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Meta-Analysis
. 2020 Nov 4;11(11):CD013218.
doi: 10.1002/14651858.CD013218.pub2.

Rapid diagnostic tests for Plasmodium vivax malaria in endemic countries

Ridhi Agarwal  1 , Leslie Choi  2 , Samuel Johnson  2 , Yemisi Takwoingi  3
Affiliations
Meta-Analysis

Rapid diagnostic tests for Plasmodium vivax malaria in endemic countries

Ridhi Agarwal et al. Cochrane Database Syst Rev. .

Abstract

Background: Plasmodium vivax (P vivax) is a focus of malaria elimination. It is important because P vivax and Plasmodium falciparum infection are co-endemic in some areas. There are asymptomatic carriers of P vivax, and the treatment for P vivax and Plasmodium ovale malaria differs from that used in other types of malaria. Rapid diagnostic tests (RDTs) will help distinguish P vivax from other malaria species to help treatment and elimination. There are RDTs available that detect P vivax parasitaemia through the detection of P vivax-specific lactate dehydrogenase (LDH) antigens.

Objectives: To assess the diagnostic accuracy of RDTs for detecting P vivax malaria infection in people living in malaria-endemic areas who present to ambulatory healthcare facilities with symptoms suggestive of malaria; and to identify which types and brands of commercial tests best detect P vivax malaria.

Search methods: We undertook a comprehensive search of the following databases up to 30 July 2019: Cochrane Infectious Diseases Group Specialized Register; Central Register of Controlled Trials (CENTRAL), published in the Cochrane Library; MEDLINE (PubMed); Embase (OVID); Science Citation Index Expanded (SCI-EXPANDED) and Conference Proceedings Citation Index-Science (CPCI-S), both in the Web of Science.

Selection criteria: Studies comparing RDTs with a reference standard (microscopy or polymerase chain reaction (PCR)) in blood samples from patients attending ambulatory health facilities with symptoms suggestive of malaria in P vivax-endemic areas.

Data collection and analysis: For each included study, two review authors independently extracted data using a pre-piloted data extraction form. The methodological quality of the studies were assessed using a tailored Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. We grouped studies according to commercial brand of the RDT and performed meta-analysis when appropriate. The results given by the index tests were based on the antibody affinity (referred to as the strength of the bond between an antibody and an antigen) and avidity (referred to as the strength of the overall bond between a multivalent antibody and multiple antigens). All analyses were stratified by the type of reference standard. The bivariate model was used to estimate the pooled sensitivity and specificity with 95% confidence intervals (CIs), this model was simplified when studies were few. We assessed the certainty of the evidence using the GRADE approach.

Main results: We included 10 studies that assessed the accuracy of six different RDT brands (CareStart Malaria Pf/Pv Combo test, Falcivax Device Rapid test, Immuno-Rapid Malaria Pf/Pv test, SD Bioline Malaria Ag Pf/Pv test, OnSite Pf/Pv test and Test Malaria Pf/Pv rapid test) for detecting P vivax malaria. One study directly compared the accuracy of two RDT brands. Of the 10 studies, six used microscopy, one used PCR, two used both microscopy and PCR separately and one used microscopy corrected by PCR as the reference standard. Four of the studies were conducted in Ethiopia, two in India, and one each in Bangladesh, Brazil, Colombia and Sudan. The studies often did not report how patients were selected. In the patient selection domain, we judged the risk of bias as unclear for nine studies. We judged all studies to be of unclear applicability concern. In the index test domain, we judged most studies to be at low risk of bias, but we judged nine studies to be of unclear applicability concern. There was poor reporting on lot testing, how the RDTs were stored, and background parasitaemia density (a key variable determining diagnostic accuracy of RDTs). Only half of the included studies were judged to be at low risk of bias in the reference standard domain, Studies often did not report whether the results of the reference standard could classify the target condition or whether investigators knew the results of the RDT when interpreting the results of the reference standard. All 10 studies were judged to be at low risk of bias in the flow and timing domain. Only two brands were evaluated by more than one study. Four studies evaluated the CareStart Malaria Pf/Pv Combo test against microscopy and two studies evaluated the Falcivax Device Rapid test against microscopy. The pooled sensitivity and specificity were 99% (95% CI 94% to 100%; 251 patients, moderate-certainty evidence) and 99% (95% CI 99% to 100%; 2147 patients, moderate-certainty evidence) for CareStart Malaria Pf/Pv Combo test. For a prevalence of 20%, about 206 people will have a positive CareStart Malaria Pf/Pv Combo test result and the remaining 794 people will have a negative result. Of the 206 people with positive results, eight will be incorrect (false positives), and of the 794 people with a negative result, two would be incorrect (false negative). For the Falcivax Device Rapid test, the pooled sensitivity was 77% (95% CI: 53% to 91%, 89 patients, low-certainty evidence) and the pooled specificity was 99% (95% CI: 98% to 100%, 621 patients, moderate-certainty evidence), respectively. For a prevalence of 20%, about 162 people will have a positive Falcivax Device Rapid test result and the remaining 838 people will have a negative result. Of the 162 people with positive results, eight will be incorrect (false positives), and of the 838 people with a negative result, 46 would be incorrect (false negative).

Authors' conclusions: The CareStart Malaria Pf/Pv Combo test was found to be highly sensitive and specific in comparison to microscopy for detecting P vivax in ambulatory healthcare in endemic settings, with moderate-certainty evidence. The number of studies included in this review was limited to 10 studies and we were able to estimate the accuracy of 2 out of 6 RDT brands included, the CareStart Malaria Pf/Pv Combo test and the Falcivax Device Rapid test. Thus, the differences in sensitivity and specificity between all the RDT brands could not be assessed. More high-quality studies in endemic field settings are needed to assess and compare the accuracy of RDTs designed to detect P vivax.

PubMed Disclaimer

Conflict of interest statement

RA has no known conflicts of interest. LC has no known conflicts of interest. SJ has no known conflicts of interest. YT has no known conflicts of interest.

Figures

1
1
Study flow diagram.
2
2
Risk of bias and applicability concerns summary: review authors' judgements about each domain for each included study
3
3
Forest plot of brands of rapid diagnostic tests verified against PCR or microscopy corrected with PCR
4
4
Forest plot of brands of rapid diagnostic tests verified against microscopy, within each brand sorted by sensitivity and specificity
5
5
Summary ROC plot for CareStart Malaria Pf/Pv Combo test verified against microscopy. The size of each study point was scaled by the sample size of the diseased and non‐diseased groups used to estimate the study's sensitivity and specificity respectively, and reflects the precision of sensitivity and specificity in the study relative to other study points.The solid circle (summary point) represents the summary estimate of sensitivity and specificity. The summary point is not surrounded by a 95% confidence region because the bivariate model was simplified to univariate models.
1
1. Test
CareStart Malaria Pf/Pv Combo test (Access Bio Inc, New Jersey, USA) (Microscopy)
2
2. Test
Falcivax Device Rapid test for malaria Pv/Pf (Zephyer Biomedicals Goa) (Microscopy)
3
3. Test
Immuno‐Rapid Malaria Pf/Pv test (Wama Diagnostica, Sao Paulo, Brazil) (Microscopy)
4
4. Test
OnSite Pf/Pv test (CTK Biotech Inc, USA) (Microscopy)
5
5. Test
SD Bioline Malaria Ag Pf/Pv test (Microscopy)
6
6. Test
Falcivax Device Rapid test for malaria Pv/Pf (Zephyer Biomedicals Goa) (PCR)
7
7. Test
OnSite Pf/Pv test (CTK Biotech Inc, USA) (PCR)
8
8. Test
SD Bioline Malaria Ag Pf/Pv test (PCR)
9
9. Test
Test Malaria Pf/Pv rapid test (Alltest Biotech, China) (PCR)
10
10. Test
SD Bioline Malaria Ag Pf/Pv test (Microscopy corrected by PCR)
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD013218

References

References to studies included in this review

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Pattanasin 2003 {published data only}
    1. Pattanasin S, Proux S, Chompasuk D, Luwiradaj K, Jacquier P, Looareesuwan S, et al. Evaluation of a new Plasmodium lactate dehydrogenase assay (OptiMAL-IT) for the detection of malaria. Transactions of the Royal Society of Tropical Medicine and Hygiene 2003;97(6):672-4. - PubMed
Puri 2013 {published data only}
    1. Puri B, Mehta P, Ingole NA, Prasad P, Mathure T. Laboratory tests for malaria: A diagnostic conundrum? South African Medical Journal 2013;103(9):625-7. - PubMed
Rakotonirina 2008 {published data only}
    1. Rakotonirina H, Barnadas C, Raherijafy R, Andrianantenaina H, Ratsimbasoa A, Randrianasolo L, et al. Accuracy and reliability of malaria diagnostic techniques for guiding febrile outpatient treatment in malaria-endemic countries. American Journal of Tropical Medicine and Hygiene 2008;78(2):217-21. - PubMed
Ranjan 2016 {published data only}
    1. Ranjan P, Ghoshal U. Utility of nested polymerase chain reaction over the microscopy and immuno-chromatographic test in the detection of Plasmodium species and their clinical spectrum. Parasitology Research 2016;115(9):3375-85. - PubMed
Ratsimbasoa 2007 {published data only}
    1. Ratsimbasoa A, Randriamanantena A, Raherinjafy R, Rasoarilalao N, Ménard D. Which malaria rapid test for Madagascar? Field and laboratory evaluation of three test and expert microscopy of samples from suspected malaria patients in Madagascar. American Journal of Tropical Medicine and Hygiene 2007;76(3):481-5. - PubMed
Ratsimbasoa 2008 {published data only}
    1. Ratsimbasoa A, Fanazava L, Radrianjafy R, Ramilijaona J, Rafanomezantsoa H, Ménard D. Evaluation of two new immunochromatographic assays for diagnosis of malaria. American Journal of Tropical Medicine and Hygiene 2008;79(5):670-2. - PubMed
Samane 2010 {published data only}
    1. Samane AK, Nahid HZ, Saaed S, Khazen H, Ali H, Ahmad R, et al. Comparison of microscopy and RDTs techniques for laboratory detection of malaria. African Journal of Biotechnology 2010;9(10):1514-6.
Selimuzzaman 2010 {published data only}
    1. Selimuzzaman SM, Islam SJ, Nahar Z, Das R, Rahman MA, Rahman MA. Malariagen malaria Pf/Pv antigen rapid test: A simple and effective tool for diagnosis of malaria in the far-flung hilly areas of Bangladesh. Mymensingh Medical Journal 2010;19(1):94-9. - PubMed
Shaikh 2013 {published data only}
    1. Shaikh S, Memon S, Memon H, Ahmed I. Role of rapid diagnostic tests for guiding outpatient treatment of febrile illness in Liaquat University Hospital. Pakistan Journal of Medical Sciences 2013;29(5):1167-72. - PMC - PubMed
Sharma 2014 {published data only}
    1. Sharma J. Prevalence of malaria cases in tea garden areas of Lakhimpur District, Assam. International Journal of Pharmacy and Pharmaceutical Sciences 2014;6(8):571-3.
Singh 2000a {published data only}
    1. Singh N, Saxena A, Valecha N. Field evaluation of the ICT malaria P.f/P.v immunochromatographic test for diagnosis of Plasmodium falciparum and P. vivax infection in forest villages in Chhindwara, Central India. Tropical Medicine and International Health 2000;5(11):765-70. - PubMed
Singh 2003 {published data only}
    1. Singh N, Valecha N, Nagpal AC, Mishra SS, Varma HS, Subbaro SK. The hospital- and field-based performances of the OptiMAL test, for malaria diagnosis and treatment monitoring in Central India. Annals of Tropical Medicine and Parasitology 2003;97(1):5-13. - PubMed
Singh 2013 {published data only}
    1. Singh N, Bharti PK, Singh MP, Mishra S, Shukla MM, Sharma RK, et al. Comparative evaluation of bivalent malaria rapid diagnostic tests versus traditional methods in field with special reference to heat stability testing in Central India. PLoS One 2013;8(3):e58080. - PMC - PubMed
Siwal 2018 {published data only}
    1. Siwal N, Singh US, Dash M, Kar S, Rani S, Rawal C, et al. Malaria diagnosis by PCR revealed differential distribution of mono and mixed species infections by Plasmodium falciparum and P. vivax in India. PLoS One 2018;13(3):e0193046. - PMC - PubMed
Stijnberg 2013 {published data only}
    1. Stijnberg D, Cairo H. Rapid diagnostic test (RDT) performance of the malaria gold mining program in Suriname: Comparing the performance of two RDT's. In: 62nd Annual Meeting of the American Society of Tropical Medicine and Hygiene; 2013 13-17 November; Washington, DC. Vol. 89(5 Suppl 1). Washington, DC, USA: The American Society of Tropical Medicine and Hygiene, 2013:384.
Strom 2014 {published data only}
    1. Strøm GE, Moyo S, Fataki M, Langeland N, Blomberg B. PCR targeting Plasmodium mitochondrial genome of DNA extracted from dried blood on filter paper compared to whole blood. Malaria Journal 2014;13:137. - PMC - PubMed
Thongdee 2014 {published data only}
    1. Thongdee P, Chaijaroenkul W, Kuesap J, Na-Bangchang K. Nested-PCR and a new ELISA-based NovaLisa test kit for malaria diagnosis in an endemic area of Thailand. Korean Journal of Parasitology 2014;52(4):377-81. - PMC - PubMed
Tjitra 1999 {published data only}
    1. Tjitra E, Suprianto S, Dyer M, Currie BJ, Anstey NM. Field evaluation of the ICT malaria P.f/P.v immunochromatographic test in detection of Plasmodium falciparum and Plasmodium vivax in patients with a presumptive clinical diagnosis of malaria in Eastern Indonesia. Journal of Clinical Microbiology 1999;37(8):2412-7. - PMC - PubMed
Trouvay 2013 {published data only}
    1. Trouvay M, Palazon G, Berger F, Volney B, Blanchet D, Faway E, et al. High performance of histidine-rich protein 2 based rapid diagnostic tests in French Guiana are explained by the absence of pfhrp2 gene deletion in P. falciparum. PLoS One 2013;8(9):e74269. - PMC - PubMed
Valecha 2003 {published data only}
    1. Valecha N, Singh N, Yadav RS, Dev V, Aggarwal A, Subbarao SK. Field evaluation of OptiMAL48 rapid malaria diagnostic test in India. Acta Parasitologica 2003;48(3):229-32.
van den Broek 2006 {published data only}
    1. den Broek I, Hill O, Gordillo F, Angarita B, Hamade P, Counihan H, et al. Evaluation of three rapid tests for diagnosis of P. falciparum and P. vivax malaria in Colombia. American Journal of Tropical Medicine and Hygiene 2006;75(6):1209-15. - PubMed
Vohra 2014 {published data only}
    1. Vohra P, Mengi S, Bunger R, Pathania D, Singh VA. Comparison of peripheral blood film stained by Giemsa stain, acridine orange staining and rapid diagnostic tests for detection of P. vivax and P. falciparum in clinically suspected cases of malaria. International Journal of Pharma Medicine and Biological Sciences 2014;3(3):108-112.
Wang 2014 {published data only}
    1. Wang ZY, Jiang L, Zhang YG, Zhang XP, Cai L. Comparison of two rapid diagnostic tests in detection of malaria parasites. Zhongguo Ji Sheng Chong Xue Yu Ji Sheng Chong Bing Za Zhi 2014;32(1):50-3. - PubMed
Wongsrichanalai 2003 {published data only}
    1. Wongsrichanalai G, Arevalo I, Laoboonchai A, Yingyuen K, Miller RS, Magill AJ, et al. Rapid diagnostic devices for malaria: Field evaluation of a new prototype immunochromatographic assay for the detection of Plasmodium falciparum and non-falciparum Plasmodium. American Journal of Tropical Medicine and Hygiene 2003;69(1):26-30. - PubMed
Woyessa 2013 {published data only}
    1. Woyessa A, Deressa W, Ali A, Lindtjørn B. Evaluation of CareStart™ Malaria Pf/Pv Combo test for Plasmodium falciparum and Plasmodium vivax malaria diagnosis in Butajira area, South-Central Ethiopia. Malaria Journal 2013;12:218. - PMC - PubMed
Xiaodong 2013 {published data only}
    1. Xiaodong S, Tambo E, Chun W, Zhibin C, Yan D, Jian W, et al. Diagnostic performance of CareStart™ malaria HRP2/pLDH (Pf/pan) Combo test versus standard microscopy on falciparum and vivax malaria between China-Myanmar endemic borders. Malaria Journal 2013;12:6. - PMC - PubMed
Yan 2013 {published data only}
    1. Yan J, Li N, Wei X, Li P, Zhao Z, Wang L, et al. Performance of two rapid diagnostic tests for malaria diagnosis at the China-Myanmar border area. Malaria Journal 2013;12:73. - PMC - PubMed

References to studies awaiting assessment

Boni 2015 {published data only}
    1. Boni MF, Lover AA, Ngo TD, Nguyen TX, Sutamihardja A, Tran DT, et al. Potential impact of rapid diagnostic test diagnostic error on increased malaria transmission of emerging untreatable malaria. In: 64th Annual Meeting of the American Society of Tropical Medicine and Hygiene; 2015 October 25-29; Philadelphia (PA). Vol. 93(4 Suppl). Philadelphia (PA), USA: The American Society of Tropical Medicine and Hygiene, 2015:371.
Cheng 2013 {published data only}
    1. Cheng Z, Sun X, Yang Y, Wang H, Zheng Z. A novel, sensitive assay for high-throughput molecular detection of Plasmodia for active screening of malaria for elimination. Journal of Clinical Microbiology 2013;51(1):125-30. - PMC - PubMed
Reda 2016 {published data only}
    1. Reda AG. Evaluation of the performance of SD bioline malaria AG PF/PV and carestartTM malaria PF/PV combo tests for the diagnosis of malaria in two malarious areas in central Ethiopia. In: 65th Annual Meeting of the American Society of Tropical Medicine and Hygiene; 2016 November 13-17; Atlanta (GA). Vol. 95(5 Suppl). Atlanta (GA), USA: The American Society of Tropical Medicine and Hygiene, 2016:82-83.

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