Evaluation of a malaria antibody enzyme immunoassay for use in blood screening

Abstract

Transfusion-transmitted malaria is rare, but it may produce severe problem in the safety of blood transfusion due to the lack of reliable procedure to evaluate donors potentially exposed to malaria. Here, we evaluated a new enzyme-linked immunosorbent assay malaria antibody test (ELISA malaria antibody test, DiaMed, Switzerland) Malaria can be transmitted by the transfusion of any blood component containing infected red blood cells (Mollison et al. 1997). The frequency of transfusion transmitted malaria varies from less than 0.2 in nonendemic countries to 50 or more cases per million in endemic countries (Mollison et al. 1997). Unfortunately, there is no reliable approved laboratory test to screen donated blood for malaria at present. The malaria antibody test was used for this purpose in some non-endemic countries (Seed et al. 2005). Consequently, exclusion of potentially infected donors is widely used to prevent transfusion transmitted malaria (Reesink 2005). Previous reports suggested that a malaria antibody test is effective in detecting malaria infection in travelers returning from overseas (Knappik et al. 2002) and in non-immune visitors to endemic areas after their departure (Jelinek et al. 1998, Knappik et al. 2002.In the Republic of Korea (ROK), Plasmodium vivax is the only indigenous malaria, and was almost eradicated in the late 1970s. However, it has recently reemerged, especially North in the Delimited Militarized Zone (DMZ) areas, and cases have gradually increased to 4,140 in 2000 (KCDCP 2006). In the meantime, ten cases of transfusion transmitted malaria were reported in ROK (Cho et al. 2001b, Lee et al. 2001. Because a high sero- positive rate is expected in the residents of risky areas, the application of P. vivax antibody screening of blood donors in risky areas has been often questioned. Fortunately, the prevalence of malaria is very low in the ROK as a whole. Cases are largely restricted to sparsely populated areas near the North DMZ and are most abundant in the summer. The aim of this study is to evaluate a new enzyme-linked immunosorbent assay (ELISA) malaria antibody test for malaria detection in acute stages and in follow-up after treatment. We also evaluated the ELISA test for detection of malaria infection in visitors to endemic areas. Giemsa-stained blood smears were used as a standard method. In cases where results from ELISA malaria antibody test and microscopic examination differed, polymerase chain reaction (PCR) test was used to confirm the presence of parasite. SUBJECTS, MATERIALS AND METHODS

Detection ofPlasmodium falciparum,P. vivax,P. ovale, andP. malariaeMerozoite Surface Protein 1-p19 Antibodies in Human Malaria Patients and Experimentally Infected Nonhuman Primates

“…A study using an assay from DiaMed AG (Switzerland) that utilizes extracts of cultured P. falciparum and P. vivax recombinant circumsporozoite protein demonstrated poor sensitivity for detection of antibodies among symptomatic individuals with microscopically confirmed P. vivax infection (18/24) but evaluated only 4 individuals with P. ovale or P. malariae infection, though all of the individuals were antibody positive (13). Assessment of the DiaMed assay in Korea, where P. vivax malaria predominates, indicated sensitivity of only 53% relative to microscopy and PCR (38). The poor detection of antibodies in cases of P. vivax-confirmed infection may be due to the choice of CSP, an antigen of sporozoites that is also found in the liver (39,46), or possibly to strain differences.…”

Malaria Diagnosis: A Brief Review

“…Until recently, it was a validated method for detecting Plasmodiumspecific antibodies in various blood bank units, which was useful for screening prospective blood donors, so avoiding transfusion-transmitted malaria [52,53]. In France, for example, IFA is used as a part of a targeted screening strategy, combined with a donor questionnaire [54]. The principle of IFA is that, following infection with any Plasmodium species, specific antibodies are produced within 2 wk of initial infection, and persist for 3-6 months after parasite clearance.…”

“…LDMS is rapid, high throughput, and automated. Compared with the microscopic method, which requires a skilled microscopist and up to Recently, other reliable malaria-diagnostic tests have been developed and introduced, and some tests are commercially available, for example, enzyme linked immunosorbent assay (ELISA)/ enzyme immunoassay (EIA) [50,54,85], latex agglutination assay [86], and cultivation of live malaria parasites [87,88]. Post-mortem organ diagnoses, by investigating malaria parasites in tissue autopsy, e.g.…”

Malaria diagnosis from pooled blood samples: comparative analysis of real-time PCR, nested PCR and immunoassay as a platform for the molecular and serological diagnosis of malaria on a large-scale

“…The comparison of the Se between the molecular and the serological tests showed a statistically significant difference and a regular concordance. The RDT had a Se of 69.56% and a Sp of 100%, while the ELiSA test developed by Oh et al (2008) that used recombinant P. vivax MSP1 and circumsporozoite surface antigens had a Se of 53% and a Sp of 94% when compared with microscopy and the nested PCR. Upon comparison of the two molecular assays, there was no statistically significant difference and there was an excellent concordance, which is similar to results of Perandin et al (2004).…”