Check4® RSV

The method employs a unique combination of monoclonal dye conjugate and polyclonal solid phase antibodies to selectively identify RSV with a high degree of sensitivity and specificity. After collection and treatment, the sample is added to the sample well (A) of the reaction device. As the test sample flows through the absorbent device, the labelled antibody-dye conjugate binds to the RSV antigen (when present in the sample) forming an antibody antigen complex. This complex binds to the polyclonal antibody in the positive reaction window producing a rose-pink coloured band (B). In the absence of RSV, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device, past the positive reaction zone and control zone. Unbound conjugate binds to the reagent in the control window (C) producing a rose-pink coloured band demonstrating that the reagents are functioning correctly.

Respiratory syncytial virus (RSV) is the most important cause of pneumonia and bronchiolitis in infants and small children1,2. Like the other respiratory viruses, RSV causes a range of respiratory illnesses, the most common being a cold with profuse rhinorrhea. Between 1% and 2% of infected infants require hospitalisation, the most severe disease occurring in the first year of life and in those with underlying cardiopulmonary disease. In normal infants and children, the virus is shed for 2 to 3 weeks overall or 1 or 2 weeks after the children appear in the hospital3. Because of its high infectivity and because hospital staff as well as patients are susceptible, RSV has emerged as the most frequent cause of nosocomial infections on paediatric wards.

RSV is recovered almost exclusively from the respiratory tract. Secretions are ideally obtained as such, either by aspiration through a catheter or by suction into a soft rubber bulb. Swabs, either nasopharyngeal or throat, may also be used but are somewhat inferior to aspirated secretions. If the sample analysis is not performed immediately, store the swabs in a clean and dry container (not supplied) at 2-8°C and proceed with the analysis in the next 24 hours. Do not use any holding medium.

1.This test is designed for in vitro diagnostic use and for professional use only.
2.Please read the instruction leaflet carefully before using this test.
3.Do not use beyond the expiry date which appears on the package label.
4.Do not use a test from a damaged protective wrapper.
5.All reagents and materials coming in contact with potentially infectious specimens must be treated with appropriate disinfectants or autoclaved at +121°C for at least one hour.
6. Wear protective clothing such as laboratory coats and disposable gloves while assaying samples.

If there is no distinct coloured band visible in the control window, the test is invalid. It is recommended that in this case the test be repeated with a fresh device.

A study was performed on 49 positive nasopharyngeal aspirate samples obtained from children suffering from RSV type bronchiolitis (RSV.A, RSV.B or non-identified RSV) and on 48 other nasopharyngeal aspirate free of virus. The Check4® RSV results were compared with Immunofluorescence (IF) results obtained using the IMAGEN VRS kit (DAKO). From this study, it appears that Check4® RSV has a sensitivity of 85.7%, a specificity of 91.6% and an overall agreement of 88.6% with the immunofluorescence method.

For more information on RSV you can visit the below:

• https://www.nhs.uk/conditions/bronchiolitis/
• https://elht.nhs.uk/patients/self-care-and-treatments-home/rsv