COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2608

CE Marking

✓Yes

HSC common list (RAT)

✓Yes

Physical Support

Cassette

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Nasal swab, Nasopharyngeal swab, Oropharyngeal swab

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Varicella Zoster Virus (VZV)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

This reagent is used for in vitro qualitative test of COVID 19 antigen N protein in human nasal samples. Synthetic spinous protein and genetic variants of UK cannot be detected. It is only used as a supplementary test indicator for suspected cases with negative result of COVID 19 test or combined with the 2019-nCov IgG / IgM antibody test kit for the auxiliary diagnosis of suspected cases. It cannot be used as a basis for confirmation or diagnosis of pneumonia caused by COVID 19 infection. A positive test result needs further confirmation, and a negative test result cannot exclude the possibility of infection. The test kit is recommended to be used by individuals above 18 years old. For the individuals under the age of 18 years old or older than 65 years old, the test should be done under the supervision or assistance of another adult. The 2019 novel coronavirus is also known as COVID 19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the COVID 19 are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Detection Principle

Colloidal gold

LOD

0.1 ng/mL

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0.8 % ((1/123))

False negatives

4.1 % ((5/123))

Precision

Evaluated

Accuracy

97.56 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

95.93 %

Clinical Specificity

99.19 %

Type of antigen

Nucleocapsid protein