Key result
The HTLV-1/2 LAMP assay demonstrated an overall accuracy (95% CI 74.8-85.5%) slightly superior to qPCR and similar to PCR-RFLP for diagnosing HTLV-1/2 infection.
Why the study?
Diagnosis of HTLV-1 and 2 requires serological screening and confirmation, prompting the development of a loop-mediated isothermal nucleic acid amplification assay.
Does the LAMP assay provide accurate and sensitive confirmatory diagnosis of HTLV-1/2 infection compared to qPCR and PCR-RFLP?
Observational (n=226)
Does the LAMP assay provide accurate and sensitive confirmatory diagnosis of HTLV-1/2 infection compared to qPCR and PCR-RFLP?
The HTLV-1/2 LAMP assay offers a rapid, accurate, and cost-effective alternative to traditional PCR-based methods for confirmatory diagnosis of HTLV infection.
LAMP may aid confirmatory HTLV-1/2 testing; leaves open larger validation trials before routine use.
Laboratory diagnosis of human T-lymphotropic viruses (HTLV) 1 and 2 infection is performed by serological screening and further confirmation with serological or molecular assays. Thus, we developed a loop-mediated isothermal nucleic acid amplification (LAMP) assay for the detection of HTLV-1/2 in blood samples. The sensitivity and accuracy of HTLV-1/2 LAMP were defined with DNA samples from individuals infected with HTLV-1 (n = 125), HTLV-2 (n = 19), and coinfected with HIV (n = 82), and compared with real-time polymerase chain reaction (qPCR) and PCR-restriction fragment length polymorphism (RFLP). The overall accuracy of HTLV-1/2 LAMP (95% CI 74.8–85.5%) was slightly superior to qPCR (95% CI 69.5–81.1%) and similar to PCR-RFLP (95% CI 79.5–89.3%). The sensitivity of LAMP was greater for HTLV-1 (95% CI 83.2–93.4%) than for HTLV-2 (95% CI 43.2–70.8%). This was also observed in qPCR and PCR-RFLP, which was associated with the commonly lower HTLV-2 proviral load. All molecular assays tested showed better results with samples from HTLV-1/2 mono-infected individuals compared with HIV-coinfected patients, who present lower CD4 T-cell counts. In conclusion, HTLV-1/2 LAMP had similar to superior performance than PCR-based assays, and therefore may represent an attractive alternative for HTLV-1/2 diagnosis due to reduced working time and costs, and the simple infrastructure needed.
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Gomes et al. (2020) conducted an observational in HTLV-1/2 infection (n=226). Loop-mediated isothermal nucleic acid amplification (LAMP) assay vs. qPCR and PCR-RFLP was evaluated on Overall accuracy (95% CI 74.8-85.5). The HTLV-1/2 LAMP assay demonstrated an overall accuracy (95% CI 74.8-85.5%) slightly superior to qPCR and similar to PCR-RFLP for diagnosing HTLV-1/2 infection.
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