In vitro diagnostic device

An in vitro test device comprising:

• a plunger having a plunger axis;
• one or more plunger sidewalls that are parallel to the plunger axis;
• a plunger base that is perpendicular to the plunger axis and open in the middle to enable communication with an interior of the plunger;
• a piercing member that is open in the middle to enable fluid communication with the interior of the plunger and that has a smaller cross-sectional area than that bounded by the one or more plunger sidewalls;
• and, a test strip channel disposed in a sidewall in the one or more plunger sidewalls;
• a housing having a housing axis;
• one or more housing sidewalls that are parallel to the housing axis;
• a housing base on a housing base end, which is perpendicular to the housing axis and closed in the middle, such that the housing base and the one or more housing sidewalls form a liquid-impermeable vessel;
• and an open end opposite the housing base that slidably receives the plunger;
• one or more reagent pouches disposed inside the housing, adjacent the housing base end, in a reagent region;
• a lateral flow test strip disposed in the test strip channel;
• and
• a locking member having a first configuration and a second configuration;
• wherein, in the first configuration, the locking member prevents the piercing member from impinging into the reagent region, and wherein, in the second configuration, the locking member allows the plunger to be translated into the housing such that the piercing member impinges into the reagent region.

A method of identifying the presence of an analyte, the method comprising:

• providing an in vitro test device and a test swab, the in vitro test device comprising (a) a plunger having a plunger axis;
• one or more plunger sidewalls that are parallel to the plunger axis;
• a plunger base that is perpendicular to the plunger axis and open in the middle to enable communication with an interior of the plunger;
• a piercing member that is open in the middle to enable fluid communication with the interior and that has a smaller cross-sectional area than that bounded by the one or more plunger sidewalls;
• and, a test strip channel disposed in a sidewall in the one or more plunger sidewalls;
• (b) a housing having a housing axis;
• one or more housing sidewalls that are parallel to the housing axis;
• a housing base on a housing base end, which is perpendicular to the housing axis and closed in the middle, such that the housing base and the one or more housing sidewalls form a liquid-impermeable vessel;
• and an open end opposite the housing base that slidably receives the plunger;
• (c) one or more reagent pouches disposed inside the housing, adjacent the housing base end, in a reagent region;
• (d) a lateral flow test strip disposed in the test strip channel;
• (e) a locking member having a first configuration and a second configuration;
• wherein, in the first configuration, the locking member prevents the piercing member from impinging into the reagent region, and wherein, in the second configuration, the locking member allows the plunger to be translated into the housing such that the piercing member impinges into the reagent region;
• obtaining a sample using the test swab;
• transitioning the locking member from the first configuration to the second configuration;
• advancing the plunger into the housing to pierce the one or more reagent pouches in the reagent region to cause reagent therein to be released and mix;
• inserting the test swab with obtained sample into the interior of the plunger;
• rotating the in vitro test device and disposing it on its plunger base;
• and
• determining whether the analyte is present.