Evaluation of the new Multi-HTLV serological assay: Improvement for HTLV-2 detection

by | Aug 30, 2023 | Publications

AIDS Res Hum Retroviruses. 2023 Aug 30. doi: 10.1089/AID.2022.0174. Online ahead of print.


BACKGROUND: Despite the accuracy of confirmatory tests for the diagnosis of HTLV, inconclusive or false-negative results still occur when diagnosing HTLV-2 positive patients. The goal of this study was to evaluate the sensitivity and accuracy of a confirmatory immunoassay, the Multi-HTLV test.

METHODS: A total of 246 plasma samples were tested by qPCR and used to calculate the sensitivity and typing accuracy of the Multi-HTLV test. Of the 246, 127 were positive for HTLV-1, 112 for HTLV-2, and seven for both HTLV-1 and HTLV-2. Thereafter, the non-parametric Mann-Whitney U test was used to calculate the concordance between the qPCR test and Multi-HTLV in 12 samples with discrepant and inconclusive qPCR results.

RESULTS: The Multi-HTLV assay showed high performance in identifying HTLV-1 and HTLV-2 with sensitivities of 97% (95% CI: 0.92-0.98) and 94% (0.87-0.96), respectively. However, due to typing performance (98% for HTLV-1 and 94% for HTLV-2) it had 95% agreement with positive HTLV-1 qPCR results (95% CI: 90.07-97.81) and 86% (78.04-91.01) of HTLV-2 qPCR results positive. Moreover, this test was able to recognize 80% of indeterminate samples and all HTLV-2 positives that showed false-negative qPCR results.

CONCLUSIONS: This study aimed to evaluate the sensitivity and accuracy of the Multi-HTLV test. The results of this investigation show that qPCR was more accurate for the diagnosis of HTLV-1/2 compared to serological techniques including Multi-HTLV. Studies have shown that the confirmatory serological results (WB or LIA) compared to the same diagnostic technologies, presented similar or inferior results to the Multiplex/ELISA, mainly in the diagnosis of HTLV-2. The Multi-HTLV test, due to its multiparametric nature and because it is easy to perform, provides new insights into the study of specific serological profiles for each patient and the immunomonitoring of disease progression.

PMID:37646414 | DOI:10.1089/AID.2022.0174

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