COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

5834

CE Marking

✓Yes

HSC common list (RAT)

×No

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, Other (-), 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

2023-01-13 01:46:41 CET

Comments

1. Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. 2.The LOD for this product is 50 TCID50/mL.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

Yes

Reader Required

No

Subcategory

Other (-)

Method

Chromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Membrane-based

Detection Principle

Colorimetry

LOD

50 % (for SARS-CoV-2)

Calibration

Evaluated

Analytical Sensitivity

100 %

Analytical Specificity

100 %

Analysis of cross reactivity

Evaluated

False positives

0.95 % (5 out of 525 (NP Swab for SARS-CoV-2))

False positives

1.19 % (3 out of 108 (NP Swab for M. Pneumoniae ))

False positives

2.24 % (5 out of 223 (NP Swab for RSV))

False positives

0.53 % (2 out of 375 (NP Swab for InfA))

False positives

0.79 % (3 out of 379 (NP Swab for InfB))

False positives

0.87 % (2 out of 231(NP Swab for RSV))

False positives

0.82 % (2 out of 223 (NP Swab for ADV))

False negatives

2.7 % (17 out of 630 (NP Swab for SARS-CoV-2))

False negatives

2.78 % (3 out of 108 (NP Swab for M. Pneumoniae ))

False negatives

1.78 % (4 out of 225 (NP Swab for ADV))

False negatives

3.03 % (5 out of 165 (NP Swab for InfB))

False negatives

2.56 % (4 out of 156 (NP Swab for InfA))

Precision

Evaluated

Accuracy

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

Robustness

Evaluated

Clinical Sensitivity

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

Clinical Sensitivity

97.22 % (NP Swab for M. Pneumoniae )

Clinical Specificity

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

Clinical Specificity

98.81 % (NP Swab for M. Pneumoniae )