Abstract：
OBJECTIVE: 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.
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%.
CONCLUSIONS: 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.
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%.
CONCLUSIONS: 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.
摘要：
目的：螺旋体抗体的检测，用于诊断梅毒，在大多数国家/地区，对于诊断目的和强制性献血者测试都很重要。我们评估了使用Kode技术制造梅毒肽红细胞kodecytes用于柱凝集血清学平台的可行性。
方法：候选Kode技术功能间隔-脂质（FSL）构建体用于梅毒螺旋体脂蛋白（TmpA）。使用肽和FSL选择算法，然后用来制作kodecytes.在柱凝集平台中针对大量梅毒抗体反应性和非反应性样品评估了发育的kodecytes，并与已建立的方法进行了比较。总的来说,使用150个反应性和2072个非反应性Syphicheck测定（改良的梅毒螺旋体颗粒凝集）供血者样品来评估开发的kodecyte测定的一致率。
结果：从三个FSL肽候选构建体，一个被发现是最适合诊断。在150份Syphicheck检测反应样本中，146个是TmpA-kodecyte反应性的(97.3%的一致性)，与相同样品的快速纤溶酶反应蛋白（RPR）测定的58.0％相比。对于2072个预期的梅毒非反应性样本，TmpA-kodecytes的同意率为98.8％。
结论：TmpA-kodecytes可用作具有成本效益的血清学试剂红细胞，用于检测螺旋体抗体以诊断梅毒，在血液中心具有高度特异性。这种kodecyte方法还可能允许将反向算法测试引入小批量实验室，利用现有的输血实验室基础设施。
方法：候选Kode技术功能间隔-脂质（FSL）构建体用于梅毒螺旋体脂蛋白（TmpA）。使用肽和FSL选择算法，然后用来制作kodecytes.在柱凝集平台中针对大量梅毒抗体反应性和非反应性样品评估了发育的kodecytes，并与已建立的方法进行了比较。总的来说,使用150个反应性和2072个非反应性Syphicheck测定（改良的梅毒螺旋体颗粒凝集）供血者样品来评估开发的kodecyte测定的一致率。
结果：从三个FSL肽候选构建体，一个被发现是最适合诊断。在150份Syphicheck检测反应样本中，146个是TmpA-kodecyte反应性的(97.3%的一致性)，与相同样品的快速纤溶酶反应蛋白（RPR）测定的58.0％相比。对于2072个预期的梅毒非反应性样本，TmpA-kodecytes的同意率为98.8％。
结论：TmpA-kodecytes可用作具有成本效益的血清学试剂红细胞，用于检测螺旋体抗体以诊断梅毒，在血液中心具有高度特异性。这种kodecyte方法还可能允许将反向算法测试引入小批量实验室，利用现有的输血实验室基础设施。
