In-line testing development diagnostic analysis
In-line testing and product delivery assemblies, methods, operations, and systems are shown and described. In one embodiment, an in-line testing and product delivery system includes a supply of product having at least one outlet with a valve closure and a downstream delivery line, a recirculation closed loop in fluid communication with the outlet and supply, and a reader to generate a rapid test result from a single use assay for detection of a presence or an absence of an analyte in the supply. The result provides monitoring of a detection of the analyte to block release of product supply into the delivery line.
1 . An in-line testing and product delivery assembly, said assembly comprising:
a. a supply of product having at least one outlet;
b. a sample feed in fluid communication with said supply of product to divert a portion of said product for testing;
c. a reader to receive a sample from said sample feed and generate a test result from an assay for detecting a presence or absence of an analyte, said reader having a defined inclined imaging cavity with a proximate cavity portion and a distal cavity portion, wherein said proximate cavity portion aligns a first end of said assay vertically offset below said distal cavity portion to incline a second end of said assay in a predetermined inclined imaging position having an incline angle from horizontal and an optical detector positioned to image said assay positioned within said inclined imaging cavity and an incubator providing a controlled incubation temperature during imaging; and
d. a delivery line in fluid communication with said at least one outlet and having a delivery output valve, and
detection of said analyte triggers a closure of said delivery output valve, and a detection of an absence of said analyte triggers an opening of said delivery output valve to release said supply of product through said delivery line.
2 . The assembly of claim 1 , wherein said reader includes a hood to removably receive said assay, and wherein said hood comprises a puncture tip protruding to puncture said assay.
3 . The assembly of claim 2 , wherein said hood includes a sample supply line in fluid communication with said sample feed to dispense sample into said assay.
4 . The assembly of claim 3 , wherein said sample feed aligned adjacent said puncture tip to dispense sample into said assay at said puncture tip.
5 . The assembly of claim 1 , wherein said inclined cavity having an elongated channel receiving and maintaining said assay in an inclined testing position.
6 . The assembly of claim 5 , wherein said inclined cavity having a proximate portion and an opposing distal portion, wherein said distal portion positioned above said proximate portion at about a forty-five degree incline.
7 . The assembly of claim 1 , wherein said reader generates a definitive test result within about fifteen seconds to about one minute.
8 . The assembly of claim 7 , wherein said reader generates a definitive test result within about thirty seconds.
9 . The assembly of claim 1 , including an auto-sampler in fluid communication with said sample feed.
10 . The assembly of claim 1 , wherein said sample feed being a closed loop recirculation system about said supply of product.
11 . The assembly of claim 10 , including an auto-sampler in fluid communication with said closed loop system at a sample release valve, wherein said recirculation loop being in fluid communication with said at least one outlet and having a re-entry fluid communication with said supply of product.
12 . The assembly of claim 10 , wherein at least a portion of said recirculation loop being a single use disposable conduit.
13 . The assembly of claim 10 , wherein said recirculation loop includes a pump.
14 . The assembly of claim 1 , wherein said assay comprises a single-use test strip.
15 . The assembly of claim 1 , wherein said reader's optical detector detects a first transmission of light on said assay and detects at least a subsequent transmission of light on said assay, and wherein incubation of said assay and detection of said transmissions of light on said assay generates said test result.
16 . The assembly of claim 1 , wherein said reader generates at least one borderline test result.