Pekit Covid-19 Rapid (Hızlı) Antigen Test
Manufactured by Labormed Tıbbi Ürünler San Ve Tic Ltd. ŞTİ, Turkey - www.labormed.biz
Device identification number
3010
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Throat swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, SARS-CoV
Pathogens detected
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
www.labormed.biz
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Subcategory
Extraction kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
580 TCID50/ml
Positive control
1.66 % (100xTP/(TP+FP)=100x238/242=98.34%)
Negative control
1.49 % (100xTN/(FN+TN)=100x530/538=98.51%)
Analytical Sensitivity
93.76 %
Analytical Specificity
97.5 %
Clinical Sensitivity
96.89 %
Clinical Specificity
99.1 %
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