Product Overview

The Rotavirus Rapid Test Device (Feces) is a qualitative visual immunoassay designed for rapid detection of rotavirus in human fecal samples. It serves as a critical tool for diagnosing rotavirus infections, offering healthcare professionals a reliable and efficient diagnostic solution.

Disease Background

Rotavirus is a leading cause of acute gastroenteritis, particularly in children under five. It is highly contagious, often causing severe dehydration and hospitalization. Transmission occurs via fecal-oral routes, with peak incidence during winter in temperate regions. The virus's resilience and ability to cause outbreaks underscore the need for accessible diagnostic tools.

Product Specification

Intended use	Detection of
Storage	4-30°C
Shelf Life	24 Months
Sensitivity	99.1%
Specificity	>99.9%
Accuracy	99.5%

Ordering Information

Product Name	Catalog No.	Specimen	Format	Certification
Rotavirus Rapid Test Device (Feces)	ROT-5012	Feces	Cassette	CE

Products Description

Rapid & Accurate: Results in 10 minutes with high sensitivity (99.1%) and specificity (>99.9%).

Easy-to-Use: Simplified workflow for professional in vitro diagnostics.

Built-in Control: Internal procedural control ensures test validity.

Stable Storage: Long shelf life (4–30°C, no freezing) until expiration.

Cost-Effective: Reduces reliance on laboratory infrastructure.

Usage Steps

1.Sample Preparation

Collect 50mg of stool (solid) or 50µL (liquid) into the extraction buffer tube. Mix thoroughly.

2.Testing

Allow components to reach room temperature (15–30°C).
Add 3 drops of diluted sample to the test device's well.

3.Result Interpretation

Read at 10 minutes (do not exceed 20 minutes).

Interpretation Standards

Positive: Two bands (Control + Test).
Negative: One band (Control only).
Invalid: No Control band (retest required)

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FAQ

Q: Why is the color intensity of the test band (T) different across positive samples?

A: The color intensity of the test band (T) depends on the concentration of rotavirus antigen in the specimen. This is a qualitative test, so any visible color in region (T) indicates a positive result-color intensity cannot be used to determine the exact antigen level.

Q: What causes an invalid test result, and how should it be addressed?

A: Common causes of invalid results include insufficient specimen volume, incorrect operation procedures, or the use of expired test devices. To resolve this:
Discard the invalid test result.
Review the operation manual to ensure all steps were followed correctly.
Repeat the test with a new, unexpired test device.
If the problem persists, discontinue using the kit and contact the local distributor immediately.

Q: Is this test suitable for detecting rotavirus in non-human specimens?

A: No. The Rotavirus Rapid Test Device (Feces) is only intended for use with human fecal specimens and not for specimens from other species.

Q: Can a negative test result rule out rotavirus infection completely?

A: No. A negative result does not preclude the possibility of rotavirus infection. Viral excretion in feces peaks 3-5 days after the onset of gastroenteritis symptoms. If specimens are collected too late (long after diarrheal symptoms start), the antigen concentration may be too low to detect. Additionally, if clinical symptoms persist despite a negative result, further testing using other clinical methods is recommended.

Q: Are external quality controls provided with the kit?

A: No. External positive and negative controls are not supplied with the kit. However, as a good laboratory practice, it is recommended to test positive and negative controls regularly to confirm the test procedure and verify proper test performance. The kit includes an internal procedural control (control band "C") to confirm sufficient specimen volume and correct operation.

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