Vibrio Cholerae Colloidal Gold Rapid Test Kit

Packaging Specifications

• O1 Serogroup Test Strip: 25 servings/box
• O139 Serogroup Test Strip: 25 servings/box

Intended Use

This product is intended for the qualitative detection of O1 and O139 serogroups of cholera vibrio in fecal specimens.

Principle of Testing

• The test kit utilizes the colloidal gold immunochromatographic sandwich method to detect O1 serogroup and O139 serogroup antigens (Ag) of cholera vibrio in specimens.
• Colloidal gold is used as a marker, and nitrocellulose membrane serves as the carrier.
• The membrane is coated with two types of antibodies: monoclonal antibodies (Ab) against cholera vibrio O1 serogroup or O139 serogroup for capturing antigens in the specimen, and polyclonal goat anti-mouse antibodies for quality control of the test strip.

Storage Conditions and Shelf Life

• Store at room temperature (4~30℃), with a shelf life of 18 months.
• Refer to the label for the production date and expiration date.

Sample Requirements

• Sample Type: Fecal specimen.
• Sample Processing: Direct testing of water-like fecal samples or freshly amplified broth specimens.

Testing Method

• Balance the sample and test strip to room temperature before testing.
• Place the test strip on a clean, dry work surface.
• Add 2-3 drops of the sample to the sample entry end of the test strip (white end) using the provided pipette or a clean dropper. Start timing.
• Observe results within 2~15 minutes; results read after 15 minutes are invalid.

Interpretation of Test Results

• Negative: One red line appears at the control line position.
• Positive: Two red lines appear at both the detection line and control line positions.
• Invalid: No red lines appear at both the detection line and control line positions.

Limitations of Testing Method

• The current detection limit of this method is 10^5 bacteria/mL, so there is a possibility of false negatives in mild cases and carrier investigations.
• After amplification culture testing, if the result is still negative using this kit, it is recommended to subculture on thiosulfate-citrate-bile salt-sucrose (TCBS) agar plates and observe bacterial growth for identification before reporting a negative result.

Product Performance Indicators

• Detection limit: 10^5 bacteria/mL.
• Specificity: No cross-reaction with common pathogenic bacteria in the gastrointestinal tract has been observed.
• Stability: Room temperature (4-30℃), 18 months.

Precautions

• Carefully read the manual before operation.
• Use fresh water-like fecal specimens or freshly amplified broth specimens; do not use old specimens.
• Do not perform the test directly on rectal samples to avoid affecting the test results.
• Use the provided pipette or prepare a clean dropper for sample application. If directly immersing the test strip into the sample, do not exceed 0.5cm.
• Judge results in good lighting conditions.
• Store the test strips in a dry environment and protect them from moisture.
• Use within the expiration date of the test strip.
• This test strip is for in vitro diagnostic use only.
• Pay attention to thorough disinfection of contaminated areas and potentially infectious materials.

Basic Information

• Registrant/Manufacturer Name: Zhengzhou Wantai Bio-Pharmaceutical Co., Ltd.
• Address: 7 Dongqing Street, Zhengzhou High-tech Industrial Development Zone
• Contact:+86 0371-67997352
• Production Address: 7 Dongqing Street, Zhengzhou High-tech Industrial Development Zone