CE marked IVD Chromatographic Immunoassay Cholera Ag O1/O139 Test Kit

INTENDED USE

The Vibrio cholerae O1/O139 Antigen Combo Rapid Test is a rapid visual immunoassay for the qualitative, presumptive detection of Vibrio cholerae O1 and/or O139 in human fecal specimens. This kit is intended for use as an aid in the diagnosis of Vibrio cholerae O1 and/or O139 infection.

SPECIMEN COLLECTION AND STORAGE

• The Vibrio cholerae O1/O139 Antigen Combo Rapid Test is intended for use with human fecal specimens only.

• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods.Specimens may be stored at 2-8°C for up to 72 hours.

• Bring specimens to room temperature prior to testing.

• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.

INTERPRETATION OF RESULTS

POSITIVE RESULT:

A colored band appears in the control band region (C) and another colored band appears in the T band region.

NEGATIVE RESULT:

One colored band appears in the control band region (C). No band appears in the test bard region (T).

INVALID RESULT:

Control band Fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the probability persists,discontinue using the kit immediately and contact your local distributor.

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