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Amid all public health measures to contain COVID-19, the most challenging has been how to break the transmission chain. This has been even more challenging in low- and middle-income countries (LMICs). A public health emergency warrants a public health perspective, which comes down to prevention. Rapid mass testing has been advocated throughout the pandemic as a way to promptly deal with asymptomatic infections, but its usefulness in LMICs is yet to be fully understood.
The study objectives of this paper are to (1) investigate the impact of the different rapid mass testing options for SARS-CoV-2 that have been delivered at point of care in LMICs and (2) evaluate the diagnostic safety (accuracy) of rapid mass testing for SARS-CoV-2 in LMICs.
This review will systematically search records in PubMed, EBSCOhost, Cochrane library, Global Index Medicus COVID-19 Register, and Scopus. Records will be managed using Mendeley reference manager and SWIFT-Review. Risk of bias for randomized controlled trials will be assessed using the RoB 2 assessment tool, while nonrandomized interventions will be assessed using the tool developed by the Evidence Project. A narrative approach will be used to synthesize data under the first objective, and either a meta-analysis or synthesis without meta-analysis for the second objective. Tables, figures, and textual descriptions will be used to present findings. The overall body of evidence for the first objective will be assessed using the Grading of Recommendations Assessment, Development, and Evaluation–Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) approach, and for the second objective using GRADE.
The screening of records has been finalized. We hope to finalize the synthesis by the end of February 2023 and to prepare the manuscript for publication by April 2023. The study will be reported in accordance with standard guidelines for the reporting of systematic reviews. Review results will be disseminated through conferences and their peer-reviewed publication in a relevant journal.
This review highlights the role of a preventive approach in infection control using rapid mass testing. It also flags the overriding need to involve users and providers in the evaluation of such tests in the settings for which they are intended. This will be the first review to the best of our knowledge to generate both qualitative and quantitative evidence regarding rapid mass testing specific to LMICs.
PROSPERO CRD42022283776; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=283776
PRR1-10.2196/41132
The real challenge of COVID-19 containment is to break the transmission chain by preventing individuals from getting infected and preventing those infected from transmitting to others [
It is reported that a major factor that can contribute to up to 50% of infected persons being overlooked during symptom screening is the inability to detect the virus during the asymptomatic stage by programs designed to diagnose cases when the disease is quite advanced [
Key questions to ask when planning to identify infections promptly include, among others, the following: (1) When to test? (2) Where to test? (3) When to get the results? (4) How safe? and (5) How regular? As the global economy learns to cope with the more silent new variant infections, it is apparent that low-cost regular rapid mass testing might assume an important role [
The specific objectives of this study are as follows: (1) to investigate the impact of the different rapid mass testing options for SARS-CoV-2 that have been delivered at point of care in LMICs and (2) to evaluate the diagnostic accuracy of rapid mass testing for SARS-CoV-2 in LMICs.
Given that our review was geared toward going beyond a quantitative evidence synthesis, the research questions were framed following the Perspective, Setting, Phenomenon, Environment, Comparison, Timing, and Findings (PerSPEcTiF) framework to incorporate the (1) setting, (2) time, and (3) place [
From a preventive health perspective in a LMIC, what do rapid tests for SARS-CoV-2—in an environment of limited resources with silent transmissions from infection up until diagnosis—mean to patients, health personnel, and the general public?
What is the diagnostic accuracy of near-the-patient rapid mass testing options for SARS-CoV-2 implemented, irrespective of symptoms in LMICs?
This is a systematic review of both qualitative and quantitative evidence synthesis. A qualitative approach will take the form of a metasynthesis while the quantitative approach will take the form of a meta-analysis.
Searched records will be screened using the inclusion and exclusion criteria. Given the important role played by both contextual variables and time in the detection of SARS-CoV-2 to break the transmission chain, we believed that rapid mass testing interventions were complex ones [
Inclusion and exclusion criteria.
Objective | Inclusion | Exclusion | |
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Perspective | Preventive care [ |
Diseased population |
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Setting | Point of care or near the patient [ |
Lab-based testing |
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Phenomenon | Non–lab-based rapid and point of care test [ |
Serology tests, lab-based tests, and non–point of care tests |
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Environment | In low- and middle-income countries [ |
High-income countries |
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Comparison | N/Ac | N/A |
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Timing | Time during which infection remains asymptomatic; results delivered in 1 visit | Time of diagnosis includes symptoms; if time to results is more than 24 hours |
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Findings | Impact of rapid tests including the knowledge, attitude, and perception of patients, health care providers, and the public | Studies not evaluating the impact of rapid tests on the public |
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Participants | Asymptomatic patients with COVID-19 and close contacts of index cases | COVID-19 or symptomatic patients |
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Intervention | Rapid antigen and point-of-care tests | Lab-based tests |
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Comparison | Lab-based reverse transcription–polymerase chain reaction [ |
Tests other than reverse transcription polymerase chain reactions |
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Outcome | Diagnostic test accuracy | Nondiagnostic test accuracy studies |
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Studies | Qualitative and mixed methods studies for objective 1; RCTse, non-RCTs, and cross-sectional cohort studies for objective 2 | Longitudinal cohort, case-control, case-control cross-sectional, and all prognostic and predictive DTAf studies |
aPerSPEcTiF: Perspective, Setting, Phenomenon, Environment, Comparison, Timing, and Findings.
bGP: general practitioner.
cN/A: not applicable.
dPICO: population, intervention, comparison, outcome.
eRCT: randomized controlled trials.
fDTA: diagnostic test accuracy.
The literature search will be performed in PubMed, EBSCOhost (CINAHL Plus), Global Index Medicus COVID-19 register, Cochrane (library and COVID-19 register), and Scopus. Gray literature from MedRxiv, BioRxiv, AiXiv, and other preprint servers will be ensured through the inclusion of the Global Index Medicus database. No restriction will be set on language. The search for records will follow the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) [
The search for useful articles will be conducted in Google scholar using the keywords of included articles, for objective 1, and the Cochrane COVID-19 Study Register for objective 2. We will also search manually through professional networks and other sources.
We hope to locate useful studies through the reference list of identified records by searching them online using their digital object identifiers in Crossref, DOI resolver, or through the journals in which they were published. Articles will also be identified through the reference list of suitable systematic reviews in the Cochrane Special Collections for COVID-19 Infection Control and Prevention.
Wherever necessary and possible, we will (1) set up email alerts in the electronic databases searched, (2) screen the citation manager’s generic suggestions as well as those from databases, and (3) screen database suggestions for similar articles.
Search terms will include “Qualitative”[Mesh], “Qualitative Study”[tiab], ”Mixed-method“[tiab], ”Interview“[Mesh], ”Attitude“[Mesh], ”Knowledge[Mesh]“, ”Practice“[Mesh], ”KAP“[tiab], ”Acceptance“[Mesh], ”Public Perception“[tiab], “Public Acceptance”[tiab], ”Public Attitude“[tiab], ”Compliance“[Mesh], “Adherence”[Mesh], ”Qualitative Research”[Mesh], “Explor*”[tiab], “COVID-19 Testing”[Mesh], “COVID-19 Nucleic Acid Testing “[Mesh], “Rapid Diagnostic Testing”[tiab], “Lateral Flow Tests”[tiab], “Nucleic Acid Testing”[Mesh], “Rapid test”[Mesh], Lateral Flow[tiab], “Mass Testing”[Mesh], “Mass Screening”[Mesh], “Diagnostic Test”[tiab], “Diagnostic Performance”[tiab], “Test Accuracy”[tiab], Test Performance”[tiab], “Universal Testing”[Mesh], “Universal Screening”[Mesh], “Point-of-Care Testing”[Mesh], “Point-of-Care”[tiab], “Point-of-Care Screening”[Mesh], “POC Testing”[Mesh], “Community Testing”[tiab], “Asymptomatic Infections”[Mesh], “Asymptomatic”[tiab], “Carrier State”[Mesh], “Asymptomatic Diseases”[Mesh], “COVID-19”[Mesh], “SARS-CoV-2”[Mesh], “2019-nCoV”[Mesh], “SARS-CoV-2 Variants”[Mesh], “VOC”[Mesh], “SARS-CoV-2 Variants”[Supplementary Concept], “RT-PCR”[tiab], “PCR”[Mesh], and “Molecular”[tiab]
Records will be searched in databases highlighted under the electronic databases subsection. A date limit will be applied using electronic filters of search engines and set to 2020 and beyond. Searches will constantly be updated throughout the research period. A detailed search strategy in PubMed can be found in the study protocol [
Search strategy for each database.
Database and query order | Search query | |
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#1 | (((((((((((((((((((((“Qualitative”[tiab]) OR (“Qualitative Study”[tiab])) OR (“Mixed-method”[tiab])) OR (“Mixed Method”[tiab])) OR (“Interview”[tiab])) OR (“Attitude”[MeSH])) OR (“Knowledge”[MeSH])) OR (“Practice”[tiab])) OR (“health personnel*”[tiab])) OR (“KAP”[tiab])) OR (“Acceptance”[tiab])) OR (“public acceptance”[tiab])) OR (“public perception”[tiab])) OR (“public attitude*”[tiab])) OR (“Compliance”[MeSH])) OR (“Patient Compliance”[MeSH])) OR (“Adherence”[tiab])) OR (“Patient adherence”[tiab])) OR (“Qualitative research”[MeSH])) OR (Explor*[tiab])) OR (“Health Knowledge, Attitudes, Practice”[MeSH])) OR (“Attitude of health personnel”[MeSH]) |
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#2 | ((((((((((“Point-of-Care Testing”[Mesh]) OR (“Point-of-Care”[tiab])) OR (“Point-of-Care Test*”[tiab])) OR (“Point-of-Care Detect*”[tiab])) OR (“Point-of-Care Screen*”[tiab])) OR (“Rapid Diagnostic Test*”[tiab])) OR (“Lateral Flow*”[tiab])) OR (“Mass Test*”[tiab])) OR (“Mass Screen*”[tiab])) OR (“Universal Test*”[tiab] OR “Universal Screen*”[tiab])) OR (“Rapid Test*”[tiab]) |
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#3 | ((“COVID-19 Testing”[Mesh]) OR (“COVID-19 testing”[tiab])) OR (“SARS-CoV-2 Testing”[tiab]) |
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#4 | ((((“SARS-CoV-2”[Mesh] OR (“COVID-19 Nucleic Acid Testing”[Mesh]) OR (“COVID-19 Nucleic Acid Testing”[tiab])) OR (“SARS-CoV-2 Nucleic Acid Testing”[tiab])) OR (“SARS-CoV-2 Nucleic Acid Detection”[tiab])) OR “SARS-CoV-2 variants” [Supplementary Concept]) |
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#5 | #3 OR #4 |
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#6 | (“PCR”[tiab]) OR (“RT-PCR”[tiab]) |
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#7 | ((((“Asymptomatic Infections”[Mesh]) OR (“Asymptomatic Infections”[tiab])) OR (“Asymptomatic”[tiab])) OR (“Asymptomatic Diseases”[tiab])) OR (“Carrier State”[tiab]) OR (“Carrier”[tiab]) |
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#8 | #1 AND #2 AND #5 AND #7 |
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#9 | #5 AND #6 AND #7 |
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#10 | #6 AND #7 |
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#11 | ((((((((((“Point-of-Care Testing”[Mesh]) OR (“Point-of-Care”[tiab])) OR (“Point-of-Care Test*”[tiab])) OR (“Point-of-Care Detect*”[tiab])) OR (“Point-of-Care Screen*”[tiab])) OR (“Rapid Diagnostic Test*”[tiab])) OR (“Lateral Flow*”[tiab])) OR (“Mass Test*”[tiab])) OR (“Mass Screen*”[tiab])) OR (“Universal Test*”[tiab] OR “Universal Screen*”[tiab])) OR (“Rapid Test*”[tiab]) AND (((“Test accuracy”[tiab]) OR (“Test performance”[tiab])) OR (“Diagnostic accuracy”[tiab])) OR (“Diagnostic performance”[tiab]) |
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#12 | #9 AND #11 |
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#13 | #10 AND #11 |
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#14 | #8 OR #12 |
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#15 | #12 OR 13 |
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#16 | #8 OR #15 |
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#1 | “Diagnostic” OR “Diagnostic test” OR “Diagnostic accuracy” OR “Diagnostic performance” OR “Test accuracy” in Title Abstract Keyword AND Mass test* OR Universal test* OR Universal screen* OR Point-of-care test* OR Rapid test* OR “PoC test*” OR Point-of-care* OR “Point-of-care test” OR “lateral flow” OR “lateral flow test” OR community test* in Title Abstract Keyword AND “Asymptomatic carrier” OR “Asymptomatic” OR SARS-CoV-2 OR “SARS-CoV-2 transmission” OR “Asymptomatic transmission” in Title Abstract Keyword AND “Qualitative study” OR Qualitative OR Mixed-method OR interview OR Acceptance OR Knowledge OR Attitude OR Practice OR Perspective OR Perception OR Adherence OR “Public acceptance” OR “Public perception” OR “Public attitude” OR “Public adherence” in Title Abstract Keyword - (Word variations have been searched) |
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#2 | “Diagnostic” OR “Diagnostic test” OR “Diagnostic accuracy” OR “Diagnostic performance” OR “Test accuracy” in Title Abstract Keyword AND Mass test* OR Universal test* OR Universal screen* OR Point-of-care test* OR Rapid test* OR Point-of-care* OR “Point-of-care test” OR “lateral flow” OR “lateral flow test” OR community test* in Title Abstract Keyword AND “RT PCR” OR RT-PCR OR “RT PCR test*” OR “RT-PCR analys*” OR “Molecular” in Title Abstract Keyword AND “Asymptomatic carrier” OR “Asymptomatic” OR SARS-CoV-2 OR “SARS-CoV-2 transmission” OR “Asymptomatic transmission” in Title Abstract Keyword - (Word variations have been searched) |
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#3 | #3= #1 OR #2 |
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#1 | AB (covid-19 or coronavirus or 2019-ncov or sars-cov-2 or cov-19 or pandemic or 2019 novel coronavirus or coronavirus disease) AND AB (rapid testing or antigene test or lateral flow test or mass test or universal test or mass screen or universal screen or point of care testing or poc or poct) AND AB (qualitative research or qualitative study or qualitative methods or interview or ethnographic or phenomenological) |
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#2 | AB (point of care testing or poc or poct ) OR AB mass screen* OR AB universal test* OR AB universal screen* OR AB lateral flow* OR AB rapid test* AND AB turnaround time AND AB diagnostic accuracy |
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#3 | AB (covid-19 or coronavirus or 2019-ncov or sars-cov-2 or cov-19) AND AB asymptomatic covid-19 NOT AB immune* NOT AB antibod* NOT AB immunoassay* NOT AB serolog* NOT AB seroprevalence NOT AB influenza NOT animal* |
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#4 | AB RT-PCR AND AB Asymptomatic* |
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#5 | S2 AND S3 AND S4 |
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#6 | S1 OR S5 |
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#1 | tw:((tw:(rapid test* OR lateral flow* OR point-of-care test* OR poc test* OR antigene test)) AND (tw:(covid-19 asymptomatic OR asymptomatic*))) |
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#2 | tw:((tw:(mass test*)) OR (tw:(universal screen*)) OR (tw:(universal test*)) OR (tw:(rapid test*)) OR (tw:(lateral flow*)) OR (tw:(point-of-care test*)) OR (tw:(poc test*))) |
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#3 | tw:((tw:(rt-pcr*)) AND (tw:(test accuracy OR test performance OR diagnostic accuracy OR diagnostic performance))) |
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#4 | tw:((tw:(covid-19 asymptomatic)) OR (tw:(asymptomatic*))) |
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#5 | #2 AND #3 AND #4 |
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#6 | #1 OR #5 |
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#1 | (TITLE-ABS-KEY ( covid-19 OR coronavirus OR 2019-ncov OR sars-cov-2 OR “novel coronavirus” ) AND TITLE-ABS-KEY (“rapid test*” OR “antigene test*” OR “lateral flow test*” OR “lateral flow” OR “mass test*” OR “universal test*” OR “point of care test*” OR “point-of-care”) AND TITLE-ABS-KEY (qualitative* OR mixed-method OR interview* OR perspective* OR knowledge OR attitude* OR practice OR perception OR “public perspective*” OR acceptance OR “public attitude”)) |
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#2 | (TITLE-ABS-KEY (rapid AND test*) OR TITLE-ABS-KEY (lateral AND flow*) OR TITLE-ABS-KEY (mass AND test*) OR TITLE-ABS-KEY (universal AND test*) OR TITLE-ABS-KEY (point-of-care AND test*) OR TITLE-ABS-KEY (“point of care”)) |
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#3 | (TITLE-ABS-KEY (covid-19) OR TITLE-ABS-KEY (sars-cov-2) OR TITLE-ABS-KEY (2019-ncov) AND TITLE-ABS-KEY (asymptomatic*)) |
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#4 | (TITLE-ABS-KEY (rt-pcr* OR rt-pcr AND test*) AND TITLE-ABS-KEY (test AND accuracy OR diagnostic AND accuracy OR diagnostic AND performance)) |
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#5 | #2 AND #3 AND #4 |
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#6 | #1 OR #5 |
Search terms will be performed and verified by a second person to ensure search reproducibility. Both results were then compared, and any differences were resolved by modifying and rerunning the searches.
Mendeley reference manager (Elsevier) and SWIFT-Review (Sciome) will be used to manage search records. SWIFT-Review workbench will be used to deduplicate, screen records, and code [
We will start by identifying and removing duplicates in the first phase followed by the screening of titles and abstracts in the second phase, following the outlined inclusion and exclusion criteria. Screening of titles and abstracts will be conducted by 2 independent reviewers (PK and KA) while a third reviewer will serve as an arbitrator. If necessary, full articles will be read should it not be possible to screen records by title or abstract alone. The unavailability of full text will lead to exclusion.
Data extraction for the first objective will be performed by the author leading the protocol development (MM) using SWIFT-Review. This will be done with the help of the SWIFT-Review Tag Browser and manually applied tags. Two reviewers (PK and KA) will independently extract data for the second objective using a customized data extraction template for RCTs and non-RCTs) [
A reference management software (Mendeley reference manager) will be used to manage records both for citations and for the generation of bibliography.
Data items to be extracted will include study title, year, author, country, study objective, conflicts of interest, funding, study design, population (age, sex, and ethnicity), setting, sample size, eligibility criteria, type of test, the time interval between the index and reference tests, the sample collected, statistical analysis, test status, time to results (turnaround time), test accuracy, and study limitations.
The outcome of interest for the first objective is the test impact (patients, health personnel, and the general public). The outcome of the intervention for the second objective based on PICO is the status of SARS-CoV-2/COVID-19, which involves how well the test can identify those with the target condition and reject those without the conditions. Studies comparing the index and reference tests regarding the above will be prioritized.
The assessment of the risk of bias of included studies will be conducted using the most relevant tools and based on study design [
Publication bias will be reduced through the inclusion of gray literature [
Our synthesis approach for objective 1 to a greater part will take the form of a narrative synthesis [
For outcomes under objective 1, the synthesis will follow four elements regarding the implementation of rapid mass testing, including (1) theoretical modeling, (2) preliminary synthesis (3), data interrelatedness, and (4) synthesis robustness [
Concerning objective 2, we will perform a meta-analysis using the bivariate hierarchical logistic regression [
The review findings will be presented using tables, figures, and case descriptions. Risk-of-bias assessment visualizations will be conducted using the robvis web application [
The search strategy will follow the PRISMA search guidelines [
This study does not warrant any ethical approval. This protocol has been registered with the International Prospective Register of Systematic Reviews (PROSPERO; CRD42022283776) [
This protocol will be in line with the PRISMA protocol checklist [
The second round of screening has been finalized.
Preliminary PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram. GIM: Global Index Medicus; nCoV19: COVID-19.
This protocol is based on the diagnostic usefulness and safety of rapid diagnostic tests in LMICs. A point-of-care test is one that can be delivered at the point of sample collection or near the patient, with results made available almost immediately. By “near the patient,” we refer to settings as specified by the Centers for Disease Control and Prevention [
A search for reviews evaluating rapid point-of-care test against the gold standard on asymptomatic carriers in Cochrane library found 3 reviews [
Although rapid mass testing programs came under serious criticism early in the pandemic [
This protocol presents many strengths starting with its registration with PROSPERO. It is the first protocol that seeks to investigate both qualitative and quantitative evidence regarding the diagnostic safety of rapid mass tests in LMICs. The protocol’s specific objectives, search strategy, and reporting are all in line with the guidelines for the undertaking of systematic reviews.
This review highlights the role of context in infection prevention and control using rapid mass testing. It flags the overriding need to involve users and providers in the evaluation of such tests in the settings for which they are intended. This will be the first review, to the best of our knowledge, to generate both qualitative and quantitative evidence regarding rapid mass testing specific to LMICs.
Data extraction form.
Risk-of-bias assessment tools.
Confidence in the Evidence from Reviews of Qualitative research
Grading of Recommendations Assessment, Development, and Evaluation
low- and middle-income country
Medical Subject Headings
Perspective, Setting, Phenomenon, Environment, Comparison, Timing, and Findings
population, intervention, comparison, outcome
Preferred Reporting Items for Systematic Reviews and Meta-Analysis
International Prospective Register of Systematic Reviews
Realist and Metanarrative Evidence Syntheses: Evolving Standards
MM is an independent researcher. He can be reached at Alumni Relations, London School of Hygiene & Tropical Medicine.
Data sharing is not applicable to this article as no data sets were generated or analyzed during the current study.
MM developed and registered the protocol and generated the first draft of the manuscript. PK and KA pilot-tested the data collection form. The manuscript was reviewed and approved by all authors.
None declared.