COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3142

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 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV)

Pathogens detected

Influenza A H1N1, Influenza A H3N2, Influenza B, SARS-CoV

Lineages detected

A.23.1, AT.1, B.1.1.529 (Omicron), 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

The COVID-19 and Flu A/B Multiplex Panel for Home Use (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2, Influenza A and Influenza B virus that causes COVID-19 and/or Influenza with self-collected nasal swab specimen. The test is intended for use in symptomatic/asymptomatic individuals who are suspected of being infected with SARS-CoV-2 and/or Influenza A+B. Results are for the detection of SARS-CoV-2 nucleocapsid protein, Influenza A and Influenza B nucleoproteins antigens. An 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 are indicative of the presence of SARS-CoV-2 and/or Influenza A+B. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 and/or Influenza A+B infection. Individuals who test negative and continue to experience COVID-like or flu-like symptoms should seek follow up care from their healthcare provider. Test for children and young people should be used with an adult. Other pathogens tested for cross-reactivity: pathogens Human Rhinovirus 14,Human Rhinovirus 16,Measles

Assay Type

Immuno-Antigen

Self Test

Yes

Reader Required

No

Subcategory

Validity test kit

Method

Immunochromatography

Measurement

Qualitative

Time

10 minutes

Subclass

Sandwich

LOD

100 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0.0285 AU

False negatives

0.0046 AU

Precision

Evaluated

Accuracy

98.69 % (Antigen)

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

97.15 % (Antigen)

Clinical Specificity

99.56 % (Antigen)

Type of antigen

Nucleocapsid protein

Notes

The current VOC including Alpha, Beta, Gamma, Delta, Omicron and Omicron BA.2 which will not influence the performance of the Test. antigen_epi NTD (44-180), N-CTD, 209-232a.