Check4® Rota + Adeno

The test device consists of a plastic housing containing two different sticks for the detection of Rotavirus and Adenovirus. A colored anti Rotavirus or Adenovirus monoclonal antibody colloidal gold conjugate is placed at the left end of the membrane. After collection in a tube containing the extraction solution, the faeces sample is dissolved and few drops of this extract are added into each well of the reaction device.

As the test sample flows through the absorbent device, the labelled antibody-dye conjugate binds to the Rotavirus and Adenovirus antigen (when present in the sample) forming an antibody antigen complex. This complex binds in the positive reaction zone producing a rose-pink coloured band. In absence of Rotavirus or Adenovirus, 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 zone producing a rose-pink coloured band demonstrating that the reagents are functioning correctly.

Rotavirus and Adenovirus are both a major cause of infectious gastroenteritis and related syndromes in infants and children. Rotaviral gastroenteritis may result in mortality for populations at risk such as infants, the elderly, and immunocompromised patients. In temperate climates, Rotavirus infections occur mainly in the winter months. Endemics as well as epidemics affecting some thousand people have been reported. With hospitalised children suffering from acute enteric disease up to 50 % of the analysed specimen were positive for Rotavirus. The viruses replicate in the cell nucleus and tend to be host species specific producing a characteristic cytopathic effect (CPE).

Adenoviruses have been recovered from virtually every organ system of humans and have been associated with many clinical syndromes including pharyngitis, pharyngo conjunctival fever, bronchitis pneumonia for the respiratory tract in addition to gastroenteritis. Severe eye diseases like Epidemic keratoconjunctivitis (EKC) or acute hemorrhagic cystitis are also caused by Adenovirus.

Rotavirus or Adenovirus infections can be easily transferred as the virus breeds in the gut and is secreted with faeces. Therefore, nosocomial infections with these viruses are dangerous, particularly in paediatric wards and neonatal nurseries, and their management is difficult.

Stool specimen should be collected as soon as possible after onset of symptoms.

1.Check4® Rota + Adeno test is designed to detect Rotavirus and Adenovirus antigen in the stool samples.
2.As for any diagnostic procedure, the physician or clinician should evaluate data obtained by the use of this kit in light of other clinical information.
3.A negative result does not exclude an infection. If a reasonable suspicion of an infection exists, another stool specimen should be investigated.
4.A positive result does not exclude presence of other pathogens.

1.This test is designed for in vitro diagnostic use and for healthcare professional use only.
2.Carefully read the instructions before carrying out the test.
3.Do not use after the expiry date printed on the package label.
4.All reagents and materials coming in contact with potential infectious specimens must be treated with appropriate disinfectants or autoclaved at 121°C for at least one hour.
5.If any Check4® Rota + Adeno test sealed aluminium pouches are damaged and/or previously opened then the devices should not be used.
6.Wear protective clothing such as laboratory coats and disposable gloves while assaying samples.
7.Follow relevant local procedures to facilitate the safe disposal of the device and all materials (including sample containers and used kit contents) which could be contaminated with infection or microbial hazards, such as potentially infectious substances of human origin. Clean area where samples have been handled.

ROTAVIRUS

Sensitivity and Specificity

A study was performed on 70 stool samples pretested with FUMOUZE latex (ROTALEX).

There was 100% correlation for sensitivity and specificity between the ROTALEX test and the Check4® ROT-AD DUO TEST.

ADENOVIRUS

Sensitivity and Specificity

A study was performed on 49 stool samples pretested using the MERIDIAN Elisa test.

There was 100% correlation for sensitivity and specificity between the MERIDIAN Elisa test and the Check4® ROT-AD DUO TEST.

Important: The two bands can be any shade of red/pink and can be lighter or darker than the other.

For more information you can visit the below:

• https://www.mayoclinic.org/diseases-conditions/rotavirus/symptoms-causes/syc-20351300
• https://www.nhs.uk/conditions/vaccinations/rotavirus-vaccine/