COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2086

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Microplate

Target type

Nucleic acid

Targets

envelope protein/gene, ORF1ab polyprotein/gene

Specimen

Bronchoalveolar lavage fluid, Nasopharyngeal swab, Oropharyngeal swab, Sputum

Cross-reactivity (pathogens tested)

Coronaviruses (HCoV)

Lineages detected

B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), P.3 (Theta),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

This kit is used for in vitro qualitative detection of novel coronavirus 2019-nCoV in respiratory specimens including oropharyngeal swab, sputum, bronchoalveolar lavage fluid and nasopharyngeal swab. Primer sets and FAM labeled probe are designed for specific detection of ORF1ab gene of 2019-nCoV, VIC labeled probe for N gene of 2019-nCoV. Human RNase P gene extracted concurrently with the test sample provides an internal control to validate nucleic extraction procedure and reagent integrity. Probe targeting human RNase P gene is labeled with CY5.

Assay Type

Nucleic acid-PCR

Reader Required

No

Subcategory

Validity test kit

Method

RT-PCR

Measurement

Qualitative

Subclass

JRC-S

LOD

200 cpm

Type of antigen

ORF1ab, N gene