Livzon Rapid Test for SARS-CoV-2 Antigen (Lateral Flow)
Manufactured by Zhuhai Livzon Diagnostics Inc., China - http://www.livzondiagnostics.com/
Device identification number
1441
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual, Near POC / POC
Physical Support
Cassette, Lateral flow, Latex, Strip
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal 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, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus B
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
We did a prospective clinical study in US with 221 mid-turbinate nasal samples collected within 7 days of symptom onset, to compare Livzon Rapid Test for 2019-nCoV Antigen (Lateral Flow) with the Roche SARS-CoV-2 RT-PCR test (comparator method). The positive percent agreement is 90% (95%CI: 74.4%-96.5%), the negative percent agreement is 100% (95%CI: 98.0%-100.0%), the overall agreement is 98.6% (95%CI: 96.1%-99.5%).
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
30 minutes
Subclass
Sandwich
LOD
3000 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.68 % (Nasal：1/147)
False positives
0.34 % (Oropharyngeal：1/288 )
False positives
0.34 % (Nasopharyngeal：1/288 )
False negatives
0.3 (Nasopharyngeal：ct≤25 2/162 )
False negatives
6.19 (Nasopharyngeal ct≤30 15/242 )
False negatives
0.3 (Oropharyngeal：ct≤25 2/162)
False negatives
6.19 (Oropharyngeal：ct≤30 15/242 )
False negatives
1.63 (Nasal：ct≤25 2/122 )
False negatives
4.57 % (Nasal：ct≤30 7/153)
Precision
Evaluated
Accuracy
97.3 % (Nasopharyngeal)
Accuracy
97.7 % (Nasal)
Accuracy
97.3 % (Oropharyngeal)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.8 % (Nasopharyngeal：ct≤30 )
Clinical Sensitivity
98.8 % (Nasopharyngeal：ct≤25 )
Clinical Sensitivity
98.4 % (Nasal：ct≤25 )
Clinical Sensitivity
95.4 % (Nasal：ct≤30 )
Clinical Sensitivity
98.8 % (Oropharyngeal：ct≤25 )
Clinical Sensitivity
93.8 % (Oropharyngeal：ct≤30)
Clinical Specificity
99.7 % (Nasopharyngeal)
Clinical Specificity
99.7 % (Oropharyngeal)
Clinical Specificity
99.5 % (Nasal)
Type of antigen
Nucleocapsid protein
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