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 (Updated as of 7 September 2022)

Interim guidlines for product evaluation of COVID-19 self-administered rapid antigen test kit (UpdatedAs of 7 September 2022)

Status Dashboard
As of September 30, 2022
IVDMDCOMPLETEDSTAGE 4STAGE 3STAGE 2STAGE 1
Rapid Antigen test650170
Rapid Antigen Test (Self-administered) 2951423
Rapid Antibody test440000
EIA Antibody test40000
Equipment based Antibody test400110
RT PCR Detection kit911223
Other NAAT120000
Nucleic Acid Extraction kit430000
Viral Transport Media
780000
*numbers refer to unique products. some products are carried by multiple suppliers.
Standard Evaluation Protocol

PCR

Antibody

Antigen

Antigen (Alternative Protocol)

PCR (Saliva)

Product Evaluation
LIST OF RITM COVID-19 ENHANCED PRODUCT EVALUATION INITIATIVE PARTNER LABORATORIES FOR PERFORMANCE VALIDATION OF SARS CoV-2 IVDMD
  1. DOH Center for Health Development 7/Cebu TB Reference Laboratory.
  2. University of the Philippines-Philippine General Hospital.
  3. Mariano Marcos Memorial Hospital and Medical Center.
RITM RECOMMENDATIONS BASED ON OTHER INDEPENDENT EVALUATIONS
As of September 30, 2022

SARS-COV-2 RAPID ANTIGEN TEST

NoProduct NameManufacturerReference Link
1Panbio COVID-19 Ag Test – NasalAbbott Rapid DiagnosticsFIND-
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-
16VITROS 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.-
17Novel Coronavirus 2019-nCov Antigen Test (Colloidal Gold)Beijing Hotgen Biotech Co., Ltd.FINDLink
18COVID-19 Antigen Detection KitNew Gene (Hangzhou) Bioengineering Co., Ltd Institute for Medical Research in Kuala Lumpur-
19AllCheck COVID-19 AgCALTH INCNational Public Health Laboratory, Ministry of Health Malaysia-
20SARS-COV-2 ANTIGEN ASSAY KIT (COLLOIDAL GOLD METHOD)
(Product number 2061701)
Zybio, Inc.Mahidol University in Thailand as of June 20, 2021-
21MAGLUMI® SARS-CoV-2 Ag (CLIA)Shenzhen New Industries Biomedical Engineering Co. LtdFIND-
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.-
23PCL 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-
24OnSite® COVID-19 Ag Rapid Test (R0182C)CTK Biotech Inc.FIND -
25SARS-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.-
26VAZYME 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. Ltdby Ramathibodi Hospital, Mahidol University in Thailand as of September 2021. -
27SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-BasedNanjing Vazyme Medical Technology Co. Ltd. Dr. Lukasz Szarpak, Maria Sklodowsa-Curie Medical Academy in Warsaw, Poland as of March 21, 2021-
28COVID-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.-
29NowCheck COVID-19 Ag Test
Sample Type: Nasal Swab
Product no: RG190DGN
Bionote, Inc.FIND as of March 30, 2021-
30COVID-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-
31SARS-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-
32SARS-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-
33SARS-CoV-2 Antigen Rapid Test Kit Product number: K511416DTriplex International Biosciences (China) Co., Ltd."Department of Pathology-Faculty of Medicine, Prince of
Songkla University in Thailand as of November 26, 2021."
34ASAN 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"

SARS-COV-2 RAPID ANTIBODY TEST

NoProduct NameManufacturerReferenceLink
1Acon SARS-COV-2 IgG/IgM Rapid TestACON Biotech (Hangzhou) CO., LTD. Frederick National Laboratory for Cancer Research (FNLCR), a Federally Funded Research and Development Center (FFRDC)no available link for online viewing
2SARS-CoV-2 IgG/IgM Rapid Test*Zhuhai Encode Medical Engineering Co., LTD“Point-of-care serological assays for delayed SARS-CoV-2 case identification among health-care workers in the UK: A prospective multicentre cohort study.” Pallett, S.C, Rayment, M., et. al. Lancet Respiratory Med 2020; 8: 885–94.no available link for online viewing
32019-nCoV Antibody Test Collodial Gold*Innovita (Tangshan) Biologic Technology Co., Ltd. Frederick National Laboratory for Cancer Research (FNLCR) as adapted by US FDA -

SARS-COV-2 ENZYME IMMUNO ASSAY (EIA) ANTIBODY TEST

NoProduct NameManufacturerReference Link
1SCoV-2 Detect IgG ELISAInbios International Inc.US FDA EUALink
2SCoV-2 Detect IgM ELISAInbios International Inc.US FDA EUALink
3LIAISON® SARS-CoV-2 S1/S2 IgGDiaSorin S.P.APublic Health England-

SARS-COV-2 EQUIPMENT-BASED ANTIBODY TEST

NoProduct NameManufacturerReference Link
1VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgGOrtho-Clinical Diagnostics, Inc.US FDA EUALink
2SARS-CoV-2 IgG ASSAY for ARCHITECT INSTRUMENTAbbot Ireland Diagnostics DivisionUS FDA/Open FDALink
3MAGLUMI 2019-nCOV IgM/IgG (CLIA)* Shenzhen New Industries Biomedical Engineering Co. Ltd. Fundação Oswaldo Cruz (FIOCRUZ) in Brazil-
4Access SARS-COV-2 IgM Beckman Coulter, Inc.Institute for Medical Research, Kuala Lumpur Malaysia-
5Access SARS-COV-2 IgGBeckman Coulter, Inc. National Public Health Laboratory, Ministry of Health Malaysia-
6MAGLUMI® 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 -
7ARCHITECT SARS-CoV-2 IgG II QuantAbbott 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
8SuperFlex 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. -
9SuperFlex 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 DiagnosticsImmunology Laboratory Department of Pathology, Faculty of Medicine Ramathibodi Hospital in Bangkok, Thailand as of April 9, 2021-
11VITROS® 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-
12Alinity 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. -
13GenBody 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."

SARS-COV-2 CARTRIDGE-BASED PCR

NoProduct NameManufacturerReference Link
1Xpert® Xpress SARS-CoV-2Cepheid Inc.FINDLink
2TrueNat SARS-CoV-2Molbio Diagnostics Pvt LtdFINDLink

NEUTRALIZING ANTIBODIES

NoProduct NameManufacturerReference Link
1Ichroma COVID-19 Neutralizing Ab
(CFPC-120)
Boditech Med IncorporatedGyeongsang National University Changwon Hospital in Korea as of April 22, 2021-
2SARS-CoV-2 Neutralizing Antibodies Test Kit
Product number: 65307
Lansion Biotechnology Co., Ltd. Ministry of Public Health, Institute of Biomedical Sciences, Academy of Medicine in Thailand as of November 2, 2021-
REVIEWS OF OTHER PERFORMANCE EVALUATIONS/EQUIVALENCE
As of September 15, 2022

SARS-COV-2 RAPID ANTIGEN TEST

NoProduct NameDocument Submitted
1SARS-COV-2 Rapid Antigen Test (Roche) Certificate of equivalency with Standard Q COVID-19 Rapid Antigen (SD Biosensor Inc.) submitted
2SARS-COV-2 Rapid Antigen Test (Roche) Nasal swabCertificate 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.

.entry-content p{ text-align:justify!important; }