Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. A sample membrane is utilized having a collection region and a detection region, the collection region having a known saturation volume for the intended test sample. A barrier is defined between the collection region and the detection region. The collection region is saturated with the test sample having a volume of less than about 100 microliters so that a known volume of the test sample is contained in the collection region. The barrier is removed from between the collection region and detection region of the membrane and a diluent is supplied to the collection region of the membrane to facilitate flow of the test sample from the collection region to the detection region of the membrane.

Abstract: A diagnostic test kit for simultaneously detecting the presence of amines (e.g., putrescine, cadaverine, tyramine, and trimethylamine) and C-reactive protein in a vaginal sample is provided. The test kit includes a lateral flow assay device containing a chromatographic medium (e.g., porous membrane, fluidic channel, etc.). The chromatographic medium defines a first detection zone within which is contained an amine-sensitive chromogen and a second detection zone within which is contained an immunoreactive receptive material that preferentially binds with C-reactive protein or a specific binding member thereof. The first and second detection zones may produce signals that are detectable, either visually or through the use of instrumentation. In this manner, the kit provides a complimentary system for both predicting and identifying the onset of premature membrane rupture.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. A sample membrane is utilized having a collection region and a detection region, the collection region having a known saturation volume for the intended test sample. A barrier is defined between the collection region and the detection region. The collection region is saturated with the test sample having a volume of less than about 100 microliters so that a known volume of the test sample is contained in the collection region. The barrier is removed from between the collection region and detection region of the membrane and a diluent is supplied to the collection region of the membrane to facilitate flow of the test sample from the collection region to the detection region of the membrane.