COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

4095

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Lab-based, Manual, Near POC / POC, Semi-automated

Physical Support

Chip

Target type

Nucleic acid

Targets

ORF1ab polyprotein/gene

Specimen

Anterior nasal swab, Bronchoalveolar lavage fluid, Deep (cough) sputum, Mid-turbinates swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Serum, Whole blood, Whole blood with anti-coagulants

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Anti-Nuclear Antibody, 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, Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex (HSV), Human Immunodeficiency Virus (HIV), Human Metapneumovirus (HMPV), Influenza A, 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, 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, SARS-CoV-2, Varicella Zoster Virus (VZV)

Pathogens detected

SARS-CoV-2

Lineages detected

A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta),

Commercial Status

Commercialised

Last Update

2022-09-29 08:57:08 CET

Comments

These Rapid PCR solution allow PCR test kit to be transported in freeze-dried solid state and realized one-step operation within 1 min, 16 results can be obtained within 30 minutes, The accuracy of the detection results is higher than that of antigen detection reagents over 100 times.

Assay Type

Nucleic acid-PCR

Rapid Diagnostic

Yes

Self Test

No

Reader Required

Yes

Subcategory

Validity test kit

Method

RT-PCR

Measurement

Qualitative

Time

25 minutes

Subclass

China-CDC-ORF1ab

Detection Principle

Immunofluorescence

LOD

400 copies/ml

Analytical Sensitivity

100 %

Analytical Specificity

100 %

Clinical Sensitivity

97 %

Clinical Specificity

99.65 %