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. 2019 Jan 22;18(1):17.
doi: 10.1186/s12936-019-2650-0.

Risk of transfusion-transmitted malaria: evaluation of commercial ELISA kits for the detection of anti-Plasmodium antibodies in candidate blood donors

Valentina D Mangano  1   2 , Francesca Perandin  3 , Natalia Tiberti  3 , Massimo Guerriero  4 , Franca Migliaccio  2 , Marco Prato  2 , Lucia Bargagna  2 , Stefano Tais  3 , Monica Degani  3 , Federica Verra  3 , Zeno Bisoffi  5   6 , Fabrizio Bruschi  7   8
Affiliations

Risk of transfusion-transmitted malaria: evaluation of commercial ELISA kits for the detection of anti-Plasmodium antibodies in candidate blood donors

Valentina D Mangano et al. Malar J. .

Abstract

Background: Transfusion with Plasmodium-infected blood represents a risk for malaria transmission, a rare but severe event. Several non-endemic countries implement a strategy for the screening of candidate blood donors including questionnaire for the identification of at-risk subjects and laboratory testing of blood samples, often serology-based, with temporary deferral from donation for individuals with a positive result. In Italy, the most recent legislation, issued in November 2015, introduced the use of serological tests for the detection of anti-Plasmodium antibodies.

Methods: In the absence of a gold standard for malaria serology, the aim of this work was to evaluate five commercial ELISA kits, and to determine their accuracy (sensitivity and specificity) in comparison to immuno-fluorescence antibody test (IFAT), and their agreement (concordance of results). Serum samples from malaria patients or from subjects with malaria history (N = 64), malaria naïve patients with other parasitic infections (N = 15), malaria naïve blood donors (N = 8) and malaria exposed candidate blood donors (N = 36) were tested.

Results: The specificity of all ELISA kits was 100%, while sensitivity ranged between 53 and 64% when compared to IFAT on malaria patients samples. When tested on candidate blood donors' samples, ELISA kits showed highly variable agreement (42-94%) raising the possibility that the same individual could be included or excluded from donation depending on the test in use by the transfusion centre.

Conclusions: These preliminary results indicate how the lack of a gold standard for malaria serology must be taken into account in the application and future revision of current legislation. There is need of developing more sensitive serological assays. Moreover, the adoption of a unique serological test at national level is recommended, as well as the development of screening algorithms based on multiple laboratory tests, including molecular assays.

Keywords: ELISA; IFAT; Plasmodium; Transfusion transmitted malaria.

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Figures

Fig. 1
Fig. 1
Qualitative comparison of the results obtained with ELISA and IFAT. The results obtained with the five ELISA kits and with the IFAT reference standard on N = 64 serum samples from malaria patients are reported. For IFAT, samples were classified as negative if IFAT titre = 0, or positive if IFAT titre ≥ 20; IFAT titres are reported on the left of the graph. For ELISA, samples were classified as negative, positive or “grey zone” according to the indications of the manufacturer of each kit
Fig. 2
Fig. 2
Distribution of ELISA indexes according to IFAT titres. The Figure shows, for each ELISA kit under study, a Tukey box-plot describing the distribution of ELISA indexes (ODsample/ODcutoff × 10), according to IFAT titre. For each category represented, N = 8
Fig. 3
Fig. 3
Frequency of ELISA positive results according to IFAT titre. The Figure shows, for each ELISA kit under study, the frequency of positive results according to IFAT titre. For each category represented, N = 8
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References

    1. Kitchen AD, Chiodini PL, Tossell J. Detection of malarial DNA in blood donors–evidence of persistent infection. Vox Sang. 2014;107:123–131. doi: 10.1111/vox.12142. - DOI - PubMed
    1. Verra F, Angheben A, Martello E, Giorli G, Perandin F, Bisoffi Z. A systematic review of transfusion-transmitted malaria in non-endemic areas. Malar J. 2018;17:36. doi: 10.1186/s12936-018-2181-0. - DOI - PMC - PubMed
    1. WHO . World malaria report 2017. Geneva: World Health Organization; 2017.
    1. Guerra CA, Howes RE, Patil AP, Gething PW, Van Boeckel TP, Temperley WH, et al. The international limits and population at risk of Plasmodium vivax transmission in 2009. PLoS Negl Trop Dis. 2010;4:e774. doi: 10.1371/journal.pntd.0000774. - DOI - PMC - PubMed
    1. O’Brien SF, Delage G, Seed CR, Pillonel J, Fabra CC, Davison K, et al. The epidemiology of imported malaria and transfusion policy in 5 nonendemic countries. Transfus Med Rev. 2015;29:162–171. doi: 10.1016/j.tmrv.2015.03.004. - DOI - PubMed

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