Point-Of-Birth System And Instrument, Biochemical Cartridge, And Methods For Newborn Screening

A point-of-birth instrument for processing sample fluid comprising:

• a housing;
• a loading deck for receiving a biochemical cartridge having sample fluid;
• a smart display that interfaces with a user;
• an input reader;
• and
• a biochemical testing module that includes a processor for testing assays;
• wherein the smart display provides results from the testing assays.

A biochemical cartridge for newborn screening comprising:

• a bottom substrate;
• a top substrate spaced from the bottom substrate by a gap;
• a cover positioned adjacent the top substrate;
• and
• a sample input well having a loading port and a well cap assembly for opening and closing the loading port;
• wherein the sample input well is for collection of newborn testing fluids and the biochemical cartridge is for insertion into a newborn screening instrument for testing.

A method for newborn screening comprising the steps of:

• providing a point-of-birth testing system comprising:
• a point-of-birth instrument for processing sample fluid;
• a smart display that interfaces with the point-of-birth instrument;
• and
• a biochemical cartridge having a reservoir for receiving sample fluid for processing;
• providing identification information to the testing system;
• loading sample fluid into the reservoir of the biochemical cartridge;
• sealing the reservoir of the biochemical cartridge after loading with sample fluid;
• loading the biochemical cartridge into the point-of-birth instrument;
• releasing the sample fluid into an assay of the biochemical cartridge for processing;
• processing of the sample fluid by the point-of-birth instrument;
• interfacing with the smart display to obtain results of the processed sample fluid;
• and
• communicating the results.