COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2161

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual, Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Saliva

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

HOW ARE EON BIOTECHNOLOGY’S PRODUCTS BETTER? Eon Biotechnology controls biotechnology assets which include clones for SARS-CoV2 antigens & antibodies, vaccine platforms, ScFv libraries for SARS-CoV-2 antibodies and the derived immunodiagnostic & therapeutic products with a specific purpose of translation & commercialization across the world. This platform technology is leveraged for COVID-19 currently and eventually to other emerging infectious diseases and lifestyle disease conditions. Eon operates a compliant biotherapeutic infrastructure with governing structure for ‘Genetic Engineering Approval Committee’, Animal Ethics Committee, and Institutional Ethics committee and product approvals from an R&D perspective. CE certificate in Europe, EN ISO 13485, ISO 9001, WHO – GMP and other requisite infrastructure compliances form the quality support system behind products of Eon Biotechnology. Eon Biotechnology’s offerings are backed by: 1. Technology refined by experience in deep research. 2. Physical infrastructure - associated hospitals that attend to COVID-19 positive subjects every day & therefore a constant real time opportunity to monitor & test improved versions of the test. 3. Physical manufacturing infrastructure capable of producing large volumes of tests. 4. EONbtTM COVID-19 Rapid Antigen test is a quality driven product backed by comprehensive real time know-how and infrastructure. Background of SARS-COV-2: SARS-CoV-2 is a novel, zoonotic coronavirus that emerged in late 2019 in patients with pneumonia of unknown cause. The virus was named SARS-CoV-2 because of its similarity to the coronavirus responsible for severe acute respiratory syndrome (SARS-CoV, a lineage B betacoronavirus). SARS-CoV-2 is an enveloped, positive sense, single stranded RNA virus sharing more than 70% of its sequence with SARS-CoV, and ~50% with the coronavirus responsible for Middle Eastern respiratory syndrome (MERS-CoV).The SARS-CoV-2 spike glycoprotein (S), which is a main target for neutralizing antibody, binds to its receptor human angiotensin converting enzyme 2 (hACE2) to initiate infection.SARS-CoV-2 is the cause of COVID-19, an infectious disease with respiratory and systemic manifestations. Disease symptoms vary, with many persons presenting with asymptomatic or mild disease and some progressing to severe respiratory tract disease including pneumonia and acute respiratory distress syndrome (ARDS), leading to multi organ failure and death. Corona virus can be extracted through respiratory secretions or transmitted through oral fluid, sneezing, physical contact, and other air droplets. There are 2 main proteins involved and necessary for the infection of humans by coronavirus. These are: 1. Spike protein (which is a trimeric protein containing 3 different sub-units, among three subunits subunit S2 is highly conserved and subunit S1 is essential to make an entry into the host cell). 2. Nucleocapsid protein which is essential for viral assembly. 3. These 2 proteins play an important role in the infection and viral life cycle in human beings. They are the potential target molecules in the development of rapid tests for detection of coronavirus infection in humans. EXECUTIVE SUMMARY: EONbtTM COVID-19 ANTIGEN-SALIVA is marketed by EON BIOTECHNOLOGY LTD., U.K and manufactured by Angstrom Biotech Private Limited is intended for Point of Care (POC) diagnosis of coronavirus infection. The product is CE approved in Europe. COVID-19 ANTIGEN-SALIVA is a lateral flow immunoassay intended for in vitro qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in saliva specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of symptom onset. This test is designed for Point of Care use, as an aid to early diagnosis of SARS-CoV-2 infection in patients with clinical symptoms with SARS-CoV-2 infection. It provides only an initial screening test result. The administration of the test and the interpretation of the results should be done by a trained health professional. The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required. EONbtTM COVID-19 ANTIGEN-SALIVA is an antigen-capture immunochromatographic assay, detecting presence of COVID-19 viral nucleoprotein antigen in saliva samples. The detection kit uses the principle of immunochromatography: separation of components in a mixture through a medium using capillary force and the specific and rapid binding of an antibody to its antigen. Why Saliva? Infrastructure Benefits: Nasopharyngeal and oropharyngeal swabs are inconvenient to collect and pose a transmission risk to healthcare workers due to coughing induced during the collection process. The Saliva sampling method will allow for broader population screening than the current method of nose and throat swabs. It allows people of any ability to be tested for SARS-COV-2. The impact of using Saliva samples is significant. It means health care professionals are not at risk of contracting the COVID-19 infection by administering Saliva tests when compared with performing nasopharyngeal or oropharyngeal collections. The saliva sample method preserves precious personal protective equipment (PPE) for use in vital patient care in hospitals instead of testing. The number of people tested every day can be significantly increased as sampling of saliva is quicker and more scalable than swab collections. All of this combined will have an immediate impact on testing capability across the United States.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Reader Required

No

Method

Immunochromatography

Measurement

Qualitative

Time

20 minutes

Subclass

Membrane-based

LOD

4 AU

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

0.7 % ( (In trial of 428 negative samples compared with RTqPCR test ,3 False Positives were detected))

False negatives

8.05 % ( (In trial of 149 positive samples compared with RTqPCR test, 12 False negatives were detected))

Precision

Evaluated

Accuracy

99.04 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

91.95 %

Clinical Specificity

99.27 %

Type of antigen

Nucleoprotein