COVID-19 In Vitro Diagnostic Medical Device - detail

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 %