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A novel syphilis Treponema pallidum lipoprotein peptide antigen diagnostic assay using red cell kodecytes in routine
Suvro Sankha Datta1, Radhika Nagappan2,3, Durba Biswas1
1Department of Transfusion Medicine, Tata Medical Center, Kolkata, India.
Insights
New TmpA-kodecytes offer a cost-effective method for syphilis diagnosis using treponemal antibodies. This diagnostic tool shows high specificity and agreement rates in blood donor testing.
Area of Science:
- Medical Diagnostics
- Immunoserology
- Biotechnology
Background:
- Syphilis diagnosis relies on detecting treponemal antibodies, crucial for public health and blood safety.
- Current diagnostic methods require evaluation for improved efficiency and accessibility.
Purpose of the Study:
- To assess the feasibility of using Kode Technology to create syphilis peptide red cell kodecytes.
- To evaluate these TmpA-kodecytes for syphilis antibody detection in column agglutination platforms.
Main Methods:
- Developed TmpA-kodecytes using Kode Technology's function-spacer-lipid (FSL) constructs.
- Evaluated kodecytes against reactive and non-reactive syphilis samples using column agglutination.
- Compared performance against established syphilis diagnostic assays.
Main Results:
- One FSL-peptide construct demonstrated optimal diagnostic suitability.
- TmpA-kodecytes showed 97.3% agreement with reactive samples, significantly higher than RPR (58.0%).
- An agreement rate of 98.8% was observed for non-reactive samples.
Conclusions:
- TmpA-kodecytes are effective, cost-efficient serologic reagents for syphilis diagnosis with high specificity.
- This method facilitates reverse-algorithm testing in low-volume labs using existing infrastructure.
Background 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.
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