The COVID-19 pandemic has ushered in the introduction of new laboratory diagnostic tests (PCR detection kits, antibody tests, antigen tests). In accordance with the DOH Department Order 2020-0820 “Institutionalizing and Strengthening the National Reference Laboratories in the Philippines,” the Research Institute for Tropical Medicine has been mandated to perform evaluations of In-Vitro Diagnostic Medical Devices (IVDMDs) in collaboration with the FDA to ensure their quality and good performance in the local setting.
In fulfillment of this mandate and to ensure access to novel quality diagnostic assays for COVID-19, RITM has standardized its evaluation protocols and endeavored to streamline the product evaluation pathway into 4 stages as described below.
Evaluation Guidelines
Guidelines on the Evaluation of In Vitro Diagnostic Medical Devices and other related Laboratory Diagnostic supplies for Covid-19 (As of 7 September 2021)
Status Dashboard
As of October 5, 2021
| IVDMD | COMPLETED | STAGE 4 | STAGE 3 | STAGE 2 | STAGE 1 |
|---|---|---|---|---|---|
| Rapid Antigen Test | 67 | 0 | 0 | 0 | 1 |
| Rapid Antigen Test (Self-administered) | 45 | 1 | 0 | 1 | 2 |
| Rapid Antibody Test | 44 | 0 | 0 | 0 | 0 |
| EIA Antibody Test | 4 | 0 | 0 | 0 | 0 |
| Equipment-based Antibody Test | 5 | 0 | 0 | 3 | 0 |
| RT PCR Detection Kit | 95 | 0 | 0 | 0 | 2 |
| Other NAAT | 12 | 0 | 0 | 0 | 0 |
| Nucleic Acid Extraction Kit | 43 | 0 | 0 | 0 | 0 |
| Viral Transport Media and Swabs | 78 | 0 | 0 | 0 | 0 |
Standard Evaluation Protocol
PCR
Antibody
Antigen
Product Evaluation
RITM RECOMMENDATIONS BASED ON OTHER INDEPENDENT EVALUATIONS
As of October 10, 2021
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. |
SARS-COV-2 ENZYME IMMUNO ASSAY (EIA) ANTIBODY TEST
| No | Product Name | Manufacturer | Reference | Link |
|---|---|---|---|---|
| 1 | SCoV-2 Detect IgG ELISA | Inbios International Inc. | US FDA EUA | Link |
| 2 | SCoV-2 Detect IgM ELISA | Inbios International Inc. | US FDA EUA | Link |
| 3 | LIAISON® SARS-CoV-2 S1/S2 IgG | DiaSorin S.P.A | Public Health England | - |
SARS-COV-2 EQUIPMENT-BASED ANTIBODY TEST
| No | Product Name | Manufacturer | Reference | Link |
|---|---|---|---|---|
| 1 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG | Ortho-Clinical Diagnostics, Inc. | US FDA EUA | Link |
| 2 | SARS-CoV-2 IgG ASSAY for ARCHITECT INSTRUMENT | Abbot Ireland Diagnostics Division | US FDA/Open FDA | Link |
| 3 | MAGLUMI 2019-nCOV IgM/IgG (CLIA)* | Shenzhen New Industries Biomedical Engineering Co. Ltd. | Fundação Oswaldo Cruz (FIOCRUZ) in Brazil | - |
| 4 | Access SARS-COV-2 IgM | Beckman Coulter, Inc. | Institute for Medical Research, Kuala Lumpur Malaysia | - |
| 5 | Access SARS-COV-2 IgG | Beckman Coulter, Inc. | National Public Health Laboratory, Ministry of Health Malaysia | - |
| 6 | MAGLUMI® SARS-CoV-2 S-RBD IgG (CLIA) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Clinical Research Group, Clinical Research Center, Medical Life Sciences Institute, Department of Medical Sciences, Ministry of Public Health Thailand | - |
| 7 | ARCHITECT SARS-CoV-2 IgG II Quant | Abbott Ireland Diagnostics Division | “Performance of the Abbott SARS-CoV-2 IgG II Quantitative Antibody Assay Including the New Variants of Concern, VOC 202012/V1 (United Kingdom) and VOC 202012/V2 (South Africa), and First Steps towards Global Harmonization of COVID-19 Antibody Methods” English, Emma.; Cook, Laura.; Piec, Isabelle.; Derviservic, Samir.; Fraser, William; W., Garry John; et. al., Journal of Clinical Microbiology September 2021, 59, 9, | Link |
| 8 | SuperFlex Anti-SARS-CoV-2 IgG Product number: SARS-CoV-2-SG-C | Suzhou Sym-bio Lifescience Co., Ltd. | Department of Clinical Laboratory Medicine, Kyoto University Graduate School of Medicine as published by BMC in the article “Comparison of six antibody assays and two combination assays for COVID-19.” Yamamoto, M.; Okazaki, K.; Kitai, Y.; Shinohara, K.; Yukawa,S.; Noguchi, T.; Tanaka, M.; Matsumura, Y.; Nishiyama, Y.; Nagao,M .;et al. Virology Journal (2022) 19:24 https://doi.org/10.1186/s12985-022-01752-y. | - |
| 9 | SuperFlex Anti-SARS-CoV-2 Ab Product number: SARS-CoV-2-SMG-C | Suzhou Sym-bio Lifescience Co., Ltd. | Department of Clinical Laboratory Medicine, Kyoto University Graduate School of Medicine as published by BMC in the article “Comparison of six antibody assays and two combination assays for COVID-19.” Yamamoto, M.; Okazaki, K.; Kitai, Y.; Shinohara, K.; Yukawa,S.; Noguchi, T.; Tanaka, M.; Matsumura, Y.; Nishiyama, Y.; Nagao,M .;et al. Virology Journal (2022) 19:24 https://doi.org/10.1186/s12985-022-01752-y. | - |
| 10 | "VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 IgG 2 Reagent Pack used in combination with the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 IgG 2 Calibrator Product number: 6199955" | Ortho-Clinical Diagnostics | Immunology Laboratory Department of Pathology, Faculty of Medicine Ramathibodi Hospital in Bangkok, Thailand as of April 9, 2021 | - |
| 11 | VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 IgG 2 Quantitative Reagent Pack used in combination with the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 IgG 2 Calibrator Product number: 6199964 | Ortho-Clinical Diagnostics | Immunology Laboratory Department of Pathology, Faculty of Medicine Ramathibodi Hospital in Bangkok, Thailand as of July 27, 2021 | - |
| 12 | Alinity i SARS-CoV-2 IgG II Product number: H18534R04 | Abbott Ireland Diagnostics Division | Faculty of Medicine and Health, University of East Anglia. Department of Clinical Biochemistry and Immunology. And Department of Virology in Norfolk and Norwich University Hospital in United Kingdom as published in the manuscript “Performance of the Abbott SARS-CoV-2 IgG II Quantitative Antibody Assay Including the New Variants of Concern, VOC 202012/V1 (United Kingdom) and VOC 202012/V2 (South Africa), and First Steps towards Global Harmonization of COVID-19 Antibody Methods” English, Emma.; Cook, Laura.; Piec, Isabelle.; Derviservic, Samir.; Fraser, William; W., Garry John; et. al., Journal of Clinical Microbiology September 2021, 59, 9, https://doi.org/10.1128/JCM.00288-21. | - |
| 13 | GenBody COVID-19 Ag Test Product number: COVAG025* | GenBody, Inc. | Yeungnam University Medical Center | - |
| 14 | ARCHITECT SARS-CoV-2 IgM Reagent Kit Product number: H07914R04 | Abbot Ireland Diagnostics Division | "Department of Pathology and Laboratory Medicine, Beaumont Health, Royal Oak in Michigan, USA as published in the article “Longitudinal characterization of the IgM and IgG humoral response in symptomatic COVID-19 patients using the Abbott Architect” Maine,G.N.; Lao,K.M.; Krishnan, S.M., et. al. Journal of Clinical Virology. 133 (2020) 104663 https://doi.org/10.1016/j.jcv.2020.104663." | |
| 15 | VIDAS SARS-CoV-2 IgM Product number: 423833 | Biomérieux Sa | Immunology Laboratory, Department of Pathology, Faculty of Medicine, Ramathibodi Hospital in Bangkok, Thailand as of November 27, 2020 |
SARS-COV-2 CARTRIDGE-BASED PCR
| No | Product Name | Manufacturer | Reference | Link |
|---|---|---|---|---|
| 1 | Xpert® Xpress SARS-CoV-2 | Cepheid Inc. | FIND | Link |
| 2 | TrueNat SARS-CoV-2 | Molbio Diagnostics Pvt Ltd | FIND | Link |
REVIEWS OF OTHER PERFORMANCE EVALUATIONS/EQUIVALENCE
As of October 10, 2021
SARS-COV-2 RAPID ANTIGEN TEST
| No | Product Name | Document Submitted |
|---|---|---|
| 1 | SARS-COV-2 Rapid Antigen Test (Roche) | Certificate of equivalency with Standard Q COVID-19 Rapid Antigen (SD Biosensor Inc.) submitted |
| 2 | SARS-COV-2 Rapid Antigen Test (Roche) Nasal swab | Certificate of equivalency with Standard Q COVID-19 Rapid Antigen Nasal Swab (SD Biosensor Inc.) submitted |
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.