Introduction: According to German Guidelines (GG), persons with a special risk for Malaria may only be admitted for blood donation if laboratory diagnostics show that there is no evidence for infectivity. After a restriction period of 3 years an antibody test is performed, although the specificity is low. In 2022 we were able to identify two potential donors who had reproducible reactive plasmodia genome in the NAT test. Since only one case showed a reactive result for antibodies against plasmodia, we combine infection serological testing with a NAT method.

Methods: In accordance with GG, nucleic acid testing by NAT is performed at our facility after a retention period of 3 years using the AltoStar Purification Kit 1.5 combined with RealStar Malaria PCR Kit 1.0 and Alto Star AM 16 system (altona Diagnostics). In addition to the molecular biological testing, an infectious serological examination by means of an ELISA, which is approved for donor testing in Germany, is performed. Therefore, the NovaLISA malaria immunoassay and the ETI-Max 3000 analyzer are used. The results of the two methods are shown and compared.

Results: Since January 2024, 439 people have been tested with both methods. A reactive ELISA result was found in 31 samples (7.1%, 22 male and 9 female persons). 18 persons were tested before first-time donation, 4 were first-time donors and 7 repeat donors. Two persons were undergoing preliminary testing for a bone marrow or stem cell donation. A reactive result in the PCR test was obtained in 2 of 31 people (0.5%). In 29 cases, the antibody screening led to donor exclusion. A confirmatory test was not possible in any case.

Discussion/conclusion: The results are discussed against the background of the GG recommendation. The question is be raised how to deal with reactive findings in a serological screening test and if PCR tests are dispensable. As a further conclusion the necessity of a confirmatory test is discussed. More specific and sensitive tests are desirable.

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