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.

References

1.
Chan
,
C. P. Y.
,
Mak
,
W. C.
,
Cheung
,
K. Y.
,
Sin
,
K. K.
,
Yu
,
C. M.
,
Rainer
,
T. H.
, and
Renneberg
,
R.
,
2013
, “
Evidence-Based Point-of-Care Diagnostics: Current Status and Emerging Technologies
,”
Annu. Rev. Anal. Chem.
,
6
, pp.
191
211
.
2.
Drain
,
P. K.
,
Hyle
,
E. P.
,
Noubary
,
F.
,
Freedberg
,
K. A.
,
Wilson
,
D.
,
Bishai
,
W. R.
,
Rodriguez
,
W.
, and
Bassett
,
I. V.
,
2014
, “
Diagnostic Point-of-Care Tests in Resource-Limited Settings
,”
Lancet Infect. Dis.
,
14
(
3
), pp.
239
249
.
3.
Jani
,
I. V.
, and
Peter
,
T. F.
,
2013
, “
How Point-of-Care Testing Could Drive Innovation in Global Health
,”
N. Engl. J. Med.
,
368
(
24
), pp.
2319
2324
.
4.
Vashist
,
S. K.
,
Luppa
,
P. B.
,
Yeo
,
L. Y.
,
Ozcan
,
A.
, and
Luong
,
J. H.
,
2015
, “
Emerging Technologies for Next-Generation Point-of-Care Testing
,”
Trends Biotechnol.
,
33
(
11
), pp.
692
705
.
5.
Chin
,
C. D.
,
Linder
,
V.
, and
Sia
,
S. K.
,
2007
, “
Lab-on-a-Chip Devices for Global Health: Past Studies and Future Opportunities
,”
Lab Chip
,
7
(
1
), pp.
41
57
.
6.
Gubala
,
V.
,
Harris
,
L. F.
,
Ricco
,
A. J.
,
Tan
,
M. X.
, and
Williams
,
D. E.
,
2011
, “
Point of Care Diagnostics: Status and Future
,”
Anal. Chem.
,
84
(
2
), pp.
487
515
.
7.
Gervais
,
L.
,
De Rooij
,
N.
, and
Delamarche
,
E.
,
2011
, “
Microfluidic Chips for Point‐of‐Care Immunodiagnostics
,”
Adv. Mater.
,
23
(
24
), pp.
H151
H176
.
8.
Wongsrichanalai
,
C.
,
Barcus
,
M. J.
,
Muth
,
S.
,
Sutamihardja
,
A.
, and
Wernsdorfer
,
W. H.
,
2007
, “
A Review of Malaria Diagnostic Tools: Microscopy and Rapid Diagnostic Test (RDT)
,”
Am. J. Trop. Med. Hyg.
,
77
(
Suppl. 6
), pp.
119
127
.http://www.ajtmh.org/content/journals/10.4269/ajtmh.2007.77.119
9.
Kumar
,
S.
,
Kumar
,
S.
,
Ali
,
M.
,
Anand
,
P.
,
Agrawal
,
V. V.
,
John
,
R.
,
Maji
,
S.
, and
Malhotra
,
B. D.
,
2013
, “
Microfluidic‐Integrated Biosensors: Prospects for Point‐of‐Care Diagnostics
,”
Biotechnol. J.
,
8
(
11
), pp.
1267
1279
.
10.
Palamountain
,
K. M.
,
Baker
,
J.
,
Cowan
,
E. P.
,
Essajee
,
S.
,
Mazzola
,
L. T.
,
Metzler
,
M.
,
Schito
,
M. L.
,
Stevens
,
W. S.
,
Young
,
G. J.
, and
Domingo
,
G. J.
,
2012
, “
Perspectives on Introduction and Implementation of New Point-of-Care Diagnostic Tests
,”
J. Infect. Dis.
,
205
(Suppl. 2), pp. S181–S190.
11.
Bamberg
,
R.
,
Schulman
,
K.
,
MacKenzie
,
M.
,
Moore
,
J.
, and
Olchesky
,
S.
,
2005
, “
Effect of Adverse Storage Conditions on the Performance of Glucometer Test Strips
,”
Clin. Lab. Sci.
,
18
(
4
), pp.
203
209
.
12.
Louie
,
R. F.
,
Sumner
,
S. L.
,
Belcher
,
S.
,
Mathew
,
R.
,
Tran
,
N. K.
, and
Kost
,
G. J.
,
2009
, “
Thermal Stress and Point-of-Care Testing Performance: Suitability of Glucose Test Strips and Blood Gas Cartridges for Disaster Response
,”
Disaster Med. Public Health Preparedness
,
3
(
1
), pp.
13
17
.
13.
Anderson
,
D. A.
,
Crowe
,
S. M.
, and
Garcia
,
M.
,
2011
, “
Point-of-Care Testing
,”
Curr. HIV/AIDS Rep.
,
8
(
1
), pp.
31
37
.
14.
Miller
,
E.
, and
Sikes
,
H. D.
,
2015
, “
Addressing Barriers to the Development and Adoption of Rapid Diagnostic Tests in Global Health
,”
Nanobiomedicine
,
2
, p.
6
.
15.
WHO
,
2015
, “Good Practices for Selecting and Procuring Rapid Diagnostic Tests for Malaria,” World Health Organization, Geneva, Switzerland, accessed Dec. 1, 2017, http://www.who.int/malaria/publications/atoz/9789241501125/en/
16.
Gomes
,
L. T.
,
Tada
,
M. S.
,
Katsuragawa
,
T. H.
,
Povoa
,
M. M.
,
Viana
,
G. M.
,
Maria das Gracas
,
C. A.
,
de Santana-Filho
,
F. S.
,
Arcanjo
,
A. R. L.
,
Couto
,
A. A.
,
Calvosa
,
V. S.
, and
Nery
,
A. F.
,
2013
, “
Low Sensitivity of Malaria Rapid Diagnostic Tests Stored at Room Temperature in the Brazilian Amazon Region
,”
J. Infect. Dev. Countries
,
7
(
3
), pp.
243
252
.
17.
Mikhail
,
A. F.
,
Leslie
,
T. J.
,
Mayan
,
M. I.
,
Zekria
,
R.
,
Mohammad
,
N.
,
Hasanzai
,
M. A.
,
Safi
,
N.
,
Whitty
,
C. J.
, and
Rowland
,
M.
,
2011
, “
Field Trial of Three Different Plasmodium Vivax-Detecting Rapid Diagnostic Tests With and Without Evaporative Cool Box Storage in Afghanistan
,”
Malaria J.
,
10
(
1
), p.
169
.
18.
Lam
,
M.
,
Louie
,
R. F.
,
Curtis
,
C. M.
,
Ferguson
,
W. J.
,
Vy
,
J. H.
,
Truong
,
A. T.
,
Sumner
,
S. L.
, and
Kost
,
G. J.
,
2014
, “
Short-Term Thermal-Humidity Shock Affects Point-of-Care Glucose Testing Implications for Health Professionals and Patients
,”
J. Diabetes Sci. Technol.
,
8
(
1
), pp.
83
88
.
19.
Albertini
,
A.
,
Lee
,
E.
,
Coulibaly
,
S. O.
,
Sleshi
,
M.
,
Faye
,
B.
,
Mationg
,
M. L.
,
Ouedraogo
,
K.
,
Tsadik
,
A. G.
,
Feleke
,
S. M.
,
Diallo
,
I.
, and
Gaye
,
O.
,
2012
, “
Malaria Rapid Diagnostic Test Transport and Storage Conditions in Burkina Faso, Senegal, Ethiopia and the Philippines
,”
Malaria J.
,
11
(
1
), p.
406
.
20.
Ginsberg
,
B. H.
,
2009
, “
Factors Affecting Blood Glucose Monitoring: Sources of Errors in Measurement
,”
J. Diabetes Sci. Technol.
,
3
(
4
), pp.
903
913
.
21.
Yager
,
P.
,
Domingo
,
G. J.
, and
Gerdes
,
J.
,
2008
, “
Point-of-Care Diagnostics for Global Health
,”
Annu. Rev. Biomed. Eng.
,
10
, pp.
107
144
.
22.
Jorgensen
,
P.
,
Chanthap
,
L. O. N.
,
Rebueno
,
A.
,
Tsuyuoka
,
R.
, and
Bell
,
D.
,
2006
, “
Malaria Rapid Diagnostic Tests in Tropical Climates: The Need for a Cool Chain
,”
Am. J. Trop. Med. Hyg.
,
74
(
5
), pp.
750
754
.http://www.ajtmh.org/docserver/fulltext/14761645/74/5/0740750.pdf?expires=1515756854&id=id&accname=guest&checksum=5DE111C39D0A03D5C882F91306003EF6
23.
Somero
,
G. N.
,
1995
, “
Proteins and Temperature
,”
Annu. Rev. Physiol.
,
57
(
1
), pp.
43
68
.
24.
Bischof
,
J. C.
, and
He
,
X.
,
2006
, “
Thermal Stability of Proteins
,”
Ann. New York Acad. Sci.
,
1066
(
1
), pp.
12
33
.
25.
Argentieri
,
M. C.
,
Pilla
,
D.
,
Vanzati
,
A.
,
Lonardi
,
S.
,
Facchetti
,
F.
,
Doglioni
,
C.
,
Parravicini
,
C.
, and
Cattoretti
,
G.
,
2013
, “
Antibodies Are Forever: A Study Using 12–26‐Year‐Old Expired Antibodies
,”
Histopathology
,
63
(
6
), pp.
869
876
.
26.
Sydow
,
J. F.
,
Lipsmeier
,
F.
,
Larraillet
,
V.
,
Hilger
,
M.
,
Mautz
,
B.
,
Mølhøj
,
M.
,
Kuentzer
,
J.
,
Klostermann
,
S.
,
Schoch
,
J.
,
Voelger
,
H. R.
, and
Regula
,
J. T.
,
2014
, “
Structure-Based Prediction of Asparagine and Aspartate Degradation Sites in Antibody Variable Regions
,”
PloS One
,
9
(
6
), p.
e100736
.
27.
Chiodini
,
P. L.
,
Bowers
,
K.
,
Jorgensen
,
P.
,
Barnwell
,
J. W.
,
Grady
,
K. K.
,
Luchavez
,
J.
,
Moody
,
A. H.
,
Cenizal
,
A.
, and
Bell
,
D.
,
2007
, “
The Heat Stability of Plasmodium Lactate Dehydrogenase-Based and Histidine-Rich Protein 2-Based Malaria Rapid Diagnostic Tests
,”
Trans. R. Soc. Trop. Med. Hyg.
,
101
(
4
), pp.
331
337
.
28.
WHO
,
2015
, “TGS 2 Establishing Stability of an In Vitro Diagnostic for WHO Prequalification,” EMP Prequalification Diagnostics, World Health Organization, Geneva, Switzerland, accessed Dec. 1, 2017, http://www.who.int/diagnostics_laboratory/guidance/160613_tgs2_ stability.pdf
29.
Barbé
,
B.
,
Gillet
,
P.
,
Beelaert
,
G.
,
Fransen
,
K.
, and
Jacobs
,
J.
,
2012
, “
Assessment of Desiccants and Their Instructions for Use in Rapid Diagnostic Tests
,”
Malaria J.
,
11
(
1)
, p.
326
.
30.
Truong
,
A. T.
,
Louie
,
R. F.
,
Vy
,
J. H.
,
Curtis
,
C. M.
,
Ferguson
,
W. J.
,
Lam
,
M.
,
Sumner
,
S.
, and
Kost
,
G. J.
,
2014
, “
Effects of Humidity on Foil and Vial Packaging to Preserve Glucose and Lactate Test Strips for Disaster Readiness
,”
Disaster Med. Public Health Preparedness
,
8
(
1
), pp.
51
57
.
31.
Ramachandran
,
S.
,
Fu
,
E.
,
Lutz
,
B.
, and
Yager
,
P.
,
2014
, “
Long-Term Dry Storage of an Enzyme-Based Reagent System for ELISA in Point-of-Care Devices
,”
Analyst
,
139
(
6
), pp.
1456
1462
.
32.
Learmonth
,
K. M.
,
Chiu
,
C. Y.
,
Galang
,
H.
,
Nawang
,
M. J.
, and
Dax
,
E. M.
,
2011
, “
Assessment of the Heat Stability of Seven Rapid HIV Assays
,”
Trans. R. Soc. Trop. Med. Hyg.
,
105
(
7
), pp.
388
395
.
33.
Chin
,
C. D.
,
Linder
,
V.
, and
Sia
,
S. K.
,
2012
, “
Commercialization of Microfluidic Point-of-Care Diagnostic Devices
,”
Lab Chip
,
12
(
12
), pp.
2118
2134
.
34.
Tantra
,
R.
, and
van Heeren
,
H.
,
2013
, “
Product Qualification: A Barrier to Point-of-Care Microfluidic-Based Diagnostics?
,”
Lab Chip
,
13
(
12
), pp.
2199
2201
.
35.
WHO,
2006
, “
Regulation of In Vitro Diagnostics: A Global Perspective
,”
Annex in: Diagnostics for Tuberculosis: Global Demand and Market Potential
,
World Health Organization
,
Geneva, Switzerland
, pp.
194
203
.
36.
Smith
,
S.
,
Sewart
,
R.
,
Land
,
K.
,
Roux
,
P.
,
Gärtner
,
C.
, and
Becker
,
H.
,
2016
, “
Blister Pouches for Effective Reagent Storage and Release for Low Cost Point-of-Care Diagnostic Applications
,”
Proc. SPIE
,
9705
, p. 97050F.
37.
Oró
,
E.
,
De Gracia
,
A.
,
Castell
,
A.
,
Farid
,
M. M.
, and
Cabeza
,
L. F.
,
2012
, “
Review on Phase Change Materials (PCMs) for Cold Thermal Energy Storage Applications
,”
Appl. Energy
,
99
, pp.
513
533
.
38.
Chanthap
,
L.
,
Ariey
,
F.
,
Socheat
,
D.
,
Tsuyuoka
,
R.
, and
Bell
,
D.
,
2010
, “
Low-Technology Cooling Box for Storage of Malaria RDTs and Other Medical Supplies in Remote Areas
,”
Malaria J.
,
9
(
1
), p.
31
.
39.
Buser
,
J. R.
,
Diesburg
,
S.
,
Singleton
,
J.
,
Guelig
,
D.
,
Bishop
,
J. D.
,
Zentner
,
C.
,
Burton
,
R.
,
LaBarre
,
P.
,
Yager
,
P.
, and
Weigl
,
B. H.
,
2015
, “
Precision Chemical Heating for Diagnostic Devices
,”
Lab Chip
,
15
(
23
), pp.
4423
4432
.
40.
Farid
,
M. M.
,
Khudhair
,
A. M.
,
Razack
,
S. A. K.
, and
Al-Hallaj
,
S.
,
2004
, “
A Review on Phase Change Energy Storage: Materials and Applications
,”
Energy Convers. Manage.
,
45
(
9
), pp.
1597
1615
.
41.
Ho
,
C. J.
, and
Cheng
,
Y. T.
,
1999
, “
On Cooling Behavior of a Vertical Plate in a Phase Change Material/Water Composite Enclosure Under Pulsating Heat Load
,”
Heat Mass Transfer
,
34
(
6
), pp.
509
515
.
42.
Ying
,
Y.
,
Hongyuan
,
Y.
, and
Haiying
,
S.
,
2010
, “
Development of a Low-Temperature Phase Transforming Composed Material for Cool Storage
,”
J. Supercond. Novel Magn.
,
23
(
6
), pp.
1115
1117
.
43.
Jamekhorshid
,
A.
,
Sadrameli
,
S. M.
, and
Farid
,
M.
,
2014
, “
A Review of Microencapsulation Methods of Phase Change Materials (PCMs) as a Thermal Energy Storage (TES) Medium
,”
Renewable Sustainable Energy Rev.
,
31
, pp.
531
542
.
44.
Cho
,
J. S.
,
Kwon
,
A.
, and
Cho
,
C. G.
,
2002
, “
Microencapsulation of Octadecane as a Phase-Change Material by Interfacial Polymerization in an Emulsion System
,”
Colloid Polym. Sci.
,
280
(
3
), pp.
260
266
.
45.
Millipore Corporation
,
2014
, “Rapid Lateral Flow Test Strips. Considerations for Product Development,” Millipore Corporation, Bedford, MA, accessed Dec. 1, 2017, https://www.emdmillipore.com/Web-US-Site/en_CA/-/USD/ShowDocument-Pronet?id=201306.12550
46.
Posthuma-Trumpie
,
G. A.
,
Korf
,
J.
, and
van Amerongen
,
A.
,
2009
, “
Lateral Flow (Immuno) Assay: Its Strengths, Weaknesses, Opportunities and Threats. A Literature Survey
,”
Anal. Bioanal. Chem.
,
393
(
2
), pp.
569
582
.
47.
Pauling
,
L.
,
1988
,
General Chemistry
,
W. H.
,
Freeman
, ed.,
Courier Corporation
, North Chelmsford, MA, pp.
564
569
.
48.
O'Farrell
,
B.
,
2009
, “
Evolution in Lateral Flow–Based Immunoassay Systems
,”
Lateral Flow Immunoassay
,
Humana Press
, New York, pp.
1
33
.
49.
Wong
,
R.
, and
Tse
,
H.
, eds.,
2009
,
Lateral Flow Immunoassay
,
Humana Press
,
Totowa, NJ
, pp.
1
158
.
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