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1 | ||||||||||||||||||||||||||
2 | 以下資訊取自 PEI 於 2022.05.05 發布的快篩評測報告 | |||||||||||||||||||||||||
3 | https://www.pei.de/SharedDocs/Downloads/EN/newsroom-en/dossiers/evaluation-sars-cov2-antigen-tests-overview-excel.xlsx?__blob=publicationFile&v=15 | |||||||||||||||||||||||||
4 | ||||||||||||||||||||||||||
5 | 以下PEI合格清單，已將Total 敏感度由大至小排序 | |||||||||||||||||||||||||
6 | 1. 純黃底色，為超過敏感度80%的部分 | |||||||||||||||||||||||||
7 | 2. 天藍底色，應該是指有以Omicron測試過的部分 | |||||||||||||||||||||||||
8 | 3. 紅色字體，是台灣本地有販售(並通過EUA)的品牌型號 | |||||||||||||||||||||||||
9 | 4. 橘色字體，是網路外購可能買得到的(未通過EUA)的品牌型號 (有購買管道歡迎告知) | |||||||||||||||||||||||||
10 | ||||||||||||||||||||||||||
11 | PEI合格清單 2022.05.05 | |||||||||||||||||||||||||
12 | AT-Nr. ---------- AT-No. | AT-Nr. Selbsttest # ------------------ AT-No. self-test # | Ref-Nr. * -------------- ID-No. * | Hersteller --------------------- Manufacturer | Testname ----------------- Test name | Zielantigen --------------------- target antigen | Cq ≤25 | Cq 25-30 | Cq ≥30 | Gesamt- Sensitvität ----------------- total sensitivity | Omikron Erkennung entsprechend der Bridging Prüfung --------------------------- Omicron detection by bridging | 備註 | ||||||||||||||
13 | AT731/21 | LS-C-T-009 | Guangdong Longsee Biomedical Co.,Inc. | Longsee 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) | N | 100.0% | 100.0% | 100.0% | 100.0% | Ja | 廣東 南芯 | |||||||||||||||
14 | AT1054/21 | n.a. | Lifecosm Biotech Limited | COVID-19 Rapid Test Cassette Antigen Test Kit | N | 100.0% | 100.0% | 100.0% | 100.0% | Ja | ||||||||||||||||
15 | AT889/21 | AT1350/21 | n.a. | CITEST Diagnostics Inc. | COVID-19 Antigen Rapid Test (Oral Fluid) | N | 100.0% | 100.0% | 90.0% | 98.0% | Ja | |||||||||||||||
16 | AT1024/21 | n.a. | Acro Diagnostics Co., Ltd | SARS-CoV-2 Antigen Rapid Detection Kit (LFA) | N | 100.0% | 100.0% | 80.0% | 96.0% | |||||||||||||||||
17 | AT961/21 | n.a. | Hangzhou Jucheng Medical Products Co., Ltd | SARS-CoV-2 Ag Schnelltestkit | N | 100.0% | 100.0% | 80.0% | 96.0% | Ja | ||||||||||||||||
18 | AT637/21 | BT1389 | Innova Medical Group,Inc. | INNOVA SARS-CoV-2 Selbsttest (Qualitativer-Antigen-Schnelltest) | N | 100.0% | 100.0% | 80.0% | 96.0% | Ja | ||||||||||||||||
19 | AT830/21 | n.a. | Suzhou Soochow University Saier Immuno Biotech Co., Ltd. | InstantSure Covid-19 Ag CARD | N | 100.0% | 100.0% | 80.0% | 96.0% | Ja | ||||||||||||||||
20 | AT1073/21 | n.a. | Innovation Biotech (Beijing) Co. LTD | INVBIO One Step Diagnostic Rapid Test Cassette | N | 100.0% | 100.0% | 70.0% | 94.0% | Ja | ||||||||||||||||
21 | AT928/21 | CG201A | Shenzhen CAS-Envision Medical Technology Co., Ltd. | SARS-Cov-2 Antigen Rapid Detection Kit | N | 100.0% | 100.0% | 70.0% | 94.0% | Ja | V 香港 便利妥 (深圳 中科先見 代工) | |||||||||||||||
22 | AT805/21 | n.a. | Bioscience (Tianjin) Diagnostic Technology Co., Ltd | Novel Coronavirus(2019-nCoV) Antigen Rapid Test | N | 100.0% | 100.0% | 60.0% | 92.0% | 無 | V 天津 博奧賽斯 | |||||||||||||||
23 | AT342/21 | DNK-1425-1 | Dynamiker Biotechnology (Tianjin) Co., Ltd. | Dynamiker SARS-CoV-2 AG Rapid Test | N | 100.0% | 100.0% | 60.0% | 92.0% | Ja | 天津 丹娜 | |||||||||||||||
24 | AT755/21 | 600008 | Glallergen CO., LTD. | Novel Corona Virus (2019-nCoV) Ag Rapid Test Kit | N | 100.0% | 100.0% | 60.0% | 92.0% | |||||||||||||||||
25 | AT568/21 | AT1331/21 | 302281 | Hangzhou Biotest Biotech Co., Ltd | Sienna COVID-19 Antigen-Schnelltestkassette (Nasenabstrich) | N | 100.0% | 95.0% | 60.0% | 90.0% | Ja | |||||||||||||||
26 | AT770/21 | n.a. | Jiangxi Province JinHuan Medical Instrument Co.,LTD. | COVID-19 antigen Schnelltest (Kolloidales Gold) / Novel Coronavirus(SARS-CoV-2) Antigen Rapid Detection Kit | N | 100.0% | 95.0% | 60.0% | 90.0% | Ja | ||||||||||||||||
27 | AT425/21 | n.a. | Nantong Egens Biotechnology | SARS-CoV-2 Antigen Rapid Test | N | 100.0% | 100.0% | 50.0% | 90.0% | Ja | ||||||||||||||||
28 | AT1019/21 | 150129 | Shenzhen Kingfocus Biomedical Engineering Co., Ltd. | COVID-19 Antigen Detection Kit (Quantum Dots-Based Immunofluorescence Chromatography) | N | 100.0% | 95.0% | 60.0% | 90.0% | Ja | ||||||||||||||||
29 | AT412/21 | MU00325 | Amper,Inc. | Amper COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) | N | 100.0% | 100.0% | 40.0% | 88.0% | Ja | ||||||||||||||||
30 | AT1287/21 | NCV11 | Koch Biotechnology (Beijing) Co., Ltd. | COVID-19 Antigen Rapid Test Kit | N | 100.0% | 100.0% | 40.0% | 88.0% | Ja | ||||||||||||||||
31 | AT1100/21 | CoVSLFA-20 | Genobio Pharmaceutical Co., Ltd. | Virusee® SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) (Saliva/Swab) | N | 100.0% | 95.0% | 40.0% | 86.0% | |||||||||||||||||
32 | AT883/21 | CO-05 | Jiangsu Well Biotech Co., Ltd. | COVID-19 Schnelltestgerät | N | 100.0% | 95.0% | 40.0% | 86.0% | Ja | ||||||||||||||||
33 | AT417/20 | n.a. | Shenzhen Lvshiyuan Biotechnology Co., Ltd. | Green Spring SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | N | 100.0% | 95.7% | 40.0% | 86.0% | Ja | ||||||||||||||||
34 | AT941/21 | T3701W, T3702W, T3706W | Sichuan Xincheng Biological Co., Ltd. | SARS-CoV-2 Antigen Assay Kit by Latex Immunochromatography method | N | 100.0% | 95.0% | 40.0% | 86.0% | |||||||||||||||||
35 | AT379/20 | 2276-20 | Toda Pharma | Toda Coronadiag Ag | N | 100.0% | 95.7% | 40.0% | 86.0% | |||||||||||||||||
36 | AT981/21 (AT574/21) | ITP16010-TC25 | InTec Products, Inc. | Rapid SARS-CoV-2 Antigen Test Colloidal Gold (Nasopharyngeal/Nasal specimen) | N | 100.0% | 95.0% | 30.0% | 84.0% | Ja | ||||||||||||||||
37 | AT518/20 | A03-50-422 | Artron Laboratories Inc. | COVID-19 Antigentest | N | 100.0% | 95.0% | 20.0% | 82.0% | Ja | ||||||||||||||||
38 | AT879/21 | 209.01.25.01 | Biohit Healthcare (Hefei) Co., Ltd. | SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method) | N | 100.0% | 95.0% | 20.0% | 82.0% | Ja | ||||||||||||||||
39 | AT108/20 | AT004/22 | LFA0401-25N | Shenzhen Watmind Medical Co., Ltd. | SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) | N | 100.0% | 95.7% | 20.0% | 82.0% | Ja | |||||||||||||||
40 | AT075/21 | 012G521 | ulti med Products (Deutschland) GmbH | COVID-19 Antigen Speicheltest (Immunochromatographie) | N | 100.0% | 95.7% | 20.0% | 82.0% | Ja | ||||||||||||||||
41 | AT122/21 | TG1417 | Beijing Tigsun Diagnostics Co.;Ltd. | Tigsun COVID-19 Saliva Antigen Rapid Test | N | 100.0% | 87.0% | 30.0% | 80.0% | Ja | ||||||||||||||||
42 | AT151/20 | 71110 | LumiQuick Diagnostics, Inc. | Quick Profile Covid-19 Antigen Test Card | N | 100.0% | 91.3% | 20.0% | 80.0% | Ja | ||||||||||||||||
43 | AT246/21 | AT1279/21 | CG01Ag-25 | Xiamen AmonMed Biotechnology Co., Ltd. | COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | N | 100.0% | 87.0% | 30.0% | 80.0% | Ja | |||||||||||||||
44 | AT331/21 | AT1210/21 | COVID-19-NG08 | New Gene (Hangzhou) Bioengineering Co., Ltd. | Covid-19-Antigen-Testkit | N | 100.0% | 87.0% | 20.0% | 78.0% | Ja | |||||||||||||||
45 | AT069/20 | 34 | ScheBo Biotech AG | ScheBo SARS-CoV-2 Quick Antigen | N | 100.0% | 91.3% | 10.0% | 78.0% | Ja | ||||||||||||||||
46 | AT458/21 | HRK-6820 | Shenzhen Huaree Technology Co., Ltd. | SARS-CoV-2 Antigen Saliva Rapid Test Kit | N | 100.0% | 90.0% | 10.0% | 78.0% | |||||||||||||||||
47 | AT044/21 | C011906 | Triplex International Biosciences (China) Co., Ltd. | SARS-CoV-2 Antigen Rapid Test Kit | N | 100.0% | 87.0% | 20.0% | 78.0% | |||||||||||||||||
48 | AT818/21 | P211138 | Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | KaiBiLi COVID-19 Antigen Pro | N | 100.0% | 90.0% | 0.0% | 76.0% | Ja | ||||||||||||||||
49 | AT001/20 | AT1208/21 | GCCOV-502a-H5 | Healgen Scientific Limited Liability Company (Siemens Healthineers) | CLINITEST® Rapid COVID-19 Antigen Test | N | 100.0% | 87.0% | 0.0% | 76.0% | Ja | |||||||||||||||
50 | AT527/20 | COV-AG-20 / G10313 | JOYSBIO (Tianjin) Biotechnology Co., Ltd. | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) SPUCKTEST | N | 100.0% | 90.0% | 0.0% | 76.0% | Ja | ||||||||||||||||
51 | AT420/21 | K602-20 | Shenzhen Kisshealth Biotechnology Co., Ltd. | KISSH SARS-CoV-2 Antigen Test Kit (GICA) | N | 100.0% | 85.0% | 10.0% | 76.0% | |||||||||||||||||
52 | AT071/20 | MF-63 | Shenzhen Microprofit Biotech Co., Ltd. | SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay) | S | 100.0% | 85.0% | 10.0% | 76.0% | |||||||||||||||||
53 | AT516/21 | n.a. | Zhejiang Gene Science Co., Ltd. | Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography) | N | 100.0% | 70.0% | 40.0% | 76.0% | |||||||||||||||||
54 | AT108/22 | GCCOV-502a | Zhejiang Orient Gene Biotech Co.,Ltd | Coronavirus Ag Rapid Test Cassette (Swab) | N | 100.0% | 87.0% | 0.0% | 76.0% | Ja | ||||||||||||||||
55 | AT025/20 | SW4000605 | BIOSYNEX SWISS SA | BIOSYNEX COVID-19 Ag BSS | N | 100.0% | 78.3% | 11.1% | 74.0% | Ja | ||||||||||||||||
56 | AT231/20 | n.a. | Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd | Konsung COVID-19 Antigen Rapid Test Kit | N | 100.0% | 70.0% | 30.0% | 74.0% | Ja | ||||||||||||||||
57 | AT500/21 | AT1280/21 | 3011035 | Mexacare COVID-19 Antigen Schnelltest | Mexacare GmbH | N | 100.0% | 80.0% | 10.0% | 74.0% | Ja | |||||||||||||||
58 | AT748/21 | n.a. | Shanghai Liangrun Biomedicine Technology Co., Ltd. | LionRun™ SARS-CoV-2 Antigen Rapid Test Kit (Lateral Flow Immunoassay) | N | 100.0% | 85.0% | 0.0% | 74.0% | Ja | ||||||||||||||||
59 | AT820/21 | 00013C | Beijing O&D Biotech Co., Ltd. | Covid-19 Antigen Rapid Test (Colloidal Gold) | N | 100.0% | 75.0% | 10.0% | 72.0% | Ja | ||||||||||||||||
60 | AT022/21 | WJ-2850 | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | Wantai SARS-CoV-2 Ag Rapid Test (FIA) | N | 100.0% | 78.3% | 0.0% | 72.0% | 無 | V 北京 萬泰 | |||||||||||||||
61 | AT166/20 | AT1257/21 | CG2061 | Getein Biotech, Inc. | One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) | N | 100.0% | 82.6% | 0.0% | 72.0% | ||||||||||||||||
62 | AT214/20 | CP01810011 | Merlin Biomedical (Xiamen) Co., Ltd. | SARS-CoV-2 Antigen Rapid Test Cassette | N | 100.0% | 82.6% | 0.0% | 72.0% | Ja | ||||||||||||||||
63 | AT722/21 | SVRAG | Neo-nostics (Suzhou) Bioengeneering Co., Ltd. | COVID 19 Antigen Test Kit (Colloidal Gold Method) | N | 100.0% | 75.0% | 10.0% | 72.0% | Ja | ||||||||||||||||
64 | AT848/21 | 04A024 | TBG Biotechnology Xiamen Inc. | TBG SARS-CoV-2 Antigen Rapid Test | N | 95.0% | 80.0% | 10.0% | 72.0% | |||||||||||||||||
65 | AT542/21 | AT1290/21 | n.a. | Zhuhai Lituo Biotechnology Co., Ltd. | COVID-19 Antigen Detection Kit (Colloidal Gold) | N | 100.0% | 80.0% | 0.0% | 72.0% | ||||||||||||||||
66 | AT084/21 | ABT-IDTB367 | AccuBioTech Co.,Ltd. | Accu-Tell Rapid In-vitro Diagnostiktest | N | 100.0% | 75.0% | 0.0% | 70.0% | Ja | ||||||||||||||||
67 | AT033/20 | RT2952 | Ameda Labordiagnostik GmbH | AMP Rapid Test SARS-CoV-2 Ag | N | 100.0% | 78.3% | 0.0% | 70.0% | |||||||||||||||||
68 | AT219/20 | COV-201 | BioRepair GmbH | Covid 19 Antigen Schnelltest | N | 100.0% | 78.3% | 0.0% | 70.0% | |||||||||||||||||
69 | AT415/21 | n.a. | Hangzhou Funworld Biotech. Co., Ltd | SARS-CoV-2-Antigen-Schnelltestgerät | N | 100.0% | 75.0% | 0.0% | 70.0% | Ja | ||||||||||||||||
70 | AT060/20 | COV-201 | Hangzhou Lysun Biotechnology Co., Ltd. | Lysun COVID-19 Antigen Rapid Test Device (Colloidal Gold) | N | 100.0% | 78.3% | 0.0% | 70.0% | Ja | ||||||||||||||||
71 | AT849/21 | n.a. | Jiangsu Bioperfectus Technologies Co., Ltd. | Novel Coronavirus (SARS-CoV-2) Ag Rapid Test Kit | N | 100.0% | 75.0% | 0.0% | 70.0% | Ja | ||||||||||||||||
72 | AT593/21 | 500200 | Nanjing Liming Bio-Products Co., Ltd. | StrongStep® SARS-COV2 Antigen Rapid Test | N | 95.0% | 80.0% | 0.0% | 70.0% | Ja | ||||||||||||||||
73 | AT839/21 | n.a. | Zhongxiu Science and Technology Co., Ltd | Neuartiges Coronavirus (2019-nCoV) Antigendetektions-reagenz (immunochromatographischer Assay) | N | 100.0% | 70.0% | 10.0% | 70.0% | Ja | ||||||||||||||||
74 | AT418/20 | n.a. | Jiangsu Diagnostics Biotechnology Co., Ltd | COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) | N | 100.0% | 78.3% | 0.0% | 68.0% | Ja | ||||||||||||||||
75 | AT837/21 | SP-SW 106 | Spring Healthcare Services Sp zoo | SARS-CoV-2 Antigen Schnelltestkassette (Abstrich) | N | 100.0% | 70.0% | 0.0% | 68.0% | Ja | ||||||||||||||||
76 | AT010/20 | CAGT025E0 | Sugentech, Inc. | SGTi-flex COVID-19 Ag | N | 100.0% | 73.9% | 0.0% | 68.0% | Ja | ||||||||||||||||
77 | AT430/20 | AT1289/21 | W-Ag03-20 | Wuhan EasyDiagnosis Biomedicine Co., Ltd. | COVID-19 (SARS-CoV-2) Antigen Test Kit | N | 100.0% | 73.9% | 0.0% | 68.0% | Ja | |||||||||||||||
78 | AT431/20 | AM3474-K | ASAN PHARM.CO.,LTD. | Asan Easy Test COVID-19 Ag | N | 100.0% | 69.6% | 0.0% | 66.0% | Ja | ||||||||||||||||
79 | AT014/20 | RG1901DG | BIONOTE | NowCheck® COVID-19 Ag Test | N | 100.0% | 65.2% | 0.0% | 66.0% | Ja | ||||||||||||||||
80 | AT1076/21 | n.a. | Hubei Jinjian Biology Co.,Ltd. | SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) | N | 100.0% | 65.0% | 0.0% | 66.0% | Ja | ||||||||||||||||
81 | AT1082/21 | R220T001B0C0 | Jiangsu Mole Bioscience Co., Ltd | SARS-CoV-2 Antigen Test Cassette | N | 100.0% | 65.0% | 0.0% | 66.0% | Ja | ||||||||||||||||
82 | AT022/20 | F-NCOV-01G | SD Biosensor, Inc. | STANDARD F COVID-19 Ag FIA | N | 100.0% | 65.2% | 0.0% | 66.0% | Ja | ||||||||||||||||
83 | AT005/20 | 41FK10 | Abbott Rapid Diagnostics Jena GmbH | Panbio™ COVID-19 Ag Rapid Test Device (NASOPHARYNGEAL) | N | 100.0% | 60.9% | 0.0% | 64.0% | Ja | 美國 亞培 (韓國代工) | |||||||||||||||
84 | AT172/21 | 1-367-K020 | BioMaxima S.A. | SARS-CoV-2 Ag Rapid Test | N | 100.0% | 60.0% | 0.0% | 64.0% | Ja | ||||||||||||||||
85 | AT582/21 | n.a. | Guangzhou Tebsun Bio-Tech Development Co., Ltd. | Tebsun 2019-nCoV Antigen Test Kit | N | 95.0% | 65.0% | 0.0% | 64.0% | |||||||||||||||||
86 | AT236/20 | AT1276/21 | n.a. | Joinstar Biomedical Technology Co., Ltd (CIV care impuls Vertrieb) | COVID-19 Antigen Schnelltest (Colloidal Gold) | N | 100.0% | 60.9% | 0.0% | 64.0% | Ja | |||||||||||||||
87 | AT455/20 | PR210101 | Lumigenex (Suzhou) Co., Ltd. | PocRoc SARS-CoV-2, Antigen Schnelltest Set (Kolloidales Gold) | N | 100.0% | 65.2% | 0.0% | 64.0% | Ja | ||||||||||||||||
88 | AT078/20 | PR-FC13 | Precision Biosensor Inc. (Axon Lab AG) | Exdia COVID-19-Ag-Test | N | 100.0% | 60.9% | 0.0% | 64.0% | Ja | ||||||||||||||||
89 | AT376/20 | V1330 | ProGnosis Biotech | Rapid Test Ag 2019-nCoV | N | 94.1% | 65.2% | 10.0% | 64.0% | Ja | ||||||||||||||||
90 | AT472/21 | 203-020 | Shenzhen Huian Biosci Technology Co., Ltd. | SARS-CoV-2Antigen Test Kit (Colloidal Gold) | N | 100.0% | 60.0% | 0.0% | 64.0% | Ja | ||||||||||||||||
91 | AT847/21 | COV-S31 | Wuxi Biohermes Bio & Medical Technology Co., Ltd. | SARS-CoV-2 Antigen Test Kit (Lateral Flow Assay) | N | 100.0% | 60.0% | 0.0% | 64.0% | Ja | ||||||||||||||||
92 | AT785/21 | FCB-103 | Anhui Formaster Biosci Co., Ltd | New Coronavirus (COVID-19) Antigen Rapid Test | N | 100.0% | 50.0% | 10.0% | 62.0% | Ja | ||||||||||||||||
93 | AT132/20 | nCOV-500 | Atlas Link Technology Co.,Ltd. | Nova Test SARS-CoV-2 Antigen Rapid Test Kit | N | 100.0% | 60.9% | 0.0% | 62.0% | |||||||||||||||||
94 | AT337/20 | CCOV-201 | Chil Tibbi Mal. San. Tic. Ltd. Şti | COVID-19 Antigen Schnell Test (Nasopharyngeal / Oropharyngeal Tupfer Kassette) | N | 100.0% | 60.9% | 0.0% | 62.0% | Ja | ||||||||||||||||
95 | AT086/20 | AT1158/21 | BE0040 | Guangdong Wesail Biotech Co., Ltd. | COVID-19 Ag Test Kit | N | 100.0% | 52.2% | 11.1% | 62.0% | Ja | |||||||||||||||
96 | AT276/21 | AT1117/21 | ICOV-802 | Hangzhou AllTest Biotech Co., Ltd. | Covid-19 Antigen Rapid Test (Oral fluid) | N | 100.0% | 55.0% | 0.0% | 62.0% | Ja | |||||||||||||||
97 | AT821/21 | IFC-SCoV2-AG | Hangzhou Zheda Dixun Biological Gene Engineering Co., Ltd. | SARS-Cov-2 Nucleocapsid(N) Antigen Rapid Test Cassette | N | 100.0% | 55.0% | 0.0% | 62.0% | |||||||||||||||||
98 | AT790/21 | CP02150011 | Merlin Biomedical (Xiamen) Co., Ltd. | SARS-CoV-2 Antigen Rapid Test Cassette | N | 100.0% | 55.0% | 0.0% | 62.0% | |||||||||||||||||
99 | AT199/20 | COV Ag-6012 | Safecare Biotech Hangzhou Co., Ltd. | Safecare COVID-19 Ag Rapid Test Kit (Swab) | N | 100.0% | 60.9% | 0.0% | 62.0% | Ja | ||||||||||||||||
100 | AT385/20 | LFB0401-25N | Shenzhen Watmind Medical Co., Ltd. | SARS-CoV-2 Ag Diagnostic Test Kit (Immunofluorescence) | N | 100.0% | 60.9% | 0.0% | 62.0% | Ja |