Test yourself or your child for rotavirus and adenovirus at home in peace and quiet with our fast, CE-marked combo test. With a simple stool sample, you get a reliable result in 10 minutes regarding the cause of acute gastrointestinal distress or diarrhea. Sent in a completely neutral and discreetly packaged envelope directly to your mailbox.
How to perform the test in short
- Sampling: Collect the stool sample on the provided stool collection paper. Unscrew the cap of the test cup and poke the sampling stick into 3 different places in the sample (for liquid stool, use the provided pipette to transfer 2 drops to the cup).
- Preparation: Insert the stick back into the test cup with buffer liquid, screw the cap tight, and shake for 10–15 seconds. Let the cup stand for 2 minutes. Peel off the plastic seal from the bottom of the cup, place it on a flat surface, and press the cup down from the top to start the reaction.
- Reading: Keep the test cup upright and read the result after 10 minutes. (Do not interpret the result after 20 minutes have passed).
Result interpretation & Important advice
- Rotavirus Positive (Line at C and T1): Rotavirus antigens have been detected in the sample. Rotavirus is the most common cause of acute gastroenteritis and diarrhea, especially in young children.
- Adenovirus Positive (Line at C and T2): Adenovirus antigens have been detected in the sample.
- Dual Positive (Line at C, T1, and T2): Both rotavirus and adenovirus antigens have been detected in the sample.
- Important advice: Ensure adequate fluid intake (preferably oral rehydration solutions) to prevent dehydration. Consult a doctor or healthcare center if symptoms are severe, if accompanied by high fever, or if a young child cannot keep fluids down.
- Negative result (Only line at C): No antigens for rotavirus or adenovirus could be detected. If diarrhea or stomach discomfort persists, you should consult a doctor.
Specifications & Product Information
CE-marked IVD product for self-testing by laypersons according to IVDR (EU) 2017/746
- Product name: Viral Diarrhea (Rotavirus + Adenovirus) Combo Rapid Test (REF: IRAC-N627H)
- Risk class (IVDR): Class C
- Intended purpose: Rapid test for the qualitative detection of rotavirus and adenovirus antigens in human stool specimens
- Results within: 10 minutes (do not interpret after 20 minutes)
- Sample type: Stool sample
- Performance characteristics:
- Rotavirus: Sensitivity 98.0 % | Specificity 98.0 % | Accuracy 98.0 %
- Adenovirus: Sensitivity 96.0 % | Specificity 99.0 % | Accuracy 98.0 %
- CE marking & Notified body: CE 0123
- Legal manufacturer: Hangzhou AllTest Biotech Co., Ltd., #550 Yinhai Street, Hangzhou, China
- EU Authorized Representative: MedNet EC-REP GmbH, Borkstrasse 10, 48163 Muenster, Germany
Package leaflet (PDF)