COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2958

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC, Semi-automated

Physical Support

Card

Target type

Nucleic acid

Targets

nucleocapsid protein/gene, ORF1ab polyprotein/gene

Specimen

Nasal swab

Cross-reactivity (pathogens tested)

Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Influenza A, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), SARS-CoV

Lineages detected

B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The Pluslife SARS-CoV-2 Card is based on isothermal amplification method and enzyme digestion probe technology, and SARS-CoV-2 N gene and ORF1ab gene is selected as the target region, designed the probe and specific primers. A large number of target sequence’s copies were generated in the reaction system during the isothermal amplification. When the probe hybridizes to the complementary sequence, it is cleaved and fluorescence is emitted. Integrated Nucleic Acid Testing Device detects and analyzes fluorescence signal automatically, reporting negative, positive or invalid result. The assay includes internal control for monitoring of sample collection, processing, and amplification to reduce false negative results.

Assay Type

Nucleic acid-PCR

Rapid Diagnostic

Yes

Self Test

No

Reader Required

Yes

Subcategory

Other ()

Method

Other ()

Measurement

Qualitative

Time

30 minutes

LOD

400 cpm

Analytical Sensitivity

100 %

Analytical Specificity

100 %

Clinical Sensitivity

98.81 %

Clinical Specificity

100 %

Throughput

Single cartridges