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Clinical Evaluation of the PANDAA Lassa Virus RT-PCR Assay in Sierra Leone
D. S. Grant, C. R. Thompson, J. Sandi, M. Manjia, T. Kallon, M. S. Kamara, I. Fofanah, T. R. Edwards, T. E. Fletcher, R. L. Byrne
Résumé : Abstract Molecular diagnosis of Lassa fever is complicated by extensive Lassa virus genetic diversity and limited laboratory capacity in endemic settings. The RealStar(C) Lassa Virus RT-PCR Kit 2.0 is a commonly used commercial dual-target assay for LASV detection, but its two-target format requires separate amplification reactions, increasing reagent use and workflow complexity. We present the diagnostic evaluation of the single-reaction, adaptive PANDAA Lassa Virus RT-PCR assay with the dual-target RealStar(C) Lassa Virus RT-PCR Kit 2.0 using 94 archived serum samples from Sierra Leone. 79 of these samples had valid paired results, and we report a positive percent agreement of 78.12% (95% CI 61.25%-88.98%), negative percent agreement of 93.62% (95% CI 82.84%-97.81%), and an overall agreement of 87.34% (95% CI 78.24%-92.98%); Cohen k; was 0.73 (95% CI 0.58-0.89). PANDAA showed substantial agreement and offers a potentially efficient single-well format, but further optimisation and prospective evaluation are needed.