Translate this page into:
Quality assurance in rapid diagnostic tests for accurate diagnosis of malaria
For correspondence: Dr Praveen Kumar Bharti, ICMR- National Institute of Malaria Research, New Delhi 110 077, India e-mail: saprapbs@yahoo.co.in
-
Received: ,
Accepted: ,
How to cite this article: Ahmed N, Yadav A, Ranjha R, Anvikar AR, Bharti PK. Quality assurance in rapid diagnostic tests for accurate diagnosis of malaria. Indian J Med Res. 2026;163:461-8. doi: 10.25259/IJMR_2477_2025
Abstract
Early and accurate detection of malaria is essential for appropriate case management, minimizing unnecessary treatment, and supporting surveillance efforts crucial for disease control and elimination. Microscopy has long been the reference method for malaria diagnosis. Rapid diagnostic tests (RDTs) have revolutionised point-of-care diagnosis of malaria, with billions of units distributed globally over the past decade. However, ensuring their reliability necessitates rigorous quality assurance measures. Inaccurate test performance can lead to misdiagnosis, inappropriate treatment, increased mortality, and the potential emergence of drug-resistant strains that can lead to delay in achieving the target of malaria elimination. Strengthening quality assurance protocols is crucial to maintain the accuracy of malaria diagnostics, enhancing disease surveillance, and bolstering global malaria elimination initiatives. This paper focuses on the role of quality assurance in optimising the performance and reliability of malaria RDTs. By implementing enhanced quality assurance frameworks, diagnostic accuracy can be safeguarded, toward malaria eradication.
Keywords
Malaria
QC panel quality assurance
Quality control
Rapid diagnostic kit test
Malaria remains one of the most life-threatening infectious diseases worldwide, with a high burden in tropical and subtropical regions. In 2023, the global burden of malaria was estimated to reach approximately 263 million cases, representing an increase of 11 million cases compared to 2022.1 The widespread prevalence of malaria imposes substantial socio-economic and healthcare burdens, particularly in endemic areas where healthcare infrastructure and resources are often limited.2,3 For malaria to be effectively managed, diagnosis is essential. A precise diagnosis ensures adequate treatment and effective malaria control. Additionally, it contributes significantly to epidemiological surveillance, which is crucial for attempts to eradicate malaria. Historically, microscopy served as the primary method for diagnosing malaria; while highly effective in controlled laboratory settings, it has notable limitations. Microscopy is labour-intensive, requires well-maintained equipment, and necessitates highly skilled personnel, particularly for detecting low-parasitaemia infections. These constraints may pose significant challenges in resource-limited settings and remote areas.4-6
Rapid diagnostic tests (RDT) for malaria are immunechromatographic assays designed to detect malaria antigens in blood samples using a membrane-based system that incorporates specific antimalarial antibodies.7 A recent study showing the sensitivity of both RDT and microscopy for detecting overall malaria infections and P. falciparum cases exceeded 80% when compared with polymerase chain reaction (PCR). In contrast, the diagnostic sensitivity for P. vivax was substantially lower (57.0%), and performance was particularly poor for mixed P. falciparum–P. vivax infections, with a sensitivity of only 18.0%.8 Another study from India, revealed that overall sensitivity, specificity and accuracy of the RDT were >90% in areas of different endemicity.9 PCR is another diagnostic modality that offers superior diagnostic accuracy. However, its routine implementation is hindered by high costs, the requirement for specialised equipment, and the need for trained personnel, making it impractical for field use.10
To ensure timely and accurate malaria diagnosis for effective disease management, the World Health Organization has established diagnostic guidelines. Since 2010, WHO has recommended confirmatory parasitological diagnosis using microscopy, recognised as the gold standard or the use of malaria RDTs at the point of care before administering antimalarial treatment.11 Globally, 3.9 billion rapid diagnostic tests for malaria were sold by manufacturers in 2010–2022, with 82% of these sales being in sub-Saharan African countries.12 Due to their accessibility, portability, and ease of use, RDTs have become indispensable components of malaria control programs. However, their reliability is contingent on strict quality control measures to ensure diagnostic accuracy.13 Although several reviews and reports have discussed malaria diagnostics, few have comprehensively addressed how quality assurance mechanisms can directly influence diagnostic accuracy, regulatory compliance, and elimination strategies. This review adds value by bridging this gap linking global quality assurance frameworks such as the World Health Organization-find innovative new diagnostics (FIND) programme with national initiatives including ICMR’s standardised protocols.
Quality assurance is essential to ensure consistent performance, as lapses in quality can lead to misdiagnosis, which can result in inappropriate treatment, increased mortality, and the emergence of drug resistance.13 Therefore, implementing rigorous quality assurance frameworks is critical to preserving diagnostic accuracy, sustaining trust in malaria diagnostic systems, minimising treatment failures, and supporting global malaria elimination efforts.14 These malaria immune-chromatographic lateral flow devices detect specific malaria antigens in a patient’s blood, such as histidine-rich protein 2 (hrp2), lactate dehydrogenase (LDH), and aldolase. These antigens bind to monoclonal antibodies conjugated with dye molecules or gold nanoparticles; the resulting antigen–antibody complexes subsequently interact with immobilised capture antibodies, generating a visible coloured line that denotes a positive result within 15–30 min, making them invaluable in settings where laboratory facilities are unavailable.15 These are categorised based on the number and type of antigens they detect, as summarised in Table I. The efficiency of this migration process is governed by the membrane’s porosity and the physicochemical properties of the buffer solution, which influence fluid dynamics and antigen-antibody interactions.4,16,17 Compared to maintaining laboratory infrastructure, RDTs offer a cost-effective alternative for large-scale malaria surveillance and diagnosis.18 Their rapid turnaround time facilitates timely treatment initiation, thereby minimising delays in patient care.19 However, environmental factors such as humidity and temperature can compromise the test kits integrity. The emergence of histidine-rich protein-II gene deletions is a growing concern in malaria diagnostics, particularly in regions with high malaria prevalence.20 A recent study from nine malaria-endemic states of India examined these gene deletions in P. falciparum isolates. The results showed that the deletion rates for Pfhrp2 and Pfhrp3 genes were 0.44% and 1.47%, respectively.21 These issues underscore the critical need for robust quality assurance measures. The potential impact of RDT kit components on diagnostic performance is summarised in Table II.15,22-26 By critically examining such performance variations in the context of quality assurance systems, this review emphasises actionable strategies to strengthen diagnostic reliability through improved lot testing, post-market surveillance, and competency-based training programmes.
| RDT type | Species detected | Target antigen (s) | Utility |
|---|---|---|---|
| Monovalent (P.falciparum) | P. falciparum | HRP2 | High P. falciparum burden areas (e.g., Africa) |
| Monovalent (P. vivax) | P. vivax | pLDH specific to P. vivax | Regions with high P. vivax prevalence |
| Bivalent (Pf+Pan) | P. falciparum + other species | HRP2 + pan-pLDH/aldolase | Areas with mixed-species infection malaria transmission |
| Bivalent (Pf+Pv) | P. falciparum + P. vivax | HRP2 + P. vivax pLDH | South Asia, Southeast Asia, Latin America |
| Trivalent (Pf+Pan+Pv) | P. falciparum + P. vivax + other species | HRP2 + P. vivax pLDH+PanpLDH | South Asia, Southeast Asia, Latin America |
RDT, rapid diagnostic test, HRP2, histidine rich protein-2, pLDH, plasmodium lactate dehydrogenase, Pf, Plasmodium falciparum, Pv, Plasmodium vivax; Pan, Plasmodium
| Component | Quality issue | Potential impact |
|---|---|---|
| Antibodies coating | Inadequate storage conditions (e.g., improper temperature) | Reduced sensitivity or specificity and false negatives or positives24 |
| Test strips | Inconsistent manufacturing quality Variability in conjugate release or antigen capture | Reduced accuracy in detection of non-reproducibility of results24 |
| Control lines | Absence or fading of control line | False-negative results, Invalid test result25 |
| Sample application zone | Cross-contamination during sample application | False positives and reduced test reliability24 |
| Shelf life and expiration | Extended shelf life beyond the recommended time | Inaccurate results due to reagent degradation15 |
| Storage conditions | Exposure to extreme temperatures, humidity, or sunlight | Decreased sensitivity and specificity non-functioning RDTs25 |
| Lot to lot variability | Variability in test performance across different batches | Inconsistent results across tests of different lots difficulty in establishing reproducibility23 |
| Manufacturing quality | Use of substandard materials and Poor manufacturing processes | Inconsistent test performance, unreliable detection of malaria antigens26 |
| Labelling and instructions | Inadequate labelling of test kit components | Misuse of the test kit incorrect interpretation of results22 |
| Packaging | Poor packaging (e.g., moisture or heat exposure) | Reduced shelf life, degradation of test components and false results22 |
Quality assurance
For malaria RDTs, quality assurance encompasses a range of activities designed to guarantee that test kits perform accurately under diverse conditions. Laboratory-based evaluations provide standardised assessments of RDT performance, facilitating to differentiate between high- and low-quality diagnostic tests.27 In 2008, the Foundation for innovative new diagnostics (FIND) and World Health Organization established a quality assurance evaluation framework to enhance the sensitivity and specificity of malaria RDTs, and adherence to internationally recognised standards, such as those set by World Health Organization.22,28 The World Health Organization recommends that all RDTs used for malaria diagnosis should be WHO-prequalified. All WHO-prequalified tests meet the minimum performance criteria required for sensitivity, specificity, and overall quality, making them acceptable for procurement and clinical diagnosis of malaria. Products that exceed this minimum performance thresholds are not expected to provide significant additional clinical benefit. This addition aligns the study context with WHO standards for ensuring the reliability and quality assurance of malaria RDTs (Supplementary Table).29 Asian Collaborative Training Network for Malaria collaborates with national health authorities to conduct systematic RDT monitoring and evaluation as part of regional training programmes for healthcare professionals, thereby reinforcing quality assurance measures.11 The quality of RDTs available in the market can vary considerably, and substandard tests may lead to inaccurate results, potentially causing misdiagnosis and inappropriate treatment. To ensure reliability, quality control and lot verification testing are of paramount importance. In alignment with WHO recommendations, all RDT lots should undergo pre-marketing evaluation to confirm their performance before field use. This addition reinforces the importance of maintaining strict quality assurance measures in malaria diagnosis. Therefore, continuous post-market surveillance of RDTs enables the early detection and mitigation of performance inconsistencies ( Table III).23,24,26,30
| Quality assurance (QA) component | Key elements | Potential impact of QA compromise |
|---|---|---|
| Panel preparation in the field | Use of quality field samples for testing RDT kits- Ensuring proper sample handling and storage during field operations- Regular preparation of test panels in endemic area | Inconsistent sample handling leading to unreliable results- Compromised samples due to poor field conditions30 |
| HR (Human resources) training | Proper training of healthcare workers (HCWs) on RDT use, sample collection, and interpretation of results- Emphasis on understanding test limitations and procedural steps | Incorrect sample collection leading to false results- Misinterpretation of test results24 |
| Panel characterization | Creation of standardized diagnostic panels (positive and negative samples)- Panels should represent a range of malaria species, including Plasmodium falciparum and Plasmodium vivax | Incorrect diagnosis due to non-representative panels- Inability to detect atypical malaria strains |
| Results interpretation | Clear, standardized guidelines for interpreting test results- Understanding of control line presence, test line strength, and timing of results | False positives/negatives due to poor interpretation- Inconsistent or inaccurate reporting of results24 |
| Observation on the lot | Regular monitoring of performance for each lot produced- Ensuring each lot meets quality control standards before distribution- Field-based surveillance of lot performance | Variability in test performance across different lots- Use of faulty or substandard lots leading to inaccurate diagnosis23 |
| Transportation and storage of QC panels | Maintenance of optimal storage conditions (temperature, humidity), secure and organized storage to prevent damage periodic inspection of stored RDTs, temperature-controlled logistics, secure and protective packaging, minimization of transit time, monitoring and documentation of transport conditions |
Reduced sensitivity or specificity due to degradation of reagents Invalid or unreliable test results. Degradation of test quality from exposure to extreme temperatures or mishandling, Increased invalid or false test results26 |
Malaria RDT quality assurance programmes
Several quality assurance programmes currently support the implementation and monitoring of malaria RDTs globally. The World Health Organization-Find Innovative New Diagnostics RDT evaluation programme has demonstrated measurable improvements in the performance of RDTs. The regular product assessments identifying and eliminating substandard tests from the market, ensuring that only high-quality tests are used in the field.31 Figure 1, shows the critical quality control checkpoints in the manufacturing process of malaria rapid diagnostic test kits. Manufacturers that achieve prequalification through these evaluations gain increased credibility and broader acceptance in the global market. FIND collaborates with both public and private sectors to develop and implement quality assurance systems, with a focus on diagnostic tools for diseases like malaria. Inadequate coordination among stakeholders can compromise the effectiveness of quality assurance efforts, potentially affecting the quality and reliability of malaria RDTs.28
Requirement of quality assurance
In many malaria-endemic regions, the inadequate laboratory infrastructure and a shortage of trained personnel impedes effective quality assurance.31 The development of RDTs is hindered by several key barriers, including poor sensitivity to low pathogen levels, instability in hot and humid conditions, and reliance on inadequately characterised antibodies. Social mistrust, cultural resistance, insufficient user training, and weak supply chains affect their effective use, while lack of regulatory oversight and quality control allows substandard products in the market. These combined challenges restrict the reliability, acceptance, and widespread adoption of RDTs in global health. Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO) jointly developed a standardised protocol for quality assurance of malaria RDTs to address regulatory challenges. ICMR also established the ‘MedTech Mitra’ initiative to facilitate streamlined regulatory approvals for diagnostics.27,32 There are also significant challenges in implementing malaria RDTs in routine practice including lack of training and logistical barriers.33 A study from Uganda investigated the feasibility, acceptability, and use of malaria RDTs at peripheral health centres and highlighted barriers for successful implementation in rural settings.34 A study from India underscored the importance of lot testing, which ensures the quality of malaria RDTs by identifying substandard products before they reach the market, improving overall diagnostic reliability. Between 2007 and 2017, 6056 lots, or approximately 1.6 billion RDTs, were examined, and 69 lots (1.1%) failed quality control. Of these, 26 lots failures, representing an estimated 7.9 million low-quality RDTs were evaluated at the lot testing laboratories.23 These studies emphasise the importance of quality assurance systems for malaria RDTs to ensure accurate results and the effectiveness of malaria elimination programmes. Collaborative efforts among international organisations, national health authorities, and manufacturers are essential to bridging gaps in resources and technical expertise. Investing in training programmes for healthcare workers and laboratory technicians can enhance their understanding of quality assurance processes, ultimately improving the accuracy and effectiveness of malaria elimination programmes.
Challenges in implementing quality assurance
Establishing robust quality control systems necessitates a structured framework of continuous monitoring and evaluation, incorporating expert-led training and supervision in collaboration with local health authorities to enhance quality assurance programmes.27 Quality assurance (QA) aspects for non-P. falciparum species have now been addressed. While current QA panels in India primarily cover P. falciparum and P. vivax, standardised panels for P. malariae, P. ovale, and P. knowlesi are limited. We are highlighting the need to develop and validate reference panels for these species to strengthen QA systems for non-falciparum malaria diagnostics.7 To strengthen malaria diagnostic programs, governments must integrate quality assurance as a fundamental component of their malaria control strategies by ensuring adequate resource allocation and implementing well-defined regulatory frameworks.35 Partnerships between international organisations, governments, and manufacturers are critical to addressing resource and knowledge gaps. Evidence suggests that trained volunteers are more likely to administer appropriate treatment based on RDT results.30 To ensure sustained accuracy, sensitivity, and effectiveness of RDTs in real-world conditions, continuous performance evaluation and monitoring are essential. Figure 2 shows the key stages requiring quality assurance in the malaria rapid diagnostic test workflow. Stringent protocols should be established to assess and replace diagnostic test batches when deviations from specified storage conditions occur.32
Discussion
As malaria elimination progresses, quality assurance systems for RDTs must adapt to the evolving landscape of transmission. It will be crucial in ensuring that sensitive and reliable RTDs are available in the field, with routine testing, batch testing, and stringent storage conditions essential to prevent substandard products from entering the supply chain. Lot testing should be mandatory and can be conducted by authorised regulatory bodies to ensure the quality and reliability of RDTs before they are marketed and used in clinical settings. Its integration into regional surveillance systems will ensure that any irregularities or quality concerns are identified and rectified before they impact malaria elimination goals. Continuous monitoring of RDT performance, along with a robust feedback system for healthcare workers and patients, will facilitate the identification and resolution of diagnostic challenges. In the post-elimination phase, the focus will shift towards maintaining a surveillance system capable of rapidly detecting any re-emergence of malaria. In this post-elimination phase, it will play a role in safeguarding the integrity of diagnostic tools used for surveillance, especially as RDTs will continue to be a primary tool for malaria detection. Ensuring quality throughout the supply chain will be crucial to prevent the distribution of substandard RDTs. By addressing the stage-specific challenges fostering international collaboration, and maintaining high standards of diagnostic quality, the global health community can advance toward a malaria-free future with confidence in the tools used to achieve this goal. Conceptual framework for exploring the quality assurance steps of malaria rapid diagnostic tests before introducing them in the public sector are mentioned in Figure 3.
Quality assurance is integral to ensuring the accuracy, reliability, and long-term effectiveness of any diagnostic tool. As efforts intensify toward elimination, robust quality assurance system for Malaria RDTs are critical to mitigating risks associated with false results and substandard diagnostics. Comprehensive quality assurance encompassing pre-market validation, manufacturing oversight, post-market surveillance, and end-user competency ensures consistent diagnostic performance across varying endemic settings. Embedding this within national surveillance systems enables early detection of quality issues, preventing diagnostic failures that could compromise intervention efforts. Even in post-elimination contexts, sustained quality assurance mechanisms will be essential to maintain diagnostic vigilance and rapidly respond to potential re-emergence, thereby preserving malaria-free gains.
Author contributions
NA: Conceptualisation, methodology, manuscript writing; AY: Data curation, investigation, manuscript writing; RR: manuscript writing; ARA: Lead, project administration, manuscript writing; PKB: Conceptualisation, supervision, manuscript writing. All authors have read and approve the final printed version of the manuscript.
Financial support and sponsorship
None.
Conflicts of Interest
None.
Use of Artificial Intelligence (AI)-Assisted Technology for manuscript preparation
The authors confirm that there was no use of AI-assisted technology for assisting in the writing of the manuscript and no images were manipulated using AI.
References
- World Health Organization. World malaria report 2024: addressing inequity in the global malaria response. Available from: https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2024, accessed on December 11, 2025.
- The global distribution of clinical episodes of Plasmodium falciparum malaria. Nature.. 2005;434:214-7.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Pricing infectious disease. EMBO Reports.. 2008;9:S13-S17.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Rapid diagnostic tests for malaria parasites. Clin Microbiol Rev.. 2002;15:66-78.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Comparison of three diagnostic methods (microscopy, RDT, and PCR) for the detection of malaria parasites in representative samples from Equatorial Guinea. Malar J.. 2018;17:333.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- First successful field evaluation of new, one-minute haemozoin-based malaria diagnostic device. EClinicalMedicine.. 2020;22:100347.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Directorate of National Vector Borne Disease Control Programme. Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. Manual on Quality Assurance for Laboratory Diagnosis of Malaria: Rapid Diagnostic Tests-Standard Operating Procedures. Available from: https://ncvbdc.mohfw.gov.in/WriteReadData/l892s/SOP-Quality-Assurance-RDT.pdf, accessed on December 11, 2025.
- Comparison of polymerase chain reaction, microscopy, and rapid diagnostic test in malaria detection in a high burden state (Odisha) of India. Pathog Glob Health.. 2021;115:267-72.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Diagnostic and prognostic utility of an inexpensive rapid on site malaria diagnostic test (ParaHIT f) among ethnic tribal population in areas of high, low and no transmission in central India. BMC Infect Dis.. 2005;5:50.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Cost-effectiveness analysis of malaria rapid diagnostic tests: A systematic review. Infect Dis Poverty.. 2019;8:104.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- World Health Organization. Malaria microscopy quality assurance manual - Version 2. Available from: https://www.who.int/docs/default-source/documents/publications/gmp/malaria-microscopy-quality-assurance-manual.pdf, accessed on accessed on December 11, 2025.
- World Health Organization. World Malaria report 2023. Available from: https://www.who.int/publications/i/item/ 9789240078025, accessed on December 11, 2025.
- World Health Organization. Drug resistance in malaria, Peter B. Bloland. Available from: https://iris.who.int/bitstream/handle/10665/66847/WHO_CDS_CSR_DRS_2001.4.pdf, accessed on December 11, 2025.
- Ensuring quality and access for malaria diagnosis: How can it be achieved? Nat Rev Microbiol. 2006. ;4:682-95.
- [Google Scholar]
- Malaria rapid diagnostic tests in elimination settings—can they find the last parasite? Clin Microbiol Infect. 2011. ;17:1624-31.
- [Google Scholar]
- A review of the WHO malaria rapid diagnostic test product testing programme (2008–2018): Performance, procurement and policy. Malar J.. 2019;18:387.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Microstructural effects on permeability of nitrocellulose membranes for biomedical applications. J Memb Sci.. 2020;595:117502.
- [CrossRef] [Google Scholar]
- Priority setting on malaria interventions in Tanzania: Strategies and challenges to mitigate against the intolerable burden. Am J Trop Med Hyg.. 2007;77:106-11.
- [CrossRef] [PubMed] [Google Scholar]
- Use and limitations of malaria rapid diagnostic testing by community health workers in war-torn democratic republic of Congo. Malar J.. 2009;8:308.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Prevalence of pfhrp2 and/or pfhrp3 Gene deletion in plasmodium falciparum population in eight highly endemic states in India. PLoS One.. 2016;11:e0157949.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Low prevalence of Plasmodium falciparum histidine-rich protein 2 and 3 gene deletions in malaria-endemic states of India. PLoS One.. 2024;19:e0315662.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Malaria rapid diagnostic kits: Quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts. Malar J.. 2011;10:39.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Quality assurance of malaria rapid diagnostic tests: An aid in malaria elimination. Indian J Med Res.. 2023;157:23-9.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Rapid diagnostic tests failing to detect Plasmodium falciparum infections in Eritrea: An investigation of reported false negative RDT results. Malar J.. 2017;16:105.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Stability testing of dried Plasmodium falciparum positive quality control samples for malaria rapid diagnostic tests in Liberia and Benin. Malar J.. 2020;19:288.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Quality issues with malaria rapid diagnostic test accessories and buffer packaging: Findings from a 5-country private sector project in Africa. Malar J.. 2017;16:160.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Addressing barriers to the development and adoption of rapid diagnostic tests in global health. Nanobiomedicine (Rij).. 2015;2:6.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Keep the quality high: The benefits of lot testing for the quality control of malaria rapid diagnostic tests. Malar J.. 2020;19:247.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- World Health Organization. Prequalification of Medical Products. In-vitro-diagnostics. Available from: https://extranet.who.int/prequal/vitro-diagnostics/prequalified/in-vitro-diagnostics, accessed on October 30, 2025.
- Update on rapid diagnostic testing for malaria. Clin Microbiol Rev.. 2008;21:97-110.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- World Health Organization. WHO Global Malaria Programme. Good practices for selecting and procuring rapid diagnostic tests for malaria. Available from: https://www.who.int/docs/default-source/documents/publications/gmp/good-practices-for-selecting-and-procuring-rapid-diagnostic-tests-for-malariaf541f81cd7474c67b8663dc567451cde.pdf?sfvrsn=ae8a7bec_2, accessed on December 11, 2025.
- Indian Council of Medical Research, Central Drugs Standard Control Organization. Ministry of Health & Family Welfare, Government of India. Standard performance evaluation protocols. Available from: https://www.icmr.gov.in/icmrobject/uploads/Static/1757913321_icmr-cdscostandardperformanceevaluationprotocols.pdf, accessed on December 11, 2025.
- Malaria rapid diagnostic tests: Literary review and recommendation for a quality assurance, quality control algorithm. Diagnostics (Basel).. 2021;11:768.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Early experiences on the feasibility, acceptability, and use of malaria rapid diagnostic tests at peripheral health centres in Uganda-insights into some barriers and facilitators. Implement Sci.. 2012;7:5.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]
- Challenges encountered by local health volunteers in early diagnosis and prompt treatment of malaria in Myanmar artemisinin resistance containment zones. Malar J.. 2016;15:308.
- [CrossRef] [PubMed] [PubMed Central] [Google Scholar]