COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1443

CE Marking

✓Yes

HSC common list (RAT)

✓Yes

Format

Manual, Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

Antigen

Antibody type

Monoclonal

Targets

nucleocapsid protein

Specimen

Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Throat swab

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Anti-Nuclear Antibody, Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), 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, MERS-CoV, 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, SARS-CoV, Varicella Zoster Virus (VZV)

Pathogens detected

Other ((-))

Type of Antigen (in case of Antigen-based)

Nucleocapsid protein

Information on antigen epitope targeted by the antibodies used in the design of the device

Origin: The immunogen is SARS- CoV-2 nucleocapsid protein expressed by E.coli through genetic recombination Sequence: Msdngpqnqrnapritfggpsdstgsnqngersgarskqrrpqglpnntaswftaltqhgkedlkfprgqgvpintnsspddqigyyrratrrirggdgkmkdlsprwyfyylgtgpeaglpygankdgiiwvategalntpkdhigtrnpannaaivlqlpqgttlpkgfyaegsrggsqassrsssrsrnssrnstpgssrgtsparmagnggdaalalllldrlnqleskmsgkgqqqqgqtvtkksaaeaskkprqkrtatkaynvtqafgrrgpeqtqgnfgdqelirqgtdykhwpqiaqfapsasaffgmsrigmevtpsgtwltytgaiklddkdpnfkdqvillnkhidayktfpptepkkdkkkkadetqalpqrqkkqqtvtllpaadlddfskqlqqsmssadstqagggshhhhhhhhhh

Lineages detected

A.23.1, AT.1, B.1.1.529 (Omicron), 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

2022-09-30 09:55:16 CET

Comments

1.This product was evaluated and approved by Ministry of Health Turkey in December 2020. 2.This product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 3. Twin test of this product evaluated and approved by Therapeutic Goods Administration (TGA) in Australia in 2022. 4.The LOD for this product is 50 TCID50/mL.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

No

Reader Required

No

Subcategory

Other ()

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Membrane-based

Detection Principle

Colorimetry

LOD

50 TCID50/ml (for SARS-CoV-2)

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0.95 % (5 out of 525 (Nasopharyngeal Swab))

False negatives

2.7 % (17 out of 630 (Nasopharyngeal Swab))

Precision

Evaluated

Accuracy

98.09 % (NP swab:(SARS-CoV-2)

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

97.3 % (NP swab:(SARS-CoV-2))

Clinical Specificity

99.05 % (NP swab:(SARS-CoV-2))

Type of antigen

Nucleocapsid protein