COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

5839

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Lateral flow

Target type

Antigen

Antibody type

Monoclonal

Targets

nucleocapsid protein

Specimen

Nasal swab

Cross-reactivity (pathogens tested)

Adenovirus, 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), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycoplasma Pneumoniae, Other (Enterovirus type 68, Streptococcus pneumonia, Candida albicans, Legionella pneumophila, Staphylococcus aureus, Staphylococcus epidermidis, Pooled human nasal wash), Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV, SARS-CoV-2

Pathogens detected

SARS-CoV, SARS-CoV-2

Type of Antigen (in case of Antigen-based)

Nucleocapsid protein

Lineages detected

A.23.1, AT.1, B.1.1.529 (Omicron), 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), Other (AY.1, AY.2, AY.3, BA.1, BA.2, BA.3, BA.4, BA.5, C.1.2, B.1.640), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)

Commercial Status

Commercialised

Last Update

2023-01-24 10:04:16 CET

Comments

In addition to the validation studies listed in the Instructions for Use (IFU), this product was evaluated independently in a study conducted by investigators at the Technical University of Munich and the Institute of Virology at Helmholtz Munich. This study prospectively enrolled 428 healthcare workers from the University Hospital Munich Rechts der Isar of the Technical University of Munich who either reported recent onset of COVID-19 associated symptoms or completed routine diagnostic testing between 24th of May and 22nd of September 2022. Rapid test performance was compared to the standard-of-care RT-PCR results at the hospital, which was also calibrated to report viral load in genomic copies (GE) / ml. All samples with a viral load above 9.5x104 GE/ml were sequenced, and results revealed a majority of infections with BA.5 followed by BA.2 and BA.4. In the entire cohort, the SARS-CoV-2 Rapid Antigen Test 2.0 Nasal demonstrated a sensitivity of 89.4% and a specificity of 99.4%.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

No

Reader Required

No

Subcategory

N.A.

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Membrane-based

Detection Principle

Colloidal gold

LOD

13 TCID50/ml

Calibration

Not evaluated

Analytical Sensitivity

100 % (With reference to the LoD and analytical studies)

Analytical Specificity

100 % (With reference to the analytical studies)

Analysis of cross reactivity

Evaluated

False positives

tests 0/487

False negatives

6 tests (6/143)

Precision

Evaluated

Accuracy

99 %

Robustness

Evaluated

Clinical Sensitivity

99.15 % (For ct≤30)

Clinical Specificity

100 %