Systems, compositions and methods for detecting a biological condition

A flow cytometry system for determining a biological condition in a mammalian subject, the system comprising:

• a) a valveless stationary cartridge for performing an assay, the cartridge comprising:
• i. a sealable sample chamber;
• ii. a first blister comprising a first reagent;
• iii. optionally a second blister comprising a second reagent;
• iv. optionally a third blister comprising a third reagent;
• v. a first mixing chamber;
• vi. a second mixing chamber;
• vii. a first bellows;
• wherein
• i. the sample chamber, first blister and optionally the second blister are each connected to the first mixing chamber;
• ii. the first bellows is connected to the second mixing chamber;
• iii. the first mixing chamber is connected to the second mixing chamber;
• and wherein:
• said cartridge is valveless;
• said cartridge is a closed system after receiving said specimen and sealing said sample chamber;
• the system further comprising:
• a) a cartridge handling unit for insertion of said cartridge;
• b) a mechanical controller;
• c) a laser
• d) a forward scatter detector;
• e) a fluorescence detector;
• f) a processor;
• g) a user interface touch-screen;
• wherein:
• the cartridge is being adapted to receive a fluid specimen from said subject into said sample chamber, to seal said sample chamber such that said cartridge is a closed system after sealing, pass a predetermined quantity of said specimen into said first mixing chamber;
• transfer at least one reagent from said first blister into said first mixing chamber, operate said first bellows to transfer liquid back and forth between said first and said second mixing chambers, to form a reaction product;
• and wherein:
• the cartridge handling unit is adapted to receive said cartridge;
• the mechanical controller is adapted to release said reagent(s) from said blister(s) and to operate said bellows;
• the laser is adapted to excite said reaction product;
• the forward scatter detector is adapted to detect forward scatter from said reaction product;
• the fluorescence detector comprising a multichannel photomultiplier (PMT) array, and is adapted to detect fluorescent signals associated with said reaction product;
• the processor is adapted to receive data from said fluorescence detector and from said forward scatter detector and to process said data;
• the user interface touch-screen is adapted to control operation of said laser and said detectors and to automatically receive and display an assay result from said processor to determine said biological condition in said subject.