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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS CoV-2 Antigen Rapid Test

Manufactured by Novatech, Turkey - www.novadiag.com 

Device identification number
1762
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal 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
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
1.7 U/ml
Analytical Sensitivity
97.54 %
Analysis of cross reactivity
Evaluated
False positives
0 % (0/517 with negative PCR result There was no false positiv sample from the sample)
False negatives
4.09 ((14/342 positive PCR result 14 false negative samples did not come out of the sample) )
Precision
Evaluated
Accuracy
98 %
Robustness
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
95 %
Clinical Specificity
100 %
Type of antigen
Nucleoprotein

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