COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2968

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Lateral flow

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Nasopharyngeal swab

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 7, 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), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), 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, Varicella Zoster Virus (VZV)

Pathogens detected

Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata

Lineages detected

A.23.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.429 (Epsilon), B.1.526 (Iota), B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The clinical performance of the SARS CoV 2 & Flu A/B Rapid Antigen Test was evaluated in a prospective, all comer’s study in the United States. This study was conducted by 8 intended users at 4 near patient testing clinical sites. Patients above 14 years of age visiting the study sites seeking testing and presenting symptoms suggestive of upper respiratory infections consistent with COVID 19 or influenza were approached to participate in the study, and those beyond 7 days since the onset of symptoms were excluded. 2 nasopharyngeal swabs were collected from each study participant. In a randomized manner, 1 swab was tested immediately at the study site using the SARS CoV 2 & Flu A/B Rapid Antigen Test, and the other was sent to a central laboratory for testing using a highly sensitive US FDA approved multiplex RT PCR method as the comparator. In total, 105 participants were enrolled in this study, and valid rapid antigen and RT PCR results were obtained for 104 participants.

Assay Type

Immuno-Antigen

Self Test

No

Reader Required

No

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich

LOD

8.29 TCID50/ml (SARS-CoV-2)

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

1.41 % (SARS-CoV-2 (0.04%-7.60%))

False negatives

15.15 % (SARS-CoV-2 (5.11%-31.90%))

Precision

Evaluated

Accuracy

94.23 % (SARS-CoV-2 Antigen)

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

84.85 % (SARS-CoV-2 Antigen)

Clinical Specificity

98.59 % (SARS-CoV-2 Antigen)

Type of antigen

Nucleocapsid protein