EVALUATION OF RAPID Ag TEST KITS
Last updated: 23 August 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||Sample type||Clinical Sensitivity (95% CI) Symptomatic||Clinical Sensitivity at Swab CT Value ≤ 30 (95% CI) - Symptomatic||Clinical Specificity (95% CI) Asymptomatic||Date Performed|
|1||Standard Q COVID-19 Ag Test||SD Biosensor Inc.||Nasopharyngeal swab||71.43% (55.42 to 84.28)||93.10% (77.23 to 99.15)||100%||August 11-September 9, 2020|
|2||Quickprofile COVID-19 Ag Test Strip||Lumiquick Diagnostics Inc.||Nasopharyngeal swab||27.78% (14.20 to 45.19)||100% (59.04 to 100)||100%||September 21-October 13, 2020|
|3||Biocredit Covid-19 Ag||Rapigen, Inc.||Nasopharyngeal swab||70% (55.39-82.14)||97.06% (84.67 to 99.93)||100%||November 17 - March 19, 2021|
|4||COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)||Lansion Biotechnology Co., Ltd.||Nasopharyngeal swab||91.43% (76.94 to 98.97)||100% (88.78 to 100)||100%||January 22 - March 8, 2021|
|5||Sofia 2 SARS Antigen FIA||Quidel Corporation||Nasopharyngeal swab||81.08% (64.84 to 92.04)||92.86% (76.50 to 99.12)||100%||November 19 - March 15, 2021|
|6||FaStep COVID-19 Antigen Rapid Test Device (NPS/ OPS Swab)||Assure Tech (Hangzhou) Co. Ltd||Nasopharyngeal swab||57.41% (43.21 to 70.77)||81.48% (61.92 to 93.70)||100%||November 23 - March 23, 2021|
|7||PanbioTM COVID-19 Ag Rapid Test Device (nasopharyngeal)||ABBOT RAPID DIAGNOSTICS JENA Gmbh||Nasopharyngeal swab||78.26% (66.69 to 87.29)||97.83% (88.47 to 99.94)||100%||October 20 - March 26, 2021|
|8||ichroma™ COVID-19 Ag||Boditech Med Inc.||Nasopharyngeal swab||78.95% (62.68 to 90.45)||96.0% (79.65 to 99.90)||95%||November 11 - May 3, 2021|
|9||GenBody COVID-19 Ag||Genbody Inc.||Nasopharyngeal swab||79.07% (63.96 to 89.96)||100% (87.23 to 100)||95%||January 11 - April 7, 2021|
|10||NADAL COVID-19 Ag Test||NAL VON MINDEN Gmbh||Nasopharyngeal swab||82.05% (66.47 to 92.46)||96.43% (81.65 to 99.91)||100.00%||February 15 - May 3, 2021|
|11||Rapid COVID-19 Antigen Test (Colloidal Gold)||Anbio (Xiamen) Biotechnology Co., Ltd.||Oropharyngeal swab||70.45% (54.80 to 83.24)||90.32% (74.25 to 97.96)||94.83%||February 22 - June 18, 2021|
|12||NowCheck COVID-19 Antigen test||Bionote Inc.||Nasopharyngeal swab||97.22% (85.47 to 99.93)||100% (87.66 to 100)||98.80%||January 11 - June 21, 2021|
|13||BD Veritor System for Rapid Detection of SARS-CoV-2||Becton, Dickinson And Company / Web Industries, Inc.||Nasopharyngeal swab||69.77% (53.87 to 82.82)||86.87% (69.28 to 96.24)||100.00%||June 22 - July 9, 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.