COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2823

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual, Near POC / POC

Physical Support

Card, Cassette, Lateral flow, Strip

Target type

IgG, IgM

Specimen

Plasma, Serum, Venous whole blood, Whole blood

Cross-reactivity (pathogens tested)

SARS-CoV

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 novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus 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. The common diagnostic methods of COVID-19 pneumonia are CT and PCR. This product is an immunoassay. This product does not require any instruments. It is used for the qualitative detection of COVID-19 IgM / IgG antibodies in humans.

Assay Type

Immuno-Antibody

Reader Required

No

Subcategory

Validity test kit

Method

Immunoassay

Measurement

Qualitative

Time

10 minutes

Subclass

Sandwich, Double

Detection Principle

Colloidal gold

LOD

100 TCID50/ml

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

2.5 %

False negatives

0.5 %

Precision

Evaluated

Accuracy

97 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

97.5 %

Clinical Specificity

99.5 %

Type of antigen

Spike protein