COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3453

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual, 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, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Influenza A, Influenza B, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus

Pathogens detected

Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Influenza A, Influenza B, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus

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

SARS-CoV-2 (Wuhan strain) N protein atgtctgataa tggaccccaa aatcagcgaa atgcaccccg cattacgtttggtggaccct cagattcaac tggcagtaac cagaatggag aacgcagtgg ggcgcgatcaaaacaacgtc ggccccaagg tttacccaat aatactgcgt cttggttcac cgctctcactcaacatggca aggaagacct taaattccct cgaggacaag gcgttccaat taacaccaatagcagtccag atgaccaaat tggctactac cgaagagcta ccagacgaat tcgtggtggtgacggtaaaa tgaaagatct cagtccaaga tggtatttct actacctagg aactgggccagaagctggac ttccctatgg tgctaacaaa gacggcatca tatgggttgc aactgagggagccttgaata caccaaaaga tcacattggc acccgcaatc ttgctaacaa tgctgcaatcgtgctacaac ttcctcaagg aacaacattg ccaaaaggct tctacgcaga agggagcagaggcggcagtc aagcctcttc tcgttcctca tcacgtagtc gcaacagttc aagaaattcaactccaggca gcagtaaacg aacttctcct gctagaatgg ctggcaatgg cggtgatgctgctcttgctt tgctgctgct tgacagattg aaccagcttg agagcaaaat gtctggtaaaggccaacaac aacaaggcca aactgtcact aagaaatctg ctgctgaggc ttctaagaagcctcggcaaa aacgtactgc cactaaagca tacaatgtaa cacaagcttt cggcagacgtggtccagaac aaacccaagg aaattttggg gaccaggaac taatcagaca aggaactgattacaaacatt ggccgcaaat tgcacaattt gcccccagcg cttcagcgtt cttcggaatgtcgcgcattg gcatggaagt cacaccttcg ggaacgtggt tgacctacac aggtgccatcaaattggatg acaaagatcc aaatttcaaa gatcaagtca ttttgctgaa taagcatattgacgcataca aaacattccc accaacagag cctaaaaagg acaaaaagaa gaaggctgatgaaactcaag ccttaccgca gagacagaag aaacagcaaa ctgtgactct tcttcctgctgcagatttgg atgatttctc caaacaattg caacaatcca tgagcagtgc tgactcaactcaggcctaa

Lineages detected

B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.429 (Epsilon), B.1.617.2 (Delta), P.1 (Gamma)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

Yes

Reader Required

No

Subcategory

N.A.

Method

Immunochromatography

Measurement

Qualitative

Time

10 minutes

Subclass

Capture

Detection Principle

Colloidal gold

LOD

1255.9 TCID50/ml

Analytical Sensitivity

97.73 %

Analytical Specificity

98.67 %

False positives

1.33 %

False negatives

2.27 %

Accuracy

94.54 %

Clinical Sensitivity

81.05 %

Clinical Specificity

99.99 %