Clinical Evaluation of the PANDAA Lassa Virus RT-PCR Assay in Sierra Leone
- 1Lassa Fever Unit, Kenema Government Hospital, Ministry of Health
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.
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BibTeX
@misc{grant2026clinical,
title = {{Clinical Evaluation of the PANDAA Lassa Virus RT-PCR Assay in Sierra Leone}},
author = {D. S. Grant and C. R. Thompson and J. Sandi and M. Manjia and T. Kallon and M. S. Kamara and I. Fofanah and T. R. Edwards and T. E. Fletcher and R. L. Byrne},
howpublished = {medRxiv},
year = {2026},
month = oct,
doi = {10.64898/2026.10.30.26366846},
url = {https://www.medrxiv.org/content/10.64898/2026.10.30.26366846v1},
note = {CC BY},
}
RIS
TY - UNPB
TI - Clinical Evaluation of the PANDAA Lassa Virus RT-PCR Assay in Sierra Leone
AU - D. S. Grant
AU - C. R. Thompson
AU - J. Sandi
AU - M. Manjia
AU - T. Kallon
AU - M. S. Kamara
AU - I. Fofanah
AU - T. R. Edwards
AU - T. E. Fletcher
AU - R. L. Byrne
PY - 2026
DA - 2026/10/30
PB - medRxiv
DO - 10.64898/2026.10.30.26366846
UR - https://www.medrxiv.org/content/10.64898/2026.10.30.26366846v1
AB - 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.
ER -