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BIONEXIA^® Rota Adeno

Aid for rapid, differential diagnosis of viral gastroenteritis

BIONEXIA^® Rota-Adeno is a qualitative immunochromatographic test that allows simultaneous detection and differentiation of Rotavirus and Adenovirus in a single stool extract. It offers a doubly simple and doubly reliable solution for rapid diagnosis of viral gastroenteritis.

User-friendly, cost-effective procedure for universal practice
Result available after only 10 minutes
State-of-the-art performance
Accurate first-line answer

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Ease of use for rapid results – State-of-the-art performance

Differentiating a bacterial gastroenteritis from a viral form is key to ensure appropriate patient management and treatment. Early diagnosis of viral infection by laboratory testing helps avoid unnecessary use of antimicrobial therapy and contain disease outbreaks.

Rotavirus group A and Adenovirus serotypes 40 & 41 are a common cause of viral gastroenteritis, with Rotavirus being the leading cause of acute gastroenteritis in infants and young children. Guidelines for the management of gastroenteritis recommend the use of Rotavirus and Adenovirus antigen tests as a first-line answer for children under the age of 5, immuno-compromised patients and disease outbreaks investigation in institutions¹.

BIONEXIA^® Rota-Adeno test allows rapid detection and differentiation of Rotavirus and Adenovirus in human stool specimens, providing an accurate first-line answer in the management of patients presenting with symptoms of gastroenteritis.

Ease of use for rapid results

Validated for use in laboratories and for near-patient testing as part of a medical consultation
A simple procedure for results in just 10 minutes:

Collect and extract the stool sample using the collection tube:

Apply 2 drops of diluted sample into the cassette sample well:

Read the result between 10 and 15 minutes later:

Solid stools:

Liquid stools:

Compatible with standard fecal transport tubes
Safe procedure: the convenient extraction vial ensures very limited contact with the stool sample
Clear instructions:
- Self-explanatory package insert
- Quick user guide printed on the box
- How-to-use video available on the internet
Long shelf life: 24 months from date of manufacturing

State-of-the-art performance

A multi-center study was carried out in 3 clinical laboratories in Europe using stool samples collected from patients showing gastroenteritis symptoms. The results of the BIONEXIA^® Rota-Adeno test were compared to those of a real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR) test and/or an immunochromatographic test (ICT):

	Performance on Rotavirus vs. RT-PCR	Performance on Rotavirus vs. ICT	Performance on Adenovirus vs. ICT
Positive % Agreement	(80/89) 89.9%	(80/82) 97.6%	(25/31) 80.7%
Negative % Agreement	(108/111) 97.3%	(117/120) 97.5%	(171/171) 100%

Performance on Adenovirus:

6 samples that were positive with the other ICT and negative with BIONEXIA^® Rota-Adeno were, for 5 of them, Adenovirus serotypes 1, 2, 3, 5 or 21, which are not common causes of gastroenteritis. Adenovirus serotypes 40 and 41 are the most common serotypes responsible for gastroenteritis, whereas other serotypes are responsible for respiratory infections². The BIONEXIA^®Rota-Adeno test is more specific for detection of serotypes 40 and 41 than the other immunochromatographic test used in the evaluation study.

1 sample was not serotyped.

Performance on Rotavirus:

Within the evaluation study presented above, the BIONEXIA^® Rota-Adeno test demonstrated 89.9% sensitivity versus RT-PCR. A recent study³ comparing several Rotavirus rapid tests with RT-PCR showed that the best test demonstrated a 78.2% sensitivity. The performances of the BIONEXIA^® Rota-Adeno test are therefore excellent.

The performance data of the BIONEXIA^® Rota-Adeno test adhere to new European accreditation requirements.

See package insert for further details.

References:

1. Standards Unit, Microbiology Services, PHE Syndromic | S 7 | Issue no: 1 | Issue date: 23.12.13

2. World Health Organization (WHO). Water Recreation and Disease. Plausibility of Associated Infections: Acute Effects, Sequelae and Mortality by Kathy Pond. Chapter 6. Published by IWA Publishing, London, UK. ISBN: 1843390663

3. Kaplon et al. DIAGNOSTIC ACCURACY OF SEVEN COMMERCIAL ASSAYS FOR THE RAPID DETECTION OF GROUP A ROTAVIRUS ANTIGENS; 6th European Rotavirus Biology Meeting, ERBM 2015, 17-20 May, Dijon, France

	BIONEXIA^® Rota-Adeno
Reference	418 227
Contents of the kit	Each kit includes: 20 individually-sealed pouches each containing a test cassette, a pipette and a desiccant 20 stool extraction vials containing specimen dilution buffer Package insert Quick user guide printed on the box
Sample type	Stools
Sample volume	50 mg Liquid stools : 50 μL ± 10 μL
Performance*	ROTAVIRUS: Positive % agreement = 97.6% vs ICT Negative % agreement = 97.5% vs ICT Positive % agreement = 89.9% vs RT-PCR Negative % agreement = 97.3% vs RT-PCR ADENOVIRUS: Positive % agreement = 80.7 % vs ICT Negative % agreement = 100 % vs ICT
Time to result	10 minutes The test result is stable for 5 minutes.
Storage temperature	2 – 30°C
Shelf life	24 months from date of manufacturing