Intended Use

This qualitative immunochromatographic Plague F1 Antigen Rapid Test Kit detects Yersinia pestis F1 capsular antigen in multiple human/animal specimens for presumptive plague diagnosis and outbreak alert, with all positive results requiring lab confirmation.

Principle

The Plague F1 Antigen Rapid Test Kit is a qualitative membrane strip based immunoassay for the detection of Yersinia pestis F1 capsular antigen in human clinical specimens, animal specimens and post-mortem tissue homogenates. In this test procedure, anti-F1 capture antibodies are immobilized in the test line region of the device. After the specimen is placed in the specimen well, it reacts with colloidal-gold-labeled anti-F1 antibody conjugates that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-F1 capture antibodies. If the specimen contains Yersinia pestis F1 capsular antigen, a colored red line will appear in the test line region indicating a positive result. If the specimen does not contain Yersinia pestis F1 capsular antigen, no red line will appear in this region indicating a negative result. To serve as a procedural control, a red line will always appear at the control line region, confirming that proper volume of specimen has been added and membrane wicking has occurred.