Device identification number

2741

CE Marking

✓Yes

HSC common list (RAT)

✓Yes

Format

Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

Antigen

Antibody type

Monoclonal

Targets

nucleocapsid protein

Specimen

Nasal swab, Nasopharyngeal swab, Oropharyngeal 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), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Hemophilus Influenzae, Influenza A, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, 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

Pathogens detected

SARS-CoV

Information on antigen epitope targeted by the antibodies used in the design of the device

Target Epitope : 47-173 - Monoclonal ani-SARS-CoV-2 nucleoprotein antibody (detection Ab) Target Epitope : 44-175 -Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (capture Ab)

Lineages detected

B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma), P.2 (Zeta)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

Published article 1 : https://www.mdpi.com/2075-4418/12/5/1126 - Title : Validation of GeneFinder COVID-19 Ag Plus Rapid Test and Its Potential Utility to Slowing Infection Waves: A Single-Center Laboratory Evaluation Study - Published article 2: - https://www.mdpi.com/2673-8112/2/3/16 - Title : BA.1 Omicron Variant of SARS-CoV-2: First Case Reported in Calabria Region, Italy * Clinical Performance 1. Direct Nasopharyngeal Swab (Prospective study) Total : 603 Samples (Positive : 151, Negative : 452) Sensitivity: 96.03% (95% CI 91.55 - 98.53) Specificity: 99.78% (95% CI: 98.77 - 99.96) 2. Direct Oropharyngeal Swab (Prospective study) Total : 544 Samples (Positive : 144, Negative : 400) Sensitivity: 90.28% (95% CI 84.34 - 94.12) Specificity: 100.00% (95% CI: 99.05 - 100.00) 3. Direct Nasal Swab (Prospective study) Total : 170 Samples (Positive : 70, Negative : 100) Sensitivity: 92.86% (95% CI 84.34 - 96.91) Specificity: 100.00% (95% CI: 96.30 - 100.00) 4. Stored swab samples in transport media (Retrospective study) Total : 500Samples (Positive : 100, Negative : 400) Sensitivity: 89.00% (95% CI 81.37 - 93.75) Specificity: 100.00% (95% CI: 99.05 - 100.00)

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

No

Reader Required

No

Subcategory

Other ()

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Capture

LOD

750 TCID50/ml (RdRP/S gene : Ct value 27.67)

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

0.68 % (Predict Postivie Value : 99.32% (95% CI : 96.25 - 99.88))

False negatives

1.1 % (Predict Negative Value : 98.69% (95% CI : 97.46 - 99.53))

Precision

Evaluated

Accuracy

99 % (95% CI : 97.85 - 99.54, 597/603)

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

96.03 (95% CI : 91.55% - 98.53%, 146/151)

Clinical Specificity

99.78 (95% CI : 98.76% - 99.96%, 451/452)

Type of antigen

Nucleocapsid protein

Notes

1) Available to detect asymptomatic patients => 90% (63/70) sensitivity and 100% specificity (28/28) in brazil clinical study (Total 70 positive patients and 28 negative out of 98 asymptomatic participants); 2) Available to use stored freeze specimens in transport media (UTM/VTM) : Please refer to manual file. lineages_performances 1. Positve standard material : 750 TCID50/mL 2. B.1.1.7 (Alpha) : 750 TCID50/mL 3. B.1.351 (Beta) : 380 TCID50/mL 4. B.1.617.2 (Delta) : 750 TCID50/mL 5. P.1 (Gamma) : 750 TCID50/mL 6. B.1.1.529 (Omicron) : 750 TCID50/mL. antigen_epi Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (detection Ab) Epitope Target : 47-173 Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (capture Ab) Epitope arget : 44-175. Ohter variants detected: BA2 (Stealth)