EVALUATION OF RAPID Ag TEST KITS
Last updated: 16 March 2023
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 Name | Manufacturer | Sample type | Clinical Sensitivity (95% CI) Symptomatic | Clinical Specificity (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) | 100% (91.96 to 100) | 93.10% (77.23 to 99.15) | 100% | August 11-September 4, 2020 |
| 2 | Quickprofile COVID-19 Ag Test Strip | Lumiquick Diagnostics Inc. | Nasopharyngeal swab | 27.78% (14.20 to 45.19) | 98.10% (93.29 to 99.77) | 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) | 100% (97.62 to 100) | 97.06% (84.67 to 99.93) | 100% | October 20 - March 19,2021 |
| 4 | COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay) | Lansion Biotechnology Co., Ltd. | Nasopharyngeal swab | 91.43% (76.94 to 98.20) | 95.08% (86.29 to 98.97) | 100% (88.78 to 100) | 100% | January 22 - March 8, 2021 |
| 5 | Sofia 2 SARS Antigen FIA | Quidel Corporation | Nasopharyngeal swab | 78.79% (61.09 to 91.02) | 95.65% (85.16 to 99.47) | 92% (73.97 to 99.02) | 100% | October 29 - March 29, 2021 |
| 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) | 96.43% (87.69 to 99.56) | 81.48% (61.92 to 93.70) | 100% | November 16 - April 8, 2021 |
| 7 | PanbioTM COVID-19 Ag Rapid Test Device (nasopharyngeal) | ABBOT RAPID DIAGNOSTICS JENA Gmbh | Nasopharyngeal swab | 78.26% (66.69 to 87.29) | 100% (88.43 to 100) | 97.83% (88.47 to 99.94) | 100% | October 20 - April 8, 2021 |
| 8 | ichroma COVID-19 Ag | Boditech Med Inc. | Nasopharyngeal swab | 78.95% (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 |
| 9 | GenBody COVID-19 Ag | Genbody Inc. | Nasopharyngeal swab | 79.07% (63.96 to 89.96) | 78.72% (64.34 to 89.30) | 100% (87.23 to 100) | 88% | January 11 - April 21, 2021 |
| 10 | NADAL COVID-19 Ag Test | NAL VON MINDEN Gmbh | Nasopharyngeal swab | 82.05% (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 |
| 11 | Rapid COVID-19 Antigen Test (Colloidal Gold) | Anbio (Xiamen) Biotechnology Co., Ltd. | Oropharyngeal swab | 70.45% (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 |
| 12 | NowCheck COVID-19 Antigen test | Bionote Inc. | Nasopharyngeal swab | 97.22% (85.47 to 99.93) | 97.67% (87.71 to 99.94) | 100% (87.66 to 100) | 98.80% | January 11 - June 21, 2021 |
| 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) | 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 swab | 96.64% (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 swab | 66.67% (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 Ag | Sugentech Inc. | NPS | 87.32% (77.30 to 94.04 | 73.58% ( 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 Gold | Nantong Diagnos Biotechnology Co Ltd | NPS | 80.56% (69.53 to 88.94 | 100% (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 TEST | Firstep Bioresearch, Inc. | NPS | 93.59% (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 Ag | Boditech Med Inc. | NPS | 88.57% (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 |
| 20 | SAVANT™ New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography) | Beijing Savant Biotechnology Co. Ltd | NPS | 84.06% (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. Ltd | NPS | 81.16% (69.94 to 89.57 | 45.33% (33.79 to 57.25 | 87.27% (75.52 to 94.73 | - | Setember 8 to December 3, 2021 |
| 22 | VivaDiag™ PRO SARS-CoV-2 Ag Rapid Test | Vivachek Biotech Hangzhou Co. Ltd. | NPS | 86.96% (73.74 to 95.06 | 87.21% (78.27 to 93.44) | 97.14% (85.08 to 99.93 | - | August 26, 2021 to January 3, 2022 |
| 23 | SARS-CoV-2 Antigen Test Kit (Colloidal Gold)** | Genrui Biotech Inc. | NPS | 68.18% (52.42 to 81.39) | 100% (89.42 to 100.00) | 70.83% (48.91 to 87.38) | 100% | November 24 2021 to December 20,2021 |
| 24 | GENEDIA W COVID-19 AG | Green Cross Medical Science | NPS | 77.16% (69.92 to 83.38) | 100% (88.43 to 100.00) | 85.71% (78.80 to 91.05) | - | January 04, 2022 to January 12, 2022 |
| 25 | 2019-nCoV Ag Test (Latex Chromatography Assay) | Innovita (Tangshan) Biological Technology Co., Ltd. | NPS | 88.0%(80.98 to 93.13) | 100%(88.43 to 100.00) | 96.15% (90.44 to 98.94) | January 07, 2022 to February 04, 2022 | |
| 26 | VTRUST COVID-19 (SARS-COV-2) Antigen Rapid Test** | Taidoc Technology Corporation Wugu Factory | NPS | 86.0% (73.26 to 94.18) | 94.74%(82.25 to 99.36% | 90.32%(74.25 to 97.96) | 96.55% | January 18, 2022 to January 24, 2022 |
| 27 | SARS-CoV-2 Antigen Test Kit (LFIA) Medomics** | Jiangsu Medomics medical technology Co., Ltd | NPS | 87.18% (72.57 to 95.70) | 96.15% (89.17 to 99.20) | 100% (83.16 to 100.00) | 96.15% | January 31, 2022 to February 27, 2022 |
| 28 | Humasis COVID-19 Ag Test | Humasis Co., Ltd. | NPS | 86.67% (69.28 to 96.24) | 96.67% (82.78 to 99.92) | 100% (71.51 to 100.00) | - | March 16, 2022 |
| 29 | Asan Easy Test® COVID-19 Ag (Specimen: Nasopharyngeal Swab) | Asan Pharmaceutical Co., Ltd. | NPS | 96.67% (82.78 to 99.92) | 93.33% (77.93 to 99.18) | 100% (71.51 to 100.00) | - | March 18, 2022 |
| 30 | SARS-CoV-2 Antigen | Dia.Pro Diagnostic Bioprobes S.r.l | NPS | 100% (88.43 to 100.00) | 96.67% (82.78 to 99.92) | 100% (69.15 to 100.00) | - | March 17, 2022 |
| 31 | PARTNERS COVID-19 Antigen Rapid Test Cassette | Hangzhou Biotest Biotech Co., Ltd. | NPS | 96.67% (82.78 to 99.92 | 96.67% (82.78 to 99.92) | 100% (71.51 to 100.00) | - | March 24, 2022 |
| 32 | Cellex qSARS-CoV-2 Antigen Rapid Test (Lateral Flow Chromatographic Immunoassay) | Cellex Inc. | NPS | 96.67% (82.78 to 99.92) | 93.33% (77.93 to 99.18) | 100% (71.51 to 100.00) | - | March 22, 2022 |
| 33 | Veri-Q Covid-19 Ag Rapid Test | MiCo Biomed Co. Ltd. | NPS | 90.00% (73.47 to 97.89) | 100% (88.43 to 100.00) | 100% (71.51 to 100.00) | - | March 26, 2022 |
| 34 | ORIGHT COVID-19 Antigen Rapid Test Cassette | Hangzhou Biotest Biotech Co., Ltd. | NPS | 100.00% (88.43 to 100.00) | 100.00% (88.43 to 100.00) | 100.00% (71.51 to 100.00) | - | April 4, 2022 |
| 35 | Clinitest Rapid COVID19 Antigen Test | Healgen Scientific Limited Liability Company | NPS | 100.00% (88.43 to 100.00) | 96.67% (82.78 to 99.92) | 100.00% (71.51 to 100.00) | - | Macrh 28, 2022 |
| 36 | COVID-19 Antigen Test Cassette | HangZhou Testsea biotechnology Co., Ltd | NPS | 93.33% (77.93 to 99.18) | 100.00% (88.43 to 100.00) | 100.00% (71.51 to 100.00) | - | March 29, 2022 |
| 37 | SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit (Colloidal Gold) | HUNAN RUNMEI GENE TECHNOLOGY CO., LTD | NPS | 86.67% (69.28 to 96.24) | 96.67% (82.78 to 99.92) | 90.91% (58.72 to 99.77) | - | April 1, 2022 |
| 38 | MauveTM Covid-19 Antigen Test | InTelos Inc. | NPS | 96.67% (82.78 to 99.92) | 93.33% (77.93 to 99.18) | 100.00% (69.15 to 100.00) | - | April 2, 2022 |
| 39 | SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Biobase Biodustry (Shandong) Co., Ltd. | NPS | 96.67% (82.78 to 99.92) | 93.33% (77.93 to 99.18) | 100.00% (71.51 to 100.00) | - | March 21, 2022 |
| 40 | CareStart COVID-19 Antigen test** | Access Bio, Inc. | NPS | 81.08% (64.84 to 92.04) | 100% (89.11 to 100.00) | 87.10% (70.17 to 96.37) | 100% | Sept. 9, 2021/November 9, 2021 |
| 41 | Novel Coronavirus (SARS-CoV-2) Antigen rapid test Cassette | Hangzhou Realy Tech Co., Ltd. | NPS | 100.00% (88.43 to 100.00) | 100.00% (88.43 to 100.00) | 100.00% (71.51 to 100.00) | March 22, 2022 | |
| 42 | Finecare 2019-nCov Antigen Test | Guangzhou Wondfo Biotech Co., Ltd. | NPS | 100.00% (88.43 to 100.00) | 96.67% (82.78 to 99.92) | 100.00% (69.15 to 100.00) | March 22, 2022 | |
| 43 | V-CODE ENCODE SARS-COV-2 Antigen Rapid Test Device | Zhuhai Encode Medical Engineering Co., Ltd | NPS | 83.33% (65.28 to 94.36) | 100.00% (71.51 to 100.00) | 100.00% (71.51 to 100.00) | January 13/ January 25, 2022 | |
| 44 | CLUNGENE® COVID-19 Antigen Rapid Test Cassette | Hangzhou Clongene Biotech Co. Ltd | NPS | 100.00% (88.43 to 100.00) | 93.33% (77.93 to 99.18) | 100.00% (83.16 to 100.00) | - | April 19, 2022 |
| 45 | Coronavirus Ag Rapid Test Cassette (Swab) | Zhejiang Orient Gene Biotech Co., LTD | NPS | 93.33% (77.93 to 99.18) | 100.00% (88.43 to 100.00) | 100% (69.15 to 100.00) | - | May 4, 2022 |
| 46 | CareUs Covid-19 Antigen | WELLS BIO, INC. | NPS | 83.33% (65.28 to 94.36% | 100.00% (88.43 to 100.00) | 100.00% (71.51 to 100.00) | March 23, 2022 | |
| 47 | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal gold method) | Biohit Healthcare (Hefei) Co., Ltd. | NASAL SWAB | 96.67% (82.78 to 99.92) | 100.00% (88.43 to 100) | 100.00% (69.15 to 100.00) | - | April 21, 2022 |
| 48 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method)** | Beijing Jinwofu Bioengineering Technology Co., Ltd. | NPS | 76.81% (65.09 to 86.13) | 97.73% (87.98 to 99.94) | 83.05% (71.03 to 91.56) | - | Dec. 14, 2021/ Dec. 21, 2021 |
| 49 | Rapid SARS-CoV-2 Antigen Test Card | Xiamen Boson Biotech Co., Ltd. | NPS | 96.67% (82.78 to 99.92) | 96.67% (82.78 to 99.92) | 100.00% (69.15 to 100.00) | - | April 27, 2022 |
| 50 | Novel Coronavirus(2019-nCoV) Antigen Rapid Test | Bioscience (Tianjin) Diagnostic Technology Co.,Ltd | NASAL SWAB | 96.67% (82.78 to 99.92) | 96.67% (82.78 to 99.92) | 100.00% (73.54 to 100.00) | - | April 27, 2022 |
| 51 | "SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method) " | Synthgene Medical Technology Co., Ltd. | NPS | 86.67% (69.28 to 96.24) | 100.00% (88.43 to 100) | 100.00% (69.15 to 100.00) | - | April 29, 2022 |
| 52 | VSTRIP COVID-19 Antigen Rapid Test | Panion & Bf Biotech Inc. | NPS | 76.67% (57.72 to 90.07) | 100.00% (88.43 to 100.00) | 100.00% (69.15 to 100.00) | - | May 6, 2022 |
| 53 | VivaDiag SARS-CoV-2 Ag FIA Test VID44 | Vivachek Biotech Hangzhou Co. Ltd. | NPS | 100% (88.43 to 100.00) | 100% (88.43 to 100.00) | 100.00% (69.115 to 100.00) | - | May 18, 2022 |
| 54 | Novel Coronavirus (Covid-19) Antigen Test Kit (Colloidal Gold) | Hangzhou Laihe Biotech Co., Ltd. | NPS | 100% (88.43 to 100.00) | 100% (88.43 to 100.00) | 100.00% (69.15 to 100.00) | - | May 24, 2022 |
| 55 | Healgen Coronavirus Ag Rapid Test Cassette (Nasal Swab) | Healgen Scientific Limited Liability Company | NASAL SWAB | 100% (88.43 to 100.00) | 100% (88.43 to 100.00) | 100.00% (69.15 to 100.00) | - | May 30, 2022 |
| 56 | Immunoquick Covid-19 Antigen Rapid Test Kit | ImmunoScience India Private Limited | NPS | 90.00% (73.47 to 97.89) | 96.67% (82.78 to 99.92) | 100.00% (69.15 to 100.00) | - | June 1, 2022 |
| 57 | COVID-19 Antigen Rapid Test (Colloidal Gold) | Joinstar Biomedical Technology Co., Ltd | NPS | 80.00% (61.43 to 92.29) | 100.00% (88.43 to 100.00) | 100.00% (69.15 to 100.00) | - | May 31, 2022 |
| 58 | Medsan SARS COV-2 Antigen Rapid Test | MEDsan® GmbH | NPS | 100% (88.43 to 100.00) | 76.67% (57.72 to 90.07) | 100% (69.15 to 100.00) | - | June 10, 2022 |
| 59 | BD Kit for Rapid Detection of SARS-CoV-2 | Becton, Dickinson and Company | NASAL SWAB | 80.00% (61.43 to 92.29) | 96.67% (82.78 to 99.92) | 100.00% (66.37 to 100.00) | - | June 20, 2022 |
| 60 | Genedian Covid-19 Antigen Test Cassette (Professional) | Hangzhou Dian Biotechnology Co. Ltd | NPS | 100.00% (88.43 to 100.00) | 100.00% (88.43 to 100.00) | 100.00%(83.89 to 100.00) | - | June 22, 2022 |
| 61 | Meril Meriscreen COVID-19 Antigen | Meril Diagnostics Pvt. Ltd | NPS | 76.67%(57.72 to 90.07) | 100.00% (88.43 to 100.00) | 100.00% (6.37 to 100.00) | - | June 24, 2022 |
| 62 | SARS-CoV-2 Antigen Test | Wuxi Techstar Technology Co., Ltd. | NPS | 100.00% (88.43 to 100.00) | 80.00% (61.43 to 92.29) | 100.00% (66.37 to 100.00) | - | June 30, 2022 |
| 63 | Biobase COVID-19 Antigen Rapid Test | Biobase Diagnostic Technology (Shandong) Co., Ltd. | NPS | 96.67% (82.78 to 99.92) | 100% (88.43 to 100.00) | 90.00% (55.50 to 99.75) | - | July 14, 2022 |
| 64 | Ixensor Pixo Test COVID-19 Ag Test Kit | iXensor Co., Ltd | NPS | 30.00% (14.73 to 49.40) | 100% (88.43 to 100.00) | 66.67% (29.93 to 92.51) | - | July 21, 2022 |
| 65 | SIENNA COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal swab/Saliva) | Salofa Oy | NPS/SALIVA | 96.67%(82.78 to 99.92) | 100%(88.43 to 100.00) | 100.00%(66.37 to 100.00) | - | August 8, 2022 |
| 66 | Strongstep SARS-CoV-2 Antigen Rapid Test | Nanjing Liming Bio-Products Co. Ltd. | NASAL SWAB | 100% (88.43 to 100.00) | 96.67% (82.78 to 99.92) | 100.00% (66.67 to 100.00) | - | November 25, 2022 |
| 67 | INDICAID COVID-19 Rapid Antigen Test | PHASE Scientific International Limited | NPS | 90.00% (73.47 to 97.89) | 100% (88.43 to 100.00) | 90.00%(68.30 to 98.77) | - | December 16, 2022 |
Note: *asymptomatic population not done due to surge of cases
Products with external validation results*
SARS-COV-2 RAPID ANTIGEN TEST
| No | Product Name | Manufacturer | Reference | Link |
|---|---|---|---|---|
| 1 | Panbio COVID-19 Ag Test – Nasal | Abbott Rapid Diagnostics | FIND | - |
| 2 | NowCheck COVID-19 Ag Test – NasopharyngeaL | Bionote, Inc. | FIND | Link |
| 3 | Novel coronavirus (2019-nCOV) antigen detection kit (colloidal gold method)/ (Lateral flow method) | Guanzhou Wondfo Biotech Co., Ltd. | FIND | Link |
| 4 | STANDARD F COVID-19 Ag FIA | SD BIOSENSOR, INC. | FIND | Link1 Link2 |
| 5 | Standard Q COVID-19 Ag Test (Nasal swab) | SD Biosensor, Inc. | FIND | Link |
| 6 | Sure Status Covid-19 Antigen Card test (Nasopharyngeal) | Premier Medical Corporation Private Limited | FIND | Link |
| 7 | Mologic COVID-19 Rapid Test | Mologic, Ltd. | FIND | Link |
| 8 | Flowflex SARS-COV-2 Antigen Rapid Test | Acon Biotech (Hangzhou) Co. Ltd. | FIND | Link |
| 9 | COVID-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 |
| 10 | NADAL COVID-19 Ag Test* | NAL VON MINDEN GmbH | FIND | Link |
| 11 | SGTI-flex COVID-19 Ag* | Sugentech, Inc. | SICHH and IMR | no available link for online viewing |
| 12 | Healgen Coronavirus Ag Rapid Test Cassette (swab) | Healgen Scientific Limited Liability Company | Department of Clinical Microbiology, Center for Interdisciplinary Research on Medicines (CIRM), University of Liege, Belgium | Link |
| 13 | PBCheck COVID-19 Ag Test Kit | Precision 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., Ltd | Institute for Medical Research in Kuala Lumpur, Malaysia | - |
| 15 | FUJIFILM COVID-19 Ag Test | FUJIFILM Corporation | Mahidol University | - |
| 16 | VITROS Immunodiagnostic Products SARS-COV-2 Antigen Reagent Pack (619 9941) | Ortho-Clinical Diagnostics, Inc. | Clinical Microbiology, Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, Belgium as published in the manuscript “Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2.” Favresse, J.; Gillot, C. et. al., Journal of Clinical Medicine 2021, 10, 265, https://doi.org/10.3390/jcm10020265. | - |
| 17 | Novel Coronavirus 2019-nCov Antigen Test (Colloidal Gold) | Beijing Hotgen Biotech Co., Ltd. | FIND | Link |
| 18 | COVID-19 Antigen Detection Kit | New Gene (Hangzhou) Bioengineering Co., Ltd | Institute for Medical Research in Kuala Lumpur | - |
| 19 | AllCheck COVID-19 Ag | CALTH INC | National Public Health Laboratory, Ministry of Health Malaysia | - |
| 20 | SARS-COV-2 ANTIGEN ASSAY KIT (COLLOIDAL GOLD METHOD) (Product number 2061701) | Zybio, Inc. | Mahidol University in Thailand as of June 20, 2021 | - |
| 21 | MAGLUMI® SARS-CoV-2 Ag (CLIA) | Shenzhen New Industries Biomedical Engineering Co. Ltd | FIND | - |
| 22 | "Dynamiker SARS-CoV-2 Ag Rapid Test DNK-1425-1 Sample type: Nasopharyngeal swab " | Dynamiker Biotechnology (Tianjin) Co., Ltd. | The Ministry of Health Republic Indonesia, Health Laboratory Jakarta as of July 26, 2021. | - |
| 23 | PCL COVID-19 Ag Gold Product number: COV04S Specimen type: Saliva | PCL, Inc. | National Institutes of Health, Institute for Medical Research in Kuala Lumpur, Malaysia as of July 2, 2021 | - |
| 24 | OnSite® COVID-19 Ag Rapid Test (R0182C) | CTK Biotech Inc. | FIND | - |
| 25 | SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) (G10314) Specimen type: Saliva | Joysbio (Tianjin) Biotechnology Co., Ltd. | the Ministry of Health, National Cancer Institute in Putrajaya, Malaysia as of July 21, 2021. | - |
| 26 | VAZYME Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) Product number: Specimen type: Nasopharyngeal swab | Nanjing Vazyme Medical Technology Co. Ltd | by Ramathibodi Hospital, Mahidol University in Thailand as of September 2021. | - |
| 27 | SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based | Nanjing Vazyme Medical Technology Co. Ltd. | Dr. Lukasz Szarpak, Maria Sklodowsa-Curie Medical Academy in Warsaw, Poland as of March 21, 2021 | - |
| 28 | COVID-19 Antigen Rapid Test Sample type: Nasopharyngeal swab* Product no: ICOV-502 | Hangzhou Alltest Biotech Co., Ltd. | Institute for Medical Research in Kuala Lumpur, Malaysia as of June 13, 2021. | - |
| 29 | NowCheck COVID-19 Ag Test Sample Type: Nasal Swab Product no: RG190DGN | Bionote, Inc. | FIND as of March 30, 2021 | - |
| 30 | COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)* Product no: 64828 | Lansion Biotechnology Co., Ltd. | FZMB GmbH-Research Centre for Medical Technology and Biotechnology in Germany as of March 16, 2021 | - |
| 31 | SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Immunochromatography) Product number: CE-InCG27* | Beijing Lepu Medical Technology Co., Ltd. | Ramathibodi Hospital, Mahidol University in Thailand as of June 2021 | - |
| 32 | SARS-CoV-2 Antigen Rapid Test (Nasal Swab) Product no: INCP-502-N* | Hangzhou Alltest Biotech Co., Ltd. | University Clinical Center in Gdańsk, Poland as of June 23, 2021 | - |
| 33 | SARS-CoV-2 Antigen Rapid Test Kit Product number: K511416D | Triplex International Biosciences (China) Co., Ltd. | "Department of Pathology-Faculty of Medicine, Prince of Songkla University in Thailand as of November 26, 2021." | |
| 34 | ASAN Easy Test COVID-19 Ag (re-evaluation) * | Asan Pharmaceutical Co., Ltd | Chung-Ang University Hospital, Department of Diagnostic Testing in Seoul, Korea as of April 6, 2021. | |
| 35 | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)* Product number: CG2725 | Beijing Lepu Medical Technology Co., Ltd | Ramathibodi Hospital, Mahidol University in Thailand as of April 23, 2021. | |
| 36 | COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay) Product no: 64828 | Lansion Biotechnology Co., Ltd. | FZMB GmbH-Research Centre for Medical Technology and Biotechnology in Germany as of March 16, 2021. Attached | |
| 37 | Rapid Response COVID-19 Antigen Rapid Test Device Product no: COV-19C25 | BTNX, Inc. | Institute of Epidemiological Diagnosis and Reference in Mexico, City, Mexico as of March 23, 2022. | |
| 38 | COVID-19 Antigen Rapid Test Cassette | Hangzhou Clongene Biotech Co., Ltd. | University Clinical Center in Gdańsk, Poland as of December 15, 2021. | |
| 39 | Standard Q COVID-19 Ag Saliva Test Product No. 09COV9D | SD Biosensor, Inc. | Institute for Medical Research in Kuala Lumpur, Malaysia as of February 10, 2021. | |
| 40 | COVID-19 Antigen Rapid Test (Oral Fluid) Product number: ICOV-802 | Hangzhou Alltest Biotech Co., Ltd. | Central Clinical Laboratory of University Clinical Center in Gdańsk, Poland as of August 9, 2021. | |
| 41 | SARS-CoV-2 Antigen Rapid Test (INCP-502-N) | by Hangzhou Alltest Biotech Co., Ltd. | "University Clinical Center in Gdańsk, Poland as of June 23, 2021." | |
| 42 | SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Immunochromatography) Product number: CE-InCG27* | Beijing Lepu Medical Technology Co., Ltd. | Ramathibodi Hospital, Mahidol University in Thailand as of June 2021 | |
| 43 | SARS-CoV-2 Antigen Rapid Test (Nasal Swab) Product no: INCP-502-N* | Hangzhou Alltest Biotech Co., Ltd. | University Clinical Center in Gdańsk, Poland as of June 23, 2021 | |
| 44 | SARS-CoV-2 Antigen Rapid Test Kit Product number: K511416D | Triplex International Biosciences (China) Co., Ltd. | Department of Pathology-Faculty of Medicine, Prince of Songkla University in Thailand as of November 26, 2021. | |
| 45 | : ASAN Easy Test COVID-19 Ag (re-evaluation) * | Asan Pharmaceutical Co., Ltd | Chung-Ang University Hospital, Department of Diagnostic Testing in Seoul, Korea as of April 6, 2021. | |
| 46 | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)* Product number: CG2725 | Beijing Lepu Medical Technology Co., Ltd | Ramathibodi Hospital, Mahidol University in Thailand as of April 23, 2021. | |
| 47 | COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay) Product no: 64828 | Lansion Biotechnology Co., Ltd. | FZMB GmbH-Research Centre for Medical Technology and Biotechnology in Germany as of March 16, 2021. Attached | |
| 48 | Rapid Response COVID-19 Antigen Rapid Test Device Product no: COV-19C25 | BTNX, Inc. | Institute of Epidemiological Diagnosis and Reference in Mexico, City, Mexico as of March 23, 2022. | |
| 49 | COVID-19 Antigen Rapid Test Cassette | Hangzhou Clongene Biotech Co., Ltd. | University Clinical Center in Gdańsk, Poland as of December 15, 2021. | |
| 50 | Standard Q COVID-19 Ag Saliva Test Product No. 09COV9D | SD Biosensor, Inc. | Institute for Medical Research in Kuala Lumpur, Malaysia as of February 10, 2021. | |
| 51 | COVID-19 Antigen Rapid Test (Oral Fluid) Product number: ICOV-802 | Hangzhou Alltest Biotech Co., Ltd. | Central Clinical Laboratory of University Clinical Center in Gdańsk, Poland as of August 9, 2021. | |
| 52 | COVID-19 Antigen Rapid Test Cassette | Hangzhou Clongene Biotech Co., Ltd. | University Clinical Center in Gdańsk, Poland as of December 15, 2021. | |
| 53 | SARS-CoV-2 Antigen Rapid Test (INCP-502-N) | by Hangzhou Alltest Biotech Co., Ltd. | University Clinical Center in Gdańsk, Poland as of June 23, 2021. |
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.