Saliva test

Overview of SARS-CoV-2 rapid antigen tests that were evaluated by the Paul Ehrlich Institute and rated as "corresponding to the current state of the art":

Test name  -        Manufacturer (Sales) 

Panbio™COVID-19 Ag Rapid Test Device (NASOPHARYNGEAL) - Abbott Rapid Diagnostics Jena GmbH
RIDA®QUICK SARS-CoV-2 Antigen - R-Biopharm AG
SARS-CoV-2 Rapid Antigen Test - SD BIOSENSOR (Roche Diagnostics GmbH)
NADAL® COVID-19 Ag Schnelltest - nal von minden gmbh
STANDARD™ F COVID-19 Ag FIA - SD BIOSENSOR
STANDARD™ Q COVID-19 Ag Test - SD BIOSENSOR
BIOSYNEX COVID-19 Ag BSS - BIOSYNEX SWISS SA
MEDsan® SARS-CoV-2 Antigen Rapid Test - MEDsan GmbH
TestNOW® - COVID-19 Antigen - Affimedix
NowCheck® COVID-19 Ag Test - BIONOTE
Coronavirus Ag Rapid Test Cassette (Swab) -  Zhejiang Orient Gene Biotech Co.,Ltd
Sofia SARS Antigen FIA - Quidel Corporation
COVID-19 Ag Test Kit - Guangdong Wesail Biotech Co., Ltd.
CLINITEST® Rapid COVID-19 Antigen Test - Siemens Healthineers
ESPLINE® SARS-CoV-2 - Fujirebio Inc. (Mast Diagnostica GmbH)
BD Veritor™ System for Rapid Detection of SARS-CoV-2 - Becton Dickinson
GenBody COVID-19 Ag - IVC Pragen Healthcare
LumiraDx SARS-CoV-2 Ag Test - LumiraDX
Exdia COVID-19-Ag-Test - Precision Biosensor Inc. (Axon Lab AG)
SARS-CoV-2 Ag Rapid Test (FIA) - Wantai (Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.)
SARS-CoV-2 Antigen Schnelltest - Xiamen Boson Biotech Co., Ltd
COVID-19 Antigen Schnelltest (Colloidal Gold) - Joinstar Biomedical Technology Co., Ltd (CIV care impuls Vertrieb)
mö-screen Corona Antigen Test - Mölab GmbH
Rapid SARS-CoV-2 Antigen Test Card - MP Biomedicals Germany GmbH
Lyher Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) - Hangzhou Laihe Biotech Co., Ltd. (Lissner Qi GmbH)
AMP Rapid Test SARS-CoV-2 Ag - Ameda Labordiagnostik GmbH
Clungene COVID-19 Antigen Rapid Test - Hangzhou Clongene Biotech Co., Ltd.
DIA-COVID® COVID-19 Ag Rapid Test Kit - GenSure Biotech Inc.
SARS-CoV-2 Antigen Rapid Test Kit - Beijing Lepu Medical Technology Co., Ltd
Hightop SARS-CoV-2 (Covid-19) Antigen Rapid Test - Qingdao Hightop Biotech Co., Ltd.
Rapid Covid-19 Antigen Test (Colloidal Gold ) - Anbio (Xiamen) Biotechnology Co., Ltd
Safecare COVID-19 Ag Rapid Test Kit (Swab) - Safecare Biotech Hangzhou Co., Ltd.
QuickProfile Covid-19 Antigen Test Card - LumiQuick Diagnostics, Inc.
Covid 19 Antigen Schnelltest - BioRepair GmbH
Green Spring SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) - Shenzhen Lvshiyuan Biotechnology Co., Ltd.
CAT Antigen Covid Rapid Test - Oncosem Onkolojik Sistemler San. Ve Tic. A.S.
ScheBo SARS-CoV-2 Quick Antigen - ScheBo Biotech AG
Nova Test SARS-CoV-2 Antigen Rapid Test Kit  Atlas Link Technology Co.,Ltd.
Toda Coronadiag Ag - Toda Pharma
Humasis COVID-19 Ag Test - Humasis Co., Ltd.
Novel Coronavirus 2019-nCoV Antigen Test (Colloidal gold) - Beijing Hotgen Biotech Co., Ltd.
COVID-19 Antigen Rapid Test Kit (Colloidal Gold) - AmonMed (Xiamen) Biotechnology Co., Ltd.
Canea COVID-19 Antigen Schnelltest  - Core Technology Co., Ltd.
fluorecare COVID-19 SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay) - Shenzhen Microprofit Biotech Co., Ltd
Testsealabs® Rapid Test Kit COVID-19 Antigen Test Cassette - Hangzhou Testsea Biotechnology Co., Ltd
Lysun COVID-19 Antigen Rapid Test Device (Colloidal Gold) - Hangzhou Lysun Biotechnology Co., Ltd.
Wizbiotech SARS-CoV-2 Antigen Rapid Test - Xiamen WIZ Biotech Co., Ltd.
SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay) - PerGrande BioTech Development Co., Ltd.
salocor SARS-CoV-2 Antigen Rapid Test Cassette (Nasopharyngeal swab) - Salofa OY Genrui
SARS-CoV-2 Antigen Test Kit (Colloidal Gold) - Genrui Biotech Inc.
Wondfo SARS-CoV-2 Antigen Test (Lateral Flow Method) - Guangzhou Wondfo Biotech Co. Ltd
Aesku Rapid SARS-CoV-2 Rapid Test - Aesku Diagnostics GmbH
Rapid Response COVID-19 Rapid Test Device - BTNX, Inc. (Biotrend Chemikalien GmbH)
Dia Sure Covid-19 Antigen Rapid Test Device (Nasopharyngeal/Oropharyngeal Swab) - Azure Biotech Inc.
Labnovation SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) - Labnovation Technologies, Inc.
V-Chek SARS-CoV-2 Rapid Ag Test Kit (Colloidal Gold) - SGA Mühendislik DAN. EG. Icve DIS.Ltd.STI
SGTi-flex COVID-19 Ag - Sugentech, Inc.
softec SARS COV-2 (Covid-19) Antigen Test Kit - Zet Medikal Tekstil Dis Ticaret Ltd. STI.
Genedia W Covid-19 Ag - Green Cross Medical Science Corp. (Weko Pharma GmbH)
COVID-19 (SARS CoV-2) Antigen Test Kit (Colloidal Gold) - Anhui Deepblue Medical Technology Co. , Ltd.
FRENDTM COVID-19 Ag - NanoEntek Inc
RapidFor SARS-CoV-2 Rapid Antigen Test Colloidal Gold  - Vitrosens Biyoteknoloji Ltd. Sti
COVID-19 (SARS-CoV-2) Antigen Test Kit  - Wuhan EasyDiagnosis Biomedicine Co., Ltd
PCL COVID19 Ag Gold Saliva - PCL, Inc.
reOpenTest COVID-19 Antigen Rapid Test (Colloidal Gold) - Zhejiang Anji Saianfu Biotech Co.,Ltd.
IMMUNOBIO SARS-CoV-2 Antigen-Schnelltest (COVID-19 Ag) - Hangzhou Immuno Biotech Co.,Ltd.
Zhenrui COVID-19 (SARS-COV-2) Antigen Test Kits - Shenzhen Zhenrui Biotech co.Ltd.
SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) - Shenzhen Watmind Medical Co.,Ltd.
2019-nCoV Antigen Test Kit(colloidal gold method) - Guangdong Hecin Scientific,Inc.
Asan Easy Test COVID-19 Ag - ASAN PHARM.CO.,LTD.
COVID-19 Antigen Saliva Test Kit (Colloidal Gold) - Nantong Diagnos Biotechnology Co., Ltd.
Axiom Diagnostics COVID-19 Ag Schnelltest - AXIOM Gesellschaft für Diagnostica und Biochemica mbH
Tigsun COVID-19 Saliva Antigen Rapid Test - Beijing Tigsun Diagnostics Co.;Ltd.
PocRoc SARS-CoV-2, Antigen Schnelltest Set (Kolloidales Gold) - Lumigenex (Suzhou) Co., Ltd.
Flowflex SARS-CoV-2-Antigenschnelltest (Nasopharynxtupfer) - ACON Biotech (Hangzhou) Co., Ltd
SARS-CoV-2 Ag Diagnostic Test Kit (Immunofluorescence) - Shenzhen Watmind Medical Co.,Ltd.
Covid-19-Antigen-Testkit - New Gene (Hangzhou) Bioengineering Co., Ltd.
CoroVisio Covid-19 Ag Versieglungsröhrchen Teststreifen (Kolloidales Gold) - Amazing Biotech (Shanghai) Co., Ltd
COVID-19 Antigen Schnell Test (Nasopharyngeal / Oropharyngeal Tupfer Kassette) - Chil Tibbi Mal. San. Tic. Ltd. Şti
SARS-CoV-2-Antigen-Testkit (LFIA) - Jiangsu Medomics Medical Technology Co., Ltd
SARS-CoV-2 Antigen Assay Kit (Immunochromatography) - Wuhan Life Origin Biotech Joint Stock Co., Ltd.
COVID-19-Antigen-Schnelltest (Nasopharyngeal-Abstrich) - BIOMERICA Inc.
Covid-19 Antigen Schnelltest - Beijing Beier Bioengineering Co., Ltd.
Ksmart® SARS-COV2 Antigen Rapid Test - Avalun
Rapid Test Ag 2019-nCoV - ProGnosis Biotech
SARS-CoV-2 Antigen Rapid Test Kit - Wuhan UNscience Biotechnology Co., Ltd.
One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) - Getein Biotech, Inc.
SARS-CoV-2 Antigen Rapid Test Kit - Triplex International Biosciences (China) Co., Ltd.
Novel Coronavirus (2019-nCOV) Antigen Testing Kit (Colloidal Gold) - Nanjing Norman Biological Technology Co.,Ltd
SARS-CoV-2 Antigen Rapid Test Cassette - Merlin Biomedical (Xiamen) Co., Ltd.
Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Testing Kit - Edinburgh Genetics Limited
Covid-19 Antigen Detection Kit - DNA Diagnostic A/S.
COVID-19 Antigen Speicheltest (Immunochromatographie) - ulti med Products (Deutschland) GmbH
EBS SARS-CoV-2 Ag Rapid Test - Eurobio Scientific
COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) - Jiangsu Diagnostics Biotechnology Co., Ltd
novacheck®-Ag SARS-CoV-2 Covid-19 Antigen Rapid Test - Novatech Tibbi Cihaz Ürünleri San. Ve Tic.A.S.

(Quelle: https://www.pei.de/DE/newsroom/dossier/coronavirus/coronavirus-inhalt.html)


List BfArM
(Source: https://antigentest.bfarm.de/ords/f?p=101:100:14123116050246:::::&tz=2:00)
date 23.4.2021:

Please pay particular attention to the yes-evaluation by the Paul Ehrlich Instute (PEI) in the list: Bitte achten Sie hier insbesondere auf die Ja-Evaluierung durch das Paul Ehrlich Institut (PEI) in der Liste

Das BfArM bietet eine Liste von Antigen-Tests zum direkten Erregernachweis des Coronavirus SARS-CoV-2 an. In dieser Liste befinden sich diejenigen Tests, die sich laut Herstellerangaben gemäß den Vorgaben des Medizinproduktegesetzes (MPG) rechtmäßig in Europa bzw. Deutschland in Verkehr befinden und alle vom Paul-Ehrlich-Institut in Abstimmung mit dem Robert Koch-Institut (RKI) festgelegten Mindestkriterien für Antigen-Tests erfüllen. The BfArm offers a list of antigen tests for direct detection of the pathogen of the SARS-CoV-2 coronavirus. This list contains those test wich, according to the manufactuerer, are legally on the market in Europe or Germany in accordance with the specifications of the Medical Devices Act (MPG) and all the minimum criteria specified by the Paul Ehrlich Institute in coordination with the Robert Koch Institute (RKI) for antigen testing.

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