Point of need diagnostic with thermal control
Provided herein are systems and methods for a point of need testing system. In some embodiments, the point of need testing system includes a first collector and a sample amplifier. The first collector is configured to collect a first biofluid sample. The sample amplifier includes an inlet dimensioned to receive the first biofluid sample. The sample amplifier further includes a filter, a heater, and a second collector. In some embodiments, a reader can be used with the sample amplifier to read a second biofluid produced by the sample amplifier.
1 . A point of need testing system comprising:
a first collector configured to collect a first biofluid sample;
a sample amplifier configured for performing an amplification reaction to generate amplification products of a target nucleic acid to produce a second biofluid sample, the sample amplifier comprising:
a first inlet;
wherein the sample amplifier is fluidly coupled to the first collector by the first inlet,
wherein the first inlet is dimensioned to receive the first biofluid sample from the first collector;
a reagent reservoir containing one or more reagents for performing the amplification reaction to generate amplification products of the target nucleic acid;
a filter fluidly coupled to the first collector and to the reagent reservoir, and configured to remove particulates from the first biofluid sample;
an amplifier heater positioned adjacent to the reagent reservoir and configured to accelerate reaction kinetics of the amplification reaction of the target nucleic acid within the first biofluid sample to produce the second biofluid sample;
a sample amplifier housing,
wherein the filter, the reagent reservoir, and the amplifier heater are disposed within the sample amplifier housing,
a second collector removably coupled to the reagent reservoir and configured to collect the second biofluid sample;
an excitation array;
a photodetector; and
a reader configured to accept the second biofluid sample and produce an output, the reader comprising:
a second inlet dimensioned to receive the second biofluid sample from the second biofluid collector;
a lateral flow test strip coupled to the second inlet and configured to transport the second biofluid sample from the second inlet to a detection site positioned between the excitation array and the photodetector;
wherein the excitation array is arranged to irradiate the detection site and the photodetector is arranged to detect electromagnetic radiation emitted from the detection site and configured to produce the output;
a reader heater positioned adjacent to the lateral flow test strip configured to heat the second biofluid sample transporting along the lateral flow test strip; and
a reader housing, wherein the lateral flow test strip, the detection site, and the reader heater are disposed within the reader housing.
2 . The point of need testing system of claim 1 , wherein the photodetector is configured to detect a signal from the second biofluid sample at the detection site, wherein the second biofluid sample comprises amplification products of the target nucleic acid, wherein the target nucleic acid originates from a pathogen.
3 . The point of need testing system of claim 1 , wherein the reagent reservoir contains one or more reagents for performing an amplification reaction to generate amplification products of a control nucleic acid and the amplifier heater is configured to accelerate reaction kinetics of the amplification reaction of the control nucleic acid within the first biofluid sample to produce the second biofluid sample.
4 . The point of need testing system of claim 3 , wherein the photodetector is configured to detect a signal from a detection sample at the detection site, wherein the detection sample comprises amplification products of the control nucleic acid originating from a subject and the target nucleic acid originating from a pathogen.
5 . The point of need testing system of claim 1 , wherein the sample amplifier is removably coupled to the reader.
6 . The point of need testing system of claim 5 , wherein the sample amplifier is configured as a portable sample amplifier and the reader is configured as a stationary reader so that the portable sample amplifier can be brought into contact with the stationary reader such that the stationary reader accepts the second biofluid sample from the portable sample amplifier.
7 . The point of need testing system of claim 1 , wherein the sample amplifier includes an indicator configured to produce an indication that the second biofluid sample has been produced from the first biofluid sample.
8 . The point of need testing system of claim 1 , wherein the photodetector is configured to communicate a signal wirelessly.
9 . The point of need testing system of claim 1 , wherein the reader further comprises:
a first optical filter positioned between the excitation array and the detection site; the first optical filter is arranged to selectively provide the detection site with a first wavelength of electromagnetic radiation from the excitation array; and
a second optical filter positioned between the detection site and the photodetector; the second optical filter is arranged to selectively provide a second wavelength of electromagnetic radiation emitted from the detection site to the photodetector.
10 . The point of need testing system of claim 9 , wherein the photodetector is configured to detect the presence of amplification products of the target nucleic acid in the second biofluid sample as altered electromagnetic radiation intensity emitted at the second wavelength relative to an amplification product free second biofluid sample.
11 . The point of need testing system of claim 1 , wherein the amplifier heater is configured to provide heat for an isothermal application reaction.