Skip to main content
Live, work, travel in the EU
COVID-19 In Vitro Diagnostic Devices and Test Methods Database
Home
Update form for ImmunoAssay device
Update form for ImmunoAssay device
Name
Email
Device ID
Commercial name
Manufacturer
Manufacturer country
- None -
Afghanistan
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bonaire, Sint Eustatius and Saba
Bosnia and Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
British Virgin Islands
Brunei
Bulgaria
Burkina Faso
Burundi
Cabo Verde
Cambodia
Cameroon
Canada
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos [Keeling] Islands
Colombia
Comoros
Congo
Cook Islands
Costa Rica
Croatia
Cuba
Curaçao
Cyprus
Czechia
Democratic Republic of the Congo
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Eswatini
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Polynesia
French Southern and Antarctic Lands
Gabon
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and McDonald Islands
Honduras
Hong Kong S.A.R
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Isle of Man
Israel
Italy
Ivory Coast
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
Kosovo
Kuwait
Kyrgyzstan
Laos
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macao S.A.R
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Mauritania
Mauritius
Metropolitan France
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar/Burma
Namibia
Nauru
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
North Korea
North Macedonia
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestine
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn Islands
Poland
Portugal
Puerto Rico
Qatar
Romania
Russia
Rwanda
Saint Barthélemy
Saint Helena, Ascension and Tristan da Cunha
Saint Kitts and Nevis
Saint Lucia
Saint Pierre and Miquelon
Saint Vincent and the Grenadines
Samoa
San Marino
São Tomé and PrÃncipe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Sint Maarten
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and the South Sandwich Islands
South Korea
South Sudan
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen
Sweden
Switzerland
Syria
Taiwan ROC
Tajikistan
Tanzania
Thailand
The Gambia
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
U.S. Minor Outlying Islands
U.S. Virgin Islands
Uganda
Ukraine
United Arab Emirates
United Kingdom
United States
Uruguay
Uzbekistan
Vanuatu
Vatican City State
Venezuela
Vietnam
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Manufacturer website
CE Marking
- None -
Yes
No
Commercial status
- None -
Commercialized
In development
Other
URL for additional information
Detection principle
- None -
ImmunoAssay-Antigen
ImmunoAssay-Antibody
N.A.
Other
Physical support
Biochip
Card
Cartridge
Cassette
Chip
Dipstick
Dotblot
Fingertip
Lateral flow
Latex
Microblot
Microplate
Microtiter plate
Strip
Format
Manual
Near POC / POC
Semi-automated
Automated
Fully automated (robot)
Lab-based
Target
Antibody
IgG
IgM
IgA
Antigen
Antibody type
- None -
Monoclonal
Polyclonal
Specimen
ACD plasma
Anal swab
Anterior nasal swab
Bronchoalveolar lavage fluid
Deep (cough) sputum
Mid-turbinates swab
Nasal aspirate
Nasal aspiration
Nasal swab
Nasopharyngeal swab
Oropharyngeal swab
Other biological fluids
Peripheral blood
Plasma
Saliva
Serum
Sputum
Stool
Throat secretion
Throat swab
Tissue homogenates
Urine
Venous whole blood
Wash aspirate
Whole blood
Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
Adenovirus
Adenovirus 3
Adenovirus 7
Adenovirus Subtype B
Adenovirus Subtype C
Anti-Nuclear Antibody
Bordetella Pertussis
Chlamydia Pneumoniae
Coronaviruses (HCoV)
Alpha Coronavirus 229E (HCoV-229E)
Alpha Coronavirus Nl63 (HCoV-Nl63)
Beta Coronavirus HKU1 (HCoV-HKU1)
Beta Coronavirus OC43 (HCoV-OC43)
MERS-CoV
SARS-CoV
Cytomegalovirus (CMV)
Enterovirus A71 (EV-A71)
Epstein-Barr Virus (EBV)
Hemophilus Influenzae
Hepatitis A Virus (HAV)
Hepatitis B Virus (HBV)
Hepatitis C Virus (HCV)
Herpes Simplex (HSV)
Human Immunodeficiency Virus (HIV)
Human Metapneumovirus (HMPV)
Influenza A
Influenza A H1N1
Influenza A H3N2
Influenza A H5N1
Influenza B
Influenza B Victoria
Influenza B Yamagata
Mumps Virus (MuV)
Mycobacterium Tuberculosis
Mycoplasma Pneumoniae
Parainfluenza Virus Type
Parainfluenza Virus Type 1
Parainfluenza Virus Type 2
Parainfluenza Virus Type 3
Parainfluenza Virus Type 4
Respiratory Syncytial V (RSV)
Respiratory Syncytial V (RSV) Type A
Respiratory Syncytial V (RSV) Type B
Rhinovirus
Rhinovirus A
Rhinovirus B
Varicella Zoster Virus (VZV)
No other pathogens tested
Pathogens detected
Adenovirus
Adenovirus 3
Adenovirus 7
Adenovirus Subtype B
Adenovirus Subtype C
Anti-Nuclear Antibody
Bordetella Pertussis
Chlamydia Pneumoniae
Coronaviruses (HCoV)
Alpha Coronavirus 229E (HCoV-229E)
Alpha Coronavirus Nl63 (HCoV-Nl63)
Beta Coronavirus HKU1 (HCoV-HKU1)
Beta Coronavirus OC43 (HCoV-OC43)
MERS-CoV
SARS-CoV
Cytomegalovirus (CMV)
Enterovirus A71 (EV-A71)
Epstein-Barr Virus (EBV)
Hemophilus Influenzae
Hepatitis A Virus (HAV)
Hepatitis B Virus (HBV)
Hepatitis C Virus (HCV)
Herpes Simplex (HSV)
Human Immunodeficiency Virus (HIV)
Human Metapneumovirus (HMPV)
Influenza A
Influenza A H1N1
Influenza A H3N2
Influenza A H5N1
Influenza B
Influenza B Victoria
Influenza B Yamagata
Mumps Virus (MuV)
Mycobacterium Tuberculosis
Mycoplasma Pneumoniae
Parainfluenza Virus Type
Parainfluenza Virus Type 1
Parainfluenza Virus Type 2
Parainfluenza Virus Type 3
Parainfluenza Virus Type 4
Respiratory Syncytial V (RSV)
Respiratory Syncytial V (RSV) Type A
Respiratory Syncytial V (RSV) Type B
Rhinovirus
Rhinovirus A
Rhinovirus B
Varicella Zoster Virus (VZV)
No other pathogens tested
Variants detected
B.1.1.7 (Alpha)
B.1.351 (Beta)
P.1 (Gamma)
B.1.525 (Eta)
B.1.427 (Epsilon)
B.1.429 (Epsilon)
P.3 (Theta)
B.1.616
B.1.617.1 (Kappa)
B.1.617.2 (Delta)
B.1.617.3
B.1.621 (Mu)
A.23.1
C.37 (Lambda)
C.36
AT.1
B.1.526 (Iota)
B.1.526.1
B.1.526.2
B.1.1.529 (Omicron)
P.2 (Zeta)
No other variants tested
Targets
ORF1ab polyprotein
ORF1a polyprotein
ORF1b polyprotein
non-structural protein NSP1
non-structural protein NSP2
non-structural protein NSP3
non-structural protein NSP4
non-structural protein NSP5
non-structural protein NSP6
non-structural protein NSP7
non-structural protein NSP8
non-structural protein NSP9
non-structural protein NSP10
non-structural protein NSP12
non-structural protein NSP13
non-structural protein NSP14
non-structural protein NSP15
non-structural protein NSP16
spike protein
non-structural protein NS3a
non-structural protein NS3b
envelope protein
membrane protein
non-structural protein NS6
non-structural protein NS7a
Nonstructural protein NS7b
nucleocapsid protein
non-structural protein NS9a
non-structural protein Ns9b
non-structural protein NS10
Other
Unknown
angiotensin-converting enzyme 2
Rapid diagnostic
- None -
Yes
No
N.A.
Self test
- None -
Yes
No
N.A.
Method
- None -
RT-PCR
Digital-PCR
LAMP
NEAR
CRISPR
ELISA
CLIA
Immunochromatography
Nephelometry
Chromatography
Immunoassay
N.A.
Other
Subclass
- None -
Capture
Enzyme-linked
Microarray
Neutralization Antibody (NAb)
Sandwich
Sandwich, Double
Membrane-based
Microfluidic
Microtiter
N.A.
Other
Subcategory
- None -
Sample preparation
Purification test
Sample collection device
Extraction kit
Validity test kit
Transport kit
Visualisation system
Calibrant / control sample
N.A.
Other
Reader required
- None -
Yes
No
N.A.
Measurement
- None -
Qualitative
Semiquantitative
Quantitative
N.A.
Other
Time (minutes)
False positives
False negatives
Limit of detection (LOD)
(as number - units)
Analysis of cross reactivity
- None -
Evaluated
Not evaluated
Robustness
- None -
Evaluated
Not evaluated
Precision
- None -
Evaluated
Not evaluated
Calibration
- None -
Evaluated
Not evaluated
Sensitivity percent
Specificity percent
Accuracy percent
Reproducibility
- None -
Evaluated
Not evaluated
Type of Antigen (in case of Antigen-based)
- None -
ORF1a protein
ORF1b protein
Spike protein
Nonstructural protein NS3
Envelop protein
Membrane protein
Nonstructural protein NS6
Nonstructural protein NS7a
Nonstructural protein NS7b
Nonstructural protein NS8
Nucleocapsid protein
Nonstructural protein NS9a
Nonstructural protein NS9b
Nonstructural protein 10
Other
Information on antigen epitope targeted by the antibodies used in the design of the device
Lineages performances
Additional information
Accept the
privacy statement
(required)
Submit
