COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1818

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC, Semi-automated

Physical Support

Lateral flow

Target type

Antigen

Specimen

Nasopharyngeal swab

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The GreenLight SARS-CoV-2 antigen test is an in-vitro-diagnostic for the detection of SARS-CoV-2 antigen in human nasopharyngeal swab specimens from individuals who meet COVID-19 clinical or epidemiological criteria. GreenLight SARS-CoV-2 antigen test is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. Results must be interpreted together with clinical information i.e. symptoms, suspect of infection, clinical methods and other in-vitro diagnostic procedures. The product may be used in any medical laboratory or non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulations. The test provides primarily the test results and optional additional information compiled in a report sent to the smart-phone of the user or a smartphone within a work group.

Assay Type

Immuno-Antigen

Reader Required

No

Subcategory

Visualisation system

Method

Immunochromatography

Measurement

Quantitative

Time

12 minutes

Detection Principle

Colorimetry

LOD

502 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

3.9 % (4 FP out of 102 PCR negatives)

False negatives

5.2 % (2 negatives out of 38 PCR positives)

Precision

Evaluated

Accuracy

98 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

90 % ((CI95% :80.7 – 99))

Clinical Specificity

98 % ((CI95%: 95.3 – 100))

Type of antigen

N Protein