The One-Step H. pylori Rapid Tests (Whole Blood/Serum/Plasma) are qualitative membrane strip based immunoassay for the detection of H. pylori IgG antibodies in whole blood, serum or plasma. In this test procedure, anti-human IgG is immobilized in the test line region of the device. The sample reacts with H. pylori antigen coated particles that have been applied to the label pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-human IgG. If the sample contains H. pylori IgG antibodies, a colored line will appear in the test line region indicating a positive result. If the sample does not contain H. pylori IgG antibodies, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.