Products Description

why choose our products

The Vibrio Cholerae O139 Antigen Rapid Test is a one-step immunochromatographic assay designed for the qualitative detection of Vibrio Cholerae O139 antigen in human stool specimens. The test works by using highly specific monoclonal antibodies to bind to the antigen, resulting in a visible test line on the strip. The results can be read within 10 minutes, and there is no need for additional instruments or equipment.
The Rapid Test is a highly accurate and reliable method for the rapid detection of Vibrio Cholerae O139. This test is particularly useful for early diagnosis and quick management of cholera outbreaks in areas with limited laboratory facilities. It is also ideal for use in field settings, where quick and accurate diagnosis can help control the spread of cholera.
The Vibrio Cholerae O139 Antigen Rapid Test is easy to use, with clear instructions provided on the package insert. The test also has a long shelf life, making it ideal for stockpiling in emergency response kits or outbreak response plans.

Sample pad, colloidal gold conjugate pad, nitrocellulose membrane, absorbent paper and PVC board. Colloidal gold marked pad labeled with vibrio cholerae O139 monoclonal antibody, nitrocellulose membrane coated with vibrio cholerae O139 monoclonal antibody, control line coated with goat anti-mouse IgG antibody.

Sample diluent: Phosphate containing buffer.

Sample collection tube.

Disposable plastic straws (optional).

Description: Different components of different batches cannot be used at the

same time to avoid erroneous results.

Operation Flow

Instruction for use must be read entirely before taking the test. Allow the reagent to equilibrate to room temperature for 30 minutes (10-30°C) prior totesting. Do not open the inner packaging until ready, it must be used in onehour if opened (Humidity≤60%, Temp: 10-30°C). Please use Vibrio Cholerae O139 Antigen Rapid Test immediately when

the humidity exceed to 60%.

To collect fecal samples

Collect sufficient quantity of feces (1-2 mL or 1-2 g) in a clean, dry sample collection container to obtain maximum antigens (if present).

To process fecal samples

Unscrew the cap of the sample collection tube, then randomly stab the sample collection applicator into the fecal sample in at least 3 different sites to collect approximately 50mg of Feces.

Take out the casttettte

Invert the sample collection tube and transfer 3 full drops (80-100µL) of the extracted sample to the sample well (S) of the test cassette ,then start the timer. Avoid trapping air bubbles in the sample well (S).

Products Description

Clinical trial results A clinical evaluation was conducted on 1040 samples comparing the results obtained using the Diagnostic Kit for Vibrio Cholerae O139 Antigen Rapid Test other commercially available Cholerae tests. Comparison for all subjects is showed in the following table:

Method		Reference Product		Total Results
Vibrio Cholerae O139 Antigen Rapid Test	Results	Positive	Negative	Total Results
	Positive	233	6	239
	Negative	7	794	801
Total Results		240	800	1040

PPA: 97.08% (95%CI: 94.10%-98.58%);

NPA: 99.25% (95%CI: 98.37%-99.66%);

OPA: 98.75% (95%CI: 97.87%-99.27%)

The limit of detection limit of Vibrio Cholerae O139 Antigen Rapid Test wasdetermined to be 6.2x10 7CFU/ml .

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