COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2374

CE Marking

✓Yes

HSC common list (RAT)

✓Yes

Format

Manual, Near POC / POC

Physical Support

Cassette, Strip

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Throat swab

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), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, MERS-CoV, Mumps Virus (MuV), Respiratory Syncytial V (RSV), SARS-CoV, Varicella Zoster Virus (VZV)

Lineages detected

A.23.1, AT.1, 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

The product is intended for in vitro diagnosis only. The test result must not be used as the sole index to evaluate the patient's condition, and the patient's clinical manifestation and other laboratory tests must be combined to perform a comprehensive analysis of the condition. Inspection of the product packaging and seal and expiration date is required before performing the test. The test should be performed as soon as possible. Exposure of the test to air and moisture for an extended period of time will result in invalid results. Overloading the specimen may cause unexpected results, such as false positives. The accuracy of the test may be affected by ambient temperature (40°C) and relative humidity (>80%).

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Reader Required

No

Subcategory

Calibrant / control sample

Method

Immunoassay

Measurement

Qualitative

Time

10 minutes

LOD

1231 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

231 AU

False negatives

1000 AU

Precision

Evaluated

Accuracy

99.6 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

98.7 %

Clinical Specificity

99.8 %

Type of antigen

Nucleocapsid protein