Vibrio Cholera Test Kit

【INTENDED USE】

  The V. Cholerae O1/O139 Ag Combo Rapid Test (feces) is a rapid chromatographic immunoassay for the qualitative detection of Vibrio Cholera O1 and O139 in feces.

【REAGENTS】

  The test cassette contains Vibrio Cholera O1 and O139 antibodies conjugated colloid gold and Vibrio Cholera O1 and O139 antibodies coated on the membrane and the phosphate buffer solution.

【DIRECTIONS FOR USE】

  Allow test cassette, specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing. 1. Unscrew the cap of the specimen collection tube, then randomly stab the specimen collection applicator into the fecal specimen in at least 3 different sites. Do not scoop the fecal specimen. 2. Screw on and tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Specimens prepared in the specimen collection tube may be stored for 6 months at -20°C if not tested within 1 hour after preparation. 3. Hold the specimen collection tube upright and open the cap onto the specimen collection tube. invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approximately 80μ L) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below. 4. Read the results within 15 minutes. Note: strong specimens may produce positive results in as little time as 1 minute. Confirm negatives in 15-30 minutes.

【INTERPRETATION OF RESULTS】

(Please refer to the illustration above)

POSITIVE:

Vibrio Cholerae O1 Positive: a clear pink control line(C)and a detectable test line(T2) appears, indicating positive result for Vibrio Cholerae O1 infections.

Vibrio Cholerae O139 Positive: a clear pink control line(C)and a detectable test line(T1) appears, indicating positive result for Vibrio CholeraeO139 infections.

1. Cholerae O1 and O139 Positive: a clear pink control line(C)and two detectable test line (T1 and T2) appears, indicating positive results for both types.

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Fecal Occult Blood present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: A pink colored band appears only at the control region(C),indicating a negative result for Vibrio Cholerae infections.

INVALID: No visible band at the control region. Repeat with a new test device. lf the test still fails, please contact the distributor with the lot number

【QUALITY CONTROL】

Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal valid procedural control. It confirms sufficient specimen volume. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.