Datta, SSNagappan, RBiswas, DBasu, DGupta, KMondal, PKTuzikov, ABovin, NVHenry, SM2024-10-142024-10-142024-06-30Vox Sanguinis, ISSN: 0042-9007 (Print); 1423-0410 (Online), Wiley, 119(8), 821-826. doi: 10.1111/vox.136280042-90071423-0410http://hdl.handle.net/10292/18126Background and Objectives: The detection of treponemal antibodies, which are used to make a diagnosis of syphilis, is important both for diagnostic purposes and as a mandatory blood donor test in most countries. We evaluated the feasibility of using Kode Technology to make syphilis peptide red cell kodecytes for use in column agglutination serologic platforms. Materials and Methods: Candidate Kode Technology function-spacer-lipid (FSL) constructs were made for the Treponema pallidum lipoprotein (TmpA) of T. pallidum, using the peptide and FSL selection algorithms, and then used to make kodecytes. Developmental kodecytes were evaluated against a large range of syphilis antibody reactive and non-reactive samples in column agglutination platforms and compared against established methodologies. Overall, 150 reactive and 2072 non-reactive Syphicheck assay (a modified T. pallidum particle agglutination) blood donor samples were used to evaluate the agreement rate of the developed kodecyte assay. Results: From three FSL-peptide candidate constructs, one was found to be the most suitable for diagnostics. Of 150 Syphicheck assay reactive samples, 146 were TmpA–kodecyte reactive (97.3% agreement), compared with 58.0% with the rapid plasmin reagin (RPR) assay for the same samples. Against the 2072 expected syphilis non-reactive samples the agreement rate for TmpA–kodecytes was 98.8%. Conclusion: TmpA–kodecytes are viable for use as cost-effective serologic reagent red cells for the detection of treponemal antibodies to diagnose syphilis with a high level of specificity in blood centres. This kodecyte methodology also potentially allows for introduction of the reverse-algorithm testing into low-volume laboratories, by utilizing existing transfusion laboratory infrastructure.© 2024 The Authors. Vox Sanguinis published by John Wiley & Sons Ltd on behalf of International Society of Blood Transfusion. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.http://creativecommons.org/licenses/by/4.0/Treponema pallidumblood safetyinfectious diseasenovel diagnostic assaysyphilis resurgence32 Biomedical and Clinical Sciences3202 Clinical SciencesInfectious DiseasesSexually Transmitted InfectionsRare Diseases1103 Clinical Sciences1116 Medical PhysiologyCardiovascular System & Hematology3202 Clinical sciencesHumansTreponema pallidumSyphilisLipoproteinsAntigens, BacterialErythrocytesAgglutination TestsSyphilis SerodiagnosisAntibodies, BacterialErythrocytesHumansTreponema pallidumSyphilisLipoproteinsAntibodies, BacterialAntigens, BacterialAgglutination TestsSyphilis SerodiagnosisHumansTreponema pallidumSyphilisLipoproteinsAntigens, BacterialErythrocytesAgglutination TestsSyphilis SerodiagnosisAntibodies, BacterialJournal ArticleOpenAccess10.1111/vox.13628