Pluridiag SARS-COV-2 Ag Rapid Test
Manufactured by Zhejiang Aibu Biotech Co. Ltd., China
Device identification number
2780
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
PluridiagTM SARS-CoV-2 Ag Rapid Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab, oropharyngeal swab or nasopharyngeal swab specimen[1]. The test is for in vitro diagnostic use only. For professional use only. It is intended for clinical laboratories and healthcare professional use only for point-of-care testing[3].It provides only an initial screening test result. More specific alternative diagnosis methods (molecular diagnostic and / or CT) should be performed in order to obtain the confirmation of SARS-CoV-2 infection. Not for at-home testing.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Quantitative
Time
15 minutes
Subclass
Sandwich
LOD
75.5 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.28
False negatives
3.9
Precision
Evaluated
Accuracy
97.86 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.1 % (Antigen)
Clinical Specificity
98.72 % (Antigen)
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