A Scoping Review Protocol for Supply Chain Management Systems for Point of Care Diagnostics Services: Optimising COVID-19 Testing Capacity in Resource-limited Settings

Abstract


Background
The World Health Organisation (WHO) recommends using reverse transcription polymerase chain reaction (RT-PCR) tests for detecting severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) as a gold standard for diagnosing coronavirus 19 (COVID-19) (1)(2)(3).RT-PCR requires sophisticated laboratory equipment, often lacking in resource-limited settings, hindering fast and accurate detection of SARS-CoV-2 (4).Additionally, RT-PCR is time-consuming and getting results may take a number of days (5).In resource-limited settings this has resulted in a large backlog when testing patient samples suspected of SARS-CoV-2 (4).
In resource-limited settings, alternative diagnostic methods such as point of care (POC) testing may ease the burden on healthcare facilities and laboratory services (1,2).POC testing refers to diagnostic testing that uses innovative medical technologies that enable near patient disease diagnosis to inform clinical decisions (6).POC tests are cheap, easy to perform and can be deployed both at the site of triage and outside health care facilities to guide disease management (1,6).POC tests deliver prompt results, therefore, they are of utmost importance in containing highly infectious diseases such as SARS-CoV-2 (6).The WHO recommended scaling up testing programmes for SARS-CoV-2 by testing all suspected cases (7).This recommendation was prompted by a resurgence of COVID-19 and the continuum of limited testing capacity in settings that have poor access to laboratory infrastructure (8).
For the e cient control and management of COVID-19, POC tests are required on a large scale (9).
Globally, POC tests are being rapidly developed for SARS-CoV-2 (10).To ensure equitable availability and accessibility of POC tests, e cient supply chain management (SCM) is necessary.Supply chain refers to resources and processes needed to deliver goods and services to consumers with complete satisfaction in a cost-optimized manner (11,12).Optimal SCM of SARS-CoV-2 POC tests will ensure that health care professionals have the available resources to perform tests for patients (6).An ineffective SCM may limit the availability and accessibility of POC tests and negatively impact health outcomes (12,13).Evidence on supply chain systems for POC diagnostics is not clear.This scoping review protocol outlines the methods that will be used to map evidence of SCM systems of POC diagnostic services globally.We anticipate that the results of the planned scoping review will guide future research on SCM for SARS-CoV-2 POC testing and guide implementation of SARS-CoV-2 POC diagnostics in resource-limited settings.In this study, we de ne resource-limited settings as settings with poor access to laboratory infrastructure.

Methodology
This study is part of a multi-phase PhD study investigating supply chain management of SARS-CoV-2 POC diagnostic services.To map evidence on SCM systems for POC diagnostics services, we will conduct a scoping review.The review will be guided by the methodological framework proposed by Arksey and O'Malley (14) and further advanced by Levac et al. (15).According to this framework the review will be conducted in ve stages: (i) identify the research question, (ii) identify relevant studies, (iii) select eligible studies, (iv) charting the data, and (v) collating, summarising and reporting the results.Arksey and O'Malley proposed a sixth stage comprising optional consultation with key stakeholders to provide insights beyond those found in literature.This scoping review will not include consultation with stakeholders.

Identi cation of the research question
The research question is: What is the evidence on SCM systems for POC diagnostics services, globally?To determine the eligibility of the proposed research question for a scoping review, we used the Population, Concept and Context (PCC) framework as depicted in Table 1.Resources and processes needed to deliver goods and services to consumers with complete satisfaction in a cost-optimized manner (11,12).

Context Globally
Identi cation of relevant studies We will identify relevant studies by conducting a comprehensive and reproducible search of all literature published in the following electronic databases: Medline Ovid, Medline Elton B. Stephens Company (EBSCO), Scopus, PubMed, PsycInfo, Web of Science and EBSCOHost.We will also search gray literature including dissertations/theses, conference proceedings, websites of international organisations such as WHO and government reports.We will identify additional relevant studies by manually searching all references cited in the included studies to identify studies that have not been indexed by the electronic databases.Language restrictions will not be applied to minimise the risk of excluding relevant articles.
The comprehensive search strategy will be co-developed by the principal investigator (PI), subject specialist and university librarian to ensure the correct use of indexing terminology and Medical Subject Headings (MeSH) terms.The following keywords or MeSH terms will be used: 1) "supply chain management" or "supply chain" or "supply chain ow" or "supply chain systems" 2) "point of care" or "point of care testing" or "point of care diagnosis" or "point of care diagnostic services".Keywords may be re ned to suit each database.Each search will be documented in detail showing the keywords/MeSH terms, date of search, electronic database and number of retrieved studies.We piloted the search strategy on one of the electronic databases and the results of the search are tabulated in table 2. We will summarise the literature in a narrative report.We will extract data from all included studies and map evidence on SCM systems of POC diagnostics services, summarise existing research ndings and reveal gaps in the existing literature.The results will be described in the form of a table and graphs.We will include a map showing the countries where the studies were conducted.A thematic summary will describe how the ndings from the included studies relate to the research question.

Quality appraisal
We will use the mixed method appraisal tool (MMAT) version 2018 to evaluate the quality of the included studies (17).Two independent reviewers will carry out the quality appraisal process.The following percentage scores will be used to grade the quality of evidence: i) ≤50% will represent low quality evidence ii) 51-75% will represent average quality evidence iii) 76-100% will represent high quality evidence.This quality appraisal method will enable us to appraise a variety of study methods, i.e. qualitative, quantitative or mixed methods studies (17).

Ethical considerations
This scoping review involves synthesis of current evidence therefore ethical approval is not required.

Discussion
To control the spread of SARS-CoV-2, governing bodies across the globe enforced travel restrictions to limit the movement of people (18).Policymakers have been working around the clock to ensure that supplies of essential medical equipment remain uninterrupted (18).To optimise the supply of essential medical equipment, e cient SCM operations needed to ensure accessibility and availability of POC tests, especially since the WHO has encouraged all countries to scale up SARS-CoV-2 testing services.To ensure that all countries have enough supplies of SARS-CoV-2 POC tests, the WHO established the COVID-19 supply chain system (CSCS) that provides essential SARS-CoV-2 supplies to all countries (19).The CSCS coordinates multiple-channel procurement and distribution through the identi cation of demand, demand aggregation, forecasting, certi cation, market scanning, sourcing, allocation and delivery of essential supplies to where they are needed most at national and subnational level (19).
Managing SARS-CoV-2 requires accurate laboratory diagnosis and POC testing can supplement laboratory testing to boost testing capacity in resource-limited settings with poor laboratory infrastructure.In this scoping review, we will exclude all articles reporting SCM systems of laboratory diagnosis and focus solely on POC testing to provide a clear overview of the available research evidence.We will also exclude articles that do not report SCM systems of POC diagnostic services as this will not address the research question.
The proposed scoping review will collate global evidence on SCM systems of POC diagnostics services published since inception.We anticipate that the scoping review will provide a comprehensive insight on the evidence of SCM systems of POC diagnostics services globally and reveal research gaps.Our review will also guide implementation of SARS-CoV-2 POC diagnostics in resource-limited settings.The results will be published in a scienti c journal, presented at relevant conferences and form part of workshops with key stakeholders involved in SCM systems for POC diagnostics services.

Supplementary Files
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Table 1
Framework for determining the eligibility of the research question