Development and Validation of a Novel ELISA Kit for Quantification of Human T-lymphotropic Virus 2 (HTLV-2) p24 Capsid Protein

The Human T-lymphotropic virus 2 (HTLV-2) is an oncogenic retrovirus primarily associated with T-cell malignancies and neurological disorders. The p24 capsid protein of HTLV-2 plays a crucial role in viral assembly and immune response modulation. Here, we report the development and validation of a highly sensitive and specific enzyme-linked immunosorbent assay (ELISA) kit for the quantification of HTLV-2 p24 capsid protein in biological samples. The assay demonstrates excellent performance characteristics, making it a valuable tool for both research and clinical applications in HTLV-2-associated diseases.

HTLV-2 belongs to the Retroviridae family and is closely related to HTLV-1, sharing similar genomic organization and modes of transmission. While HTLV-1 is predominantly associated with adult T-cell leukemia/lymphoma (ATLL) and HTLV-1-associated myelopathy/tropical spastic paraparesis (HAM/TSP), HTLV-2 has been implicated in lymphoproliferative disorders, including hairy cell leukemia and T-cell lymphoma, as well as neurological complications. The p24 capsid protein is a key structural component of HTLV-2 virions, playing essential roles in viral assembly, maturation, and immune evasion.


The development of the HTLV-2 p24 ELISA kit involved several steps. Firstly, recombinant HTLV-2 p24 capsid protein was expressed and purified using a bacterial expression system. Monoclonal antibodies specific to HTLV-2 p24 were generated through hybridoma technology and screened for specificity and sensitivity. The optimal coating and detection antibodies were selected based on their performance in preliminary assays. Standard curves were generated using recombinant p24 protein at known concentrations to establish the assay's linear range, sensitivity, and reproducibility. The assay protocol was optimized for sample dilution, incubation times, and temperature conditions to ensure optimal performance.


The developed HTLV-2 p24 ELISA kit demonstrated high specificity, with minimal cross-reactivity with related retroviruses or host proteins. The assay exhibited a wide dynamic range, with a lower limit of detection (LOD) of X ng/mL. The intra-assay and inter-assay coefficients of variation (CVs) were below X% and X%, respectively, indicating excellent precision and reproducibility. Spike and recovery experiments performed using spiked plasma samples showed accurate quantification of HTLV-2 p24 with minimal interference from biological matrices.

In conclusion, we have successfully developed and validated a novel ELISA kit for the quantification of HTLV-2 p24 capsid protein. The assay demonstrates high sensitivity, specificity, and reproducibility, making it a valuable tool for research studies investigating the role of HTLV-2 in various diseases and for clinical applications such as diagnosis, prognosis, and monitoring of HTLV-2-associated disorders. Further validation in clinical samples and longitudinal studies are warranted to assess its utility in clinical settings and its potential for informing therapeutic interventions.

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