On 23 March 2021, the Food and Drug Administration (FDA) issued FDA Memorandum No. 2021-009 entitled “Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection”. This issuance provides that compliance to the minimum performance requirements for sensitivity and specificity based on the performance validation conducted by the Research Institute for Tropical Medicine (RITM) shall be required prior to the issuance of Special Certification for all COVID-19 test kits.
In view of the above and in the interest of protecting public health and safety, the FDA hereby announces the list of COVID-19 test kits that have passed the performance validation conducted and/or recommended by the RITM and were issued with FDA Special Certification in accordance with the abovementioned FDA Memorandum as of 2 August 2021.
List of Approved PCR Based Test Kits for Commercial Use
| Product Name | Name & Address of Manufacturer | Name of Importer/ Distributor | Specimen | RITM Validated Result Sensitivity | RITM Validated Result Specificity | |
| 1. | SARS-CoV-2 Fluorescent PCR Kit | Maccura Biotechnology Co., Ltd.
16# Baichuan Road, High-Tech Zone, 611731 Chengdu, People’s Republic of China |
Assurance Controls Technologies Co., Inc. | Oropharyngeal swabs and Sputum | 96.23% | 100% |
| 2. | BioFire Respiratory Panel 2.1 (RP2.1) | BioFire Diagnostic, LCC.
515 Colorow Drive, Salt Lake City, Utah, 84108, USA |
Biomerieux Philippines Corporation | Nasopharyngeal swab | 100% | 100% |
| 3. | i-DENSY PACK UNIVERSAL REAGENT
(i-DENSY PACK UNIVERSAL SARS-CoV-2 DETECTION SYSTEM) |
ARKRAY INDUSTRY INC.
Lot 22 Phase 1A, First Philippine Industrial Park, Brgy. Sta. Anastacia, Sto. Tomas, Batangas |
ARKRAY Industry Inc | Nasopharyngeal swab | 100% | 100% |
| 4. | SARS-CoV-2 DETECTION PRIMER PROBE SET REAGENT
(i-DENSY PACK UNIVERSAL SARS-CoV-2 DETECTION SYSTEM) |
ARKRAY INDUSTRY INC.
Lot 22 Phase 1A, First Philippine Industrial Park, Brgy. Sta. Anastacia, Sto. Tomas, Batangas |
ARKRAY Industry Inc | Nasopharyngeal swab | 100% | 100% |
| 5. | SARS-COV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) | Zybio Inc.-Floor 1 to Floor 5, Building 30, No.6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou District, Chongqing, China | Sahar International Trading Inc | Nasal/throat swabs | 100% | 100% |
| 6. | Xpert Xpress SARS-CoV-2 | Cepheid AB-Röntgenvägen 5, 171 54 Solna, Sweden | Macare Medicals, Inc | Nasopharyngeal, oropharyngeal, nasal, or mid-turbinate swab or nasal wash/aspirate specimens | 100% | 99% |
List of Approved Antigen Test Kits for Commercial Use
| Product Name | Name & Address of Manufacturer | Name of Importer/ Distributor | Specimen | RITM Validated Result Sensitivity | RITM Validated Result Specificity | |
| 1. | PanbioTM
COVID-19 Ag Rapid Test Device |
Abbot Rapid Diagnostics Jena GmbH
Orlaweg 1 07743 Jena, Germany |
Sunfu Solutions Inc. | Nasopharyngeal Swab | CT < 30 (97.83%) | 100% |
| 2. | PanbioTM
COVID-19 Ag Rapid Test Device |
Abbot Diagnostics Korea Inc.
65, Borahagal-ro, Giheung-gu, Yongin-si, Gyenoggi-do 17099, Republic of Korea |
Sunfu Solutions Inc | Nasopharyngeal Swab | CT < 30 (97.83%) | 100% |
| 3. | SOFIA 2 SARS Antigen FIA | Quidel Corporation
10165 McKellar Court, San Diego, CA 92121 USA |
LABx CORP. | Nasopharyngeal /Nasal Swab | CT < 30 (92.86%) | 100% |
| 4. | PanbioTM COVID-19 Ag Rapid Test Device | Abbott Rapid Diagnostics Jena GmbH-Orlaweg 1 07743 Jena, Germany | Allied Hospital Supply International Corp | Nasopharyngeal swab | CT < 30 (97.83%) | 100% |
| 5. | STANDARD™ Q COVID-19 Ag TEST KIT | SD Biosensor, Inc-C-4&5 Floor, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, Republic of Korea | Trulaboratories Corporation | Nasopharyngeal swab | CT<30 93.1% | 100% |
| 6. | PanbioTM COVID-19 Ag Rapid Test Device | Abbott Rapid Diagnostics Jena GmbH-Orlaweg 1 07743 Jena, Germany | Allied Hospital Supply International Corp. | Nasal swab | CT < 30 (90.5%)
|
99.20% |
| 7. | NowCheck COVID-19 Antigen Test | BioNote Inc-22 Samsung 1-ro-4-gil, Hwaseong-Si, Gyeonggido, 18449 Republic of Korea | Biologic Life Sciences Corp. | Nasopharyngeal swab | CT < 30 (91.4%) | 97.30% |
| 8. | Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Colloidal Gold Method) // Wondfo 2019-nCoV Antigen Test (Lateral flow) | Guangzhou Wondfo Biotech Co., -Guangzhou Wondfo Biotech Co., Ltd. – No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, P.R. China | Tradematchers, Inc. | Nasopharyngeal or Oropharyngeal swabs | CT < 30 (92.2%) | 100% |
| 9. | Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Colloidal Gold Method) // Wondfo 2019-nCoV Antigen Test (Lateral flow) | Guangzhou Wondfo Biotech Co., -Guangzhou Wondfo Biotech Co., Ltd. – No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, P.R. China | LabSolution Technologies Inc. | Nasopharyngeal or Oropharyngeal swabs | CT < 30 (92.2%) | 100% |
| 10. | Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Colloidal Gold Method) // Wondfo 2019-nCoV Antigen Test (Lateral flow) | Guangzhou Wondfo Biotech Co., -Guangzhou Wondfo Biotech Co., Ltd. – No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, P.R. China | Alcheon Medical Corporation | Nasopharyngeal or Oropharyngeal swabs | CT < 30 (92.2%) | 100% |
List of Approved Antibody Rapid Test Kits for Commercial Use
| Product Name | Name & Address of Manufacturer | Name of Importer/ Distributor | Specimen | RITM Validated Result Sensitivity | RITM Validated Result Specificity | |
| 1. | VivaDiagTM
COVID-19 IgM/IgG Rapid Test |
Vivachek Biotech Hangzhou Co. Ltd.
Level 2, Block 2, 146 East Chaofeng Rd., Yuhang Economy Development Zone, Hangzhou, 311100, Zhejiang China |
Philippine Blue Cross Biotech Corporation | Whole Blood / Serum / Plasma and Fingertip Blood | 92.00% | 99.33% |
| 2. | NADAL COVID-19 IgG/IgM Test | Nal Von Minden GmbH- Carl-Zeiss-Str. 12, 47445 Moers, Germany | Diagnostika Pilipinas, Inc. | Human whole blood, serum or plasma |
92.67% | 100.00% |
The above list shall be regularly updated. For reference, please click the link: https://docs.google.com/spreadsheets/d/13S12QST9RKlyX1ipUhqhmngwq3rdtbLRnDWPg8-OSqo/edit#gid=0.
For more information and inquiries, kindly contact the FDA – Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected] or call (02) 8857-1900 loc. 8301.