The Vibrio Cholerae O1 Antigen Rapid Test Cassette is a quick, accurate tool for detecting Vibrio cholerae O1 antigens in human feces. Designed exclusively for professional and in vitro diagnostic use, this rapid test assists healthcare professionals in diagnosing O1 group Cholera infection in a matter of minutes.
Intended Use:
The Vibrio Cholerae O1 Antigen Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of Vibrio cholerae O1 antigens in human fecal samples. It is intended to support diagnosis of cholera infection in clinical settings.
Background:
Cholera, caused by Vibrio cholerae, is a severe intestinal infection characterized by sudden onset of watery diarrhea and vomiting, which can lead to rapid dehydration, electrolyte imbalance, and even death if untreated. Cholera spreads mainly through contaminated water or food, making it a significant concern in areas with poor sanitation. Immediate treatment focuses on rehydration through oral or intravenous solutions. Antibiotics are also beneficial for severe cases, reducing the duration and intensity of symptoms.
Test Principle:
This rapid test employs a lateral flow immunoassay mechanism. During testing, antibodies specific to Vibrio cholerae O1 carbohydrate antigen are immobilized in the test line region. A sample of fecal matter is applied to the cassette, where it reacts with labeled antibodies. If the Vibrio cholerae O1 antigen is present, a colored line appears in the test region, indicating a positive result. An internal procedural control ensures test accuracy by displaying a separate coloured line in the control region.
Key Features:
- Results Within 15 Minutes: Provides quick and reliable results, aiding in the prompt diagnosis and treatment of cholera.
- Qualitative Detection: Indicates presence of Vibrio cholerae O1 antigens but does not measure concentration.
- Easy to Use: Suitable for healthcare professionals at point-of-care locations.
- Internal Control Line: Assures proper specimen volume and procedural accuracy.
Warnings and Precautions:
- For professional in vitro diagnostic use only.
- Ensure test cassettes are used within expiration date.
- Handle all specimens as potentially infectious.
- Dispose of used materials according to local, state, and federal regulations.
Contents:
- Test Cassette: Contains membrane strip coated with Vibrio cholerae O1 antibody for specific detection.
- Buffer Solution: Included for specimen processing.
- Package Insert: Instructions for proper use.
Additional Materials Required (Not Provided):
- Specimen collection container
Storage and Stability:
- Temperature Range: Store between 4–30°C (40–86°F) in sealed packaging.
- Stability: Stable until expiration if unopened. Once opened, use within one hour to prevent deterioration.
Sample Collection and Preparation:
- Sample Type: Fecal sample (1-2 mL or 1-2 g).
- Storage: Test within 6 hours of collection for optimal results. Samples may be stored at 2-8°C for up to 3 days or frozen below -20°C for extended storage.
- Preparation: Collect sample using the provided collection tube; mix thoroughly with buffer solution. Bring sample to room temperature before testing.
Test Procedure:
- Allow the test device, specimen, and buffer solution to reach room temperature (15–30°C).
- Remove the test cassette from its pouch and place it on a flat surface.
- Add 3 drops (approx. 100 µL) of processed sample to the specimen well on the cassette.
- Start the timer; read results after 15 minutes. Do not interpret results after 20 minutes.
Interpretation of Results:
- Positive Result: Two lines appear (control line “C” and test line “T”).
- Negative Result: One line appears in the control region (C) only.
- Invalid Result: No line appears in the control region (C); repeat the test with a new cassette.
Quality Control:
The test includes an internal procedural control. A colored control line should always appear to confirm test accuracy and procedural integrity. Positive and negative control standards are recommended as good laboratory practice.
Limitations:
- For qualitative detection only; does not quantify antigen levels.
- Negative results must be confirmed by culture, as low antigen levels may not be detectable.
- Blood in the sample may interfere with results.
Performance Characteristics:
- Accuracy: In studies, the Vibrio Cholerae O1 Antigen Rapid Test showed a 98.82% agreement with commercially available tests for positive samples and a 98.09% agreement for negative samples.
- Cross-Reactivity and Interference: Tested for cross-reactivity with various organisms and endogenous substances. No cross-reactivity or interference observed.
References:
- Bhuiyan NA et al. “Use of Dipsticks for Rapid Diagnosis of Cholera Caused by Vibrio Cholera O1 and O139.” J Clin Microbiol, 2003.
- Peruski AH, Peruski LF. “Immunological Methods for Detection and Identification of Infectious Disease and Biological Warfare Agents.” Clin Diagn Lab Immunol, 2003.
- Hasan JA et al. “A Novel Kit for Rapid Detection of Vibrio Cholera O1.” J Clin Microbiol, 1995.