Kit Evaluation

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 November 29, 2021
IVDMDCOMPLETEDSTAGE 4STAGE 3STAGE 2STAGE 1
Rapid Antigen test1905895
Rapid Antibody test432015
EIA Antibody test40120
Equipment based Antibody test202370
RT PCR Detection kit612159
Other NAAT80000
Nucleic Acid Extraction kit361043
Viral Transport Media
740012
Standard Evaluation Protocol

PCR

Antibody

Antigen

Product Evaluation
RITM RECOMMENDATIONS BASED ON OTHER INDEPENDENT EVALUATIONS
As of November 29, 2021

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

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

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 EUALink1
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

SARS-COV-2 CARTRIDGE-BASED PCR

NoProduct NameManufacturerReference Link
1Xpert® Xpress SARS-CoV-2Cepheid Inc.FINDLink
2TrueNat SARS-CoV-2Molbio Diagnostics Pvt LtdFINDLink
REVIEWS OF OTHER PERFORMANCE EVALUATIONS/EQUIVALENCE
As of November 15, 2021

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.