COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2467

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Cartridge

Target type

Antigen

Specimen

Nasal swab, Nasopharyngeal swab

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

PBCheck COVID-19 Ag is a rapid immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal or nasopharyngeal swab from individuals who are suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management. The PBCheck COVID-19 Ag is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures and individuals similarly trained in point of care settings.

Assay Type

Immuno-Antigen

Reader Required

No

Subcategory

Other ()

Method

Immunochromatography

Measurement

Qualitative

Time

10 minutes

Subclass

Enzyme-linked

LOD

1510 TCID50/ml ((1.51 x 103 TCID50/mL))

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

Positive Percent Agreement (PPA, %) = (90/100) ⅹ 100 = 90.0% (Wilson 95% CI: 82.6-94.5)

False negatives

Negative Percent Agreement (NPA, %) = (108/108) ⅹ 100 = 100% (Wilson 95% CI: 96.6-100)

Precision

Evaluated

Accuracy

95.19 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

90 %

Clinical Specificity

100 %

Type of antigen

Nucleoprotein