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We compared the performance of Paracheck-Pf, a new and cheap rapid malaria test, with ICT-Pf/PvR and microscopy in two malaria surveys in Thai villages on the Thai-Burmese border. The specificity, sensitivity, predictive positive and negative values of the Paracheck-PfR and ICT-PfR tests were calculated taking microscopy results as the gold standard. The 294 ICT-Pf/Pv tests resulted in two invalid (no control line) and 11 doubtful results. Both the ICT-Pf/PvR and Paracheck-PfR tests reliably detected P. falciparum infections. However, Paracheck-PfR failed to detect three P. falciparum cases and likewise, ICT-Pf/PvR failed to detect the same three cases and an additional four cases. These seven cases were detected by microscopy and had a parasitaemia under 150 parasites/microl. At a cost of c. US $1.00, the Paracheck-PfR test, based on the detection of the P. falciparum specific HRP-2 protein, is a reliable, easy to use and affordable tool for the diagnosis of P. falciparum malaria.
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PMID:Paracheck-Pf: a new, inexpensive and reliable rapid test for P. falciparum malaria. 1125 4

The rapid immunocapture assays, OptiMal and ICT, were evaluated from 87 individuals for the diagnosis of malaria infections directly from whole blood. A total of 87 individuals was examined for malaria parasites by microscopic examination of Giemsa-stained blood smears, and 65 cases were positive for Plasmodium vivax by microscopy. Correspondingly, the OptiMal test identified malaria infection in 45 cases (69.2%) of microscopy positive cases. Of these, two cases were misinterpreted as Plasmodium falciparum, whereas ICT detected P. vivax infection in 29 (44.6%) patients. We would like to propose that rapid immuno capture assays are an easy method that can serve as a useful tool in addition to microscopy for the diagnosis of malaria, but sensitivity is not yet satisfactory for diagnosis of P. vivax in Korea.
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PMID:Evaluation of rapid immunocapture assays for diagnosis of Plasmodium vivax in Korea. 1141 42

This study was conducted to evaluate the performance of two rapid non-microscopic assays: Plasmodium lactate dehydrogenase (pLDH) assay (OptiMAL) and Plasmodium falciparum histidine-rich protein 2 (PfHRP-2) assay (ICT Malaria). The assays were used to detect malaria infection in 515 immigrants living in Kuwait. The performance of both assays was compared to that of microscopy of Giemsa-stained thick blood films and to each other. Of the 515 patients tested, 163 were positive for malaria parasites by microscopy of thick blood film. Of these, 87 were infected with Plasmodium vivax parasites, 63 with P. falciparum, 1 with Plasmodium malariae, and 12 had mixed infections of P. falciparum and P. vivax. The PfHRP-2 assay detected 53 P. falciparum infections and, as expected, failed to detect all but one case of P. vivax. Three cases of mixed infections were also not detected by this assay. The pLDH assay detected 56 P. falciparum cases and 77 P. vivax infections but failed to detect 4 cases of mixed infections. Compared to microscopy, the performance of both the assays to diagnose P. falciparum infection was comparable. The sensitivity for the PfHRP-2 assay was 82% with a specificity of 99.0% and for the pLDH assay the sensitivity was 89% with a specificity of 99.5%. The PfHRP-2 assay detected 4 false positive cases, 2 of which were also detected by the pLDH assay. These patients reported treatment with chloroquine in the last 2-5 weeks. Though the immunocapture diagnostic assays may be helpful in certain situations, microscopy of thick blood film is still the method of choice in diagnosing imported malaria.
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PMID:Diagnosis of imported malaria by Plasmodium lactate dehydrogenase (pLDH) and histidine-rich protein 2 (PfHRP-2)-based immunocapture assays. 1142 56

The algorithm developed for the integrated management of childhood illness (IMCI) provides guidelines for the treatment of paediatric malaria. In areas where malaria is endemic, for example, the IMCI strategy may indicate that children who present with fever, a recent history of fever and/or pallor should receive antimalarial chemotherapy. In many holo-endemic areas, it is unclear whether laboratory tests to confirm that such signs are the result of malaria would be very relevant or useful. Children from a holo-endemic region of Tanzania were therefore checked for malarial parasites by microscopy and by using two rapid immunochromatographic tests (RIT) for the diagnosis of malaria (ICT Malaria P.f/P.v and OptiMal. At the time they were tested, each of these children had been targeted for antimalarial treatment (following the IMCI strategy) because of fever and/or pallor. Only 70% of the 395 children classified to receive antimalarial drugs by the IMCI algorithm had malarial parasitaemias (68.4% had Plasmodium falciparum trophozoites, 1.3% only P. falciparum gametocytes, 0.3% P. ovale and 0.3% P. malariae). As indicators of P. falciparum trophozoites in the peripheral blood, fever had a sensitivity of 93.0% and a specificity of 15.5% whereas pallor had a sensitivity of 72.2% and a specificity of 50.8%. The RIT both had very high corresponding sensitivities (of 100.0% for the ICT and 94.0% for OptiMal) but the specificity of the ICT (74.0%) was significantly lower than that for OptiMal (100.0%). Fever and pallor were significantly associated with the P. falciparum asexual parasitaemias that equalled or exceeded the threshold intensity (2000/microl) that has the optimum sensitivity and specificity for the definition of a malarial episode. Diagnostic likelihood ratios (DLR) showed that a positive result in the OptiMal test (DLR = infinity) was a better indication of malaria than a positive result in the ICT (DLR = 3.85). In fact, OptiMal had diagnostic reliability (0.93) which approached that of an ideal test and, since it only detects live parasites, OptiMal is superior to the ICT in monitoring therapeutic responses. Although the RIT may seem attractive for use in primary health facilities because relatively inexperienced staff can perform them, the high cost of these tests is prohibitive. In holo-endemic areas, use of RIT or microscopical examination of bloodsmears may only be relevant when malaria needs to be excluded as a cause of illness (e.g. prior to treatment with toxic or expensive drugs, or during malaria epidemics). Wherever the effective drugs for the first-line treatment of malaria are cheap (e.g. chloroquine and Fansidar), treatment based on clinical diagnosis alone should prove cost-saving in health facilities without microscopy.
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PMID:Malaria diagnosis and treatment under the strategy of the integrated management of childhood illness (IMCI): relevance of laboratory support from the rapid immunochromatographic tests of ICT Malaria P.f/P.v and OptiMal. 1148 66

The case was a 47-year-old Nigerian male who was thought to have contracted malaria in Nigeria and then manifested fever with chill, arthralgia and diarrhea in Japan. The blood test at International Medical Center of Japan revealed thrombocytopenia and anemia. Ring forms of 0.03% of his RBCs and ICT Malaria P.f/P.v test was also positive for Plasmodium falciparum. We prescribed mefloquine to him, but the number of the paresites in his peripheral blood did not decrease, and, in fact, they came to increase (maximum 6.66%) 20 hours after the drug treatment. As clinical condition of malaria were liable to change seriously, intravenous Artesunate (a qinghaosu derivative) was decided to be given additionally to the patient. Consequently the parasites disappeared in 20 hours from his blood but a low grade fever still continued possibly because of cholecystitis. At the same time of Artesunate treatment, hemoglobinuria started and anemia worsened partly because of his G-6-PD deficiency. All pending problems were improved by the time he left Japan and those parasites were finally found to be susceptible for mefloquine by the in vitro susceptibility test. This is the first reported case of falciparum malaria successfully treated with intravenous Artesunate in Japan.
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PMID:[A case of falciparum malaria successfully treated with intravenous artesunate]. 1160 94

In regions with drug-resistant malaria, the ability to rapidly detect or predict treatment failure (TF) soon after a course of standard therapy for Plasmodium falciparum malaria would facilitate the prompt institution of second-line therapy. We thus evaluated longitudinally the ability of the ICT Malaria Pf/Pv immunochromatographic test to predict treatment outcome. Sixty-six Sumbanese Indonesians with uncomplicated falciparum malaria were treated with chloroquine and followed for 28 days by use of 1997 World Health Organization criteria for assessment of therapeutic efficacy of antimalarial drugs. The ICT Pf/Pv testing could be compared with microscopy in approximately half of the patients on each day of follow-up. Although strongly positive histidine rich protein 2 (HRP2) line intensities (equal to or greater than the control band) in convalescence were highly predictive of TF, any degree of positivity for the HRP2 and panmalarial antigens in convalescence was only moderately predictive of TE Positive predictive values of the HRP2 and panmalarial antigens for TF were 76.9% and 87.0%, respectively, on Day 3, 82.4% and 87.5% on Day 7, and 78.9% and 78.9% on Day 14. Negative HRP2 and panmalarial antigen results in convalescence were even less predictive of an adequate clinical response, and false-negative HRP2 and panmalarial antigen test results were found in one-sixth (6 of 37) of recrudescent infections diagnosed by microscopy among patients with late treatment failure. To reliably predict treatment outcome with rapid antigen tests, further development appears necessary to improve sensitivity for viable asexual parasites while avoiding detection of both gametocytes and persistent antigen in convalescence.
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PMID:Detection of histidine rich protein 2 and panmalarial ICT Malaria Pf/Pv test antigens after chloroquine treatment of uncomplicated falciparum malaria does not reliably predict treatment outcome in eastern Indonesia. 1171 20

Logistic, economic and technical factors limit rapid access to microscopic confirmation of symptomatic diagnosis of malaria in many rural areas in endemic countries such as Myanmar. A study was conducted to evaluate a rapid on-site immunochromatographic test (ICT Malaria Pf/Pv) for detection of Plasmodium falciparum and P. vivax in two villages in the Taikkyi region of Myanmar. The ICT Malaria tests were performed by a volunteer health worker (VHW) in Yae-Aye-San village and by a professionally trained midwife (MW) in Kankone village. A total of 1000 symptomatic patients participated in the study by providing blood samples for an ICT test and for microscopy. The ICT performance indices, relative to microscopy, were better for the trained MW compared with the less experienced VHW. For P. falciparum and/or P. vivax infections, the sensitivities were 82.7% for the VHW compared with 93.7% for the MW. For P. falciparum infections, the sensitivities were 82.2% for the VHW and 91.3% for the MW, while the corresponding values for P. vivax infections were 66.7 and 79%, respectively. Although the test kit appeared to perform better in more experienced hands, this study questions whether this difference is related to the use of the ICT Malaria Pf/Pv test kit, or related to other factors such as differences in the quality of blood slides prepared by the VHW and MW for microscopic examination. Overall, the results suggest that a rapid diagnostic assay such as the ICT Malaria Pf/Pv test kit can be used in rural settings by relatively inexperienced persons, such as VHWs, with a reasonable degree of sensitivity, thus providing on-site confirmation of symptomatic diagnosis of malaria.
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PMID:Performance appraisal of rapid on-site malaria diagnosis (ICT malaria Pf/Pv test) in relation to human resources at village level in Myanmar. 1175 28

In a group of 596 delivering Ghanaian women, the sensitivities of peripheral blood thick film microscopy, ICT Malaria P.f/P.v test, and PCR in detecting microscopically confirmed placental Plasmodium falciparum infection were 42, 80, and 97%, respectively. In addition to the gross underestimation of placental malaria by peripheral blood film microscopy, submicroscopic infections were found to be a risk factor for maternal anemia.
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PMID:Diagnosis of placental malaria. 1177 40

In Myanmar, we tested two rapid malaria immunochromatographic kits: the OptiMAL assay for the detection of parasite lactate dehydrogenase (pLDH), and the ICT Malaria P.f./P.v. test for histidine-rich protein 2 (PfHRP2) and panmalarial antigens. A total of 229 patients were examined, of whom 133 were found to be malaria positive by Giemsa microscopy. Both OptiMAL and ICT gave lower sensitivities than previously reported. ICT sensitivity for Plasmodium falciparum and non-falciparum parasites were 86.2 and 2.9%, respectively; specificity was 76.9 and 100%, respectively. OptiMAL sensitivity for P. falciparum and non-falciparum parasites were 42.6 and 47.1%, respectively; specificity was 97.0 and 96.9%, respectively. The sensitivity of both tests for the detection of both P. falciparum and non-falciparum parasites increased with parasite density. Several explanations for these results are explored. Our results raise particular concern over batch quality variations of malaria rapid diagnostic devices (MRDDs).
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PMID:A comparison of two rapid field immunochromatographic tests to expert microscopy in the diagnosis of malaria. 1190 3

A prospective, multicentre study was carried out in Italy to assess the sensitivity and specificity of a rapid dipstick test (ICT Malaria P.f./P.v.) in the diagnosis of imported malaria caused by Plasmodium falciparum and other Plasmodium spp. The test is based on the detection of histidine-rich protein-2 (HRP-2) from P. falciparum and 'panmalarial' antigen in peripheral blood. The 241 subjects were international travellers or immigrants from areas where malaria is endemic. When compared with the microscopical examination of bloodsmears (used as the 'gold standard'), the dipsticks were found to be 94.4% sensitive and 94.5% specific for pure infections with P. falciparum. The performance of the tests when used on patients infected with species other than P. falciparum or more than one Plasmodium spp. showed a high degree of variability. Although the dipsticks represent a very simple, rapid, and valuable diagnostic aid, they should not be considered a complete substitute for direct microscopical diagnosis using stained bloodsmears.
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PMID:Multicentre study, in patients with imported malaria, on the sensitivity and specificity of a dipstick test (ICT Malaria P.f./P.v.) compared with expert microscopy. 1198 28


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