COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3069

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Lab-based

Target type

Nucleic acid

Targets

nucleocapsid protein/gene, ORF1ab polyprotein/gene

Specimen

Throat swab

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV, Varicella Zoster Virus (VZV)

Lineages detected

B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.3 (Theta),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

other pathogens tested for cross-reactivity: Influenza A H7N9；Measles virus

Assay Type

Nucleic acid-PCR

Self Test

No

Reader Required

Yes

Subcategory

Validity test kit

Method

RT-PCR

Measurement

Qualitative

Time

90 minutes

LOD

500 cpu

Positive control

ORF1ab, N and RdRp gene plasmid

Negative control

DEPC DW

Clinical Sensitivity

97.57 %

Clinical Specificity

99.29 %

Throughput

Single tube