COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2445

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Fully automated (robot), Lab-based, Manual, Semi-automated

Physical Support

Microplate, Microtiter plate, Strip

Specimen

Anterior nasal swab, Bronchoalveolar lavage fluid, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum, Throat swab

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)

Commercial Status

Commercialised

Last Update

2022-12-02 09:22:17 CET

Comments

The kit is able to simultaneously detect the presence of COVID infection of both the “common” strain and the English, South African, and Brazilian P2 variants with RT-PCR the method in a single “well”. Not Sequencing required! This kit is designed with specific primers and Taqman probes for the New Coronavirus ORF1ab and the conservative region of the N gene sequence encoding the nucleocapsid protein of the new coronavirus to diagnose or differentially diagnose whether the tested patient is infected with the new coronavirus, the British B.1.1.7 strain-specific N501Y mutation site and the South African B.1.351 and Brazilian P2 B.1.1.28.P2 strain-specific E484K mutation sites.

Assay Type

Unknown

Reader Required

No

Method

RT-PCR

Measurement

Quantitative

Time

45 minutes

LOD

500 cpm

Positive control

yes

Negative control

yes

Analytical Sensitivity

100

Analytical Specificity

100

Clinical Sensitivity

100

Clinical Specificity

100