SARS CoV-2 Antigen Rapid Test
Manufactured by Novatech Tıbbi Cihaz Ürünleri Sanayi ve Ticaret A.Ş., Turkey - www.novadiag.com
Device identification number
2157
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Intended Use The Novacheck SARS-CoV-2 rapid diagnostic test is an immunochromatographic per-patient test based on the sandwich principle, which contains two specific antibodies for qualitative detection of N-protein antigen in human nasal swab samples. This test kit is used to detect the SARS-CoV-2 N-protein antigen that occurs in the acute phase of an infection. An antigen is generally detectable in upper respiratory specimen during the acute phase of the infection (within the first 5 to 7 days from symptom onset). The Novacheck SARS-CoV-2 rapid diagnostic test can be used in symptomatic and asymptomatic people for lay users.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Extraction kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
1.7 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % 517 with negative PCR result There was no false positiv sample from the sample. 0/517
False negatives
4.09 % (342 positive PCR result 14 false negative samples did not come out of the sample. 14/342)
Precision
Evaluated
Accuracy
98.37 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
95.91 %
Clinical Specificity
100 %
Type of antigen
N-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