Genenzyme SARS-CoV-2 RT-PCR Kit
Manufactured by Asterion Otel Ä°nÅŸaat BiliÅŸim Medikal Maden Tic. Ltd. Åžti., Turkey - http://www.asterion.com.tr/en/
Device identification number
2961
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Specimen
Nasal aspirate, Nasal aspiration, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Throat swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Enterovirus A71 (EV-A71), Influenza A
Pathogens detected
Bordetella Pertussis, Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, MERS-CoV, SARS-CoV
Lineages detected
A.23.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.526 (Iota), B.1.617.2 (Delta), B.1.621 (Mu)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
Genenzyme SARS-CoV-2 RT-PCR Diagnostic Kit is a test for the detection of SARSCoV-2 RNA in nasopharyngeal or oropharyngeal, anterior nasal, mid-turbinate nasal, nasal aspirate, nasal wash and bronchoalveolar lavage fluid samples from individuals who are suspected of having COVID-19. It is an RT-PCR test designed for qualitative detection of SARS-CoV-2 virus. Application of the test is limited to laboratories approved by "1988 Clinical Laboratory Improvement Studies (CLIA), 42 U.S.C. §263" or similarly qualified laboratories outside the United States to perform high complexity tests. The results are used for the detection of SARS-CoV-2 RNA. SARS-CoV-2 RNA can usually be detected in respiratory samples during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA, but clinical correlation with patient history and other diagnostic information is required to determine patient infection status. Positive results do not indicate the absence of a bacterial infection or infections caused by other viruses. The detected agent may not be the definitive cause of the disease. Negative results do not indicate the absence of SARS-CoV-2 infection. Negative results should be evaluated in combination with clinical observations, patient history, and epidemiological information. The Genenzyme SARS-CoV-2 RT-PCR Diagnostic Kit is designed to be use by qualified clinical laboratory personnel trained in real-time PCR and in vitro diagnostic procedures. The Genenzyme SARS-CoV-2 RT-PCR Diagnostic Kit can only be used with the authorization of the FDA (US Food and Drug Administration) or similar agencies in the relevant countries.
Assay Type
Nucleic acid-PCR
Self Test
No
Reader Required
Yes
Method
RT-PCR
Measurement
Semiquantitative
Time
50 minutes
LOD
16 copies/reaction
Positive control
Synthetic viral RNA containing N and ORF1ab genes
Negative control
Nuclease free water
Analytical Sensitivity
98 %
Analytical Specificity
97 %
Clinical Sensitivity
98 %
Clinical Specificity
97 %
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