Systems and Methods for Assay Processing

Abstract

Methods for obtaining a sample from a subject include providing a sample collection room within a retail store; and obtaining a sample from a subject at a retail location. Sample collection rooms may house a sample analysis device or system. Samples may be small, e.g., a finger-stick capillary blood sample.

What is claimed is: 
     
         1 . A method for obtaining a sample from a subject, said subject having a body part, the method comprising:
 obtaining, in a sample collection room, a sample from said body part of said subject, wherein the sample obtained comprises capillary blood in a volume between about 10 to about 400 μL; and   performing at least one HSV1 assay on said sample.   
     
     
         2 . The method of  claim 1 , wherein said volume of capillary blood is in the range of about 50 to about 400 μL. 
     
     
         3 . The method of  claim 1 , wherein said volume of capillary blood is in the range of about 100 to about 400 μL. 
     
     
         4 . The method of  claim 1 , wherein said volume of capillary blood is in the range of about 150 to about 400 μL. 
     
     
         5 . The method of  claim 1 , wherein said volume of capillary blood is in the range of about 200 to about 400 μL. 
     
     
         6 . The method of  claim 1 , wherein said volume of capillary blood is from one or more fingerstick puncture sites. 
     
     
         7 . A method of performing an assay on an instrument, the method comprising:
 storing assay cartridge in a pouch at a temperature above freezing, between 2 to 4° C.;   scanning a sample container identifier on a sample container into SampleID field of a tracking file;   opening cartridge pouch and discard pouch and desiccant in biohazard bin;   scanning cartridge identifier on the cartridge into Barcode field of the tracking file and enter data into the PatientID field;   orienting the cartridge such that an indicator on the cartridge confirms that cartridge is correctly aligned with the instrument;   transferring 20-40 μL of plasma using a pipette into a vessel highlighted with a visual indicator on the cartridge;   displaying instructions prompts on a display of instrument to insert the cartridge into the instrument and to start testing;   inserting the cartridge into the instrument;   once the cartridge is pulled into the instrument, the display will indicate that processing is initializing;   once initialization is complete, the instrument automatically executes the protocol and the display will show a circular indicator displaying a percentage of the total time to execute the protocol, and an estimated countdown of the time remaining to complete the protocol;   when the protocol is successfully completed, a “complete” message will appear briefly indicating that the process completed successfully, followed by a “Test complete” screen on the display;   displaying an Eject Screen on the display to indicate that the test has been completed and the cartridge may be ejected by pressing the button;   opening a cartridge door on the instrument and ejecting the cartridge, wherein the cartridge door will remain open for up to a threshold period of time after which the instrument retracts the cartridge and shuts the cartridge door to maintain the temperature within the instrument, in that case, the screen will go back to the Eject Screen;   discarding the cartridge into a biohazard bin; and   once the ejected cartridge is removed, the instrument detects such removal and the cartridge door will close and the display will navigate back to the Home Screen.   
     
     
         8 . The method of  claim 7 , wherein the cartridge is kept right-side-up as indicated by a sticker on the top side of each pouch around each cartridge. 
     
     
         9 . The method of  claim 7  comprising wherein once the instrument has initialized, the Home Screen will appear; tapping the Home Screen to begin processing. 
     
     
         10 . The method of  claim 7  comprising tapping on the Home Screen brings you to the Open Screen. 
     
     
         11 . The method of  claim 7  comprising touching the Open Button to open the cartridge door on the front of the instrument, starting a countdown timer. 
     
     
         12 . The method of  claim 7  wherein if the cartridge is not inserted within the 90-second period, the door will close, and if this happens, the screen will go back to the Open Screen;
 pressing the Open Button to reopen the cartridge door. 
 
     
     
         13 . A method for processing a sample from a subject in an instrument, the method comprising:
 after a cartridge with the sample is loaded into the instrument, the following steps are automatically implemented in sequence by a processor in the instrument over a period of time less than a threshold time period;   mixing diluent with sample plasma containing HSV-1 IgG antibodies, negative control material and positive control material containing HSV-1 IgG antibodies to yield sample diluent in a first vessel, diluted positive control sample in a second vessel, and diluted negative control sample in a third vessel;   during a first incubation step, reacting HSV-1 IgG antibodies present in the diluted positive control sample and sample to bind an HSV-1 glycoprotein G (gG) recombinant antigen on a coated surface;   following the first incubation step, removing unbound materials with a wash cycle;   adding a detection reagent-AP conjugate and during a second incubation step, reacting the detection reagent-AP conjugate with HSV-1 IgG antibodies already bound to the coated surface;   following the second incubation, removing unbound materials with a wash cycle;   adding a chemiluminescent substrate to a capture-analyte-detection complex during a third incubation step to initiate a chemiluminescence reaction; and   detecting light generated by the chemiluminescence reaction and analyzed by the instrument using a calibration function to determine the cut-off index (COI) values for the sample.   
     
     
         14 . The method of  claim 13  wherein the coated surface comprises a coated surface of at least one bead. 
     
     
         15 . The method of  claim 13  wherein the coated surface comprises a plurality of coated beads, each with a coated surface. 
     
     
         16 . The method of  claim 13  wherein the coated surface comprises a coated surface of at least one pipette tip. 
     
     
         17 . The method of  claim 13  wherein the threshold time period is between about 60 to about 80 minutes.