Cited by 1,065Biosensors and Analytical DetectionClinical Laboratory Practices and Quality ControlSARS-CoV-2 detection and testing

REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes

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Land, Kevin J., Boeras, Debrah I., Chen, Xiang-Sheng, Ramsay, Andrew R., Peeling, Rosanna W.·2018·Nature Microbiology

Abstract

Lack of access to quality diagnostics remains a major contributor to health burden in resource-limited settings. It has been more than 10 years since ASSURED (affordable, sensitive, specific, user-friendly, rapid, equipment-free, delivered) was coined to describe the ideal test to meet the needs of the developing world. Since its initial publication, technological innovations have led to the development of diagnostics that address the ASSURED criteria, but challenges remain. From this perspective, we assess factors contributing to the success and failure of ASSURED diagnostics, lessons learnt in the implementation of ASSURED tests over the past decade, and highlight additional conditions that should be considered in addressing point-of-care needs. With rapid advances in digital technology and mobile health (m-health), future diagnostics should incorporate these elements to give us REASSURED diagnostic systems that can inform disease control strategies in real-time, strengthen the efficiency of health care systems and improve patient outcomes.

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  • The implementation of POCT outside the laboratory has facilitated access to diagnostics for remote and regional populations, disadvantaged communities and individuals at high risk of infection.

    “The implementation of POCT outside the laboratory has facilitated access to diagnostics for remote and regional populations, disadvantaged communities and individuals at high risk of infection [66].”

    From Point-of-care testing: state-of-the art and perspectives (2025) · cites this paper as [66]

    The ASSURED criteria section (page unavailable) explains that point-of-care tests can serve community and primary-care settings with limited laboratory access, and the implementation section describes rapid testing in the Amazon forest and rural China. The paper also discusses increased access in low- and middle-income countries, but the passages found do not establish improved access specifically for individuals at high risk of infection. (LLM, conf=0.82)

    Experimental — accuracy not yet measured
  • An independent FDA-university-commercial evaluation of RAgTs provided repeat home testing performance data used in theoretical calculations.

    “An independent FDA-university-commercial evaluation of RAgTs provided repeat home testing performance data [66] used in theoretical calculations.”

    From Point-of-care testing: state-of-the art and perspectives (2025) · cites this paper as [66]

    The ASSURED diagnostic tests section discusses rapid tests for HIV, malaria, syphilis and TB, not an independent evaluation of repeat at-home RAgT testing. Searches for FDA–university–commercial evaluation and serial home-testing performance found no passage addressing the attributed data; the copy provides no page numbers for these passages. (LLM, conf=0.76)

    Experimental — accuracy not yet measured

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  1. [1]Mabey D Peeling RW Ustianowski A Perkins MD Diagnostics for the developing world Nat. Rev. Microbiol. 2004 2 231 240 10.1038/nrmicro841 15083158 · DOI · Paper page
  2. [3]Sweeney S The costs of accessible quality assured syphilis diagnostics: informing quality systems for rapid syphilis tests in a Tanzanian setting Health Policy Plan. 2014 29 633 641 10.1093/heapol/czt049 23894075 · DOI
  3. [5]Aledort JE Reducing the burden of sexually transmitted infections in resource-limited settings: the role of improved diagnostics Nature 2006 444 59 72 10.1038/nature05447 17159895 · DOI
  4. [6]Gift TL Pate MS Hook EW Kassler WJ The rapid test paradox: when fewer cases detected lead to more cases treated: A decision analysis of tests for Chlamydia trachomatis Sex. Transm. Dis. 1999 26 232 240 10.1097/00007435-199904000-00010 10225593 · DOI
  5. [7]Frost L Reich M Access: How Do Good Health Technologies Get to Poor People in Poor Countries 2008 Cambridge Harvard Univ. Press
  6. [8]Nkengasong JN Yao K Onyebujoh P Laboratory medicine in low-income and middle-income countries: progress and challenges Lancet 2018 391 1873 1875 10.1016/S0140-6736(18)30308-8 29550031 PMC5962422 · DOI
  7. [9]Alemnji GA Zeh C Yao K Fonjungo PN Strengthening national health laboratories in sub-Saharan Africa: a decade of remarkable progress Trop. Med. Int. Heal. 2014 19 450 458 10.1111/tmi.12269 PMC4826025 24506521 · DOI
  8. [10]Hay Burgess DC Wasserman J Dahl CA Global health diagnostics Nature 2006 444 1 2 10.1038/nature05440 17159888 · DOI · Paper page
  9. [11]Urdea M Requirements for high impact diagnostics in the developing world Nature 2006 444 73 79 10.1038/nature05448 17159896 · DOI
  10. [13]Pai NP Tulsky JP Cohan D Colford JM Reingold AL Rapid point-of-care HIV testing in pregnant women: A systematic review and meta-analysis Trop. Med. Int. Heal. 2007 12 162 173 10.1111/j.1365-3156.2006.01812.x 17300622 · DOI
  11. [15]Ghani AC Burgess DH Reynolds A Rousseau C Expanding the role of diagnostic and prognostic tools for infectious diseases in resource-poor settings Nature 2015 528 50 52 10.1038/nature16038 26633765 · DOI
  12. [16]Fonjungo PN Ensuring quality AIDS 2016 30 1317 1323 10.1097/QAD.0000000000001031 26807969 PMC4856175 · DOI
  13. [17]WHO-FIND Malaria RDT Evaluation Programme (WHO, 2017). PMC5433078 28506275
  14. [18]Poyer S Availability and price of malaria rapid diagnostic tests in the public and private health sectors in 2011: Results from 10 nationally representative cross-sectional retail surveys Trop. Med. Int. Heal. 2015 20 744 756 10.1111/tmi.12491 25728761 · DOI
  15. [20]Cheng Q Plasmodium falciparum parasites lacking histidine-rich protein 2 and 3: a review and recommendations for accurate reporting Malar. J. 2014 13 283 10.1186/1475-2875-13-283 25052298 PMC4115471 · DOI
  16. [21]Rennie W Minimising human error in malaria rapid diagnosis: clarity of written instructions and health worker performance Trans. R. Soc. Trop. Med. Hyg. 2007 101 9 18 10.1016/j.trstmh.2006.03.011 17049572 · DOI
  17. [22]Harvey SA Improving community health worker use of malaria rapid diagnostic tests in Zambia: package instructions, job aid and job aid-plus-training Malar. J. 2008 7 160 10.1186/1475-2875-7-160 18718028 PMC2547110 · DOI
  18. [23]Peeling RW Syphilis Nat. Rev. Dis. Prim. 2017 3 17073 10.1038/nrdp.2017.73 29022569 PMC5809176 · DOI · Paper page
  19. [27]Tucker JD Accelerating worldwide syphilis screening through rapid testing: a systematic review Lancet Infect. Dis. 2018 10 381 386 10.1016/S1473-3099(10)70092-X 20510278 · DOI
  20. [28]Jafari Y Are Treponema pallidum specific rapid and point-of-care tests for syphilis accurate enough for screening in resource limited settings? Evidence from a meta-analysis PLoS ONE 2013 8 e54695 10.1371/journal.pone.0054695 23468842 PMC3582640 · DOI
  21. [29]Swartzendruber A Steiner RJ Adler MR Kamb ML Newman LM Introduction of rapid syphilis testing in antenatal care: a systematic review of the impact on HIV and syphilis testing uptake and coverage Int. J. Gynecol. Obstet. 2015 130 15 21 10.1016/j.ijgo.2015.04.008 PMC6799988 26001704 · DOI
  22. [30]Shelley KD Scaling down to scale up: a health economic analysis of integrating point-of-care syphilis testing into antenatal care in Zambia during pilot and national rollout implementation PLoS ONE 2015 10 e0125675 10.1371/journal.pone.0125675 25970443 PMC4430530 · DOI
  23. [31]Ansbro EacuteM Introduction of syphilis point-of-care tests, from pilot study to national programme implementation in Zambia: a qualitative study of healthcare workers’ perspectives on testing, training and quality assurance PLoS ONE 2015 10 e0127728 10.1371/journal.pone.0127728 26030741 PMC4452097 · DOI
  24. [32]Peeling RW Mabey D Fitzgerald DW Watson-Jones D Avoiding HIV and dying of syphilis Lancet 2004 364 1561 1563 10.1016/S0140-6736(04)17327-3 15519615 · DOI
  25. [33]Taylor M Elimination of mother-to-child transmission of HIV and Syphilis (EMTCT): process, progress, and program integration PLoS Med. 2017 14 e1002329 10.1371/journal.pmed.1002329 28654643 PMC5486952 · DOI
  26. [34]Wijesooriya NS Global burden of maternal and congenital syphilis in 2008 and 2012: a health systems modelling study Lancet Glob. Health 2016 4 e525 e533 10.1016/S2214-109X(16)30135-8 27443780 PMC6759483 · DOI
  27. [35]Peeling RW Mabey D Celebrating the decline in syphilis in pregnancy: a sobering reminder of what’s left to do Lancet Glob. Health 2016 4 e503 e504 10.1016/S2214-109X(16)30154-1 27443768 · DOI
  28. [36]Gliddon HD A systematic review and meta-analysis of studies evaluating the performance and operational characteristics of dual point-of-care tests for HIV and syphilis Sex. Transm. Infect. 2017 93 S3 S15 10.1136/sextrans-2017-053099 28747410 PMC6754342 · DOI
  29. [37]WHO Guideline on Syphilis Screening and Treatment for Pregnant Women (WHO, 2017). 29757595
  30. [39]Lawn SD Kerkhoff AD Vogt M Wood R Diagnostic accuracy of a low-cost, urine antigen, point-of-care screening assay for HIV-associated pulmonary tuberculosis before antiretroviral therapy: a descriptive study Lancet Infect. Dis. 2012 12 201 209 10.1016/S1473-3099(11)70251-1 22015305 PMC3315025 · DOI
  31. [41]Pathmanathan I Rolling out Xpert MTB/RIF® for tuberculosis detection in HIV-positive populations: An opportunity for systems strengthening Afr. J. Lab. Med. 2017 6 460 10.4102/ajlm.v6i2.460 PMC5523912 28785533 · DOI
  32. [42]Lawn SD Advances in tuberculosis diagnostics: the Xpert MTB/RIF assay and future prospects for a point-of-care test Lancet Infect. Dis. 2013 13 349 361 10.1016/S1473-3099(13)70008-2 23531388 PMC4844338 · DOI
  33. [43]Schito M Perspectives on advances in tuberculosis diagnostics, drugs, and vaccines Clin. Infect. Dis. 2015 61 S102 S118 10.1093/cid/civ609 PMC4583570 26409271 · DOI
  34. [44]Hermans S Caldwell J Kaplan R Cobelens F Wood R The impact of the roll-out of rapid molecular diagnostic testing for tuberculosis on empirical treatment in Cape Town, South Africa Bull. World Health Organ. 2017 95 554 563 10.2471/BLT.16.185314 28804167 PMC5537747 · DOI
  35. [46]Abubakar I Drug-resistant tuberculosis: time for visionary political leadership Lancet Infect. Dis. 2013 13 529 539 10.1016/S1473-3099(13)70030-6 23531391 · DOI
  36. [47]Clouse K Implementation of Xpert MTB/RIF for routine point-of-care diagnosis of tuberculosis at the primary care level South African Med. J. 2012 102 805 807 10.7196/SAMJ.5851 23034211 · DOI
  37. [48]Peeling RW Evaluation of diagnostic tests: dengue Nat. Rev. Microbiol. 2010 8 S30 S38 10.1038/nrmicro2459 21548185 · DOI
  38. [49]Goncalves A Innovative and new approaches to laboratory diagnosis of Zika and Dengue: a meeting report J. Infect. Dis. 2018 217 1060 1068 10.1093/infdis/jix678 29294035 PMC6279137 · DOI
  39. [50]Chappuis F Visceral leishmaniasis: what are the needs for diagnosis, treatment and control? Nat. Rev. Microbiol. 2007 5 873 882 10.1038/nrmicro1748 17938629 · DOI
  40. [51]Marks M Metaanalysis of the performance of a combined treponemal and nontreponemal rapid diagnostic test for syphilis and yaws Clin. Infect. Dis. 2016 63 627 633 10.1093/cid/ciw348 27217216 PMC4981758 · DOI
  41. [52]Kelly H Systematic reviews of point-of-care tests for the diagnosis of urogenital Chlamydia trachomatis infections Sex. Transm. Infect. 2017 93 S22 S30 10.1136/sextrans-2016-053067 29223960 · DOI
  42. [53]Guy RJ Performance and operational characteristics of point-of-care tests for the diagnosis of urogenital gonococcal infections Sex. Transm. Infect. 2017 93 S16 S21 10.1136/sextrans-2017-053192 29223959 · DOI
  43. [54]Gift TL Pate MS Hook IIIEW Kassler WJ The rapid test paradox: when fewer cases detected lead to more cases treated: a decision analysis of tests for Chlamydia trachomatis Sex. Transm. Dis. 1999 26 232 240 10.1097/00007435-199904000-00010 10225593 · DOI
  44. [55]Meggi B Point-of-care p24 infant testing for HIV may increase patient identification despite low sensitivity PLoS ONE 2017 12 e0169497 10.1371/journal.pone.0169497 28060886 PMC5218410 · DOI
  45. [56]Peeling RW McNerney R Emerging technologies in point-of-care molecular diagnostics for resource-limited settings Expert Rev. Mol. Diagn. 2014 14 525 534 10.1586/14737159.2014.915748 24784765 · DOI
  46. [57]LaBarre P A simple, inexpensive device for nucleic acid amplification without electricity-toward instrument-free molecular diagnostics in low-resource settings PLoS ONE 2011 6 e19738 10.1371/journal.pone.0019738 21573065 PMC3090398 · DOI
  47. [58]Bissonnette L Bergeron MG Expert review of molecular diagnostics portable devices and mobile instruments for infectious diseases point-of-care testing Expert Rev. Mol. Diagn. 2017 17 471 494 10.1080/14737159.2017.1310619 28343420 · DOI
  48. [59]Laksanasopin T A smartphone dongle for diagnosis of infectious diseases at the point of care Sci. Transl. Med. 2015 7 273re1 10.1126/scitranslmed.aaa0056 25653222 · DOI
  49. [60]Sharma S Zapatero-Rodríguez J Estrela P O’Kennedy R Point-of-care diagnostics in low resource settings: present status and future role of microfluidics Biosensors 2015 5 577 601 10.3390/bios5030577 26287254 PMC4600173 · DOI
  50. [61]Sackmann EK Fulton AL Beebe DJ The present and future role of microfluidics in biomedical research Nature 2014 507 181 189 10.1038/nature13118 24622198 · DOI · Paper page
  51. [62]Yang K Peretz-Soroka H Liu Y Lin F Novel developments in mobile sensing based on the integration of microfluidic devices and smartphones Lab Chip 2016 16 943 958 10.1039/C5LC01524C 26899264 PMC5142836 · DOI
  52. [63]Roda A Integrating biochemiluminescence detection on smartphones: mobile chemistry platform for point-of-need analysis Anal. Chem. 2014 86 7299 7304 10.1021/ac502137s 25017302 · DOI
  53. [64]O’Farrell B Lateral flow technology for field-based applications—basics and advanced developments Top. Companion Anim. Med. 2015 30 139 147 10.1053/j.tcam.2015.12.003 27154597 · DOI
  54. [65]Wedderburn CJ Murtagh M Toskin I Peeling RW Using electronic readers to monitor progress toward elimination of mother-to-child transmission of HIV and syphilis: an opinion piece Int. J. Gynecol. Obstet. 2015 130 S81 S83 10.1016/j.ijgo.2015.04.006 25983212 · DOI
  55. [66]Fitzpatrick C Engels D Leaving no one behind: a neglected tropical disease indicator and tracers for the Sustainable Development Goals Int. Health 2015 8 i15 i18 10.1093/inthealth/ihw002 PMC4777229 26940304 · DOI
  56. [67]Smit PW The trade-off between accuracy and accessibility of syphilis screening assays PLoS ONE 2013 8 e75327 10.1371/journal.pone.0075327 24066175 PMC3774815 · DOI
  57. [68]Bell D Wongsrichanalai C Barnwell JW Ensuring quality and access for malaria diagnosis: how can it be achieved? Nat. Rev. Microbiol. 2006 4 682 695 10.1038/nrmicro1474 16912713 · DOI
  58. [69]Nkengsong J Boeras DI Abimiku A Peeling RW Assuring the quality of diagnostic testing: the future is now Afr. J. Lab. Med. 2016 5 4 5 PMC5433833 28879134
  59. [70]Boeras DI Peeling RW External quality assurance for HIV point-of-care testing in Africa: a collaborative country-partner approach to strengthen diagnostic services Afr. J. Lab. Med. 2016 5 2 PMC5433831 28879132
  60. [71]Boeras DI Nkengasong JN Peeling RW Implementation science: the laboratory as a command centre Curr. Opin. HIV AIDS 2017 12 171 174 10.1097/COH.0000000000000349 28079592 · DOI
  61. [72]Vassall A Cost-effectiveness of Xpert MTB/RIF for tuberculosis diagnosis in South Africa: a real-world cost analysis and economic evaluation Lancet Glob. Heal. 2017 5 e710 e719 10.1016/S2214-109X(17)30205-X PMC5471605 28619229 · DOI
  62. [73]Churchyard GJ Xpert MTB/RIF versus sputum microscopy as the initial diagnostic test for tuberculosis: a cluster-randomised trial embedded in South African roll-out of Xpert MTB/RIF Lancet Glob. Heal. 2015 3 e450 e457 10.1016/S2214-109X(15)00100-X 26187490 · DOI
  63. [74]Mabey DC Point-of-care tests to strengthen health systems and save newborn lives: the case of syphilis PLoS Med. 2012 9 8 10.1371/journal.pmed.1001233 PMC3373627 22719229 · DOI
  64. [75]García PJ Rapid syphilis tests as catalysts for health systems strengthening: a case study from Peru PLoS ONE 2013 8 e66905 10.1371/journal.pone.0066905 23840552 PMC3694115 · DOI
  65. [76]St John A Price CP Existing and emerging technologies for point-of-care testing Clin. Biochem. Rev. 2014 35 155 167 25336761 PMC4204237
  66. [77]O’Neill, J. Tackling Drug-Resistant Infections Globally: Final Report and Recommendations (AMR Review, 2016).
  67. [78]Gous N Expert review of molecular diagnostics: the impact of digital technologies on point-of-care diagnostics in resource-limited settings Expert Rev. Mol. Diagn. 2018 18 385 397 10.1080/14737159.2018.1460205 29658382 · DOI
  68. [79]Denkinger, C. M., Grenier, J., Stratis, A. K., Akkihal, A. & Pai, M. Mobile health to improve tuberculosis care and control: a call worth making. 17, 719–727 (2013). 23541232
  69. [80]Wood, C. et al. Bringing mHealth connected infectious disease diagnostics to the field. Nature (in the press).
  70. [81]Hamedi MM Integrating electronics and microfluidics on paper Adv. Mater. 2016 28 5054 5063 10.1002/adma.201505823 27135652 · DOI
  71. [83]Liang T Zou X Mazzeo AD A flexible future for paper-based electronics Proc. SPIE 2016 10.1117/12.2224391 · DOI
  72. [84]Turner APF Biosensors: sense and sensibility Chem. Soc. Rev. 2013 42 3184 10.1039/c3cs35528d 23420144 · DOI
  73. [85]Chen XS Rapid diagnostic tests for neurosyphilis Lancet Infect. Dis. 2013 13 918 919 10.1016/S1473-3099(13)70293-7 24156896 · DOI
  74. [86]Engel N Compounding diagnostic delays: a qualitative study of point-of-care testing in South Africa Trop. Med. Int. Heal. 2015 20 493 500 10.1111/tmi.12450 25496070 · DOI
  75. [87]Cheng B Data connectivity: a critical tool for external quality assessment Afr. J. Lab. Med. 2016 5 535 10.4102/ajlm.v5i2.535 28879129 PMC5433828 · DOI
  76. [88]Smith S Oberholzer A Land K Korvink JG Mager D Functional screen printed radio frequency identification tags on flexible substrates, facilitating low-cost and integrated point-of-care diagnostics Flex. Print. Electron. 2018 3 025002 10.1088/2058-8585/aabc8c · DOI
  77. [89]Govindarajan AV Ramachandran S Vigil GD Yager P Böhringer KF A low cost point-of-care viscous sample preparation device for molecular diagnosis in the developing world; an example of microfluidic origami Lab Chip 2012 12 174 181 10.1039/C1LC20622B 22068336 · DOI
  78. [90]Nery EW Kubota LT Sensing approaches on paper-based devices: a review Anal. Bioanal. Chem. 2013 405 7573 7595 10.1007/s00216-013-6911-4 23604524 · DOI
  79. [91]Martinez AW Phillips ST Whitesides GM Carrilho E Diagnostics for the developing world: microfluidic paper-based analytical devices Anal. Chem. 2010 82 3 10 10.1021/ac9013989 20000334 · DOI
  80. [92]Cate DM Adkins JA Mettakoonpitak J Henry CS Recent developments in paper-based microfluidic devices Anal. Chem. 2015 87 19 41 10.1021/ac503968p 25375292 · DOI
  81. [93]Pardee K Paper-based synthetic gene networks Cell 2014 159 940 954 10.1016/j.cell.2014.10.004 25417167 PMC4243060 · DOI

Cited by

Sorted by citations

Authors
Land, K. J., Boeras, D. I., Chen, X.-S., Ramsay, A. R., & Peeling, R. W.
Affiliations
  • Council for Scientific and Industrial Research (ZA)
  • Chinese Center For Disease Control and Prevention (CN)
  • University of St Andrews (GB)
  • London School of Hygiene & Tropical Medicine (GB)
Corresponding author
  • Chen, Xiang-Sheng
  • Peeling, Rosanna W.
Venue
Nature Microbiology
Published
2018-12-13
Volume
4
Issue
1
Pages
46-54
ISSN
2058-5276 (ISSN-L)
OpenAlex
W2901655212
Cited by
1,065
References
2
Citations by year
2026: 194 · 2025: 220 · 2024: 224 · 2023: 177 · 2022: 129 · 2021: 70 · 2020: 37 · 2019: 13
FWCI
2.44
Type
journal article
Language
en
Open access
Locations
  • Nature Microbiology (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
Engineering and Physical Sciences Research Council (EP/K031953/1)
Topics
  • Physical Sciences › Engineering › Biomedical Engineering › Biosensors and Analytical Detection
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 detection and testing
Keywords
point-of-care testing, resource-limited settings, infectious disease diagnostics, mobile health, digital diagnostics, disease control strategies, health system strengthening
MeSH terms
Communicable Disease Control, Communicable Diseases, Diagnostic Services, Humans, Malaria, Syphilis, Tuberculosis, Pulmonary, HIV Infections, Point-of-Care Systems

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