Point-of-Birth System and Instrument, Biochemical Cartridge, and Methods for Newborn Screening

Abstract

A point-of birth system and instrument, biochemical cartridge, and methods for newborn screening is disclosed. Namely, a point-of-birth system is provided the includes a point-of-birth instrument for receiving and processing a biochemical cartridge for performing newborn screening. Further, a portable smart device, such as a smartphone or tablet, is in communication with point-of birth instrument, wherein the smart device may include a newborn screening (NBS) mobile app. In one example, the point-of-birth system and point-of-birth instrument support newborn biological screening only. However, in another example, the point-of-birth system and point-of birth instrument support both newborn biological screening and newborn physiological screening.

1 . A point-of-birth testing system for newborn screening comprising:
 a point-of-birth instrument for processing sample fluid of a newborn;   a smart display communicatively coupled to the point-of-birth instrument to provide user interface and operate the point-of-birth instrument; and   a biochemical cartridge for receiving sample fluid to be processed;   wherein the biochemical cartridge inserts into the point-of-birth instrument for processing the sample fluid, and wherein the smart display communicates results of processed sample fluid.   
     
     
         2 . The point-of-birth testing system of  claim 1  wherein the biochemical cartridge is disposable. 
     
     
         3 . The point-of-birth testing system of  claim 1  wherein the point-of-birth instrument is portable. 
     
     
         4 . The point-of-birth testing system of  claim 1  wherein the smart display is a portable smart device or laptop computer. 
     
     
         5 . The point-of-birth testing system of  claim 1  wherein the system only supports newborn biological screening. 
     
     
         6 . The point-of-birth testing system of  claim 1  wherein the system supports newborn biological screening and newborn physiological screening. 
     
     
         7 . The point-of-birth testing system of  claim 6  wherein the system further comprises a pulse oximetry mechanism. 
     
     
         8 . The point-of-birth testing system of  claim 6  wherein the system further comprises a hearing screening mechanism. 
     
     
         9 . The point-of-birth testing system of  claim 1  wherein the system supports multiplexed testing. 
     
     
         10 . The point-of-birth testing system of  claim 1  wherein the system is capable of testing multiple analyte with a single sample fluid on the biochemical cartridge. 
     
     
         11 . The point-of-birth testing system of  claim 1  wherein the point-of-birth instrument performs multiple types of biochemical tests. 
     
     
         12 . The point-of-birth testing system of  claim 11  wherein the multiple types of biochemical tests include an enzymatic test, a colorimetric test, an immunoassay test, and/or a nucleic acid test. 
     
     
         13 . The point-of-birth testing system of  claim 1  wherein the system performs screening for biological markers. 
     
     
         14 . The point-of-birth testing system of  claim 13  wherein the biological markers include total bilirubin, ammonia, and/or medium-chain acyl-CoA dehydrogenase. 
     
     
         15 . The point-of-birth testing system of  claim 1  wherein the smart display includes a newborn screening mobile application to interface with a user and operate the point-of-birth instrument. 
     
     
         16 . The point-of-birth testing system of  claim 1  wherein the smart display is a display built into the point-of-birth instrument. 
     
     
         17 . The point-of-birth testing system of  claim 1  wherein the biochemical cartridge includes a horizontal reservoir module for holding liquids that is angled. 
     
     
         18 . The point-of-birth testing system of  claim 1  wherein the biochemical cartridge comprises an optics interface region that corresponds to an optics detector of the point-of-birth instrument when the biochemical cartridge is inserted into the point-of-birth instrument. 
     
     
         19 . 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.   
     
     
         20 . The point-of-birth instrument of  claim 19  wherein the housing comprises a base plate, first and second side rails mounted on the base plate, a circuit board arranged between the side rails that controls the operations of the point-of-birth instrument, a cam arranged between the side rails, a cartridge engage stepper motor, a cam belt and pulley assembly, and a motor assembly to actuate dispensing of the sample fluid of the biochemical cartridge. 
     
     
         21 . The point-of-birth instrument of  claim 20  wherein the motor assembly further comprises a stepper motor on a stepper motor support, a spring-loaded adaptor, a motor shaft, and a motor engaging member. 
     
     
         22 . The point-of-birth instrument of  claim 19  wherein the housing comprises a power input port and a power supply assembly arranged on a power supply mounting plate. 
     
     
         23 . The point-of-birth instrument of  claim 19  further comprising a fluorimeter and/or an optical spectrometer. 
     
     
         24 . The point-of-birth instrument of  claim 19  wherein the smart display is a smart device and the point-of-birth instrument further comprises a docking station that electrically connects to the smart device. 
     
     
         25 . The point-of-birth instrument of  claim 19  wherein the smart display is a smart device and the point-of-birth instrument communicates wirelessly with the smart device. 
     
     
         26 . The point-of-birth instrument of  claim 19  wherein the smart display includes a software application that interfaces with a user and allows a user to communicate the results to concerned persons, provide follow-up information, provide training for use of the instrument, perform clinical calculations, and/or perform epidemiological tracking of diseases. 
     
     
         27 . The point-of-birth instrument of  claim 19  wherein the input reader is a barcode reader. 
     
     
         28 . The point-of-birth instrument of  claim 19  wherein the input reader scans newborn identification information. 
     
     
         29 . The point-of-birth instrument of  claim 19  further comprising an optical detector. 
     
     
         30 . The point-of-birth instrument of  claim 19  wherein the instrument is portable. 
     
     
         31 . The point-of-birth instrument of  claim 19  wherein the instrument further comprises a pulse oximetry module. 
     
     
         32 . The point-of-birth instrument of  claim 19  wherein the instrument further comprises a hearing screening module. 
     
     
         33 - 59 . (canceled)