| A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | |
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1 | Molecular Diagnostic Tests for SARS-CoV-2 | ||||||||||||||||||||||||
2 | NO. | IMPORTER AND DISTRIBUTOR'S NAME | PRODUCT NAME | MANUFACTURER'S NAME | SPECIMENS | CONFIRMATORY/SCREENING | PLATFORM | RITM Validated Result Sensitivity | RITM Validated Result Specificity | ||||||||||||||||
3 | 1 | ASSURANCE CONTROLS TECHNOLOGIES CO., INC. | SARS-CoV-2 Fluorescent PCR Kit | Maccura Biotechnology Co., Ltd.-16#, Baichuan Road, High-Tech Zone, 611731 Chengdu, People’s Republic of China | Oropharyngeal swabs and sputum | CONFIRMATORY | RT-PCR | 96.23% | 100% | ||||||||||||||||
4 | 2 | BIOMERIEUX PHILIPPINES CORPORATION | BioFire Respiratory Panel 2.1 (RP2.1) | BioFire Diagnostic, LLC. -515 Colorow Drive, Salt Lake City, Utah, 84108, USA | Nasopharyngeal swab | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
5 | 6 | Macare Medicals, Inc | Xpert Xpress SARS-CoV-2 | Cepheid AB-Röntgenvägen 5, 171 54 Solna, Sweden | nasopharyngeal, oropharyngeal, nasal, or mid-turbinate swab or nasal wash/aspirate specimens | CONFIRMATORY | RT-PCR | 100.00% | 99.00% | ||||||||||||||||
6 | 7 | Macare Medicals, Inc | Xpert Xpress SARS-CoV-2 | Cepheid – 904 Caribbean Drive, Sunnyvale, CA 94089-1189 USA | nasopharyngeal, oropharyngeal, nasal, or mid-turbinate swab or nasal wash/aspirate specimens | CONFIRMATORY | RT-PCR | 100.00% | 99.00% | ||||||||||||||||
7 | 8 | ROCHE (PHILIPPINES), INC | Cobas® SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the Cobas® Liat® System Material Code: 09211101190 | Roche Molecular Systems, Inc. – 1080 US Highway 202 South Branchburg, NJ 08876 USA | Nasopharyngeal Swab, Oropharyngeal Swab, Sputum | CONFIRMATORY | RT-PCR | 96.49% | 100% | ||||||||||||||||
8 | 9 | RHUMBA INCORPORATED | GENEPRO SARS-COV-2 TEST | Gencurix Inc.-#402, #908, #910, Digital-road 242, Goru-go, Seoul, 08394, Republic of Korea | Oropharyngeal swabs /
Nasopharyngeal swabs | CONFIRMATORY | RT-PCR | 96.55% | 100% | ||||||||||||||||
9 | 10 | ALLIED HOSPITAL SUPPLY INTERNATIONAL CORP | EasyNat Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (lsothermal Amplification-Real Time Fluorescence Assay) | Ustar Biotechnologies (Hanghou) Co. Ltd – 3766 Nanhuan Road FI 8 Binjiang, Dist Hangzhou, Zhejiang 310053, China | Nasopharyngeal Swab, Oropharyngeal Swab and Sputum | CONFIRMATORY | RT-PCR | 95% | 100% | ||||||||||||||||
10 | 11 | RHUMBA INCORPORATED | 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 400082 | Nasal/throat swabs | CONFIRMATORY | RT-PCR | 100.00% | 100.00% | ||||||||||||||||
11 | 12 | BIOSITE MEDICAL INSTRUMENTS | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Sansure Biotech Inc. – No.680, Lusong Road, Hi-Tech Development Zone, Yuelu District, Changsha, Hunan Province, 410205, People’s Republic of China | Nasopharyngeal Swab, Oropharyngeal Swab, Alveolar Lavage Fluid, Serum, Whole Blood | CONFIRMATORY | RT-PCR | 100.00% | 100.00% | ||||||||||||||||
12 | 13 | BIOMERIEUX PHILIPPINES CORPORATION | ARGENE® SARS-COV-2 R-GENE | BioMérieux SA-376 Chemin de l'Orme, 69280 Marcy-l’Etoile - France | Nasopharyngeal Swabs, Nasal Swabs, Oropharyngeal (Throat) Swabs and Saliva | CONFIRMATORY | RT-PCR | 98.18% | 100.00% | ||||||||||||||||
13 | 14 | ENDURE MEDICAL, INC | AllplexTM SARS-CoV-2 ASSAY | Seegene Inc. – Taewon Bldg., 91, Ogeum-ro, Songpa-gu, Seoul, Republic of Korea | Nasopharyngeal Swab, Oropharyngeal Swab, Throat swab, Bronchoalveolar Lavage and sputum | CONFIRMATORY | RT-PCR | 98.31% | 100% | ||||||||||||||||
14 | 15 | SCIENTIFIC BIOTECH SPECIALTIES INC | OPTI SARS-CoV-2 RT-PCR Test | OPTI Medical Systems, Inc. – 235 Hembree Park Drive, Roswell, Georgia 30076, USA | Nasal Swab, Nasopharyngeal Swab, Oropharyngeal Swabs, Sputum, Lower Respiratory Tract Aspirates, Bronchoalveolar Lavage, and Nasopharyngeal Wash/Aspirate or Nasal Aspirate | CONFIRMATORY | RT-PCR | 100.00% | 100.00% | ||||||||||||||||
15 | 16 | ASSURANCE CONTROLS TECHNOLOGIES CO., INC | Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) | Sun Yat-Sen University Da An Gene Company Limited – No.19 Xiangshan Road, Science park, High& New Technology Development District, Guangzhou, GuangDong, P.R. China | Throat Swabs and sputum | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
16 | 17 | MRL CYBERTEC CORPORATION | Novel coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescence PCR Method) | Shenzhen Uni-medica Technology Co. Ltd – Room 202, Block 6th, LiuXian Culture Park, XiLi Town, NanShan District, ShenZhen, Guangdong Province, P.R. China | Oropharyngeal Swab, Sputum, Nasopharyngeal Swab, Throat Swab | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
17 | 18 | ASSURANCE CONTROLS TECHNOLOGIES CO., INC. | FTD SARS-CoV-2 | Fast Track Diagnostics Luxembourg S.à.r.l. – 29, rue Henri Koch, L-4354 Esch-sur-Alzette, Luxembourg | Nasopharyngeal and Oropharyngeal Swabs | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
18 | 19 | MDX NETHERLANDS DIAGNOSTICS, INC. | Novel coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescence PCR Method) | Shenzhen Uni-medica Technology Co. Ltd – Room 202, Block 6th, LiuXian Culture Park, XiLi Town, NanShan District, ShenZhen, Guangdong Province, P.R. China | oropharyngeal swab, sputum, bronchoalveolar lavage fluid and nasopharyngeal swab | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
19 | 20 | GREPCOR DIAMONDE INC | Aptima SARS-CoV-2 Assay | Hologic, Inc.–10210 Genetic Center Drive, San Diego, CA, USA | nasopharyngeal, Nasal or oropharyngeal swab, Nasopharyngeal Washes/Aspirates | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
20 | 21 | MOHS ANALYTICS INC | Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) | Sun Yat-Sen University Da An Gene Company Limited – No.19 Xiangshan Road, Science park, High& New Technology Development District, Guangzhou, GuangDong, P.R. China | Throat Swabs, BALF and Sputum | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
21 | 22 | CHEMTRUST GLOBAL MARKET INC | SARS-COV-2 and Variants Nucleic Acid Detection Kit | Hunan Runmei Gene Technology Co., Ltd.– Room 401-1, Building 3, Shanhe Medical and Health Industrial Park, No. 1048. Zhongqing Road, Shaping Street, Kalfu District, Changsha, Hunan Province, China | Throat swabs, Nasal Swabs, Nasopharygneal Extracts, Deep Cough Sputum | CONFIRMATORY | RT-PCR | Kit name: Positive Percent Agreement (PPA) 1. Alpha Kit 96.23% 2. Delta Kit 96.23% 3. Theta Kit 100% | Negative Percent Agreement (PPA) 100% 100% 100% | NOTE: The following PPA and NPA results pertain to the SARS-CoV-2 diagnostic target (RdRP gene) of these in vitro diagnostic medical devices refer to the ability of each above-mentioned variant assay to detect SARS-CoV-2 from clinical specimens and do not pertain to the ability of the kit to detect the SARS-CoV-2 variant-associated mutations. | |||||||||||||||
22 | 23 | BIOCARE HEALTH RESOURCES INC | SARS-CoV-2 ELITe MGB® Kit | ELITechGroup S.p.A–Corso Svizzera 185, Torino,10149 Italy | Nasopharyngeal swab/ Oropharyngeal swab/Nasal Swab | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
23 | 24 | BIOSITE MEDICAL INSTRUMENTS | Real-Time Fluorescent RT-PCR Kit for Detecting 2019-nCoV | BGI Biotechnology (Wuhan) Co., Ltd.–Building B2, B1, Zone B/C/D, Wuhan National Bio industry Base, No.666 Gaoxin Avenue, East Lake High-tech Development Zone, Wuhan, Hubei, 430075, China | throat swabs and alveolar lavage fluid samples | CONFIRMATORY | RT-PCR | 96.49% | 100% | ||||||||||||||||
24 | 25 | ASSURANCE CONTROLS TECHNOLOGIES CO., INC. | Molaccu COVID-19 Detection Kit | Floor 1 to Floor 5, Building 30, No.6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou District, 400082 Chongqing, People's Republic of China | Nasopharyngeal swab/ Oropharyngeal swab | CONFIRMATORY | RT-PCR | 96.77% | 100% | ||||||||||||||||
25 | 26 | PHARMA QUEST CO. | COVID-19 Real-Time PCR Kit | Chaozhou Hybribio Biochemistry Ltd. – D5-3-3-4, High New Area, Economic Development Experimental Zone 521000 Chaozhou, Guangdong, China | Nasopharyngeal swab, Oropharyngeal swab | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
26 | 27 | PHILIPPINE BLUE CROSS BIOTECH CORPORATION | Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) | Shanghai BioGerm Medical Technology Co., Ltd–Room 1302-1307, 1309, Building 3, No. 1588 Huhang Highway, Fengxian District, Shanghai, China | Nasopharyngeal Swab Oropharyngeal Swab, Sputum | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
27 | 28 | SPARTI LOGISTICS CORPORATION | Molaccu COVID-19 Detection Kit | Zybio Inc– Floor 1 to Floor 5, Building 30, No.6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou District, 400082 Chongqing, People's Republic of China | Nasopharyngeal swab Oropharyngeal swab, Saliva | CONFIRMATORY | RT-PCR | 96.77% | 100% | ||||||||||||||||
28 | 29 | RAINPHIL INC | Molaccu COVID-19 Detection Kit | Zybio Inc– Floor 1 to Floor 5, Building 30, No.6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou District, 400082 Chongqing, People's Republic of China | Nasopharyngeal swab and Oropharyngeal swab | CONFIRMATORY | RT-PCR | 96.77% | 100% | ||||||||||||||||
29 | 30 | BIOSITE MEDICAL INSTRUMENTS | Molaccu COVID-19 Detection Kit | Zybio Inc– Floor 1 to Floor 5, Building 30, No.6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou District, 400082 Chongqing, People's Republic of China | Nasopharyngeal swab and Oropharyngeal swab | CONFIRMATORY | RT-PCR | 96.77% | 100% | ||||||||||||||||
30 | 31 | MRL CYBERTEC CORPORATION | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | Bioteke Corporation (Wuxl) Co., Ltd. – 4th Floor, D5&2nd Floor, D3 & 1st and 2nd Floor, D16, No.1719, Huishan Avenue, Wuxi, Jiangsu, China | nasopharyngeal swabs or oropharyngeal swabs | CONFIRMATORY | RT-PCR | 95% | 100% | ||||||||||||||||
31 | 32 | TOUCHSTAR ENTERPRISES | DirectDetectTM SARS-CoV-2 Detection Kit (PCR-Fluorescence Probe) | Coyote Bioscience Co., Ltd | Oropharyngeal swabs | CONFIRMATORY | RT-PCR | PPA:98.25% | NPA:100% | ||||||||||||||||
32 | 33 | CHEMTRUST GLOBAL MARKET INC | New Coronavirus COVID-19 Nucleic Acid Detection Kit | Hunan Runmei Gene Technology Co.,Ltd – Room 401-1, Building 3, Shanhe Medical and Health Industrial Park, No. 1048. Zhongqing Road, Shaping Street, Kalfu District, Changsha, Hunan Province, China | Nasal Swab | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
33 | 34 | PHILIPPINE BLUE CROSS BIOTECH CORPORATION | Detection Kit for 2019 Novel Coronavirus (2019-nCoV) (PCR-Fluorescence) | Sun Yat-Sen University Da An Gene Company Limited – No.19 Xiangshan Road, Science park, High& New Technology Development District, Guangzhou, GuangDong, P.R. China | Throat Swabs and sputum | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
34 | 35 | BIOREGEN EURO, INC. | Detection Kit for 2019 Novel Coronavirus (2019-nCoV) (PCR-Fluorescence) | Sun Yat-Sen University Da An Gene Company Limited – No.19 Xiangshan Road, Science park, High& New Technology Development District, Guangzhou, GuangDong, P.R. China | Throat Swabs and sputum | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
35 | 36 | MDX NETHERLANDS DIAGNOSTICS, INC. | 1Copy COVID-19 qPCR 4plex Kit | 1DROP INC. – A-203, Keumkang Penterium IT Tower 215, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13217, Republic of Korea | nasopharyngeal swab, anterior nasal swab, mid-turbinate nasal swab and oropharyngeal swab | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
36 | 37 | SPARTI LOGISTICS CORPORATION | 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit | Vazyme Medical Technology Co., Ltd.– Floor 1-3, Building C2, Red Maple Park of Technolngical Industry Kechuang Road, Economy & Technology Development Zone, Nanjing, China | Nasopharylngeal Swab, Nasal Swab, Nasopharylngeal Washes/ Aspirates, bronchoalveolar Lavage fluid (BALF) and Sputum | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
37 | 38 | PHILIPPINE BLUE CROSS BIOTECH CORPORATION | Novel coronavirus 2019-nCoV nucleic acid detection kit (fluorescence PCR method) | Shenzhen Uni-Medica Technology Co., Ltd.– Room 202, Block 6th, LiuXian Culture Park, XiLi Town, NanShan District, ShenZhen, Guangdong Province, P.R. China | oropharyngeal swab, sputum, nasopharyngeal swab, Throat swab, bronchoalveolar lavage | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
38 | 39 | GRAND PREMIER INTERNATIONAL TRADING INCORPORATED | 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit | Nanjing Vazyme Medical Technology Co., Ltd- Floor 1-3, Building C2, Red Maple Park of Technological Industry, Kechuang Road, Economy & Technology Development Zone, Nanjing, China | Throat Swabs and sputum specimens | CONFIRMATORY | RT-PCR | 100% | 99.37% | ||||||||||||||||
39 | 40 | PATIENT CARE CORPORATION | BD SARS-CoV-2/Flu for BD MAX Syste | Becton, Dickinson and Company – 7 Loveton Circle Sparks, Maryland 21152, USA | Nasopharyngeal Swabs | CONFIRMATORY | RT-PCR | 98.33% | 100% | ||||||||||||||||
40 | 41 | MEDICAL TEST SYSTEMS | CoviPath™ COVID-19 RT-PCR Kit | Invitrogen Bioservices Private Limited- 2nd Floor,Citius Block, First Technology Place, No.3 EPIP,Whitefield Bengaluru, Bengaluru (Bangalore) Urban, Karnataka (India) | Nasopharyngeal swabs, Nasopharyngealaspirates, Bronchoalveolar Lavage (BAL) | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
41 | 42 | Getz Bros. Philippines Inc. | SARS-CoV-2 Test Kit (Real-time PCR) | Xiamen Zeesan Biotech Co., Ltd. - Building 1, No. 3701 Xiang'an North Road, Torch Hi - Tech Industrial Development Zone (Xiang'an), Xiamen Fujian ,361101, China | nasopharyngeal swab, oropharyngeal swab, bronchoalveolar lavage fluid | CONFIRMATORY | RT-PCR | PPA : 100% | NPA:100% | ||||||||||||||||
42 | 43 | PHILIPPINE BLUE CROSS BIOTECH CORPORATION | DETECTION KIT FOR 2019 NOVEL CORONAVIRUS (2019-NCOV) RNA (PCR-FLUORESCENCE PROBING) | DaAn Gene Co., Ltd. of SunYat-sen University-No.19 Xiangshan Road, Science park, High& New Technology Development District, Guangzhou, GuangDong, P.R. China | Throat swab/Sputum | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
43 | 44 | MEDICAL TEST SYSTEMS INC. | TaqPath COVID-19, FluA, FluB Combo Kit | Life Technologies Corporation-6055 Sunol Blvd. Pleasanton, California 94566 USA | nasopharyngeal,
oropharyngeal, anterior nasal, or mid-turbinate nasal swabs | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
44 | 45 | Endure Medical Inc. | Allplex SARS-COV-2 Master Assay | Seegene Inc.- Taewon Bldg., 91, Ogeum-ro, Songpa-gu, Seoul, Republic of Korea | Oropharyngeal swabs / Nasopharyngeal swabs / Throat Swab/ Sputum, Saliva, bronchoalveolar lavage fluid (BALF) | CONFIRMATORY | RT-PCR | PPA: 100% | NPA:100% | ||||||||||||||||
45 | 46 | MDX Netherlands Diagnostics, Inc. | SARS-COV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) | Zybio Inc. | nasal/throat swab, alveolar lavage fluids | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
46 | 47 | HEALTH METRICS INC. | Detection Kit for 2019-nCoV (PCR-Fluorescence) | DaAn Gene Co., Ltd. of SunYat-sen University-" Guangzhou Hi-Tech Industry Development Zone, No. 19, Xiang Shan Rd., Guangzhou, China " | Throat swab/Sputum | CONFIRMATORY | RT-PCR | 97.64% | 99.71% | ||||||||||||||||
47 | 48 | Medical Test Systems, Inc | TaqPath COVID-19 CE-IVD RT-PCR Kit | Life Technologies Corporation-6055 Sunol Blvd. Pleasanton, California 94566 USA | upper respiratory specimens (such as nasopharyngeal, oropharyngeal, nasal, and mid‑turbinate swabs, and nasopharyngeal aspirate), bronchoalveolar lavage (BAL) specimens, and saliva specimens | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
48 | 49 | Lifeline Diagnostics Supplies, Inc. | Reliance SARS-CoV-2 Flu A Flu B RT-PCR Kit | Bio-Rad Laboratories, Inc.- 4000 Alfred Nobel Drive 94547 Hercules, California, USA | nasopharyngeal and anterior nasal swabs | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
49 | 50 | STA. ANA HEALTHCARE PLUS CORP. | SARS-CoV-2 Fluorescent PCR | Maccura Biotechnology Co., Ltd.-16#, Baichuan Road, High-Tech Zone, 611731 Chengdu, People’s Republic of China | Oropharyngeal swabs and sputum | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
50 | 51 | Trace Biomedical Corporation | Standard M nCoV Real-Time Detection Kit | SD Biosensor, Inc.-C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggido, 16690, REPUBLIC OF KOREA | Nasopharyngeal swab/ Oropharyngeal
swab/ Sputum | CONFIRMATORY | RT-PCR | PPA:100% | NPA:100% | ||||||||||||||||
51 | 52 | SAHAR INTERNATIONAL TRADING INC. | Multiple Real-Time PCR Kit for Detection of 2019-nCoV | Beijing Applied Biological Technologies Co., Ltd.-Room A204 No. 29 Shengmingyuan Road, Science Park, Changping District, 102206 Beijing China | Nasopharyngeal swab, oropharyngeal swab and sputum | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
52 | 53 | HEALTH METRICS INC. | STANDARD M nCoV REAL TIME DETECTION KIT | SD Biosensor, Inc.-C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggido, 16690, REPUBLIC OF KOREA | Nasopharyngeal swab Oropharyngeal swab Sputum | CONFIRMATORY | RT-PCR | PPA:100% | NPA:100% | ||||||||||||||||
53 | 54 | SAHAR INTERNATIONAL TRADING INC. | Multiple Real-Time PCR Kit for Detection of 2019-nCoV | Beijing Applied Biological Technologies Co., Ltd.-Room A204 No. 29 Shengmingyuan Road, Science Park, Changping District, 102206 Beijing China | Nasopharyngeal swab, oropharyngeal swab and sputum | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
54 | 55 | HEALTH METRICS INC. | STANDARD M nCoV REAL TIME DETECTION KIT | SD Biosensor, Inc.-C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggido, 16690, REPUBLIC OF KOREA | Nasopharyngeal swab Oropharyngeal swab Sputum | CONFIRMATORY | RT-PCR | PPA:100% | NPA:100% | ||||||||||||||||
55 | 56 | RAINPHIL INC. | Novel coronavirus 2019-nCoV nucleic acid detection kit (fluorescence PCR method) | Shenzhen Uni-medica Technology Co. Ltd-Room 202, Block 6th, LiuXian Culture Park, XiLi Town, NanShan District, ShenZhen, Guangdong Province, P.R. China | oropharyngeal swab, sputum, bronchoalveolar lavage fluid and
nasopharyngeal swab. | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
56 | 57 | GETZ BROS. PHILIPPINES, INC. | Ezplex ®SARS-CoV-2 FAST Kit | SML Genetree Co. Ltd.–255 Baumoe-ro, Seocho-gu, Seoul, 06740, Republic of Korea | Nasopharyngeal, Oropharyngeal and Sputum | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
57 | 58 | BIOSITE MEDICAL INSTRUMENTS | GeneFinder™ COVID-19 Plus RealAmp Kit | OSANG Healthcare Co., Ltd.–132, Anyangcheondong-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 14040 Korea | nasopharyngeal, oropharyngeal, anterior nasal, mid-turbinate nasal swab, bronchoalveolar lavage fluid (BAL), and sputum | CONFIRMATORY | RT-PCR | PPA:100% | NPA:100% | ||||||||||||||||
58 | 59 | MAN MEDICAL PHARMA AND DIAGNOSTICS, INC | GeneFinder™ COVID-19 Plus RealAmp Kit | OSANG Healthcare Co., Ltd.–132, Anyangcheondong-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 14040 Korea | nasopharyngeal, oropharyngeal, anterior nasal, mid-turbinate nasal swab, bronchoalveolar lavage fluid (BAL), and sputum | CONFIRMATORY | RT-PCR | PPA:100% | NPA:100% | ||||||||||||||||
59 | 60 | GREGAN 101 CORPORATION | Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Sansure Biotech Inc. – No.680, Lusong Road, Hi-Tech Development Zone, Yuelu District, Changsha, Hunan Province, 410205, People’s Republic of China | nasopharyngeal swab, oropharyngeal swab, alveolar lavage fluid, sputum, serum, whole blood, feces from suspected pneumonia cases with novel coronavirus infection | CONFIRMATORY | RT-PCR | PPA:100% | NPA:100% | ||||||||||||||||
60 | 61 | BIOTECHNIKA MEDICAL SUPPLY TRADING | Vazyme 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit | Nanjing Vazyme Medical Technology Co., Ltd–Floor 1-3, Building C2, Red Maple Park of Technological Industry, Kechuang Road, Economy & Technology Development Zone, Nanjing, China | nasal swabs, nasopharyngeal swabs / aspirates / washes, and sputum,respiratory aspirates, bronchial washes, bronchoalveolar lavage fluids, and lung biopsy | CONFIRMATORY | RT-PCR | PPA:100% | NPA:100% | ||||||||||||||||
61 | 62 | MAN MEDICAL PHARMA AND DIAGNOSTICS, INC | GeneFinder™ COVID-19 Plus RealAmp Kit | OSANG Healthcare Co., Ltd.–132, Anyangcheondong-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 14040 Korea | nasopharyngeal, oropharyngeal, anterior nasal, mid-turbinate nasal swab, bronchoalveolar lavage fluid (BAL), and sputum | CONFIRMATORY | RT-PCR | PPA:100% | NPA:100% | ||||||||||||||||
62 | 63 | MACARE MEDICALS, INC. | Xpert® Xpress SARS-CoV-2 | Cepheid – 904 Caribbean Drive, Sunnyvale, CA 94089-1189 USA | nasopharyngeal, oropharyngeal, nasal, or mid-turbinate swab or nasal wash/aspirate specimens | CONFIRMATORY | RT-PCR | 100.00% | 99.00% | ||||||||||||||||
63 | 64 | ELEMENT MERCANTILE TRADE PHILS INC | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Sansure Biotech Inc. – No.680, Lusong Road, Hi-Tech Development Zone, Yuelu District, Changsha, Hunan Province, 410205, People’s Republic of China | nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate swabs, nasal washes, and nasal aspirates | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
64 | 65 | BIOSITE MEDICAL INSTRUMENTS | Detection Kit for 6 mutations in S gene of SARS-CoV-2 (ARMS-PCR) | BGI PathoGenesis Pharmaceutical Technology Co., Ltd – Building No.7, BGI Park, No.21 Hongan 3rd Street, Yantian District, Shenzhen 518083, China | throat swab or sputum | CONFIRMATORY | RT-PCR | 96.55% | 100% | ||||||||||||||||
65 | 66 | MEDICAL TEST SYSTEMS, INC | TaqPath COVID-19 Combo Kit | Life Technologies Corporation – 6055 Sunol Blvd. Pleasanton, California 94566 USA | Nasopharyngeal swab, Oropharyngeal swab, Anterior Nasal, or Mid-Turbinate Nasal Swabs, Nasopharyngeal Aspirates, Brochoalveolar Lavage (BALF) | CONFIRMATORY | RT-PCR | 96.55% | 100% | ||||||||||||||||
66 | 67 | SAFEGUARD DNA DIAGNOSTICS INC | Logix Smart Coronavirus Disease 2019 (COVID-19) Kit | Co-Diagnostics, Inc. – 2401 S Foothill Dr. Suite D Salt Lake City, UT 84109, USA | lower respiratory tract fluids (e.g., bronchoalveolar lavage, sputum, tracheal aspirate), upper respiratory tract fluids (e.g., nasopharyngeal, and oropharyngeal swabs) | CONFIRMATORY | RT-PCR | 96.61% | 100% | ||||||||||||||||
67 | 71 | ROCHE (PHILIPPINES), INC. | LightMix® SARS-CoV-2 E+N UBC | TIB MOLBIOL Syntheselabor GmbH – Eresburgstr. 22-23, D-12103 Berlin ,Germany | tracheal aspirates, bronchoalveolar lavage, throat and nasopharyngeal swab | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
68 | 72 | MDX NETHERLANDS DIAGNOSTICS, INC. | Molaccu COVID-19 Detection Kit | Zybio Inc– Floor 1 to Floor 5, Building 30, No.6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou District, 400082 Chongqing, People's Republic of China | Nasopharyngeal swab/ Oropharyngeal swab | CONFIRMATORY | RT-PCR | 96.77% | 100% | ||||||||||||||||
69 | 73 | BIOSITE MEDICAL INSTRUMENTS | Real-time Fluorescent RT-PCR kit for detecting SARS-CoV-2, Influenza A Virus, and Influenza B Virus | BGI PathoGenesis Pharmaceutical Technology Co., Ltd– Buidling No. 7, BGI Park, No. 21 Hongan 3rd Street, Yantian District, Shenzhen, China | throat swab | CONFIRMATORY | RT-PCR | PPA: 100% | NPA: 100% | ||||||||||||||||
70 | 74 | MACARE MEDICALS, INC | Xpert® Xpress CoV-2/Flu/RSV plus | Cepheid USA– 7000 Gateway Boulevard, Newark, CA, 94560, United States | nasopharyngeal swab and nasal swab | CONFIRMATORY | RT-PCR | PPA: 100% | NPA: 100% | ||||||||||||||||
71 | 75 | MACARE MEDICALS, INC | Xpert® Xpress CoV-2/Flu/RSV plus | Cepheid USA –904 Caribbean Drive Sunnyvale, CA, 94089, United States | nasopharyngeal swab and nasal swab | CONFIRMATORY | RT-PCR | PPA: 100% | NPA: 100% | ||||||||||||||||
72 | 76 | MACARE MEDICALS, INC | Xpert® Xpress CoV-2/Flu/RSV plus | Cepheid AB –Rontegenvagen 5, SE-171 54 Solna, Sweden | Nasopharyngeal Swab and Nasal Swab | CONFIRMATORY | RT-PCR | PPA: 100% | NPA: 100% | ||||||||||||||||
73 | 77 | GUILL-BERN CORPORATION | Molaccu COVID-19 Detection Kit (PCR-Fluorescent Probe Method) | Zybio, Inc – Floor 1 to Floor 4, Building 30, No.6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou District, 400082 Chongqing, China | nasopharyngeal swab, oropharyngeal swab and saliva | CONFIRMATORY | RT-PCR | 96.67% | NPA: 100% | ||||||||||||||||
74 | 78 | Lifeline Diagnostics Supplies, Inc. | Tata MD CHECK RT-PCR OmiSure | Tata Medical and Diagnostics Limited– Plot No. 317/C1, Kiloy Village, Vayalur Rd, Sriperumbudur, Tamil Nadu 631402, India | oropharyngeal swab or nasopharyngeal swab | CONFIRMATORY | RT-PCR | PPA: 100% | NPA: 100% | ||||||||||||||||
75 | 79 | MRL CYBERTEC CORPORATION | Real Time PCR Kit for Novel Coronavirus 2019-nCoV (fluorescence PCR method) | Shenzhen Uni-medica Technology Co. Ltd – Room 202, Block 6th, LiuXian Culture Park, XiLi Town, NanShan District, ShenZhen, Guangdong Province, P.R. China | Nasopharyngeal Swab, Oropharyngeal Swab, Sputum, Bronchoalveolar Lavage Fluid | CONFIRMATORY | RT-PCR | PPA: 100% | NPA: 100% | ||||||||||||||||
76 | 80 | Lifeline Diagnostics Supplies, Inc. | GenePath Dx CoviQuick v2.0 RT-qPCR Kit | Genepath Diagnostics Inc.– 674, South Wagner Road, Ann Arbor, MI 48103, USA | nasopharyngeal (NP), oropharyngeal (OP), combined nasopharyngeal + oropharyngeal(NP+OP), or nasal swab | CONFIRMATORY | RT-PCR | PPA: 100% | NPA: 100% | ||||||||||||||||
77 | 84 | SAHAR INTERNATIONAL TRADING INC. | Pluslife SARS-CoV-2 Nucleic Acid Testing Card | Guangzhou Pluslife Biotech Co., Ltd.– Room 402, 6 Lianhuayan Road, Huangpu District, Guangzhou, Guangdong, China | nasal swab | SCREENING | ISOTHERMAL AMPLICATION CATRIDGE BASED | 100% | 100% | ||||||||||||||||
78 | 85 | TOTALPOWER INCORPORATED | ViroKey® SARS-CoV-2 RT PCR Test v2.0 | Vela Operations Singapore Pte Ltd. -#05-07 The Kendall, 50 Science Park Road, Singapore | nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal or nasopharyngeal aspirates, nasal washes and bronchoalveolar lavage | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
79 | 86 | RAINPHIL INC. | DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit | Solgent Co., Ltd– 3F, 32, Techno 6-ro, Yuseong-gu, Daejeon, South Korea | Nasopharyngeal swab, Oropharyngeal swab, sputum | CONFIRMATORY | RT-PCR | 98% | 100% | ||||||||||||||||
80 | 87 | BIOSITE MEDICAL INSTRUMENT | Real-time Fluorescent RT-PCR kit for detecting SARS-CoV-2 | BGI Europe A/S- Ole Maaloes Vej 3, Copenhagen, DK-2200, Denmark | throat swab and nasopharyngeal swab | CONFIRMATORY | RT-PCR | PPA: 100% | NPA: 100% | ||||||||||||||||
81 | 88 | BIOMERIEUX PHILIPPINES CORPORATION | Biofire Respiratory Panel 2.1 Plus (RP2.1 plus) | BioFire Diagnostics, LLC, -515 Colorow Drive, Salt Lake City, UT 84108, USA | Nasopharyngeal swab, Oropharyngeal swab, sputum | CONFIRMATORY | RT-PCR | PPA: 100% | NPA: 100% | ||||||||||||||||
82 | 89 | PERKINELMER INSTRUMENTS (PHILS) CORPORATION | SARS-CoV-2 Real-time RT-PCR assay | Suzhou Sym-Bio Lifescience Co., Ltd.–No. 115, North Taiping Road, Taicang, Jiangsu Province, China | Nasopharyngeal swab, Oropharyngeal swab | CONFIRMATORY | RT-PCR | N gene: 100% Orf'l Gene: 100% | N gene: 90% Orf'l Gene: 100% | ||||||||||||||||
83 | 90 | JOSMEF ENTERPRISES | MiRXES Fortitude Kit 2.1 | Mirxes Pte. Ltd.– 2 Tukang Innovative Grove JTC MedTech Hub #08-01 Singapore 618305 | Nasopharyngeal Swab | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
84 | 91 | MRL CYBERTEC CORPORATION | abTES COVID-19 qPCR Kit | Altbiotech Pte.Ltd – 25 Pandan Crescent #05-15 TIC Tech Centre Singapore 128477 | Nasopharyngeal swab, throat, sputum | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
85 | 92 | ANDAMAN MEDICAL PHILIPPINES CORPORATION | MiRXES Fortitude Kit 2.1 | Mirxes Pte. Ltd.– 2 Tukang Innovative Grove JTC MedTech Hub #08-01 Singapore 618305 | Nasopharyngeal Swab | CONFIRMATORY | RT-PCR | 100% | 100% | ||||||||||||||||
86 | 93 | UC BIOSCIENCES INC | Pluslife SARS-CoV-2 Nucleic Acid Testing Card | Guangzhou Pluslife Biotech Co., Ltd.– Room 402, 6 Lianhuayan Road, Huangpu District, Guangzhou, Guangdong, China | nasal swab | SCREENING | ISOTHERMAL AMPLICATION CATRIDGE BASED | 100% | 100% | ||||||||||||||||
87 | 94 | MRL CYBERTEC CORPORATION | STAT-NAT SARS-CoV-2 | Sentinel CH. SpA-Via Robert Koch, 2 20152 Milano, Italia | Nasopharyngeal swab | CONFIRMATORY | RT-PCR | PPA: 100% | NPA 100% | ||||||||||||||||
88 | 95 | REGICON HEALTHCARE INC | Pluslife SARS-CoV-2 Nucleic Acid Testing Card | Guangzhou Pluslife Biotech Co., Ltd.– Room 402, 6 Lianhuayan Road, Huangpu District, Guangzhou, Guangdong, China | nasal swab | SCREENING | ISOTHERMAL AMPLICATION CATRIDGE BASED | 100% | 100% | ||||||||||||||||
89 | 96 | BIOSITE MEDICAL INSTRUMENTS | Zybio SARS-CoV-2 Assay Kit | Zybio Inc.-Floor 1 to Floor 4, Building 30, No.6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou District, Chongqing, China 400082 | CONFIRMATORY | RT-PCR | Nasal , Saliva, Throat Swab | PPA: 100% | NPA: 100% | ||||||||||||||||
90 | 97 | BIOSITE MEDICAL INSTRUMENTS | Molaccu Fast SARS-CoV-2 RT-qPCR Detection Kit | Zybio Inc.-Floor 1 to Floor 4, Building 30, No.6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou District, Chongqing, China 400082 | CONFIRMATORY | RT-PCR | Nasopharyngeal swab/ Oropharyngeal swab | PPA: 100% | NPA: 100% | ||||||||||||||||
91 | 98 | SAHAR INTERNATIONAL TRADING INC | SARS-COV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) | Zybio Inc.-Floor 1 to Floor 4, Building 30, No.6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou District, Chongqing, China 400082 | CONFIRMATORY | RT-PCR | nasopharyngeal swab, sputum bronchoalveolar lavage fluids, stool specimens | 100% | 100% | ||||||||||||||||
92 | 99 | Allied Hospital Supply International Corporation | Resolute 2.0 (SARS-CoV-2 Direct Detection Kit) | Alliance Biomed- Pte Ltd 3 Tuas Lane, Singapore , 638612 Singapore | CONFIRMATORY | RT-PCR | Nasopharyngeal , Nasal (Anterior, Midturbinate) , Oropharyngeal, Human Saliva (Deep throat Saliva) | PPA: 100% | NPA: 100% | ||||||||||||||||
93 | 100 | FIL-ANASERVE, INC | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Sansure BioTech Inc. – No. 680, Lusong Road Yuelu District, Changsha, Hunan Province, People's Republic of China | CONFIRMATORY | RT-PCR | nasopharyngeal swab, oropharyngeal swab, alveolar lavage fluid, sputum, serum, whole blood, feces from suspected pneumonia cases with novel coronavirus infection | PPA: 100% | NPA: 100% | ||||||||||||||||
94 | 101 | TRULABORATORIES CORPORATION | Standard M10 SARS-CoV-2 (ORF1ab gene, E gene) | SD Biosensor, Inc. – C-4&5 Floor, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, Republic of Korea | CONFIRMATORY | RT-PCR | Nasopharyngeal swab | 97.4% 100% | 100% 100% | ||||||||||||||||
95 | 102 | PHILIPPINE BLUE CROSS BIOTECH CORPORATION | Novel coronavirus 2019-nCoV nucleic acid detection kit (PCR-fluorescent probe method) | Autobio Diagnostics Co., Ltd. – No. 87, Jingbei Yi Road, National Eco & Tech Development Area, Zhengzhou, China | CONFIRMATORY | RT-PCR | Oropharyngeal swab and sputum | 99.41% | 99.22% | ||||||||||||||||
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