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Challenges in Routine Implementation and Quality Control of Rapid Diagnostic Tests for Malaria–Rufiji District, Tanzania
Open accessAbstract
Rapid diagnostic tests (RDTs) represent an alternative to microscopy for malaria diagnosis and have shown high sensitivity and specificity in a variety of study settings. Current World Health Organization (WHO) guidelines for quality control of RDTs provide detailed instructions on pre-field testing, but offer little guidance for quality assurance once RDTs are deployed in health facilities. From September 2006 to April 2007, we introduced a histidine-rich protein II (HRP2)-based RDT (Paracheck) for suspected malaria cases five years of age and older in nine health facilities in Rufiji District, Tanzania, to assess sensitivity and specificity of RDTs in routine use at rural health facilities. Thick blood smears were collected for all patients tested with RDTs and stained and read by laboratory personnel in each facility. Thick smears were subsequently reviewed by a reference microscopist to determine RDT sensitivity and specificity. In all nine health facilities, there were significant problems with the quality of staining and microscopy. Sensitivity and specificity of RDTs were difficult to assess given the poor quality of routine blood smear staining. Mean operational sensitivity of RDTs based on reference microscopy was 64.8%, but varied greatly by health facility, range 18.8–85.9%. Sensitivity of RDTs increased with increasing parasite density. Specificity remained high at 87.8% despite relatively poor slide quality. Institution of quality control of RDTs based on poor quality blood smear staining may impede reliable measurement of sensitivity and specificity and undermine confidence in the new diagnostic. There is an urgent need for the development of alternative quality control procedures for rapid diagnostic tests that can be performed at the facility level.
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“However, blood film microscopy is time-consuming and needs significant technical skills, good-quality reagents, and clean slides; thus, its accuracy is of highly variable quality in sub-Saharan African hospitals [7-10].”
From Reliability of rapid diagnostic test for diagnosing peripheral and placental malaria in an area of unstable malaria transmission in Eastern Sudan (2013) · cites this paper as [10]
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Malaria Diagnosis: A Brief Review
Tangpukdee, N., Duangdee, C., Wilairatana, P., & Krudsood, S. (2009) · Korean Journal of Parasitology · doi:10.3347/kjp.2009.47.2.93 · Cited by 586
(2014) · Tropical Medicine & International Health · doi:10.1111/tmi.12313_2 · Cited by 568
“The diagnostic quality of microscopy is very variable in routine hospitals in sub-Saharan Africa (McMorrow et al. 2008; Nankabirwa et al. 2009).”
BackgroundTolle, M. A. (2009) · Current problems in pediatric and adolescent health care · doi:10.1016/j.cppeds.2009.01.001 · Cited by 442
Cunningham, J. A., Gatton, M. L., & Jones, S. (2014) · QUT ePrints (Queensland University of Technology) · Cited by 254
Chaudhary, V. S., Kumar, D., & Kumar, S. (2021) · IEEE Sensors Journal · doi:10.1109/jsen.2021.3085829 · Cited by 231
D’Acremont, V., Lengeler, C., Mshinda, H., Mtasiwa, D. M., Tanner, M., & Genton, B. (2008) · PLoS Medicine · doi:10.1371/journal.pmed.0050252 · Cited by 222
“Indeed, in recent studies conducted under programmatic conditions, 2%–10% of all patients with negative results were given antimalarials [16] (D’Acremont et al.”
BackgroundMsellem, M. I., Mårtensson, A., Rotllant, G., Bhattarai, A., Strömberg, J., Kahigwa, E., García, M., Petzold, M., Olumese, P. E., Ali, A., et al. (2009) · PLoS Medicine · doi:10.1371/journal.pmed.1000070 · Cited by 204
“. High adherence by prescribers in relation to RDT results was, however, also reported in a recent study conducted in mainland Tanzania”
ResultSelf-citationMalaria rapid diagnostic tests in endemic settings
Maltha, J., Gillet, P., & Jacobs, J. A. (2013) · Clinical Microbiology and Infection · doi:10.1111/1469-0691.12151 · Cited by 184
Assessment of the prozone effect in malaria rapid diagnostic tests
Gillet, P., Mori, M., Esbroeck, M. V., et al. (2009) · Malaria Journal · doi:10.1186/1475-2875-8-271 · Cited by 168
“This may also cause problems in field settings, where there is a tendency to apply more than the required sample volume [38,39].”
BackgroundMalaria misdiagnosis in Uganda – implications for policy change
Nankabirwa, J., Zurovac, D., Njogu, J. N., Rwakimari, J. B., Counihan, H., Snow, R. W., & Tibenderana, J. K. (2009) · Malaria Journal · doi:10.1186/1475-2875-8-66 · Cited by 161
“Yet, the success of this diagnostic strategy encompassing RDTs will be critically dependent on ensuring high accuracy (in particular sensitivity) of RDTs under field conditions [11,26,27], and ensuring a radical change of health workers current practices with emphasis on systematic screening of all fevers, respect of…”
Mubi, M., Janson, A., Warsame, M., Mårtensson, A., Källander, K., Petzold, M. G., Ngasala, B., Maganga, G., Gustafsson, L. L., Massele, A., et al. (2011) · PLoS ONE · doi:10.1371/journal.pone.0019753 · Cited by 155
“The validity of microscopy in peripheral health facilities has previously been questioned because of technical problems [45] and RDT results may thus turn out to be more accurate than microscopy, especially when the blood tests are performed at community level by CHWs.”
BackgroundMolecular Diagnosis of Malaria by Photo-Induced Electron Transfer Fluorogenic Primers: PET-PCR
Lucchi, N. W., Jothikumar, N., Karell, M. A., Xayavong, M. V., Kariuki, S., da Silva, A. J., Hill, V. R., & Udhayakumar, V. (2013) · PLoS ONE · doi:10.1371/journal.pone.0056677 · Cited by 148
“for malaria diagnosis ranging from conventional PCR-based assays, real-time PCR assays and more recently, isothermal amplification assays (reviewed in [7,12]).”
MethodUse of malaria RDTs in various health contexts across sub-Saharan Africa: a systematic review
Boyce, M. R., & O’Meara, W. P. (2017) · BMC Public Health · doi:10.1186/s12889-017-4398-1 · Cited by 153
“8% [43] to 100% [71], whereas specificities ranged from 39% [75] to 99.”
BackgroundKahama‐Maro, J., D’Acremont, V., Mtasiwa, D. M., et al. (2011) · Malaria Journal · doi:10.1186/1475-2875-10-332 · Cited by 120
“Other factors that contributed to this situation are the poor condition of laboratory equipment (especially microscopes), insufficient or substandard reagents, frequent power interruptions, ambiguous guidelines, inadequate supervision and virtually non-existent quality control systems [6,30,32,34,37,49].”
BackgroundMethodBatwala, V., Magnussen, P., & Nuwaha, F. (2010) · Malaria Journal · doi:10.1186/1475-2875-9-349 · Cited by 101
Kavanaugh, M. J., Azzam, S., & Rockabrand, D. (2021) · Diagnostics · doi:10.3390/diagnostics11050768 · Cited by 102
Ishengoma, D. S., Francis, F. T., Mmbando, B. P., Lusingu, J., Magistrado-Coxen, P., Alifrangis, M., Theander, T. G., Bygbjerg, I. C., & Lemnge, M. M. (2011) · Malaria Journal · doi:10.1186/1475-2875-10-176 · Cited by 92
“Although RDTs require minimal skills and are easy to read, which allow them to be used by moderately trained health workers, their accuracy (sensitivity and specificity), storage under field condition and application for treatment of malaria remain a challenge [11,12,17-21].”
BackgroundResultGething, P. W., Kirui, V., Alegana, V. A., Okiro, E. A., Noor, A. M., & Snow, R. W. (2010) · PLoS Medicine · doi:10.1371/journal.pmed.1000301 · Cited by 94
“Some argue that the expanded use of rapid diagnostic tests (RDTs) by prescribers at the point of care will significantly change diagnosis and treatment of febrile patients [10,12–15], increase the geographic reach of parasite diagnostic services, and replace the lack of prescriber confidence in poor routine microscopy…”
BackgroundMaltha, J., Gillet, P., Bottieau, E., Cnops, L., van Esbroeck, M., & Jacobs, J. (2010) · Malaria Journal · doi:10.1186/1475-2875-9-171 · Cited by 87
“The low intensities of the pan-pLDH lines, especially for the non-falciparum species, are of concern especially when extrapolating the present findings to field settings in both endemic and non-endemic settings, where disregarding faint test lines as negative results is a common mistake [29-33].”
DRAKELEY, C. J., & Reyburn, H. (2008) · Transactions of the Royal Society of Tropical Medicine and Hygiene · doi:10.1016/j.trstmh.2008.10.003 · Cited by 88
English, M., Reyburn, H., Goodman, C. A., & Snow, R. W. (2008) · PLoS Medicine · doi:10.1371/journal.pmed.1000015 · Cited by 86
“Adding a new commodity that requires distribution and quality control [1] will be a considerable challenge, and arguably one that should be taken on only once we have achieved high coverage with effective drugs and prevention.”
BackgroundInfluentialGerstl, S., Dunkley, S., Ahmed, M., Smet, M. D., Baker, S., & Maïkéré, J. (2010) · Malaria Journal · doi:10.1186/1475-2875-9-28 · Cited by 80
“Several studies demonstrate inconsistencies in blood smear reading and, therefore, possibly doubtful results for sensitivity and specificity of malaria RDTs [30,31].”
BackgroundAtroosh, W. M. M., Al‐Mekhlafi, H. M., Aljasari, A. N., et al. (2015) · Parasites & Vectors · doi:10.1186/s13071-015-1008-x · Cited by 71
“7 % (low) compared to the gold standard microscopy and/or PCR [30–34].”
Graz, B., Willcox, M. L., Szeless, T., et al. (2011) · Malaria Journal · doi:10.1186/1475-2875-10-136 · Cited by 70
Williams, H. A., Causer, L. M., Metta, E. O., Malila, A., O'Reilly, T., Abdulla, S., Kachur, S. P., & Bloland, P. B. (2008) · Malaria Journal · doi:10.1186/1475-2875-7-239 · Cited by 69
“Investigating the impact of RDTs in these different settings is important to identify operational issues that may impact the implementation of RDTs[13].”
BackgroundSelf-citationThe feasibility of introducing rapid diagnostic tests for malaria in drug shops in Uganda
Mbonye, A. K., Ndyomugyenyi, R., Asaph, T., et al. (2010) · Malaria Journal · doi:10.1186/1475-2875-9-367 · Cited by 68
“Williams HA, Causer L, Metta A, O’Reilly T, Abdulla , Kachur SP, Bloland PB: Dispensary level pilot implementation of rapid diagnostic tests: an evaluation of RDT acceptance and usage by providers and patientsTanzania, 2005.”
BackgroundInfluentialPerspectives on Introduction and Implementation of New Point-of-Care Diagnostic Tests
Palamountain, K. M., Baker, J. M., Cowan, E. P., Essajee, S. M., Mazzola, L. T., Metzler, M., Schito, M. L., Stevens, W. S., Young, G. J., & Domingo, G. J. (2012) · The Journal of Infectious Diseases · doi:10.1093/infdis/jis203 · Cited by 68
The Usefulness of Rapid Diagnostic Tests in the New Context of Low Malaria Transmission in Zanzibar
Shakely, D., Elfving, K., Aydin-Schmidt, B., Msellem, M. I., Morris, U., Omar, R. S., Weiping, X., Petzold, M., Greenhouse, B., Baltzell, K., et al. (2013) · PLoS ONE · doi:10.1371/journal.pone.0072912 · Cited by 64
Rapid diagnostic tests as a source of DNA for Plasmodium species-specific real-time PCR
Cnops, L., Boderie, M., Gillet, P., et al. (2011) · Malaria Journal · doi:10.1186/1475-2875-10-67 · Cited by 63
“Quality control of the RDT performance is a further necessity, especially in endemic regions where malaria diagnosis relies on RDT analysis alone [8,32,35-37].”
BackgroundHendriksen, I. C. E., Mtove, G. A., Pedro, A. J., Gomes, E., Silamut, K., Lee, S. J., Mwambuli, A., Gesase, S., Reyburn, H., Day, N. P. J., et al. (2011) · Clinical Infectious Diseases · doi:10.1093/cid/cir143 · Cited by 61
“The diagnostic quality of microscopy is highly variable in routine hospitals in sub-Saharan Africa [8, 9].”
BackgroundInfluentialMukadi, P., Lejon, V., Barbé, B., Gillet, P., Nyembo, C., Lukuka, A., Likwela, J. L., Lumbala, C., Mbaruku, J., der Veken, W. V., et al. (2016) · PLoS ONE · doi:10.1371/journal.pone.0146450 · Cited by 58
“However, microscopy is labour-intensive and its quality in endemic settings is often inadequate due to poor-quality stains and equipment (including but not limited to microscopes), poor maintenance, insufficient training (shortage of competent staff) or a lack of quality assurance [2–5].”
BackgroundPerformance of Malaria Rapid Diagnostic Tests as Part of Routine Malaria Case Management in Kenya
de Oliveira, A. M., Skarbinski, J., Ouma, P., Kariuki, S., Barnwell, J. W., Otieno, K., Onyona, P., Causer, L. M., Laserson, K. F., Akhwale, W. S., et al. (2009) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.2009.80.470 · Cited by 57
Uzochukwu, B. S. C., Onwujekwe, O. E., Ezuma, N. N., Ezeoke, O. P., Ajuba, M. O., & Sibeudu, F. T. (2011) · PLoS ONE · doi:10.1371/journal.pone.0014627 · Cited by 53
“Interestingly, the risk of a false-negative test and its potential consequences have PLoS ONE | www.plosone.org 4 January 2011 | Volume 6 | Issue 1 | e14627 recently been evaluated in Uganda [35] and Tanzania [36], and the safety of not treating malaria-negative children was confirmed.”
ResultBruxvoort, K. J., Kalolella, A., Nchimbi, H., Festo, C., Taylor, M., Thomson, R. M., Cairns, M. E., Thwing, J. I., Kleinschmidt, I., Goodman, C. A., et al. (2013) · Tropical Medicine & International Health · doi:10.1111/tmi.12168 · Cited by 52
Self-citationIshengoma, D. S., Sudi, L., Madebe, R. A., Nyagonde, N., Persson, O. P.-E., Vestergaard, L. S., Bygbjerg, I. C., Lemnge, M. M., & Alifrangis, M. (2011) · Malaria Journal · doi:10.1186/1475-2875-10-6 · Cited by 52
“Thus, after deployment of RDTs in the field, archived RDTs can also be used for QC of RDTs in addition to using Giemsa-stained blood smears, particularly in health facilities without capacity for performing malaria diagnosis by microscopy or lacking the skills and experience to prepare good blood smears as recently sh…”
BackgroundMethodExternal quality assessment in resource–limited countries
Carter, J. Y. (2017) · Biochemia Medica · doi:10.11613/bm.2017.013 · Cited by 52
“noted that quality monitoring of RDTs using poor quality blood films might undermine confidence in RDT use (66).”
BackgroundHerrera, S. V., Vallejo, A. F., Quintero, J. P., Arévalo‐Herrera, M., Cancino, M., & Ferro, S. (2014) · Malaria Journal · doi:10.1186/1475-2875-13-87 · Cited by 46
“However, the sustainability of this type of QA programme is highly questionable due to costs of personnel, transportation and other expenses [16,17].”
BackgroundQuality Assurance of Rapid Diagnostic Tests for Malaria in Routine Patient Care in Rural Tanzania
McMorrow, M., Masanja, M. I., Kahigwa, E., et al. (2010) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.2010.09-0440 · Cited by 45
Self-citationGillet, P., Maltha, J., Hermans, V., Ravinetto, R., Bruggeman, C. A., & Jacobs, J. A. (2011) · Malaria Journal · doi:10.1186/1475-2875-10-39 · Cited by 44
“Criteria for information inserts and device design from studies on end-users’ performance and RDT instructions were pooled [5,7,9,10,18-24].”
BackgroundThe quality of malaria care in 25 low-income and middle-income countries
Macarayan, E. R. K., Papanicolas, I. N., & Jha, A. K. (2020) · BMJ Global Health · doi:10.1136/bmjgh-2019-002023 · Cited by 46
Xiaodong, S., Tambo, E., Wei, C., Zhibin, C., Yan, D., Wang, J., Jiazhi, W., & Xiaonong, Z. (2013) · Malaria Journal · doi:10.1186/1475-2875-12-6 · Cited by 39
“While parasite-based diagnosis is increasing, most suspected cases of malaria are not properly identified, with accurate diagnosis and disease monitoring consequently remaining elusive [2].”
BackgroundShekalaghe, S. A., Cancino, M., Mavere, C., Juma, O. A., Mohammed, A., Abdulla, S., & Ferro, S. (2013) · Malaria Journal · doi:10.1186/1475-2875-12-141 · Cited by 38
“However, research has shown that although QA programmes based on direct supervision can produce good outcomes, their sustainability is highly questioned due to the costs implicated in personnel, transportation and others [11,12].”
BackgroundSelf-citationBoyce, R. M., Muiru, A. N., Reyes, R., et al. (2015) · Malaria Journal · doi:10.1186/s12936-015-0725-0 · Cited by 39
“However, the vast majority of malaria episodes occur in rural areas of sub-Saharan Africa, where microscopy is often unavailable and shortages of trained personnel further limit its use as a valid diagnostic method [2–10].”
Economic evaluation of point-of-care diagnostic technologies for infectious diseases
Loubière, S., & Moatti, J. (2010) · Clinical Microbiology and Infection · doi:10.1111/j.1469-0691.2010.03280.x · Cited by 41
“Strong compliance by prescribers with practice guidelines, when rapid diagnostic test results prove to be negative, was also reported in a recent study conducted in mainland Tanzania [45].”
ResultExternal quality assessment on the use of malaria rapid diagnostic tests in a non-endemic setting
Gillet, P., Mukadi, P., Vernelen, K., Esbroeck, M. V., Muyembe, J., Bruggeman, C. A., & Jacobs, J. A. (2010) · Malaria Journal · doi:10.1186/1475-2875-9-359 · Cited by 39
“In ITM experience as well as that of others [7,38], particular problems can arise with the use of the transfer device: without having processed high numbers of samples, it may be difficult to master the RDT kit’s loops, straws or capillary tubes, which are frequently small and not userfriendly.”
BackgroundMinja, D. T., Schmiegelow, C., Oesterholt, M., Magistrado, P. A., Boström, S., John, D., Pehrson, C., Andersen, D., Deloron, P., Salanti, A., et al. (2012) · Malaria Journal · doi:10.1186/1475-2875-11-211 · Cited by 37
“However, there are a number of challenges that need to be addressed for optimal and effective utilization of RDTs in malaria diagnosis in order to provide reliable and credible diagnoses [31].”
BackgroundEvaluation of the SD FK70 Malaria Ag Plasmodium vivax rapid diagnostic test in a non-endemic setting
Gillet, P., Bosselaers, K., Cnops, L., Bottieau, E., Esbroeck, M. V., & Jacobs, J. A. (2009) · Malaria Journal · doi:10.1186/1475-2875-8-129 · Cited by 34
“Faint test lines are a frequently described problem, which may be caused by the fact that the test line is much narrower than the control line [17,18].”
BackgroundBaiden, F., Owusu‐Agyei, S., Okyere, E., Tivura, M., Adjei, G. O., Chandramohan, D., & Webster, J. (2012) · PLoS ONE · doi:10.1371/journal.pone.0045556 · Cited by 33
“Suggestions by caregivers that the blood test is for HIV and not malaria have been similarly reported in studies in Uganda and Tanzania [35,36,37].”
ResultRisks and Benefits of Targeted Malaria Treatment Based on Rapid Diagnostic Test Results
Björkman, A., & Mårtensson, A. (2010) · Clinical Infectious Diseases · doi:10.1086/655689 · Cited by 32
“However, 2 other studies have in contrast provided evidence of high adherence to protocol for negative RDT results, 1 from the Tanzania mainland [11] and 1 from Zanzibar [12], by withholding an-”
ResultNlinwe, N. O., & Nange, T. B. (2020) · Anemia · doi:10.1155/2020/3814513 · Cited by 32
Leslie, T., Mikhail, A. F. W., Mayan, I., Cundill, B., Anwar, M., Bakhtash, S. H., Mohammed, N., Rahman, H., Zekria, R., Whitty, C. W. M., et al. (2014) · BMJ · doi:10.1136/bmj.g3730 · Cited by 31
Njozi, M., Amuri, M., Selemani, M., et al. (2013) · BMC Public Health · doi:10.1186/1471-2458-13-1097 · Cited by 30
“In addition, there is a problem of inaccurate malaria microscopic diagnosis and hence misdiagnosis of patients and over use of ACT [7].”
BackgroundKuntworbe, N., Martini, N. D., Shaw, J., & Al‐Kassas, R. (2012) · Drug Development Research · doi:10.1002/ddr.21010 · Cited by 30
“%) and worrying variability between sites (19–86% sensitivity) [McMorrow et al., 2008], hence the search for newer approaches must continue.”
BackgroundMaganda, B. A., Minzi, O., Kamuhabwa, A. A. R., Ngasala, B., & Sasi, P. G. (2014) · Malaria Journal · doi:10.1186/1475-2875-13-205 · Cited by 26
“The sensitivity of MRDT has been reported to be reduced to < 75% with < 1000 parasites/μl [57,64,65].”
BackgroundBaiden, F., Malm, K., Bart-Plange, C., Hodgson, A., Chandramohan, D., Webster, J., & Owusu‐Agyei, S. (2014) · Ghana Medical Journal · doi:10.4314/gmj.v48i2.10 · Cited by 27
Wogu, M. N., & Nduka, F. O. (2018) · Journal of Tropical Medicine · doi:10.1155/2018/3954717 · Cited by 27
Ayogu, E., Ukwe, C., & Nna, E. (2016) · Journal of Postgraduate Medicine · doi:10.4103/0022-3859.183167 · Cited by 26
“[27] The sensitivity and NPV of 82.17% and 34.29% were lower in our study than reported elsewhere.”
InfluentialRatsimbasoa, A., Ravony, H., Vonimpaisomihanta, J.-A., Raherinjafy, R., Jahevitra, M., Rapelanoro, R., Rakotomanga, J. D. D. M., Malvy, D., Millet, P., & Ménard, D. (2012) · Malaria Journal · doi:10.1186/1475-2875-11-85 · Cited by 25
“From a practical standpoint, no major difficulties in the use of RDTs were noticed by CHWs, despite reports to the contrary [23,24].”
BackgroundKorzeniewski, K., Bylicka-Szczepanowska, E., & Lass, A. (2021) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph18020814 · Cited by 23
Dried Plasmodium falciparum-infected samples as positive controls for malaria rapid diagnostic tests
Aidoo, M., Patel, J. C., & Barnwell, J. W. (2012) · Malaria Journal · doi:10.1186/1475-2875-11-239 · Cited by 23
“The burden of malaria * Correspondence: maidoo@cdc.gov Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, US Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30333, USA © 2012 Aidoo et al.; licensee BioMed Central L Commons Attribution License (http://creati…”
BackgroundInfluentialBauer, M., & Kulinsky, L. (2018) · Micromachines · doi:10.3390/mi9010027 · Cited by 23
“Sensitivity Depends on parasite density and species (below 50% for 240–2000 parasites/μL) [12] Depends on experience of microscopist (parasite counts as low as 5 parasites/μL possible [10], sensitivity 40.”
BackgroundUltra Low Loss Dual Square Groove Incorporated SPR-Based PCF Sensor for Malaria Diagnosis
Praveena, S., & Senthilnathan, K. P. (2024) · Plasmonics · doi:10.1007/s11468-024-02663-0 · Cited by 21
“The sources for operating the sensor are readily available in the commercial market.”
Gerrets, R. P. (2015) · Cambridge University Press eBooks · doi:10.1017/cbo9781316091265.007 · Cited by 22
Kalinga, A. K., Mwanziva, C. E., Chiduo, S., et al. (2018) · Malaria Journal · doi:10.1186/s12936-018-2363-9 · Cited by 19
“In 2008, in Rufiji and in Korogwe, investigators observed a sensitivity as low as 65% [35] and 88.”
BackgroundKashif, A. H., Adam, G. K., Mohmmed, A. A., Elzaki, S. E., AbdelHalim, A. M., & Adam, I. (2013) · Diagnostic Pathology · doi:10.1186/1746-1596-8-59 · Cited by 18
“However, blood film microscopy is time-consuming and needs significant technical skills, good-quality reagents, and clean slides; thus, its accuracy is of highly variable quality in sub-Saharan African hospitals [7-10].”
BackgroundMeasuring malaria by passive case detection: a new perspective based on Zambian experience
Shiff, C., Stoyanov, C. T., Choobwe, C., et al. (2013) · Malaria Journal · doi:10.1186/1475-2875-12-120 · Cited by 18
“There is also a culture of doubt in the treatment of malaria when point-of-care tests are used in the field [8].”
BackgroundComparative Performance Evaluation of Routine Malaria Diagnosis at Ho Municipal Hospital
Osei-Yeboah, J., Norgbe, G. K., Lokpo, S. Y., Kinansua, M. K., Nettey, L., & Allotey, E. A. (2016) · Journal of Parasitology Research · doi:10.1155/2016/5837890 · Cited by 18
Allen, L. K., Hatfield, J. M., DeVetten, G., Ho, J., & Manyama, M. F. (2011) · BMC Infectious Diseases · doi:10.1186/1471-2334-11-308 · Cited by 17
“One of the first and most extensively tested and utilized RDTs, ParaCheck Pf detects histidine rich protein 2 (HRP2) produced uniquely by Plasmodium falciparum [12,14-21].”
BackgroundInfluentialOgouyèmi-Hounto, A., Kindé-Gazard, D. A., Keke, C. V., et al. (2012) · Bulletin de la Société de pathologie exotique · doi:10.1007/s13149-012-0264-7 · Cited by 16
“[16], pour un test ayant une sensibilité et une spécificité données, il y aura autant de valeurs prédictives (VPP et VPN) que les différentes prévalences dans la population d’étude.”
Evaluation of the Immunoquick+4 malaria rapid diagnostic test in a non-endemic setting
van Dijk, D. P. J., Gillet, P., Vlieghe, E., Cnops, L., Esbroeck, M. V., & Jacobs, J. A. (2010) · European Journal of Clinical Microbiology & Infectious Diseases · doi:10.1007/s10096-010-0898-y · Cited by 16
“Indeed, disregarding faint line intensities is one of the most common mistakes among end-users in both endemic and non-endemic settings, even when provided with adapted job aids [24–28].”
BackgroundVersteeg, I. A. J., & Mens, P. F. (2009) · Diagnostic Microbiology and Infectious Disease · doi:10.1016/j.diagmicrobio.2009.03.012 · Cited by 15
“The need for a reliable and simple QA system for RDTs is essential because many countries implement RDTs for malaria diagnostics and management without a good QA system (Abeku et al., 2008; McMorrow et al., 2008).”
BackgroundKanté, A. M., Nathan, R., Helleringer, S., Mrema, S., Levira, F., Masanja, H., de Savigny, D., Abdulla, S., & Phillips, J. F. (2014) · Malaria Journal · doi:10.1186/1475-2875-13-180 · Cited by 15
“modality that would reduce mortality related to febrile illness [42] and to a large proportion of malaria deaths being properly recoded by the RHDSS.”
BackgroundSelf-citationUltrasound diagnosis of malaria: examination of the spleen, liver, and optic nerve sheath diameter
Zha, Y., Zhou, M., Hari, A. Y., et al. (2015) · World Journal of Emergency Medicine · doi:10.5847/wjem.j.1920-8642.2015.01.002 · Cited by 15
Luckett, R. L., Mugizi, R., Lopes, S., et al. (2015) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.15-0598 · Cited by 14
Masanja, I. M., McMorrow, M., Maganga, M. B., Sumari, D., Udhayakumar, V., McElroy, P. D., Kachur, S. P., & Lucchi, N. W. (2015) · Malaria Journal · doi:10.1186/s12936-015-0597-3 · Cited by 14
“Studies have shown that the sensitivity of RDT compared to PCR and microscopy decline sharply at low parasite densities [9,33], therefore, care must be taken when comparing RDT results with molecular based diagnostic methods.”
BackgroundResultInfluentialSelf-citationBouyou-Akotet, M. K., Mawili-Mboumba, D. P., Madoungou, B., & Kombila, M. (2013) · Diagnostic Microbiology and Infectious Disease · doi:10.1016/j.diagmicrobio.2013.05.007 · Cited by 10
“Depending on malaria transmission level and other factors, they can be considered as true positive or true negative (Allen et al., 2011; Kyabayinze et al., 2008; McMorrow et al., 2008).”
BackgroundPerformance Outcomes from Africa-Based Malaria Diagnostic Competency Assessment Courses
Worges, M., Whitehurst, N., Saye, R., et al. (2019) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.18-0361 · Cited by 11
Evaluating a Sick Child after Travel to Developing Countries
Tolle, M. (2010) · The Journal of the American Board of Family Medicine · doi:10.3122/jabfm.2010.06.090271 · Cited by 11
Kalinga, A. K., Ishengoma, D. S., Kavishe, R. A., Temu, L., Mswanya, C., Mwanziva, C. E., Mgina, E. J., Chiduo, S., Mahikwano, L., Mgata, S., et al. (2018) · PLoS ONE · doi:10.1371/journal.pone.0208583 · Cited by 11
Kamugisha, E., Mazigo, H. D., Manyama, M. F., et al. (2009) · Tanzania journal of health research/Tanzania Journal of Health Research · doi:10.4314/thrb.v11i2.45212 · Cited by 10
“The difference could also be explained by storage conditions, (Mboera et al., 2006; McMorrow et al., 2008).”
BackgroundResultBell, D., Bwanika, J. B., Cunningham, J. A., et al. (2016) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.16-0498 · Cited by 9
Ghouth, A. S. B., Nasseb, F., & Al-Kaldy, K. H. (2012) · Tropical parasitology · doi:10.4103/2229-5070.97237 · Cited by 9
“High specificity was reported in some studies [6,8,9] but one study reported low specificity of HRP2-RDT for diagnosis of falciparum malaria in children [5] and another study about all age groups; [7] in this study, high specificity was reported (94%).”
InfluentialFactoring Quality Laboratory Diagnosis into the Malaria Control Agenda for Sub-Saharan Africa
Aidoo, M. (2013) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.13-0108 · Cited by 8
“The recent push for parasitological confirmation of malaria in Africa has highlighted the severe shortage of experienced laboratory technicians and inadequate laboratory infrastructure to meet this need.(20,21) This finding has led to several attempts at retraining technicians to improve proficiency in malaria diagnos…”
BackgroundMakuuchi, R., Jere, S. W., Hasejima, N., Chigeda, T., & Gausi, J. (2017) · BMC Infectious Diseases · doi:10.1186/s12879-017-2413-x · Cited by 8
“The reason for this low sensitivity and specificity are not clear but various factors which decrease the accuracy of RDT were reported [5, 16, 50].”
BackgroundKotepui, K. U., Kotepui, M., & Punsawad, C. (2019) · Journal of Tropical Medicine · doi:10.1155/2019/1414079 · Cited by 8
A diagnostic tool for malaria based on computer software
Kotepui, M., Uthaisar, K., PhunPhuech, B., & Phiwklam, N. (2015) · Scientific Reports · doi:10.1038/srep16656 · Cited by 8
“The most common complication during malaria infection is thrombocytopenia 6,11–13 An automated blood cell counter (ACC) is a practical tool for malaria diagnosis 21 .”
BackgroundMalaria detection in early stage using optical biosensors
Goyal, M., & Sharma, M. (2025) · Journal of Modern Optics · doi:10.1080/09500340.2025.2556466 · Cited by 7
Saputra, W. A., Nugroho, H. A., & Permanasari, A. E. (2016) · International Conference on Information Technology Systems and Innovation · doi:10.1109/icitsi.2016.7858228 · Cited by 7
IMPORTED MALARIA IN A TERTIARY HOSPITAL IN BELGIUM: EPIDEMIOLOGICAL AND CLINICAL ANALYSIS
Yombi, J. C., Jonckheere, S., Colin, G., et al. (2013) · Acta Clinica Belgica · doi:10.2143/acb.2964 · Cited by 6
Kamel, M. M., Attia, S. S., Emam, G. D., et al. (2016) · Scientifica · doi:10.1155/2016/4048032 · Cited by 6
“The aim of this study was to assess the prevalence of malaria in high risk foci in Egypt and the effectiveness of rapid diagnostic tests in diagnosis and subsequently control of malaria.”
BackgroundMicrofluidic devices for viral detection
Sun, J., & Jiang, X. (2013) · Elsevier eBooks · doi:10.1533/9780857097040.4.527 · Cited by 6
Demass, T. B., Beyene, B., Bantie, G. M., et al. (2025) · PLoS ONE · doi:10.1371/journal.pone.0322366 · Cited by 5
Review: malaria rapid diagnostic tests in endemic settings
Maltha, J., Gillet, P., & Jacobs, J. A. (2013) · Cited by 5
Omondi, C. J., Kamau, L. M., Njaanake, H. K., Anyona, D. N., Onguru, D., & Estambale, B. B. A. (2017) · Open Journal of Clinical Diagnostics · doi:10.4236/ojcd.2017.71004 · Cited by 3
“The WHO recommends that malaria case management be based on parasitological test diagnosis in all cases with exception of young children in endemic areas [6] [10].”
BackgroundRahmati-Balaghaleh, M., Zarean, M., Aghaee, M. A., Shamsian, S. A., Mirahmadi, H., & Arya, A. (2018) · International Journal of Infection · doi:10.5812/iji.12286 · Cited by 4
“Whereas parasite-based identification is growing, most doubted cases of malaria are not suitably diagnosed and thus disease monitoring continues to be obscure (7).”
BackgroundMarkakpo, U., Bosompem, K. M., Dzodzomenyo, M., Danso‐Appiah, A., Essuman, E. E., Anyan, W. K., Suzuki, M., Stephens, J. K., Anim‐Baidoo, I., Asmah, R. H., et al. (2016) · Tropical Medicine & International Health · doi:10.1111/tmi.12744 · Cited by 4
Analysis of malaria diagnosis discrepancies between RDTs and microscopy by nested PCR
Mawili-Mboumba, D. P., Bouyou-Akotet, M. K., Mbouoronde, C. O., et al. (2013) · Journal of Biomedical Science and Engineering · doi:10.4236/jbise.2013.610120 · Cited by 3
“Line intensity interpretation seems to be dependent on several factors such as transmission level [9,34,35].”
Choto, R. C., Midzi, S. M., Mberikunashe, J., et al. (2015) · Open Journal of Epidemiology · doi:10.4236/ojepi.2015.53023 · Cited by 3
“This phenomenon is important especially in field conditions where interpretation of faint positive lines as negative test results is found as the most common mistake made by community health care workers even when provided with adapted job aids and problems can be expected when reading RDTs during evening and night sh…”
BackgroundUSAGE OF A RAPID DIAGNOSTIC TEST FOR MALARIA IN CHILDREN.
Nkenfou, C. N., Hell, V. N., Nguefack‐Tsague, G., Ngoufack, M. N., Nkenfou, C. N., Kamgaing, N., & Ndjolo, A. (2019) · Europe PMC (PubMed Central) · doi:10.21010/ajid.v13i1.3 · Cited by 3
“Indeed, for a test with given sensitivity and specificity, predictive values (PPV and NPV) differ with disease prevalence in the study population (Mac Morrow, 2008).”
BackgroundSarma, K., Sarma, H., & Deka, J. (2026) · Infection · doi:10.1007/s15010-026-02770-6 · Cited by 3
“Para-HIT-f [35], it employs a quick visual immuno-chromatographic technique in which the presence of malaria is detected by a visible band formed when a test instrument or dipstick reacts with the blood sample, ParaScreen [36], SD Bioline [37], Paracheck [38], and molecular diagnostic methods, such…”
Metadata
- Authors
- McMorrow, M. L., Masanja, M. I., Abdulla, S. M. K., Kahigwa, E., & Kachur, S. P.
- Affiliations
- Ifakara Health Institute (TZ)
- Malaria Branch, Division of Parasitic Diseases, National Center for Zoonotic Vector-borne and Enteric Diseases, US Centers for Disease Control and Prevention; Ifakara Health Research and Development Centre, Dares-Salaam, Tanzania
- Corresponding author
- McMorrow, Meredith L.
- Venue
- The American Journal of Tropical Medicine and Hygiene
- Published
- 2008-09
- Volume
- 79
- Issue
- 3
- Pages
- 385-390
- ISSN
- 0002-9637 (ISSN-L)
- PMC
- PMC5801444
- OpenAlex
- W4297888972
- Cited by
- 127
- References
- 15
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 2 · 2022: 2 · 2021: 4 · 2020: 4 · 2019: 5 · 2018: 5 · 2017: 6 · 2016: 8 · 2015: 10 · 2014: 12 · 2013: 16 · 2012: 10
- FWCI
- 12.58
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- American Journal of Tropical Medicine and Hygiene (publishedVersion)
- PubMed (publishedVersion)
- IHI Repository (acceptedVersion)
- PubMed Central (acceptedVersion)
- PubMed
- Funders
- National Institutes of Health (CC999999)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
- Health Sciences › Health Professions › Medical Laboratory Technology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
- Keywords
- rapid diagnostic tests, malaria diagnosis, quality control, sensitivity and specificity, microscopy, parasite density, rural health facilities, Rufiji District
- MeSH terms
- Adult, Child, Child, Preschool, Humans, Infant, Malaria, Quality Control, Reagent Kits, Diagnostic, Sensitivity and Specificity, Tanzania, Time Factors
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