The DOI matches its Crossref record; 1 of the 1 references it cites were found in a registry or an index.
Policy analysis: User monitoring of in-vitro diagnostic medical devices used for near-patient testing of infectious diseases
Open accessAbstract
Abstract Background All individuals should have equitable access to accurate and timely testing for infectious diseases, which underpins diagnosis and treatment, safeguards blood supplies, and is used to determine disease prevalence. Disadvantaged populations have limited access to laboratory-based testing, so near-patient or point-of-care testing (PoCT) has been developed and implemented. Unlike laboratory-based testing, PoCT is often performed by non-laboratory staff and outside regulatory frameworks. Quality assurance (QA) of PoCT is often lacking or inappropriate, meaning inaccurate testing can go undetected, leading to poor patient outcomes. Objective To review the application of QA of PoCT use to detect infectious diseases and propose fit-for-purpose alternatives. Method A review of the current QA of PoCT was undertaken by experienced QA providers by mapping the points of failure. Barriers to providing PoCT QA include inappropriate and unstable sample types; expensive shipping to remote sites, including dry ice shipment; cost of international QA programmes; regulatory costs; fixed test events; and a lack of technology for simple, centralized data collection facilitating rapid analysis and reporting of test results. Based on these findings, a novel, fit-for-purpose model of QA for PoCT for infectious diseases is described. Results The new model for QA for PoCT identifies and describes novel sample types, including dry tube samples, dried swabs, or liquid-stable clinical samples that are inactivated and stable at ambient temperature; modified distribution channels; and a method for data collection and analysis using mobile phone technology. Conclusion The findings of this paper seek to describe a fit-for-purpose process, which aims to improve the quality of testing for infectious diseases at PoCT, globally.
Overview
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Laboratory-based QA is not fit for the purpose of POCTs.
“Laboratory-based QA is not fi t for the purpose of POCTs.”
From Point-of-care testing: state-of-the art and perspectives (2025) · cites this paper as [68]
A recent review identified barriers to POCT sites participating in laboratory-based QA: different sample types, cost, lack of infrastructure, fixed test dates, loss of QA data.
“A recent review of barriers to POCT sites participating in laboratory-based QA identi fi ed several factors; (a) POCT often use di ff erent sample types to laboratory testing, (b) cost barrier to the purchase, shipping and importation of QA samples to individual sites, (c) POCT sites lack infrastructure required for QA, (d) they use fi xed test dates for QA programs, and (e) a loss of QA data for”
From Point-of-care testing: state-of-the art and perspectives (2025) · cites this paper as [68]
Citations
Cites
Shanks, L., Klarkowski, D., & O'Brien, D. P. (2013) · PLoS ONE · doi:10.1371/journal.pone.0059906 · Cited by 110
Flagged first, then by citations
Research works printed but not linked: 28
- Johnson, 2017, To err is human, to correct is public health: a systematic review examining poor quality testing and misdiagnosis of HIV status, J Int AIDS Soc, 20, 10.7448/IAS.20.7.21755 · DOI
- Shaw, 2021, Identifying and reducing errors in point-of-care testing, Ejifcc, 32, 298
- World Health Organization, 2011, Laboratory Quality Management System: Handbook
- Lisby, 2021, Point of care testing for infectious disease: ownership and quality, J Antimicrob Chemother, 76, iii28, 10.1093/jac/dkab247 · DOI
- International Organization for Standardization, 2016, ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
- International Medical Device Regulators Forum, 2018, IMDRF Good Regulatory Review Practices Group
- World Health Organization, 2015, Essential Medicines and Health Products
- World Health Organization, 2021, Prequalification of In Vitro Diagnostics
- Garcia, 2014, Impact of proficiency testing program for laboratories conducting early diagnosis of HIV-1 infection in infants in low- to middle-income countries., J Clin Microbiol, 52, 773, 10.1128/JCM.03097-13 · DOI
- Terris-Prestholt, 2020, The potential for quality assurance systems to save costs and lives: the case of early infant diagnosis of HIV., Trop Med Int Health, 25, 1235, 10.1111/tmi.13472 · DOI
- European Parliament and the Council of the European Union, 2017, Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices, Off J Eur Union, 60
- Kim, 2009, Identification of performance problems in a commercial human immunodeficiency virus type 1 enzyme immunoassay by multiuser external quality control monitoring and real-time data analysis., J Clin Microbiol, 47, 3114, 10.1128/JCM.00892-09 · DOI
- Dimech, 2015, Determination of quality control limits for serological infectious disease testing using historical data, Clin Chem Lab Med, 53, 329, 10.1515/cclm-2014-0546 · DOI
- Galli, 2013, Evaluation of the accuracy and ease of use of a rapid HIV-1 Antibody Test performed by untrained operators at the point of care., J Clin Virol, 58, e65, 10.1016/j.jcv.2013.08.024 · DOI
- Jani, 2014, Accurate early infant HIV diagnosis in primary health clinics using a point-of-care nucleic acid test., J Acquir Immune Defic Syndr, 67, e1, 10.1097/QAI.0000000000000250 · DOI
- Ndase, 2015, Frequency of false positive rapid HIV serologic tests in African men and women receiving PrEP for HIV prevention: implications for programmatic roll-out of biomedical interventions., PLoS One, 10, 10.1371/journal.pone.0123005 · DOI
- Baveewo, 2012, Potential for false positive HIV test results with the serial rapid HIV testing algorithm, BMC Res Notes, 5, 10.1186/1756-0500-5-154 · DOI
- Wolpaw, 2010, The failure of routine rapid HIV testing: a case study of improving low sensitivity in the field, BMC Health Serv Res, 10, 10.1186/1472-6963-10-73 · DOI
- Dimech, 2020, Validation of dried tube sample format quality controls for the monitoring of viral load and blood screening assays, J Virol Methods, 285, 10.1016/j.jviromet.2020.113957 · DOI
- Parekh, 2010, Dried tube specimens: a simple and cost-effective method for preparation of HIV proficiency testing panels and quality control materials for use in resource-limited settings., J Virol Methods, 163, 295, 10.1016/j.jviromet.2009.10.013 · DOI
- Ramos, 2013, Generation of dried tube specimen for HIV-1 viral load proficiency test panels: a cost-effective alternative for external quality assessment programs, J Virol Methods, 188, 1, 10.1016/j.jviromet.2012.11.036 · DOI
- Martianez-Vendrell, 2020, Quantification of malaria antigens PfHRP2 and pLDH by quantitative suspension array technology in whole blood, dried blood spot and plasma., Malar J, 19, 10.1186/s12936-019-3083-5 · DOI
- Lee, 2002, Stabilized viral nucleic acids in plasma as an alternative shipping method for NAT, Transfusion, 42, 409, 10.1046/j.1525-1438.2002.00068.x · DOI
- Wang, 2013, A 10-year human hepatitis B virus nucleic test external quality assessment in China: continual improvement, Clin Chim Acta, 425, 139, 10.1016/j.cca.2013.07.026 · DOI
- Carmona, 2019, Separation of plasma from whole blood by use of the cobas plasma separation card: a compelling alternative to dried blood spots for quantification of HIV-1 viral load, J Clin Microbiol, 57, 10.1128/JCM.01336-18 · DOI
- Pham, 2019, Performance of a novel low-cost, instrument-free plasma separation device for HIV viral load quantification and determination of treatment failure in people living with HIV in Malaysia: a diagnostic accuracy study, J Clin Microbiol, 57, 10.1128/JCM.01683-18 · DOI
- Dimech, 2018, Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing, Clin Chem Lab Med, 56, 1970, 10.1515/cclm-2018-0351 · DOI
- Dimech, 2020, Does a change in quality control results influence the sensitivity of an anti-HCV test?, Clin Chem Lab Med, 58, 1372, 10.1515/cclm-2020-0031 · DOI
Cited by
Sorted by citations
Point-of-care testing: state-of-the art and perspectives
Plebani, M., Nichols, J. H., Luppa, P. B., Greene, D., Sciacovelli, L., Shaw, J., Khan, A. I., Carraro, P., Freckmann, G., Dimech, W., et al. (2025) · Clinical Chemistry and Laboratory Medicine (CCLM) · doi:10.1515/cclm-2024-0675 · Cited by 119
Self-citation
Metadata
- Authors
- Dimech, W., Lamoury, F., Ding, X. C., Lastra, L. M., Vincini, G., & Sands, A.
- Affiliations
- National Serology Reference Laboratory, Australia , 4th Floor Healy Building, 41 Victoria Parade, Fitzroy, VIC 3065, Australia
- FIND (CH)
- World Health Organization (CH)
- Corresponding author
- Dimech, Wayne
- Venue
- IJQHC Communications
- Publisher
- Oxford University Press (OUP)
- Published
- 2022-07-01
- Volume
- 2
- Issue
- 2
- ISSN
- 2634-5293 (ISSN-L)
- OpenAlex
- W4289519005
- Cited by
- 3
- References
- 1
- Citations by year
- 2025: 1 · 2024: 1 · 2022: 1
- FWCI
- 0.47
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- IJQHC Communications (publishedVersion, cc-by)
- Funders
- Global Fund to Fight AIDS, Tuberculosis and Malaria
- Topics
- Health Sciences › Health Professions › Medical Laboratory Technology › Clinical Laboratory Practices and Quality Control
- Physical Sciences › Engineering › Biomedical Engineering › Biosensors and Analytical Detection
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Healthcare Regulation
- Keywords
- point-of-care testing, in vitro diagnostic medical devices, quality assurance, infectious disease testing, user monitoring, sample stability, sample distribution, mobile phone data collection, regulatory challenges
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
