One Step H. pylori Antigen Test Device (Feces)
Intended Use
The One Step H. pylori Antigen Test Device (Feces) is a rapid chromatographic immunoassay for the qualitative detection of H. pylori antigens in human feces specimens to aid in the diagnosis of H. pylori infection.
MATERIALS
Materials Provided
· Test devices ·Package insert
· Specimen collection tubes with dilution buffer ·Droppers
Materials Required But Not Provided
· Specimen collection containers ·Timer
· Centrifuge and pipette to dispense 80 µL if required
DIRECTIONS FOR USE
(Please refer to the illustration above)
POSITIVE:* Two distinct colored lines appear. One colored line should be in the control line region (C) and another colored line should be in the test line region (T).
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of H. pylori antigens present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).
INVALID: Control line (C) fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
QUALITY CONTROL
An internal procedural control is included in the test. A colored line appearing in the control line region (C) is an internal positive procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
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.
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