COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2124

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Fully automated (robot)

Physical Support

Cartridge

Target

Antigen

Specimen

Nasopharyngeal swab, Oropharyngeal swab, Saliva

Pathogens detected

SARS-CoV

Commercial Status

Commercialised

Last Update

2021-06-02 06:22:11 CET

Comments

Lumipulse G SARS-CoV-2 Ag was the first high-sensitive nucleocapsid protein antigen assay launched on a fully automated chemiluminescent platform. It has been used by Japanese authorities since August 2020 for quarantine screening of arriving travelers in major international Japanese airports. Fujirebio’s advanced technology supports also multiple European test centers to set up easily accessible, reliable and rapid COVID 19 testing e.g. testing in Germany’s largest airports and screening in Italy for specific target communities such as schools, residential care homes, prisons to control and monitor the spread of the SARS-CoV-2 virus. The excellent performance, high quality and accessibility of the Lumipulse G SARS-CoV-2 Ag testing solution has been evaluated in multiple published studies. Latest scientific literature overview: https://lnkd.in/ejZ9uau Salivary SARS-CoV-2 antigen rapid detection: A prospective cohort study:https://www.sciencedirect.com/science/article/pii/S0009898121000553?via%3Dihub Lumipulse G SARS-CoV-2 Ag assay evaluation using clinical samples from different testing groups:https://www.degruyter.com/document/doi/10.1515/cclm-2021-0182/html Evaluation of Lumipulse® G SARS-CoV-2 antigen assay automated test for detecting SARS-CoV-2 nucleocapsid protein (NP) in nasopharyngeal swabs for community and population screening:https://www.ijidonline.com/article/S1201-9712(21)00184-3/fulltext A novel strategy for SARS-CoV-2 mass screening with quantitative antigen testing of saliva: a diagnostic accuracy study:https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(21)00092-6/fulltext Clinical validation of quantitative SARS-CoV-2 antigen assays to estimate SARS-CoV-2 viral loads in nasopharyngeal swabs:https://www.jiac-j.com/article/S1341-321X(20)30428-1/fulltext Saliva Is a Valid Alternative to Nasopharyngeal Swab in Chemiluminescence-Based Assay for Detection of SARS-CoV-2 Antigen:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8038133/ Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients:https://www.ijidonline.com/article/S1201-9712(20)30658-5/fulltext

Assay Type

Immuno-Antigen

Method

CLIA

Measurement

Quantitative

Time

25 minutes

Subclass

Sandwich

LOD

2.95 TCID50/ml

Calibration

Evaluated

Crossreactivity

Evaluated

Fp

see IFU

Fn

see IFU

Precision

Evaluated

Accuracy

97.5 % (Precision: ≤ 2.5% (total %CV))

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

97.6 % ((NPS; Ct-value <30))

Clinical Specificity

99.3 % ((NPS))

Type of antigen

Nucleoprotein