Vi malaria rapid diagnostic test performance results of who product testing of malaria rdts. In malaria patients, a prompt and accurate diagnosis is the key to effective disease management. This manual and accompanying material are designed to train health workers in the safe and accurate use of malaria rapid diagnostic tests rdts. The parasight f antigen capture assay dipstick test is a new diagnostic test for p. Of great interest in this context is the development during the past ten years of rapid diagnostic tests rdts for malaria using immunochro matographic test strips. The rdts have been developed in different test formats like the dipstick, strip, card, pad, well, or cassette. Research open access malaria rapid diagnostic test as. Malaria rdt employ lateral flow immunochromatographic technology similar to rapid pregnancy tests. Access to diagnosis remains poorin half of endemic african countries, over 80% of malaria treatments are applied without diagnostic testing. Demonstration of the presence of malaria parasites is advised before treatment with. This is central to efforts to decrease malaria overdiagnosis and the consequent overuse of valuable antimalarials and underdiagnosis of alternative causes of fever.
Improving diagnosis and treatment of malaria will improve treatment outcomes, rationalize. Malaria is a serious parasitic disease characterized by fever, chills, and anaemia and is caused by a. Pan malaria test rapid diagnostic test for detecting malaria. Positivity rate at baseline, and after 60 days incubation. What is the precision of rapid diagnostic tests for malaria. This study was aimed to assess the diagnostic performance of partec rapid malaria test with reference to light microscopy for the diagnosis of malaria in northwest ethiopia. Evaluation of the rapid diagnostic test optimal for. Clinical diagnosis is the least expensive, most commonly used method and is the basis for selftreatment. Scaleup of malaria rapid diagnostic tests and artemisinin.
Patients of all ages should get diagnostic test 37 19 8 7 9 10 90 only patients 5 years get diagnostic test 4 4 rdts used at community level 20 8 6 8 6 48 malaria diagnosis is free of charge in the public sector 28 18 8 8 10 9 81 number of endemic countriesareas 43 23 12 8 10 10 106 number of p. Summary performance of malaria rdts against blood samples containing wild type p. Malaria rapid diagnostic tests rdts are generally considered as pointofcare tests. This procedure manual details a protocol for the product testing of antigendetecting. Microscopy has been the only test approved in the national policy for the diagnosis and management of malaria in haiti. Diagnosis of malaria infection requires rapid, sensitive, and specific test methods with an affordable cost. Dec 01, 2015 rapid diagnostic tests also play an important role in detecting clinically significant malaria in settings that have reduced their malaria transmission to very low levels. In these assays, the clinical sample migrates as a liquid across the surface of a nitrocellulose membrane by capillary action, 27, 33, 34.
For the rapid qualitative determination of malaria. The two diagnostic approaches currently used most often, however, do not allow a satisfactory diagnosis of malaria. These socalled rapid diagnostic tests or rdts do not require the expertise of a blood smear and only need a tiny droplet of blood, and so can even be performed at home as part of a selftesting kit. Rapid diagnostic tests rdts assist in the diagnosis of malaria by detecting evidence of malaria parasites in human blood. Plasmodium falciparum malaria is endemic to haiti and remains a major concern for residents, including displaced persons, and emergency responders in the aftermath of the january 12, 2010 earthquake. There is much heterogeneity among reported results for rdt diagnostic accuracy, which may depend on several factors. Recent progress in the development of diagnostic tests for malaria. Rapid malaria tests work, but with unexpected drawbacks the. This study was aimed at testing the diagnostic performance of carestart malaria rapid diagnostic test rdt with reference to light microscopy for the diagnosis of falciparum and vivax malaria. For a given targeted parasite antigen, two sets of monoclonal or.
In these areas, rapid detection of the malaria parasites and early treatment of infection remain the most important goals of disease management. We compared the performance of four rapid diagnostic tests rdts for imported malaria, and particularly plasmodium falciparum infection, using thick and thin blood smears as the gold standard. Laboratory diagnosis of malaria is the key for effective disease management. Comparison of partec rapid malaria test with conventional. For all species, rdt sensitivity declines at lower parasite density 34,44,45. Jul 11, 2008 malaria presents a diagnostic challenge in tribal belt of central india where two plasmodium species, plasmodium falciparum and plasmodium vivax, are prevalent. Availability e test has been transferred to companies in germany and india and is available from. Nov 08, 2015 although the peripheral blood smear examination that provides the most comprehensive information on a single test format has been the gold standard for the diagnosis of malaria, the immunochromatographic tests for the detection of malaria antigens, developed in the past decade, have opened a new and exciting avenue in malaria diagnosis. A new invention can cheaply and accurately diagnose malaria infection in just a few minutes using only a. Aug 07, 2017 a health care worker taking a blood sample of a mother to test for malaria in lagos, nigeria. By delivering readyprepared and readytouse test slides which already carry the driedin reagents safely on the slide surface therefore longterm storage and shipment are significantly. A lineup of 11 malaria rdt products is available for different combinations of plasmodium parasites that cause malaria in humans, namely p. Plasmodium vivax tolerant to lower ambient temperatures still facilitating replication in the vector is mainly.
Technicians may be unfamiliar with, or lack experience with, malaria, and fail to detect parasites when examining blood smears. An estimated 627,000 malaria deaths occurred in 2012, mostly in african children and many of them preventable with prompt diagnosis and treatment. Evaluation of the rapid diagnostic test optimal for diagnosis. Accurate and practical malaria diagnostics, such as immunochromatographic rapid diagnostic tests rdts, have the potential to avert unnecessary treatments and save lives.
Pan malaria test rapid diagnostic test for detecting malaria infection name and intended use pan malaria test is a visual, qualitative immunoassay for in vitro detection of plasmodium lactate dehydrogenase pldh, a protein specific to parasites of the genus plasmodium. Malaria rapid diagnostic tests in elimination settingscan. Guidance for choosing a malaria rapid diagnostic test rdt unicef. Rapid diagnostic tests for malaria pubmed central pmc. Malaria is endemic in 99 countries worldwide, and several million people travel from non endemic countries to malaria endemic regions each year. Malaria rapid diagnostic test performance world health. Malaria rapid test carestart malaria medical equipment. The recent rollout of rapid diagnostic tests rdts for malaria has highlighted the decreasing proportion of malariaattributable illness in endemic areas. A malaria rapid diagnostic test rdt can aid in the diagnosis of malaria by identifying a presence of malaria antigens in the human blood. It is difficult to diagnose by microscopy because of morphological similarity to plasmodium malariae. Clinical findings should always be confirmed by a laboratory test for malaria.
Although clinically indistinguishable from many other diseases, malaria is a curable disease if the patient has access to an early diagnosis and treatment. Performance of rapid diagnostic tests for imported malaria in. Interim notes on selection of type of malaria rapid diagnostic test in relation to the occurrence of different parasite species guidance for national malaria control programmes prepared by roll back malaria department world health organization with the collaboration of the regional offices for africa and the western pacific august 2005 1. Pdf rapid diagnostic tests for malaria in daily practice. The usefulness of a new rapid diagnostic test, the first. Rapid diagnostic tests for malaria rapid test kits. New the carestart malaria are qualitative rapid diagnostic tests that diagnose malaria infection from the whole blood of patients in 20 minutes. The requirements of a diagnostic test are specificity, sensitivity, ease of performance and a reasonable cost. They allow the testing of people who cannot access diagnosis based on microscopy.
A negative result at any time does not preclude the possibility of an early malaria infection. The specific performance requirements of a test will vary depending on the intended use or uses. Rapid malaria tests work, but with unexpected drawbacks. Plasmodium falciparum the most lethal species is by far the predominant species in tropical regions. Clinical diagnosis, the most widely used approach, is unreliable because the symptoms of malaria are very nonspeci. Volunteer community health workers chws represent a potentially valuable human resource for expanding this technology to where it is most needed, remote rural communities in subsaharan africa with limited health. For a given targeted parasite antigen, two sets of monoclonal or polyclonal antibodies are used, a capture antibody and. Although more than 7000 cases of imported malaria are reported annually both in european countries and in the united states, malaria remains unusual in non endemic countries and its clinical presentation is often nonspecific 2,3. Nested pcr assay is the most accurate method to distinguish p. Malaria rapid diagnostic tests in endemic settings. If the test result is negative and malaria infection suspicion still exists, additional followup testing using other clinical methods is recommended. Plasmodium knowlesi, a malaria parasite of southeast asian macaques, infects humans and can cause fatal malaria. Therefore, the usefulness of a new rapid diagnostic rdt, the first response combo.
Seasonal performance of a malaria rapid diagnosis test at. Malaria is endemic in 106 countries and accounted for 655 000 deaths in 2010, 86% of which occurred among children. Who how to use a rapid diagnostic test generic pfpan. Pdf rapid diagnostic tests for nonmalarial febrile. Volunteer community health workers chws represent a potentially valuable human resource for expanding this technology to where it is most needed, remote rural communities in subsaharan africa with limited. Rapid and accurate diagnostic tests for malaria disease. Use and limitations of malaria rapid diagnostic testing by. A study found that rapid tests have greatly improved treatment, but. A rapid and simple diagnostic test that can accurately differentiate a deadly p. Cdc malaria malaria worldwide how can malaria cases and. Histidinerich protein ii hrp2based malaria rapid diagnostic tests rdts have shown high sensitivity and specificity for detecting plasmodium falciparum malaria in a variety of study settings. Histidinerich protein 2 hrp2 and lactate dehydrogenase in human blood as an aid in the diagnosis of malaria infection. Performance of rapid diagnostic tests for imported malaria. The partec rapid malaria test in combination with the partec cyscope offers a uniquely easy and ultrarapid protocol for reliable malaria diagnostics.
Currently approved rdts for use in the malaria endemic world can detect 2 types of malaria antigens. Malaria rapid diagnostic test performance results of who product testing of malaria rdts. Laboratory diagnosis of malaria requires the identification of the parasite or its antigens products in the patients blood. The diagnosis of malaria has evolved rapidly in the last 10 years, largely because of the introduction of rapid diagnostic tests rdts for malaria. Rapid diagnostic tests rdts most often use a dipstick or cassette format, and provide results in about 20 minutes. This study aimed to assess performance of the optimal dipstick for rapid malaria. Guidance for choosing a malaria rapid diagnostic test rdt. As malaria transmission declines throughout the world, accurate diagnosis is becoming increasingly important both for individual case management and for disease surveillance. Currently approved rdts for use in the malariaendemic world can detect 2 types of malaria antigens.
Different tests have been developed to test between the. Rapid diagnostic tests rdts for malaria are at the early stages of introduction across malaria endemic countries. Introduction of effective and affordable malaria rapid diagnosis test rdt in remote areas could be an alternative tool for malaria case management. A health care worker taking a blood sample of a mother to test for malaria in lagos, nigeria.
It can detect plasmodium falciparum or one of the other three species of human malaria, providing results in 1520 minutes. Rapid diagnostic tests for nonmalarial febrile illness in the tropics article pdf available in clinical microbiology and infection 195 january 20 with 326 reads how we measure reads. In addition to ordering the malaria specific diagnostic tests described below, the healthcare provider should conduct an initial workup and request a complete blood count and a routine chemistry panel. Rapid diagnostic test rdt a guide for training at a village and clinic level modified for training in the use of the generic pfpan test for falciparum and nonfalciparum malaria a t m a e n prepared on february 11, 2010. Unfortunately, once malaria is excluded, there are few accessible diagnostic tools to guide the management of severe febrile illnesses in low resource settings.
Cdc malaria malaria worldwide how can malaria cases. The generic instructions jobaids and training manual have been developed with the aim of improving accuracy of rdt diagnosis and blood safety during the diagnostic procedure. Use of rapid diagnostic tests for diagnosis of malaria in. Based on the results of our study, our laboratory uses binaxnow as an adjunct to thin and thicksmear microscopy, primarily to aid with species identification when only early trophozoites are observed by microscopy and to provide a rapid preliminary positive result identifying p. We compared malaria diagnosis made by the rapid diagnostic test optimal with traditional microscopic examination of the thick smear in an area where there is no p. This study aimed to assess performance of the optimal dipstick for rapid malaria diagnosis in.
May 30, 2012 treatment of confirmed malaria patients with artemisininbased combination therapy act at remote areas is the goal of many anti malaria programs. Our objective was to determine the sensitivity and specificity of the rapid diagnostic test optimal in comparison with microscopic evaluation of the thick smear for diagnosis of malaria due to p. The test is intended as an aid to diagnosis of malaria infection in humans. Assessment of ultrasensitive malaria diagnosis versus. In contrast, malaria rapid diagnostic tests rdts require less equipment or training to use. Current available techniques can be separated in three categories. A study found that rapid tests have greatly improved treatment, but that many people who tested. When considering whether or not to use a malaria rapid diagnostic test in a particular setting, it is important to consider their strengths and plan how to manage the challenges.
Quality assurance of rapid diagnostic tests for malaria in. Dec 23, 2009 accurate and practical malaria diagnostics, such as immunochromatographic rapid diagnostic tests rdts, have the potential to avert unnecessary treatments and save lives. A blood specimen collected from the patient is applied to the sample pad on the test card along with certain reagents. Malaria rdt phase 2 performance in rounds against wildtype clinical samples containing p. However, rdts are susceptible to heat and humidity and variation in individual performance, which may affect their use in field settings. This test kit detects plasmodium lactate dehydrogenase in patient whole blood and is useful as a screening procedure for malaria diagnosis. Heat stability of panline of panspecific tests against a low density p. Pan malaria test rapid diagnostic test for detecting. Treatment of confirmed malaria patients with artemisininbased combination therapy act at remote areas is the goal of many antimalaria programs. More recently, a number of antibody tests have been developed to test for malaria. As with all diagnostic tests, the result must be correlated with clinical findings. We encountered a high prevalence of malaria 53% because the study was done during the malaria season. Although the test is very accurate in detecting pldh, a. All the tests are designed to detect at least one protein specific to p.