Abstract: Immunoassay devices with plurality of fluid flow channels that are discrete and designed for optimal fluid control are described. Substrates configured to control the rate of fluid flow for in-situ immunoassay measurements to detect and quantify the presence of one or more analytes of interest in a sample are also described. More specifically, the present disclosure relates to consumables for lateral flow assays, which in conjunction with an instrument detect markers or causative agents of medical conditions.

Abstract: Methods and kits for diagnosis of confirmatory diagnosis of a tick-borne infection, such as Lyme disease, is provided. The methods and kits include one or more multi-channel lateral flow immunoassay test strips. In an embodiment, the test strip comprises at least five individual, discrete fluid flow channels where each of the at least five channels includes one or more binding members (antigens) for detection of immunoglobulin antibodies against a Borrelia bacterium in a blood sample. The binding members (antigens) are, in one embodiment, selected from a group of immunoglobulin antibodies consisting of p18 (decorin-binding protein), p23, p28, p30, p39, p41 (flagellin), p45, p58, p66, p93, VlSE/C6 and p31. The kits include external controls selected from a container with a positive control, a container with a negative control, and both of a container with a positive control and a container with a negative control.