The MIRA-LFD method can detect HTLV-1 within 20 min at 37℃. The LOD for HTLV-1 using this method was
200 copies/µL. This method had no cross-reaction with the other eight viruses, with good specificity. Using qPCR as
the standard, the diagnostic sensitivity and specificity of the MIRA-LFD method for 500 clinical samples were 100%.
The MIRA-LFD and qPCR methods had 100% consistency(kappa value=1.00).
This study established a method based on MIRA-LFD for detecting HTLV-1 proviral DNA, which has
the advantages of fast, accurate, good sensitivity, strong specificity, simplicity, and portability. This method meet the
needs of rapid on-site detection and is easy to promote and use in grassroots medical institutions or blood stations.
The LOD of this assay was 200 copies/µL.The MIRA-LFD assay has good specificity
HTLV-1 was detected in 500 clinical samples using qPCR and MIRA-LFD assays (Table 2). The MIRA-LFD assay accurately identified 7 positive samples and 493 negative samples, which was the same as the results of the qPCR assay. Clinical sample detection results based on qPCR assay as the standard, the diagnostic sensitivity and specificity of the MIRA-LFD assay both were 100.00%. The results indicated good consistency(100.00%) between qPCR and MIRA-LFD assays for detecting clinical samples, with a kappa value of 1.00. But MIRA-LFD was faster, indicating the potential of MIRA-LFD for clinical diagnosis.