SARS-COV-2 Rapid Antigen (Ag) Test

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.

METHODS
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.

RITM technical evaluation standards for SARS-COV-2 Rapid Antigen kits

STANDARDS

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 NameManufacturerClinical Sensitivity at CT Value < 30 (95% CI)Overall Clinical Sensitivity (95% CI)Overall Clinical Specificity (95% CI)Date SubmittedDate Performed
1Sandard Q COVID-19 Ag TestSD Biosensor Inc.93.10% (77.23 to 99.15)71.43% (55.42 to 84.28)100% (91.96 to 100)June 5, 2020August 11-September 9, 2020
2Quickprofile COVID-19 Ag Test StripLumiquick Diagnostics Inc.100% (59.04 to 100)27.78% (14.20 to 45.19)98.10% (93.29 to 99.77)September 19, 2020September 21-October 13, 2020
3Biocredit Covid-19 AgRapigen, Inc.97.06% (84.67 to 99.93)70% (55.39-82.14)100% (97.62 to 100)September 19, 2020November 17 - March 19, 2021
4COVID-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, 2020January 22 - March 8, 2021
5Sofia 2 SARS Antigen FIAQuidel Corporation92.86% (76.50 to 99.12)81.08% (64.84 to 92.04)95.83% (85.75 to 99.49)September 22, 2020November 19 - March 15, 2021
6FaStep COVID-19 Antigen Rapid Test Device (NPS/ OPS Swab)Assure Tech (Hangzhou) Co. Ltd81.48% (61.92 to 93.70)57.41% (43.21 to 70.77)96.43% (87.69 to 99.56)November 16, 2020November 23 - March 23, 2021
7PanbioTM COVID-19 Ag Rapid Test Device (nasopharyngeal)ABBOT RAPID DIAGNOSTICS JENA Gmbh97.83% (88.47 to 99.94)78.26% (66.69 to 87.29)100% (88.43 to 100)October 7, 2020October 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.