COVID-19 and Flu A/B Multiplex Panel for Home Use (Nasal Swab)
Manufactured by CITEST DIAGNOSTICS Inc., Canada - www.citestdiagnostics.com
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.
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements