Research Papers

Low-Cost Thermal Shield for Rapid Diagnostic Tests Using Phase Change Materials

[+] Author and Article Information
Luis R. Soenksen

Department of Mechanical Engineering,
Massachusetts Institute of Technology,
77 Massachusetts Ave,
Cambridge, MA 02139
e-mail: soenksen@mit.edu

David A. Martínez-Corona

Department of Animal Sciences,
Universitat Politecnica de Valencia
Camí de Vera, s/n,
València 46022, Spain
e-mail: david.alb.corona@gmail.com

Sofía Iñiguez de Gante

School of Design,
National College of Art and Design,
Ireland100 Thomas St, Merchants Quay D08,
Dublin 8, Ireland
e-mail: sofiainiguezg@gmail.com

Pierre S. Phabmixay

Department of Mechanical Engineering,
Massachusetts Institute of Technology,
77 Massachusetts Ave,
Cambridge, MA 02139
e-mail: pierresp@mit.edu

Mauricio J. Marongiu Maggi

PCM Thermal Solutions Inc.,
13400 South Route 59, Ste. 116-264,
Plainfield, IL 60585
e-mail: maurice@pcm-solutions.com

1Corresponding author.

Manuscript received July 14, 2017; final manuscript received December 12, 2017; published online January 30, 2018. Assoc. Editor: Xiaoming He.

J. Med. Devices 12(1), 011009 (Jan 30, 2018) (12 pages) Paper No: MED-17-1268; doi: 10.1115/1.4038898 History: Received July 14, 2017; Revised December 12, 2017

The shelf life of point-of-care and rapid diagnostic tests (POC-RDTs) is commonly compromised by abrupt temperature changes during storage, transportation, and use. This situation is especially relevant in tropical regions and resource-constrained settings where cold chain may be unreliable. Here, we report the use of novel and low-cost passive thermal shield (TS) made from laminated phase change material (PCM) to reduce thermal overload in POC-RDTs. Validation of the proposed design was done through numerical simulation and testing of an octadecane shield prototype in contact with a lateral flow immunoassay. The use of our TS design provided 30–45 min delay in thermal equilibration under constant and oscillating heat load challenges resembling those of field use. The addition of a thin PCM protection layer to POC-RDTs can be a cost-effective, scalable, and reliable solution to provide additional thermal stability to these devices.

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Grahic Jump Location
Fig. 1

Proposed adaptation of a PCM thermal shield in a rapid diagnostic test: (a) thermal shield assembled at the bottom of POC-RDT strip, (b) commercially available pregnancy POC-RDT cassette with assembled thermal shield, and (c) thin film of POC-RDT in addition to the thermal shield which does not substantially increase test thickness. PCM = phase change material.

Grahic Jump Location
Fig. 2

Components and assembly of the POC-RDT thermal shield. Layers of thermally isolating and thermally conductive material are laminated to enclose a PCM material in a thin form factor. The thermal shield is then attached to the bottom of a rapid diagnostic test to provide thermal protection in temperature sensitive zones without significantly affect the design of the test. LFIA = lateral flow immunoassay.

Grahic Jump Location
Fig. 3

Shield assembly on POC-RDT and setup for thermal testing: (a) thermal shield prototype with detail on PCM layer and thermally conductive region of the laminated enclosure. (b) schematic of the thermal testing setup. Thermal sensors DS18B20 (Maxim Integrated Products, Sunnyvale, CA) were in contact with the most thermally sensitive area of the LFIA strip in both the control and the shielded prototype. Ambient temperature was controlled within the chamber using an incandescent lamp. The thermal shield was attached to the bottom of the rapid test using a PCM laminate. The shielded prototype and its control were both subject to 180 Hz vibration using a piezoelectric actuator located below the POC-RDTS throughout the duration of the experiment. ADC = analog to digital converter; RDT = rapid diagnostic test; PCM = phase change material.

Grahic Jump Location
Fig. 4

The 1D thermal model of thermal shield and behavior trends for specific heat capacity c, density ρ, and heat conductivity k of an archetypical POC-RDT + PCM construct. (a) The test strip (domain 1) and the PCM (domain 2) are depicted as the two main bulk components in the model. Tamb is the ambient temperature, and the temperature of interest is the average temperature of the test strip. (b) The rectangular function model for specific heat variation of a PCM, with a melting range ΔT, which relates to the specific heat L. (c) The step function models the shift of thermal conductivity k and the material density ρ in relationship to temperature T. PCM = phase change material.

Grahic Jump Location
Fig. 5

Generalized thermal network (electrical analogy) of the 1D heat system. A quasi-state-state assumption is used to justify this electrical analog. are internal resistances of each domain, are internal capacitances, and are external resistances.

Grahic Jump Location
Fig. 7

Representative response of shielded and unshielded (ambient) POC-RDT to a field-like thermal challenge. The absence of peaks and valleys in shielded response denotes damping and thermal switching behavior provided by the PCM. ADC = analog to digital converter; RDT = rapid diagnostic test; PCM = phase change material; POC-RDT + TS = point-of-care rapid diagnostic test with thermal shield.

Grahic Jump Location
Fig. 6

Model and experimental results of basic thermal challenge. (a) Shows an isometric view that represents a common situation, where a rapid diagnostic test (RDT) under solar load. (b) Shows simulation outputs for the first proposed phase of the thermal challenge for both shielded and unshielded POC-RDTs, while (c) shows the simulation results second phase of the challenge in which the effect of PCM is recognizable for shielded systems. (d) Shows experimental temperature measurements for three unshielded LFIA POC-RDTs and three shielded LFIA POC-RDTs prototypes during the first phase of the thermal challenge, while (e) shows measurements performed during the second phase of the thermal challenge. Notice the presence of averaged traces and shaded error bars for experimental measurements of both shielded and unshielded POC-RDT prototypes.



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