1: Trans R Soc Trop Med Hyg.

2002 May-Jun;96(3):258-65 Field and laboratory comparative evaluation of ten rapid malaria diagnostic tests. Craig MH, Bredenkamp BL, Williams CH, Rossouw EJ, Kelly VJ, Kleinschmidt I, Martineau A, Henry GF. Malaria Research Programme, Medical Research Council, 491 Ridge Road, P.O. Box 70380, Overport 4067, Durban, South Africa. craigm@mrc.ac.za The paper reports on a comparative evaluation of 10 rapid malaria tests available in South Africa in 1998: AccuCheck (AC, developmental), Cape Biotech (CB), ICT Malaria Pf (ICT1) and Pf/Pv (ICT2), Kat Medical (KAT), MakroMal (MM), OptiMAL (OP), ParaSight-F (PS), Quorum (Q), Determine-Malaria (DM). In a laboratory study, designed to test absolute detection limits, Plasmodium falciparum-infected blood was diluted with uninfected blood to known parasite concentrations ranging from 500 to 0.1 parasites per microlitre (P/microL). The 50% detection limits were: ICT1, 3.28; ICT2, 4.86; KAT, 6.36; MM, 9.37; CB, 11.42; DM, 12.40; Q, 16.98; PS, 20; AC, 31.15 and OP, 91.16 P/microL. A field study was carried out to test post-treatment specificity. Blood samples from malaria patients were tested with all products (except AC and DM) on the day of treatment and 3 and 7 days thereafter, against a gold standard of microscopy and polymerase chain reaction (PCR). OP and PS produced fewer false-positive results on day 7 (18 and 19%, respectively) than the other rapid tests (38-56%). However, microscopy, PCR, OP and PS disagreed largely as to which individuals remained positive. The tests were further compared with regard to general specificity, particularly cross-reactivity with rheumatoid factor, speed, simplicity, their ability to detect other species, storage requirements and general presentation. PMID: 12174773 [PubMed - indexed for MEDLINE] 1: Parasite. 1998 Jun;5(2):189-92 Diagnosis of Plasmodium falciparum malaria using ParaSight F, ICT malaria PF and malaria IgG CELISA assays. Gaye O, Diouf M, Dansokho EF, McLaughlin G, Diallo S. Service de Parasitologie, Faculte de Medecine, UCAD, Dakar, Senegal. A battery of sixty-six blood samples from Senegal was analysed by the ParaSight F test, the ICT Malaria PF and the Malaria IgG CELISA. These three assays detect the histidine rich protein 2 antigen of Plasmodium falciparum. Thick smear microscopy was used as the reference method. Sensitivity, specificity, predictive positive and negative values were respectively 89%, 100%, 100%, 88% for the ICT; 86%, 93%, 94%, 85% for the paraSight and 88%, 87%, 88%, 87% for the Malaria IgG CELISA. The three assays failed to detect

two positive samples with P. ovale and P. malariae. Assays were also compared with regard to the expense of equipment and reagents and speed and ease of use. The rapid ICT and ParaSight F test can be performed with minimal training and may be specially useful in areas where P. falciparum is the predominant malaria species, in epidemic malaria regions, and where skilled microscopy is not readily available. PMID: 9754317 [PubMed - indexed for MEDLINE] 1: Ann Trop Med Parasitol. 2004 Jan;98(1):15-20. Comparison of the OptiMAL rapid antigen test with field microscopy for the detection of Plasmodium vivax and P. falciparum: considerations for the application of the rapid test in Afghanistan. Kolaczinski J, Mohammed N, Ali I, Ali M, Khan N, Ezard N, Rowland M. Health Net International, 11-A Circular Lane, PO Box 889, University Town, Peshawar, Pakistan. jan.kolaczinski@lshtm.ac.uk To establish the sensitivity and specificity of a batch of 'OptiMAL 48' rapid antigen tests procured by the World Health Organization in Afghanistan, a sample was tested, in parallel with routine, microscopical diagnosis, at basic health units (BHU) within Afghan refugee camps in Pakistan. The results of both methods of field diagnosis were compared with those of cross-checking microscopy at a reference laboratory, which were taken as the 'gold standard'. Out of 499 patients examined, 36% were diagnosed as malaria cases by field microscopy and 34% by the rapid test. For the OptiMAL 48 test, cross-checking of the corresponding smears at the reference laboratory gave a sensitivity of 79.3% and a specificity of 99.7% for Plasmodium falciparum and corresponding values of 86.1% and 98.7% for P. vivax infections. The performance of the field microscopy was better, with a sensitivity and specificity of 85.2% and 99.7% for P. falciparum, and 90.4% and 98.7% for P. vivax, respectively. These results show that the performance of OptiMAL 48 is adequate for acute- and post-emergency situations when the alternative is just clinical diagnosis. However, in the developing health system of Afghanistan, the main focus should be on the expansion of the existing network for microscopical diagnosis and quality control, to meet the needs of a stable situation. Rapid antigen tests are more suited to investigations of outbreaks in remote situations, where health services are deficient or absent. PMID: 15000726 [PubMed - indexed for MEDLINE] 1: Acta Trop. 2002 Apr;82(1):51-9 A comparison of two rapid field immunochromatographic tests to expert microscopy in the diagnosis of malaria. Mason DP, Kawamoto F, Lin K, Laoboonchai A, Wongsrichanalai C.

University of California School of Medicine, San Francisco, CA, USA. 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). PMID: 11904103 [PubMed - indexed for MEDLINE]

1: New Microbiol. 2000 Oct;23(4):391-8

Evaluation of OptiMAL Assay test to detect imported malaria in Italy.

Ricci L, Viani I, Piccolo G, Fabio A, Calderaro A, Galati L, Perandin , Vecchia L, Manca N, Dettori G, Turano A, Chezzi C. Laboratorio di Microbiologia, Arcispedale S. Maria Nuova, Centrale Operativa, Reggio Emilia, Italia. This study evaluated a newly developed rapid malaria diagnostic test, OptiMAL Assay, to detect "Plasmodium falciparum malaria" and "non Plasmodium falciparum malaria" in blood samples from 139 individuals with a presumptive clinical diagnosis of imported malaria in Italy. OptiMAL Assay utilizes a dipstick coated with monoclonal antibodies against the intracellular metabolic enzyme, plasmodium Lactate Dehydrogenase (pLDH) present in and released from parasite-infected erythrocytes. Blood samples from 56 cases out of 139 were found "Plasmodium falciparum malaria" positive by microscopy; with these samples OptiMAL Assay and the ParaSight-F test, which is a kit detecting the P. falciparum histidin-rich protein 2 (HRP-2), showed an overall sensitivity of 83% and 94%, respectively, in comparison with microscopy. Parasitemia levels tested in the 56 P. falciparum positive blood samples by microscopy ranged from <0.004% to 20%. A correlation between sensitivity and parasitemia was evident and OptiMAL Assay and ParaSight-F test were more sensitive (96-100%; 100%) with samples with 0.1%-20% levels

of parasitemia, while proved less sensitive (0-44%; 50-88%) with <0.004-0.01% levels of parasitemia. PMID: 11061627 [PubMed - indexed for MEDLINE]