Viral gastroenteritis rapid test is an AllTest IMVD-645 combination antigen test for detecting norovirus (GI and GII), rotavirus, adenovirus and astrovirus in human stool samples. Results are read after 15 minutes. Each pack contains 10 individual test cassettes.
One cassette examines a single stool sample for four viruses associated with gastroenteritis. Separate test lines allow the results for each virus to be interpreted individually, including norovirus genogroups GI and GII.
Why choose this viral gastroenteritis rapid test?
- Four viruses in one cassette: norovirus, rotavirus, adenovirus and astrovirus.
- Norovirus GI and GII: separate test lines for both genogroups.
- Results in 15 minutes: no separate test reader required.
- Pack of 10: suitable for examining ten separate stool samples.
- Test materials included: cassettes, specimen collection tubes with extraction buffer and droppers.
Which viruses can be detected?
AllTest IMVD-645 is designed for qualitative detection of antigens from four virus groups in human stool:
- Norovirus GI and GII: separate result lines for genogroups 1 and 2.
- Rotavirus: a dedicated line in the combined rotavirus and adenovirus section.
- Adenovirus: a separate line in the same section.
- Astrovirus: a dedicated result window.
The cassette has three result windows: norovirus, rotavirus/adenovirus and astrovirus. Each window has its own control line.
The method provides qualitative positive or negative results. It does not measure viral load or identify other possible causes of gastrointestinal symptoms.
When can the test be used?
The combination assay can support the preliminary investigation of viral gastroenteritis, including situations involving acute diarrhoea, vomiting or other gastrointestinal symptoms.
Sample collection is recommended around the onset of symptoms. According to the manufacturer, peak norovirus antigen shedding in stool has been reported approximately 3–13 days after symptom onset. For rotavirus, adenovirus and astrovirus, peak shedding has been reported approximately 3–5 days after symptom onset. The timing of sample collection may affect detection.
What is included in the 10-test pack?
The package provides materials for examining 10 separate stool samples:
- 10 AllTest IMVD-645 combination test cassettes
- 10 specimen collection tubes containing extraction buffer
- Droppers for transferring samples
- Manufacturer’s instructions for use
A clean, dry stool collection container and a timer are also required. A centrifuge and pipette may be needed for additional specimen preparation as described in the manufacturer’s instructions.
How is the test performed?
- Collect the sample: Collect stool in a clean, dry container without detergents or preservatives.
- Prepare the specimen: For solid stool, collect approximately 50 mg from at least three different locations using the sampling applicator. For liquid stool, transfer approximately 50 µL into the collection tube containing extraction buffer.
- Mix the sample: Close the collection tube securely, shake thoroughly and allow the mixture to stand for 2 minutes.
- Apply the specimen: Add two full drops (approximately 80 µL) of the prepared sample to each of the three specimen wells on the cassette.
- Read the results: Keep the cassette on a flat surface and read the results after 15 minutes.
Allow the cassette, sample and buffer to reach room temperature (15–30 °C) before testing. Do not interpret results after 20 minutes. Always follow the instructions for use supplied with the product.
How are the results interpreted?
Positive result: A coloured line appears in the relevant virus test region together with the control line C. Even a faint test line is considered positive.
Negative result: The control line C appears, but no test line is visible for the relevant virus.
Invalid result: If the control line C does not appear, the result for that test section cannot be interpreted. The examination must be repeated using a new cassette.
Norovirus GI and GII, rotavirus and adenovirus have their own test lines. Astrovirus is interpreted in a separate result window.
A positive result indicates that the relevant viral antigen has been detected. A negative result does not completely rule out infection. Findings should be assessed alongside other clinical information, with confirmatory testing where appropriate.
How reliable is AllTest IMVD-645?
The manufacturer reports the following relative clinical performance results from comparative studies:
| Virus | Sensitivity | Specificity | Samples |
|---|---|---|---|
| Norovirus | >99.9% | 98.1% | 136 |
| Rotavirus | 97.3% | 97.1% | 501 |
| Adenovirus | 95.2% | 97.7% | 381 |
| Astrovirus | 97.0% | 97.2% | 105 |
Norovirus performance was compared with another rapid test. Rotavirus and adenovirus results were compared with latex agglutination, while astrovirus results were compared with another rapid astrovirus assay.
These figures describe relative performance against the comparison methods used in the manufacturer’s studies. Individual results may be affected by sample quality, collection timing and antigen concentration.
Storage and important information
- Store at 2–30 °C.
- Do not freeze the product or extraction buffer.
- Keep cassettes in their sealed foil pouches until use.
- Use each cassette promptly after opening the foil pouch and within one hour.
- Stool samples should preferably be examined as soon as possible after collection.
- If a sample cannot be examined within six hours, it may be stored at 2–8 °C for up to three days. For longer storage, keep the sample below -20 °C.
- According to the manufacturer, stool samples from infants under one year of age may produce false-positive norovirus results.
- Do not use expired products or cassettes with damaged packaging.
Winter delivery: Since the extraction buffer must not freeze, parcel delivery to a pickup point is recommended during freezing weather.
Frequently asked questions about the four-virus combination test
Which viruses does the test detect?
The assay detects antigens from norovirus GI and GII, rotavirus, adenovirus and astrovirus in human stool samples.
How many samples can be examined with one pack?
One pack contains 10 individual combination cassettes, allowing ten separate stool samples to be examined for the four virus groups.
How quickly are the results available?
Results are read 15 minutes after the prepared sample has been added to the cassette. Results must not be interpreted after 20 minutes.
Can the test distinguish norovirus GI from GII?
Yes. The norovirus section has separate test lines for genogroups GI and GII, allowing the two groups to be distinguished.
Can several viruses be detected in the same stool sample?
Yes. The same sample may produce positive results for more than one of the viruses included in the combination assay.
What does a positive result mean?
A positive result means that antigen from the relevant virus has been detected in the stool sample. It may help identify a possible cause of gastrointestinal symptoms but does not establish a final diagnosis on its own.
Does a negative result rule out viral gastroenteritis?
No. A negative result means that the relevant viral antigen was not detected within the assay’s detection capability. Infection cannot be completely excluded, and further examination may be appropriate if symptoms persist.
Product information and instructions for use
- Product: Norovirus + Rotavirus + Adenovirus + Astrovirus Combo Rapid Test Cassette (Feces)
- Product reference: IMVD-645
- Pack size: 10 tests
- CE marking and intended use: CE-marked medical device – for professional use (IVD)
- Manufacturer: Hangzhou AllTest Biotech Co., Ltd.
- EU authorised representative: MedNet EC-REP GmbH
- Importer: Abcell Oy
Read the manufacturer’s English instructions for use (IMVD-645).
Order AllTest IMVD-645 in a pack of 10 for examining stool samples for norovirus, rotavirus, adenovirus and astrovirus antigens.
