LEPZI Qualitative COVID-19 Test
Manufactured by Lifeassay Diagnostics Pty Ltd., United States - lifesadx.com/
Device identification number
3151
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, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B, 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, Rhinovirus
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.351 (Beta), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The LEPZI™ COVID-19 Antigen Detection Kit (or Test) is a lateral flow immunoassay for qualitative detection of nucleocapsid protein antigens from SARS-CoV-2 in nasal swab and throat swab specimens. This test is intended for individuals who are suspected of COVID-19 infection by their healthcare provider during the first five days from onset of symptoms.
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
No
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
250 PFU/mL
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
5 (1/20)
False negatives
0 0/20
Precision
Evaluated
Accuracy
95 % (Higher than 95% - Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90 % (Higher than 90% - Antigen)
Clinical Specificity
100 % (Antigen)
Type of antigen
Nucleocapsid protein
Notes
antigen_epi In the presence of SARS-CoV-2, nucleocapsid protein antigens from the virus bind to antibodies conjugated to colloidal gold particles. The antigen-conjugate complexes migrate by capillary action along the lateral flow strip inside the test cassette and bind to a capture antibody.
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements