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List of 31 COVID-19 Test Kits Registered for Commercial Use

As of April 6, 2020, the Food and Drug Administration (FDA) has now approved a total of 31 Rapid Antibody Test Kits for coronavirus disease (COVID-19) for commercial use. 

Locally Developed COVID-19 Test Kit

In the Philippines, local scientists from the University of the Philippines (UP) developed a low-cost COVID-19 test kit that can detect the disease for about 1 or 2 hours. The test kit is called GenAmplify™ Corona Virus 2019 (COVID-19) rRT PCR Detection Kit and has just been approved by the FDA as one of the 31 COVID-19 test kits registered for commercial use. 

31 COVID-19 Registered Test Kits

Here are the following COVID-19 test kits approved by FDA.

Product Name

Manufacturer

Nucleic acid detection kit for 2019 ncov Shanghai GenoeDx Biotech Co., LTD Shanghai, China
Novel coronavirus 2019-ncov nucleic acid detection kit (fluorescence PCR method) Beijing Applied Biological Technologies Co., Ltd Changping District 102206 Beijing P. R
AllplexTM 2019-nCoV Assay Seegene Inc. Seoul, Republic of Korea
SOLGENT DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit Solgent Co., Ltd. 3F, 32, Techno 6-ro, Yuseong-gu, Daejeon, South Korea
Standard M nCoV Real-time Detection Kit SD Biosensor, Inc. C-4&5 Floor, 16, Deogyeong-daero 1556beon
A*STAR Fortitude Kit 2.0 (COVID-19 Real-Time RT-PCR Test) Accelerate Technologies Pte. Ltd. Chromos Building, Singapore
TIB MOLBIOL Lightmix® Modular Wuhan CoV RdRP-Gene TIB MOLBIOL Syntheselabor GmbH Eresburgstraße 22 – 23 12103 Berlin Germany
TIB MOLBIOL Lightmix® Modular SARS and Wuhan COV E-Gene TIB MOLBIOL Syntheselabor GmbH Eresburgstraße 22 – 23 12103 Berlin Germany
Genesig® Real-Time PCR Coronavirus (COVID-19) CE IVD Kit Primerdesign Ltd. Unit 1, Watchmoor Point, Watchmoor Road, Camberley, GU15 3AD, United Kingdom
BDDS – CerTest – SARS-CoV2 BD MAX assay (Severe Acute Respiratory Syndrome-Associated Coronavirus IVDs [CT772]) Certest Biotech, S.L -Zaragoza (spain) Certest Biotech, S.L. Calle J N°1 POL. IND. RIO GALLEGO II-50840 San Mateo De Gallego (Zaragoza), Spain
BioFire COVID-19 Test Biofire Defense, LLC. 79 West 4500 South, Suite 14 Salt Lake City, Utah 84107, USA
2019-nCov Nucleic Acid-Based Diagnostic Reagent Kit (Flourescent PCR) Sansure Biotech Inc. No. 680, Lusong Road, Hi- Tech Development Zone, Yuelu District, Changsha, Hunan Province, 410205, People’s Republic of China
Xpert® Xpress SARS-CoV-2 Cepheid 904 Caribbean Drive, Sunnyvale, CA 94089- 1189 USA
Nucleic Acid Reagent Test Kits for Novel Coronavirus 2019-NCOV (Fluorometric PCR)   Shanghai ZJ Bio-Tech Co., Ltd. Floor 1, Building B, building 20, Floor 1, Building A, building 21, No. 528, Ruiqing Road, Zhangjiang high-tech Industry east district, Shanghai, China
abTES™ COVID‐19 Real‐Time qPCR I Kit AITbiotech Pte. Ltd. 25 Pandan Crescent #05-15 TIC Tech Centre, Singapore
SARS-CoV-2 Fluorescent PCR Maccura Biotechnology Co., Ltd. 16#, Baichuan Road, High-Tech Zone, 611731 Chengdu, People’s Republic of China
Real-Time FluorescenT RT-PCR Kit for Detecting 2019-nCoV BGI Biotechnology (Wuhan) Co., Ltd. Research and Development Building B2, Wuhan National Bio-Industry Base B, C, D Suite, No. 666, High-Technology Road, Wuhan Donghu High-Technology Development Zone, People’s Republic of China
TaqPath COVID-19 Combo Kit   Thermo Fisher Scientific, Inc. 5781 Ban Allen Way, Carlsbad, CA 92008, USA
ProTectTM COVID-19 RT-qPCR Kit (10024) (10027) JN Medsys Pte Ltd., 217 Henderson Road #02-08, Singapore
cobas® SARS-CoV-2 MAT CODE: 09175431190 TO INCLUDE: cobas® SARS-CoV-2 Control Kit P/N: 09175440190 and cobas® 6800/8800 Buffer Negative Control Kit P/N: 07002238190 Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA, USA  
GenAmplify™ Corona Virus Disease- 2019 (COVID – 19) rRT-PCR Detection Kit Manila HealthTek Inc. 109 Brgy. Sta. Elena, Mayor Gil Fernando Avenue, Marikina City, Philippines  
Nanjing Vazyme 2019-nCoV IgG/IgM Detection Kit Biolidics Limited 37 Jalan Pemimpin, #02-07, Mapex, Singapore
Novel Coronavirus (2019- NCOV) IgM/IgG Antibody Detection Kit (Colloidal Gold Method) Nanjing Vazyme Medical Technology Co., Ltd Level 1-3, Bldg. C2, Red Maple Sci-Tech Park, Kechuang Road, Nanjing China
Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold) Zhuhai Livzon Diagnostic Inc. 1st Building, No. 266, Tongchang Road, Xiangzhou District, Zhuhai, Guangdong Province, People’s Republic of China
2019-nCoV Antibody Test (Colloidal Gold) Innovita (Tangshan) Biological Technology Co., Ltd. No. 699 Juxin Street, High-Tech Industrial Development Zone, Qian’an 064400, Hebei, China
SARS-CoV-2 Antibody Test (Lateral Flow Method) Guangzhou Wondfo Biotech Co., Ltd. No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, People’s Republic of China
WANTAI SARS- CoV Ab Rapid Test Kit Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. 31 Kexueyuan Road, Changping District Beijing, People’s Republic of China
2019 n-CoV IgG/IgM Rapid Test Cassette Hangzhou Alltest Biotech Co., Ltd. #550, Yinhai Street, Hangzhou Economy and Technology Development Area, 310018, Hangzhou, People’s Republic of China
OnSite COVID-19 IgG/IgM Rapid Test   CTK Biotech, Inc. 13855 Stowe Dr. Poway California, USA
HIGHTOP SARS-CoV-2 IgM/IgG ANTIBODY RAPID TEST   Qingdao Hightop Biotech Co., Ltd. No. 369 Hedong Road, Hi-tech Industrial Development Zone, 266112 Qingdao, Shandong, Peoples Republic of China
Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test Cellex, Inc., 76 TW Alexander Drive, Research Triangle Park, Durham NC 27709-0002, USA
 

COVID-19 Update in the Philippines

As of today, the Philippines has 104 new positive cases of COVID-19 according to the Department of Health (DOH). And, the country has now a total of 3,764 patients who have been tested positive with COVID-19 and 84 patients already recovered from the disease. 

The detection of the COVID-19 through rapid testing is a must to prevent the possible transmission of the disease. Local and international scientists have been working hard to develop test kits that can give a faster result. As a way to help stop this pandemic, let us be cooperative and be a responsible citizen.

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