngeal)||ABBOT RAPID DIAGNOSTICS JENA Gmbh||97.83% (88.47 to 99.94)||78.26% (66.69 to 87.29)||100% (88.43 to 100)||October 7, 2020||October 20 - March 26, 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.