Clinical diagnostic system including instrument and cartridge

摘要

In embodiments disclosed herein, a diagnostic system is provided having a cartridge comprising at least one needle; at least one reservoir; at least one fluidic seal; and at least one fluidic channel of a fluidic pathway, wherein the cartridge is configured to store at least one reagent and at least one waste material on the cartridge. The diagnostic system is provided also having a diagnostic instrument comprising the fluidic pathway; an electrochemiluminescence (ECL) detection system; and a pump, wherein the fluidic pathway begins and ends in the cartridge and has a substantially single direction of flow in a pathway fluidically connecting the diagnostic instrument and the cartridge.

主权项

1. A method of performing a diagnostic test in a diagnostic system, comprising:
introducing a sample into a cartridge of the diagnostic system, the cartridge comprising:
structural members;a body and a cover, wherein the body and the cover mate together;at least one reagent handling station formed from the body;a septum seal between the body and the cover configured to establish a liquid and air-tight seal for the at least one reagent handling station and capable of establishing a fluidic connection with at least one probe of a diagnostic instrument in the diagnostic system;a bottom seal adjacent to the body;at least one fluidic channel formed from the body and sealed by the bottom seal, wherein the bottom seal defines in part the volume of the at least one fluidic channel; anda mounting apparatus for mounting a sample container to the cartridge, the mounting apparatus comprising:
a framework comprising at least one of the structural members of the cartridge; andat least one needle capable of establishing a fluidic connection between the cartridge and the sample container when the at least one needle pierces a septum of the sample container, wherein the framework is configured to guide the sample container into a position such that the sample container is capable of being fixed at an angle ranging from about 45° to about 5° from a horizontal axis of the cartridge; introducing the cartridge of the diagnostic system into the diagnostic instrument of the diagnostic system, the diagnostic instrument comprising:
a non-electrochemiluminescence (ECL) detection system;the at least one probe further comprising a first probe and a waste probe;the first probe fluidically connected to the non-ECL detection system by at least one fluidic tube;an ECL detection system fluidically connected to the non-ECL detection system by the at least one fluidic tube;a pump fluidically connected to the ECL detection system by at least one fluidic tube and fluidically connected to the waste probe by at least one fluidic tube; mixing the sample with at least one reagent to form a detectable complex, wherein the at least one reagent is stored on the cartridge; analyzing the detectable complex with the ECL detection system of the diagnostic instrument; and providing detection results through a user interface on the diagnostic instrument.