EVALUATION OF RAPID Ag TEST KITS
Last updated: 17 January 2022

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 NameManufacturerSample typeClinical Sensitivity (95% CI) SymptomaticClinical Specificity (95% CI) SymptomaticClinical Sensitivity at Swab CT Value ≤ 30 (95% CI) - SymptomaticClinical Specificity (95% CI) AsymptomaticDate Performed
1Standard Q COVID-19 Ag TestSD Biosensor Inc.Nasopharyngeal swab71.43% (55.42 to 84.28)100% (91.96 to 100)93.10% (77.23 to 99.15)100%August 11-September 4, 2020
2Quickprofile COVID-19 Ag Test StripLumiquick Diagnostics Inc.Nasopharyngeal swab27.78% (14.20 to 45.19)98.10% (93.29 to 99.77)100% (59.04 to 100)100%September 21-October 13, 2020
3Biocredit Covid-19 AgRapigen, Inc.Nasopharyngeal swab70% (55.39-82.14)100% (97.62 to 100)97.06% (84.67 to 99.93)100%October 20 - March 19,2021
4COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)Lansion Biotechnology Co., Ltd.Nasopharyngeal swab91.43% (76.94 to 98.20)95.08% (86.29 to 98.97)100% (88.78 to 100)100%January 22 - March 8, 2021
5Sofia 2 SARS Antigen FIAQuidel CorporationNasopharyngeal swab78.79% (61.09 to 91.02)95.65% (85.16 to 99.47)92% (73.97 to 99.02)100%October 29 - March 29, 2021
6FaStep COVID-19 Antigen Rapid Test Device (NPS/ OPS Swab)Assure Tech (Hangzhou) Co. LtdNasopharyngeal swab57.41% (43.21 to 70.77)96.43% (87.69 to 99.56)81.48% (61.92 to 93.70)100%November 16 - April 8, 2021
7PanbioTM COVID-19 Ag Rapid Test Device (nasopharyngeal)ABBOT RAPID DIAGNOSTICS JENA GmbhNasopharyngeal swab78.26% (66.69 to 87.29)100% (88.43 to 100)97.83% (88.47 to 99.94)100%October 20 - April 8, 2021
8ichroma™ COVID-19 AgBoditech Med Inc.Nasopharyngeal swab78.95% (62.68 to 90.45)98.0% (89.35 to 99.95)96.0% (79.65 to 99.90)100%November 11 - May 3, 2021
9GenBody COVID-19 AgGenbody Inc.Nasopharyngeal swab79.07% (63.96 to 89.96)78.72% (64.34 to 89.30)100% (87.23 to 100)88%January 11 - April 21, 2021
10NADAL COVID-19 Ag TestNAL VON MINDEN GmbhNasopharyngeal swab82.05% (66.47 to 92.46)96.88% (83.78 to 99.92)96.43% (81.65 to 99.91)100%February 15 - May 3, 2021
11Rapid COVID-19 Antigen Test (Colloidal Gold)Anbio (Xiamen) Biotechnology Co., Ltd.Oropharyngeal swab70.45% (54.80 to 83.24)96.30% (89.56 to 99.23)90.32% (74.25 to 97.96)94.83%February 22 - June 18, 2021
12NowCheck COVID-19 Antigen testBionote Inc.Nasopharyngeal swab97.22% (85.47 to 99.93)97.67% (87.71 to 99.94)100% (87.66 to 100)98.80%January 11 - June 21, 2021
13BD Veritor System for Rapid Detection of SARS-CoV-2Becton, Dickinson And Company / Web Industries, Inc.Nasopharyngeal swab69.77% (53.87 to 82.82)96.03% (90.98 to 98.70)86.87% (69.28 to 96.24)100.00%June 22 - July 9, 2021
14*COVID-19 Antigen Rapid Test (Swab)Hangzhou Alltest Biotech Co., Ltd.Nasopharyngeal swab96.64% (91.62 to 99.08)80% (64.35 to 90.95)98.94% (94.21 to 99.97)-August 12 - August 20, 2021
15*SARS-CoV-2 Antigen Rapid Test Kit (COLLOIDAL GOLD IMMUNOCHROMATOGRAPHY)Beijing Lepu Medical Technology Co., Ltd.Nasal swab66.67% (54.83 to 77.14)82.93% (67.94 to 92.85)73.13% (60.90 to 83.24)-July 26 - August 5, 2021
16*SGTi-flex COVID-19 AgSugentech Inc.NPS87.32% (77.30 to 94.0473.58% ( 59.67 to 84.74)94.74% ( 85.38 to 98.90)-August 31 -September 17, 2021
17*(2019-nCov) New Coronavirus Antigen Test (Colloidal GoldNantong Diagnos Biotechnology Co LtdNPS80.56% (69.53 to 88.94100% (88.43 to 100.00)89.83% (79.17 to 96.18)-August 23 to September 23, 2021
18*ENIMMUNE SPEEDY COVID-19 AG RAPID TESTFirstep Bioresearch, Inc.NPS93.59% (85.67 to 97.89)32.69% (23.81 to 42.59)98.53% (92.08 to 99.96)-July 26 to October 20, 2021
19*AFIAS COVID-19 AgBoditech Med Inc.NPS88.57% (73.26 to 96.80)93.06% (84.53 to 97.71)100.00% (87.66 to 100.00)-May 07 to November 05, 2021
20SAVANT™ New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography)Beijing Savant Biotechnology Co. LtdNPS84.06% (73.26 to 91.76)54.79%(42.70 to 66.48)90.00% (79.49 to 96.24)91.38%February 08 to October 29, 2021
21*Camtech COVID-19 Antigen Rapid Test Camtech Biomedical Pte. LtdNPS81.16% (69.94 to 89.5745.33% (33.79 to 57.2587.27% (75.52 to 94.73-Setember 8 to December 3, 2021
Note: *asymptomatic population not done due to surge of cases

Products with external validation results*

SARS-COV-2 RAPID ANTIGEN TEST

NoProduct NameManufacturerReference Link
1Panbio COVID-19 Ag Test – NasalAbbott Rapid DiagnosticsFINDLink1
Link2
2NowCheck COVID-19 Ag Test – NasopharyngeaLBionote, Inc.FINDLink
3Novel coronavirus (2019-nCOV) antigen detection kit (colloidal gold method)/ (Lateral flow method)Guanzhou Wondfo Biotech Co., Ltd. FINDLink
4STANDARD F COVID-19 Ag FIASD BIOSENSOR, INC.FINDLink1
Link2
5Standard Q COVID-19 Ag Test (Nasal swab)SD Biosensor, Inc.FINDLink
6Sure Status Covid-19 Antigen Card test (Nasopharyngeal)Premier Medical Corporation Private LimitedFINDLink
7Mologic COVID-19 Rapid TestMologic, Ltd. FINDLink
8Flowflex SARS-COV-2 Antigen Rapid TestAcon Biotech (Hangzhou) Co. Ltd. FINDLink
9COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)*Lansion Biotechnology Co., Ltd.Federal Office of Public Health (FOPH) and FZMB GmbH- Research Centre for Medical Technology and Biotechnology no available link for online viewing
10NADAL COVID-19 Ag Test*NAL VON MINDEN GmbHFINDLink
11SGTI-flex COVID-19 Ag*Sugentech, Inc. SICHH and IMRno available link for online viewing
12Healgen Coronavirus Ag Rapid Test Cassette (swab)Healgen Scientific Limited Liability CompanyDepartment of Clinical Microbiology, Center for Interdisciplinary Research on Medicines (CIRM), University of Liege, BelgiumLink
13PBCheck COVID-19 Ag Test KitPrecision Biosensor Inc.National Institute for Control of Vaccine and Biologicals, Ministry of Health, Vietnam
14 Novel Coronavirus Antigen Detection Kit (Colloidal Gold)New Gene (Hangzhou) Bioengineering Co., LtdInstitute for Medical Research in Kuala Lumpur, Malaysia
15FUJIFILM COVID-19 Ag TestFUJIFILM CorporationMahidol University
Note: *These product evaluation have been reviewed and recommended by the RITM and FDA.

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.