COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2863

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

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

Target type

Nucleic acid

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, Varicella Zoster Virus (VZV)

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

2022-08-24 09:08:01 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, 8 results can be obtained within 25 minutes, The accuracy of the detection results is higher than that of antigen detection reagents over 100 times.

Assay Type

Nucleic acid-PCR

Reader Required

No

Subcategory

Validity test kit

Method

RT-PCR

Measurement

Quantitative

Time

25 minutes

LOD

200 AU

Positive control

225 AU

Negative control

429 AU

Analytical Sensitivity

% 100

Analytical Specificity

% 100

Clinical Sensitivity

% 98

Clinical Specificity

% 100