COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2806

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

Antigen

Antibody type

Monoclonal

Targets

nucleocapsid protein

Specimen

Nasal 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, Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), 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

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

MFDS 22-106 approved by Korea FDA A. OI-01SA-SE : CE COC (Certification No. 1434-IVDD-082-2022) B. OI-01SA-SH : FDA EUA (EUA No. 220037) C. G-Tech COVID-19 Ag Rapid Test : ANVISA (No. 0440463227)

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

Yes

Reader Required

No

Subcategory

Other ()

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Capture

LOD

750 TCID50/ml (Ct value (RdRP/S) 27.23)

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

0 % Predict Postivie Value : 100% (95% CI : 93.79 - 100.00)

False negatives

1.68 % (Predict Negative Value : 98.32% (95% CI : 94.08 - 99.54))

Precision

Evaluated

Accuracy

98.87 (95% CI : 95.97 - 99.69 - (175/177))

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

96.67 % (95% CI: 88.64 – 99.08 - (58/60))

Clinical Specificity

100 % (95% CI: 96.82 – 100.00 - (117/117))

Type of antigen

Nucleocapsid protein

Notes

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 : 44-17; 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; other lineages detected: BA2.0 (Stealth)