COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2596

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Cassette

Target type

Antibody

Targets

nucleocapsid protein

Specimen

Saliva

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

A.23.1, AT.1, 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), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

This cassette belongs to in vitro diagnostic reagents, and is suitable for the qualitative cietection cf SARS-CoV-2's Nucleocapsid protein in human saliva specimen. It cannot be served as the basis of the confirmation or exclusion for coronavirus pneumonia. This product is used only far medicai institutions. The positive test result requires further confirmation. A negative test cannot rule out the possibility of infection. The test results of this cassette are only for clinica! reference. It is recommended to conduct a comprehensive analysis of the patient's condition in combination with clinical manifestations and other laboratory tests. A total of 443 clinical samples were tested in this clinical study. The clear diagnosis and exclusion criteria of the "SARS-CoV-2 diagnosis and treatment protocol" were taken as a reference. Clinical trials were conducted at Fujian's Fuzhou Lung Hospital and Zhangzliou Hospital. The positive coincidence rate of the SARS-CoV-2 Antigen Rapid Test Cassette, developed by Merlin was 95.5% and the negative coincidence rate of the cassette was 99.7%, the total coincidence rate of the cassette was 98 , 4% compared to the reference method (RT-PCR) which indicates a high consistency.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Method

Immunochromatography

Time

15 minutes

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

4.5 % (Positive coincidence rate = 127/ (127+6) x100%=95.5%, (95% Cl: 90.5%-98.0%))

False negatives

0.3 % (Negative coincidence rate = 299/ (299+1) x100%=99.7%, (95% Cl: 98.1%-99.9%);)

Precision

Evaluated

Accuracy

98 % ( (Antigen))

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

95 % ( (Antigen))

Clinical Specificity

99 % ( (Antigen))

Type of antigen

Nucleocapsid protein