Monday, 21 February 2011

MALARIA: Several articles on Rapid Diagnostic Testing

 What's new for 'malaria rdt' in PubMed
Malar J. 2011 Jan 12;10(1):7.
Evaluation of the rapid diagnostic test SDFK40 (Pf-pLDH/pan-pLDH) for the diagnosis of malaria in a non-endemic setting.
Maltha J, Gillet P, Cnops L, Bottieau E, Van Esbroeck M, Bruggeman C, Jacobs J.
Faculty of Health, Medicine and Life Sciences (FHML), Maastricht, The Netherlands. j.maltha@student.maastrichtuniversity.nl.
BACKGROUND: The present study evaluated the SD Bioline Malaria Ag 05FK40 (SDFK40), a three-band RDT detecting Plasmodium falciparum-specific parasite lactate dehydrogenase (Pf-pLDH) and pan Plasmodium-specific pLDH (pan-pLDH), in a reference setting.
METHODS: The SDFK40 was retrospectively and prospectively tested against a panel of stored (n = 341) and fresh (n = 181) whole blood samples obtained in international travelers suspected of malaria, representing the four Plasmodium species as well as Plasmodium negative samples, and compared to microscopy and PCR results. The prospective panel was run together with OptiMAL (Pf-pLDH/pan-pLDH) and SDFK60 (histidine-rich protein-2 (HRP-2)/pan-pLDH).
RESULTS: Overall sensitivities for P. falciparum tested retrospectively and prospectively were 67.9% and 78.8%, reaching 100% and 94.6% at parasite densities >1,000/μl. Sensitivity at parasite densities ≤ 100/μl was 9.1%. Overall sensitivities for Plasmodium vivax and Plasmodium ovale were 86.7% and 80.0% (retrospectively) and 92.9% and 76.9% (prospectively), reaching 94.7% for both species (retrospective panel) at parasite densities >500/μl. Sensitivity for Plasmodium malariae was 21.4%. Species mismatch occurred in 0.7% of samples (3/411) and was limited to non-falciparum species erroneously identified as P. falciparum. None of the Plasmodium negative samples in the retrospective panel reacted positive. Compared to OptiMAL and SDFK60, SDFK40 showed lower sensitivities for P. falciparum, but better detection of P. ovale. Inter-observer agreement and test reproducibility were excellent, but lot-to-lot variability was observed for pan-pLDH results in case of P. falciparum.
CONCLUSION: SDFK40 performance was poor at low (≤ 100/μl) parasite densities, precluding its use as the only diagnostic tool for malaria diagnosis. SDFK40 performed excellent for P. falciparum samples at high (>1,000/μl) parasite densities as well as for detection of P. vivax and P. ovale at parasite densities >500/μl.
PMCID: PMC3025908 Free PMC Article
PMID: 21226920 [PubMed - in process]


2. Malar J. 2011 Jan 12;10(1):6.
Using rapid diagnostic tests as source of malaria parasite DNA for molecular analyses in the era of declining malaria prevalence.
Ishengoma DS, Lwitiho S, Madebe RA, Nyagonde N, Persson O, Vestergaard LS, Bygbjerg IC, Lemnge MM, Alifrangis M.
National Institute for Medical Research, Tanga Centre, Bombo Road, P,O Box 5004, Tanga, Tanzania. dishengoma@tanga.mimcom.net.
BACKGROUND: Malaria prevalence has recently declined markedly in many parts of Tanzania and other sub-Saharan African countries due to scaling-up of control interventions including more efficient treatment regimens (e.g. artemisinin-based combination therapy) and insecticide-treated bed nets. Although continued molecular surveillance of malaria parasites is important to early identify emerging anti-malarial drug resistance, it is becoming increasingly difficult to obtain parasite samples from ongoing studies, such as routine drug efficacy trials. To explore other sources of parasite DNA, this study was conducted to examine if sufficient DNA could be successfully extracted from malaria rapid diagnostic tests (RDTs), used and collected as part of routine case management services in health facilities, and thus forming the basis for molecular analyses, surveillance and quality control (QC) testing of RDTs.
METHODS: One hyper-parasitaemic blood sample (131,260 asexual parasites/μl) was serially diluted in triplicates with whole blood and blotted on RDTs. DNA was extracted from the RDT dilution series, either immediately or after storage for one month at room temperature. The extracted DNA was amplified using a nested PCR method for Plasmodium species detection. Additionally, 165 archived RDTs obtained from ongoing malaria studies were analysed to determine the amplification success and test applicability of RDT for QC testing.
RESULTS: DNA was successfully extracted and amplified from the three sets of RDT dilution series and the minimum detection limit of PCR was <1 asexual parasite/μl. DNA was also successfully amplified from (1) 70/71 (98.6%) archived positive RDTs (RDTs and microscopy positive) (2) 52/63 (82.5%) false negative RDTs (negative by RDTs but positive by microscopy) and (3) 4/24 (16.7%) false positive RDTs (positive by RDTs but negative by microscopy). Finally, 7(100%) negative RDTs (negative by RDTs and microscopy) were also negative by PCR.
CONCLUSION: This study showed that DNA extracted from archived RDTs can be successfully amplified by PCR and used for detection of malaria parasites. Since Tanzania is planning to introduce RDTs in all health facilities (and possibly also at community level), availability of archived RDTs will provide an alternative source of DNA for genetic studies such as continued surveillance of parasite resistance to anti-malarial drugs. The DNA obtained from RDTs can also be used for QC testing by detecting malaria parasites using PCR in places without facilities for microscopy.
PMCID: PMC3025907 Free PMC Article
PMID: 21226910 [PubMed - in process]


3. Parasitol Res. 2011 Jan 8. [Epub ahead of print]
Detection of malaria infection in blood transfusion: a comparative study among real-time PCR, rapid diagnostic test and microscopy : Sensitivity of Malaria detection methods in blood transfusion.
Hassanpour G, Mohebali M, Raeisi A, Abolghasemi H, Zeraati H, Alipour M, Azizi E, Keshavarz H.
Medical Parasitology and Mycology Department, School of Public Health, Tehran University of Medical Sciences, 14155-6446, Tehran, Iran.
The transmission of malaria by blood transfusion was one of the first transfusion-transmitted infections recorded in the world. Transfusion-transmitted malaria may lead to serious problems because infection with Plasmodium falciparum may cause rapidly fatal death. This study aimed to compare real-time polymerase chain reaction (real-time PCR) with rapid diagnostic test (RDT) and light microscopy for the detection of Plasmodium spp. in blood transfusion, both in endemic and non-endemic areas of malaria disease in Iran. Two sets of 50 blood samples were randomly collected. One set was taken from blood samples donated in blood bank of Bandar Abbas, a city located in a malarious-endemic area, and the other set from Tehran, a non-endemic one. Light microscopic examination on both thin and thick smears, RDTs, and real-time PCR were performed on the blood samples and the results were compared. Thin and thick light microscopic examinations of all samples as well as RDT results were negative for Plasmodium spp. Two blood samples from endemic area were positive only with real-time PCR. It seems that real-time PCR as a highly sensitive method can be helpful for the confirmation of malaria infection in different units of blood transfusion organization especially in malaria-endemic areas where the majority of donors may be potentially infected with malaria parasites.
PMID: 21221645 [PubMed - as supplied by publisher]

4. Malar J. 2011 Jan 10;10:3.
Exploring provider and community responses to the new malaria diagnostic and treatment regime in Solomon Islands.< /h1>Wijesinghe RS, Atkinson JA, Bobogare A, Wini L, Whittaker M.
The University of Queensland, School of Population Health, Pacific Malaria Initiative Support Centre, Australian Centre for International and Tropical Health, Brisbane, Australia. r.wijesinghe@uq.edu.au.
BACKGROUND: Improvements in availability and accessibility of artemisinin-based combination therapy (ACT) for malaria treatment and the emergence of multi-drug-resistant parasites have prompted many countries to adopt ACT as the first-line drug. In 2009, Solomon Islands (SI) likewise implemented new national treatment guidelines for malaria. The ACT, Coartem® (artemether-lumefantrine) is now the primary pharmacotherapy in SI for Plasmodium falciparum malaria, Plasmodium vivax malaria or mixed infections. Targeted treatment is also recommended in the new treatment regime through maintenance of quality microscopy services and the introduction of Rapid Diagnostic Tests (RDTs). Ascertaining the factors that influence community and provider acceptance of and adherence to the new treatment regime will be vital to improving the effectiveness of this intervention and reducing the risk of development of drug resistance.
METHODS: In order to understand community and prescriber perceptions and acceptability of the new diagnostic and treatment interventions, 12 focus group discussions (FGDs) and 12 key informant interviews (KII) were carried out in rural and urban villages of Malaita Province, Solomon Islands four months subsequent to roll out of these interventions.
RESULTS: Lack of access to microscopy or distrust in the accuracy of diagnostic tools were reported by some participants as reasons for the ongoing practice of presumptive treatment of malaria. Lack of confidence in RDT accuracy has negatively impacted its acceptability. Coartem® had good acceptability among most participants, however, some rural participants questioned its effectiveness due to lack of side effects and the larger quantity of tablets required to be taken. Storing of left over medication for subsequent fever episodes was reported as common.
CONCLUSION: To address these issues, further training and supportive supervision of healthcare workers will be essential, as will the engagement of influential community members in health promotion activities to improve acceptability of RDTs and adherence to the new treatment regime. Exploring the extent of these issues beyond the study population must be a priority for malaria programme managers. Practices such as presumptive treatment and the taking of sub-curative doses are of considerable concern for both the health of individuals and the increased risk it poses to the development of parasite resistance to this important first-line treatment against malaria.
PMCID: PMC3023723 Free PMC Article
PMID: 21219614 [PubMed - in process]

5. APMIS. 2011 Feb;119(2):88-92. doi: 10.1111/j.1600-0463.2010.02696.x. Epub 2010 Nov 17.
Evaluation of rapid diagnostic tests for malaria in Swedish travellers.
Bronner U, Karlsson L, Evengård B.
Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden. Ulf.Bronner@karolinska.se
Rapid diagnostic tests (RDTs) for malaria have become valuable tools for the diagnosis of malaria in both endemic and non-endemic areas. During a 7-year period, first the MalaQuick rapid test and then the NOW Malaria test, were evaluated by well-trained laboratory technicians in a university hospital laboratory of parasitology. A total of 635 blood samples were selected from 4731 blood specimens obtained from travellers at the emergency department, at wards and at out-patient clinics. The samples were analysed by microscopy and RDT. Malaria parasites were detected in the blood films of 134 (21%) samples. The sensitivity of the RDT for Plasmodium falciparum was 97.7% (84 of 86 samples) with a negative predictive value of 99.6%. The two false-negative results were associated with low levels of parasitaemia. For non-falciparum species the sensitivity was only 58.3% (28 of 48 samples). Based on the excellent ability of the RDTs to detect P. falciparum infections, we recommend the use of the NOW Malaria test as a complement to microscopy in the laboratory.
PMID: 21208275 [PubMed - indexed for MEDLINE]

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