Test yourself or your child for the four most common viral causes of gastroenteritis simultaneously at home with our fast, CE-marked combo test. With a simple stool sample, you get a reliable result in 15 minutes indicating whether acute symptoms are caused by norovirus, rotavirus, adenovirus, or astrovirus. 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 collection paper. Unscrew the test cup cap 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, 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 down from the top to start the reaction.
- Reading: Keep the test upright and read the result after 15 minutes. (Do not interpret the result after 20 minutes have passed).
Result interpretation & Important advice
The test device features four separate test windows: Noro, Rota, Adeno, and Astro.
- Positive result: Two colored lines appear in one or more test windows (control line C and test line T). This indicates the presence of the corresponding viral antigen in the stool.
- Important advice: Viral gastroenteritis causes fluid loss. Ensure adequate hydration (preferably with oral rehydration solutions). Consult a doctor if symptoms are severe, if accompanied by high fever, or if a young child cannot keep fluids down.
- Negative result: Only the control line (C) appears in the test window. No antigens for that specific virus were detected. If symptoms persist, consult a physician.
Specifications & Product Information
CE-marked IVD product for self-testing by laypersons according to IVDR (EU) 2017/746
- Product name: Viral Diarrhea (Norovirus + Rotavirus + Adenovirus + Astrovirus) Combo Rapid Test (REF: IMVD-N647H)
- Risk class (IVDR): Class C
- Intended purpose: Rapid test for qualitative detection of norovirus, rotavirus, adenovirus, and astrovirus antigens in human stool specimens
- Results within: 15 minutes (do not interpret after 20 minutes)
- Sample type: Stool sample
- Performance characteristics:
- Norovirus: Sensitivity 98.1 % | Specificity 99.2 % | Overall accuracy 99.0 %
- Rotavirus: Sensitivity 98.0 % | Specificity 98.0 % | Overall accuracy 98.0 %
- Adenovirus: Sensitivity 96.0 % | Specificity 99.0 % | Overall accuracy 98.0 %
- Astrovirus: Sensitivity 95.2 % | Specificity 99.2 % | Overall accuracy 98.3 %
- 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)