A comparison of two rapid field immunochromatographic tests to expert microscopy in the diagnosis of malaria

Mason, Daniel Philippe; Kawamoto, Fumihiko; Lin, Khin; Laoboonchai, Anintita; Wongsrichanalai, Chansuda

doi:10.1016/s0001-706x(02)00031-1

Cited by 94 publications

(76 citation statements)

References 13 publications

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“…In line with other publications [3,10,22,23], lines intensities were in relation with the parasite densities, but with considerable overlaps. The finding that a unique HRP-2 line was indicative for a low parasite density of P. falciparum ≤1,000/µl is in line with a previous observation for another MRDT based on HRP2/pan-pLDH detection [3] Although the Immunoquick+4 was reliable and reproducible, we observed incomplete clearance of the test strip.…”

Section: Discussionsupporting

confidence: 91%

Evaluation of the Immunoquick+4 malaria rapid diagnostic test in a non-endemic setting

Dijk

Gillet

Vlieghe

et al. 2010

Eur J Clin Microbiol Infect Dis

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The aim of this retrospective study was to evaluate the Immunoquick+4 (BioSynex, Strasbourg, France), a three-band malaria rapid diagnostic test (MRDT) targeting histidine-rich protein-2 (HRP-2) and pan Plasmodium-specific parasite lactate dehydrogenase, in a non-endemic reference setting. Stored whole-blood samples (n=613) from international travellers suspected of malaria were used, with microscopy corrected by polymerase chain reaction (PCR) as the reference method. Samples infected by P. falciparum (n=323), P. vivax (n=97), P. ovale (n=73) and P. malariae (n=25) were selected, as well as 95 malaria-negative samples. The overall sensitivities of the Immunoquick+4 for the diagnosis of P. falciparum, P. vivax, P. malariae and P. ovale were 88.9, 75.3, 56.0 and 19.2%, respectively. Sensitivity was significantly related to parasite density for P. falciparum (93.6% versus 71.4% at parasite densities >100/µl and ≤100/µl, respectively) and P. vivax (86.8% versus 48.3% at parasite densities >500/µl and ≤500/µl, respectively). The Immunoquick+4 showed good reproducibility and reliability for both test results and line intensities. The Immunoquick+4 performed well for the detection of P. falciparum and P. vivax. Background

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Section: Discussionsupporting

confidence: 91%

Evaluation of the Immunoquick+4 malaria rapid diagnostic test in a non-endemic setting

Dijk

Gillet

Vlieghe

et al. 2010

Eur J Clin Microbiol Infect Dis

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“…It must be emphasized that Kappa values for DiaMed OptiMAL-IT using microscopy as reference standard, were 0.33 for pregnant women and 0.76 for children participants; suggesting a very weak concordance and low reliability of DiaMed OptiMAL-IT test for the former who significantly had low parasitaemias. These observation are consistent with reports of other investigations that have showed variations in DiaMed OptiMAL-IT to be strain specific-and parasite density-dependent Mason et al 2002). Moreover, compared with the field microscopy, the DiaMed OptiMAL-IT test did not perform as well in differentiating P. falciparum infections from gametocytaemia (8 cases from pregnant women).…”

Section: Discussionsupporting

confidence: 90%

Performance of rapid DiaMed OptiMal-IT® malaria test in an endemic Ghanaian setting

et al. 2011

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At peripheral health facility levels, the diagnosis of malaria is difficult due to lack of infrastructure. In the study reported here, the diagnostic performance of a batch of 'DiaMed OptiMAL-IT' (Cressier, Switzerland) rapid antigen tests were examined in parallel with routine microscopy for a select population of high risk individuals: 202 pregnant women and 200 children less than 5 years old in an endemic setting in Ghana. Results of both diagnostic methods were compared to that of cross-checking microscopy, taken as gold standard, at the Navrongo Health Research Centre. Of the 402 patients, 218 (54.2%) were confirmed with Plasmodium falciparum infections by cross-checking. All 218 patients (100%) were accurately diagnosed with malaria by routine microscopy. Of these, 151 (69.3%) were positive by DiaMed OptiMAL-IT test (26 false positives, 67 false negatives). DiaMed OptiMAL-IT had the following performance indicators for detection of P. falciparum among pregnant women and children less than 5 years respectively: Sensitivity-50.5%

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“…In line with studies on other RDTs [7,16,27,28], there was a correlation between line intensities and parasite densities, and there were, although to a lesser extent than observed for another RDT [7], diagnostic clues to parasite densities when scoring line intensities (such as a strong HRP-2 line intensity indicating a parasite density > 100/μl). 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].…”

Section: Discussionsupporting

confidence: 84%

Evaluation of a rapid diagnostic test (CareStart™ Malaria HRP-2/pLDH (Pf/pan) Combo Test) for the diagnosis of malaria in a reference setting

Maltha

Gillet

Bottieau

et al. 2010

Malar J

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BackgroundMalaria Rapid Diagnostic Tests (RDTs) are widely used for diagnosing malaria. The present retrospective study evaluated the CareStart™ Malaria HRP-2/pLDH (Pf/pan) Combo Test targeting the Plasmodium falciparum specific antigen histidine-rich protein (HRP-2) and the pan-Plasmodium antigen lactate dehydrogenase (pLDH) in a reference setting.MethodsThe CareStart™ Malaria HRP-2/pLDH (Pf/pan) Combo Test was evaluated on a collection of samples obtained in returned international travellers using microscopy corrected by PCR as the reference method. Included were P. falciparum (n = 320), Plasmodium vivax (n = 76), Plasmodium ovale (n = 76), Plasmodium malariae (n = 23) and Plasmodium negative samples (n = 95).ResultsOverall sensitivity for the detection of P. falciparum was 88.8%, increasing to 94.3% and 99.3% at parasite densities above 100 and 1,000/μl respectively. For P. vivax, P. ovale and P. malariae, overall sensitivities were 77.6%, 18.4% and 30.4% respectively. For P. vivax sensitivity reached 90.2% for parasite densities above 500/μl. Incorrect species identification occurred in 11/495 samples (2.2%), including 8/320 (2.5%) P. falciparum samples which generated only the pan-pLDH line. For P. falciparum samples, 205/284 (72.2%) HRP-2 test lines had strong or medium line intensities, while for all species the pan-pLDH lines were less intense, especially in the case of P. ovale. Agreement between observers was excellent (kappa values > 0.81 for positive and negative readings) and test results were reproducible. The test was easy to perform with good clearing of the background.ConclusionThe CareStart™ Malaria HRP-2/pLDH (Pf/pan) Combo Test performed well for the detection of P. falciparum and P. vivax, but sensitivities for P. ovale and P. malariae were poor.

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A comparison of two rapid field immunochromatographic tests to expert microscopy in the diagnosis of malaria

Cited by 94 publications

References 13 publications

Evaluation of the Immunoquick+4 malaria rapid diagnostic test in a non-endemic setting

Evaluation of the Immunoquick+4 malaria rapid diagnostic test in a non-endemic setting

Performance of rapid DiaMed OptiMal-IT® malaria test in an endemic Ghanaian setting

Evaluation of a rapid diagnostic test (CareStart™ Malaria HRP-2/pLDH (Pf/pan) Combo Test) for the diagnosis of malaria in a reference setting

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