How to implement new diagnostic products in low-resource settings: an end-to-end framework

Mugambi, Melissa Latigo; Peter, Trevor; Martins, S. F.; Giachetti, Cristina

doi:10.1136/bmjgh-2018-000914

Cited by 14 publications

(21 citation statements)

References 26 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The reasons for these differences reflect the complexities of introducing new technologies in low resource settings, including training health workers on their consistent and correct use. The need for an adequate development and evaluation process for diagnostic aids in low resource settings has also been highlighted recently in the literature [27].…”

Section: Discussionmentioning

confidence: 99%

Performance of five pulse oximeters to detect hypoxaemia as an indicator of severe illness in children under five by frontline health workers in low resource settings – A prospective, multicentre, single-blinded, trial in Cambodia, Ethiopia, South Sudan, and Uganda

et al. 2021

View full text Add to dashboard Cite

Background: Low blood oxygen saturation (SpO 2 ), or hypoxaemia, is an indicator of severe illness in children. Pulse oximetry is a globally accepted, non-invasive method to identify hypoxaemia, but rarely available outside higher-level facilities in resource-constrained countries. This study aims to evaluate the performance of different types of pulse oximeters amongst frontline health workers in Cambodia, Ethiopia, South Sudan, and Uganda. Methods: Five pulse oximeters (POx) which passed laboratory testing, out of an initial 32 potential pulse oximeters, were evaluated by frontline health workers for performance, defined as agreement between the SpO 2 measurements of the test device and the reference standard. The study protocol is registered with the Australia New Zealand Clinical Trials Registry (Ref: ACTRrn12615000348550). Findings: Two finger-tip pulse oximeters (Contec and Devon), two handheld pulse oximeters (Lifebox and Utech), and one phone pulse oximeter (Masimo) passed the laboratory testing. They were evaluated for performance on 1,313 children under five years old by 207 frontline health workers between February and May 2015. Phone and handheld pulse oximeters had greater overall agreement with the reference standard (56%; 95% CI 0.52 -0.60 to 68%; 95% CI 0.65 -0.71) than the finger-tip POx (31%; 95% CI 0.26 to 0.36 and 47%; 95% CI 0.42 to 0.52). Fingertip POx performance was substantially lower in the 0À2 month olds; having just 17% and 25% agreement. The finger-tip devices more often underreported SpO 2 readings (mean difference -7.9%; 95%CI -8.6,-7.2 and -3.9%; 95%CI -4.4,-3.4), and therefore over diagnosed hypoxaemia in the children assessed. Interpretation: While the Masimo phone pulse oximeter performed best, all handheld POx with age-specific probes performed well in the hands of frontline health workers, further highlighting their suitability as a screening tool of severe illness. The poor performance of the fingertip POx suggests they should not be used in children under five by frontline health workers. It is essential that POx are performance tested on children in routine settings (in vivo), not only in laboratories or controlled settings (in vitro), before being introduced at scale.

show abstract

Section: Discussionmentioning

confidence: 99%

Performance of five pulse oximeters to detect hypoxaemia as an indicator of severe illness in children under five by frontline health workers in low resource settings – A prospective, multicentre, single-blinded, trial in Cambodia, Ethiopia, South Sudan, and Uganda

et al. 2021

View full text Add to dashboard Cite

show abstract

“…With regard to implementation in LRS, we did not discuss the role and contribution of certain stakeholders specific to the implementation of IVDs in LRS, such as funders, implementers, technical experts-for a framework analysis and landscape analysis, see reference (121), neither did we discuss funding for diagnostics research and implantation.…”

Section: Limitationsmentioning

confidence: 99%

Implementing COVID-19 (SARS-CoV-2) Rapid Diagnostic Tests in Sub-Saharan Africa: A Review

et al. 2020

View full text Add to dashboard Cite

Introduction: For the COVID-19 (SARS-CoV-2) response, COVID-19 antigen (Ag), and antibody (Ab) rapid diagnostic tests (RDTs) are expected to complement central molecular testing particularly in low-resource settings. The present review assesses requirements for implementation of COVID-19 RDTs in sub-Saharan Africa. Methods:Review of PubMed-published articles assessing COVID-19 RDTs complemented with Instructions for Use (IFU) of products.Results: In total 47 articles on two COVID-19 Ag RDTs and 54 COVID-19 Ab RDTs and IFUs of 20 COVID-19 Ab RDTs were retrieved. Only five COVID-19 Ab RDTs (9.3%) were assessed with capillary blood sampling at the point-of-care; none of the studies were conducted in sub-Saharan Africa. Sampling: Challenges for COVID-19 Ag RDTs include nasopharyngeal sampling (technique, biosafety) and sample stability; for COVID-19 Ab RDTs equivalence of whole blood vs. plasma/serum needs further validation (assessed for only eight (14.8%) products). Sensitivity-Specificity: sensitivity of COVID-19 Ag and Ab RDTs depend on viral load (antigen) and timeframe (antibody), respectively; COVID-19 Ab tests have lower sensitivity compared to laboratory test platforms and the kinetics of IgM and IgG are very similar. Reported specificity was high but has not yet been assessed against tropical pathogens. Kit configuration: For COVID-19 Ag RDTs, flocked swabs should be added to the kit; for COVID-19 Ab RDTs, finger prick sampling materials, transfer devices, and controls should be added (currently only supplied in 15, 5, and 1/20 products). Usability and Robustness: some COVID-19 Ab RDTs showed high proportions of faint lines (>40%) or invalid results (>20%). Shortcomings were reported for buffer vials (spills, air bubbles) and their instructions for use. Stability: storage temperature was ≤30 • C for all but one RDT, in-use and result stability were maximal at 1 h and 30 min, respectively. Integration in the healthcare setting requires a target product profile, landscape overview of technologies, certified manufacturing capacity, a sustainable market, and a stringent but timely regulation. In-country deployment depends on integration in the national laboratory network. Jacobs et al. COVID-19 Rapid Tests in Sub-Saharan Africa Discussion/Conclusion: Despite these limitations, successful implementation models in triage, contact tracing, and surveillance have been proposed, in particular for COVID-19 Ab RDTs. Valuable experience is available from implementation of other disease-specific RDTs in sub-Saharan Africa.

show abstract

“…New diagnostics like Xpert® are introduced into "old systems" which have established patterns of practice/behaviour that influence technology adoption [17]. Understanding these "old systems"-the context into which the new equipment is introduced, is essential to identifying practices and behaviours that are likely to enhance or constrain uptake and use.…”

Section: Introductionmentioning

confidence: 99%

Perspectives and practices of health workers around diagnosis of paediatric tuberculosis in hospitals in a resource-poor setting – modern diagnostics meet age-old challenges

Oliwa

Odero

Nzinga

et al. 2020

BMC Health Serv Res

View full text Add to dashboard Cite

Background: Detection of tuberculosis (TB) in children in Kenya is sub-optimal. Xpert MTB/RIF® assay (Xpert®) has the potential to improve speed of TB diagnosis due to its sensitivity and fast turnaround for results. Significant effort and resources have been put into making the machines widely available in Kenya, but use remains low, especially in children. We set out to explore the reasons for the under-detection of TB and underuse of Xpert® in children, identifying challenges that may be relevant to other newer diagnostics in similar settings. Methods: This was an exploratory qualitative study with an embedded case study approach. Data collection involved semi-structured interviews; small-group discussions; key informant interviews; observations of TB trainings, sensitisation meetings, policy meetings, hospital practices; desk review of guidelines, job aides and policy documents. The Capability, Opportunity and Motivation (COM-B) framework was used to interpret emerging themes. Results: At individual level, knowledge, skill, competence and experience, as well as beliefs and fears impacted on capability (physical & psychological) as well as motivation (reflective) to diagnose TB in children and use diagnostic tests. Hospital level influencers included hospital norms, processes, patient flows and resources which affected how individual health workers attempted to diagnose TB in children by impacting on their capability (physical & psychological), motivation (reflective & automatic) and opportunity (physical & social). At the wider system level, community practices and beliefs, and implementation of TB programme directives impacted some of the decisions that health workers made through capability (psychological), motivation (reflective & automatic) and opportunity (physical).

show abstract

How to implement new diagnostic products in low-resource settings: an end-to-end framework

Cited by 14 publications

References 26 publications

Performance of five pulse oximeters to detect hypoxaemia as an indicator of severe illness in children under five by frontline health workers in low resource settings – A prospective, multicentre, single-blinded, trial in Cambodia, Ethiopia, South Sudan, and Uganda

Performance of five pulse oximeters to detect hypoxaemia as an indicator of severe illness in children under five by frontline health workers in low resource settings – A prospective, multicentre, single-blinded, trial in Cambodia, Ethiopia, South Sudan, and Uganda

Implementing COVID-19 (SARS-CoV-2) Rapid Diagnostic Tests in Sub-Saharan Africa: A Review

Perspectives and practices of health workers around diagnosis of paediatric tuberculosis in hospitals in a resource-poor setting – modern diagnostics meet age-old challenges

Contact Info

Product

Resources

About