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@article{Samuels:2022:infdis/jiac289,
author = {Samuels, AM and Towett, O and Seda, B and Wiegand, RE and Otieno, K and Chomba, M and Lucchi, N and Ljolje, D and Schneider, K and Walker, PGT and Kwambai, TK and Slutsker, L and Ter, Kuile FO and Kariuki, SK},
doi = {infdis/jiac289},
journal = {J Infect Dis},
pages = {696--707},
title = {Diagnostic Performance of Loop-Mediated Isothermal Amplification and Ultrasensitive Rapid Diagnostic Tests for Malaria Screening Among Pregnant Women in Kenya.},
url = {http://dx.doi.org/10.1093/infdis/jiac289},
volume = {226},
year = {2022}
}

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TY  - JOUR
AB  - BACKGROUND: Screen-and-treat strategies with sensitive diagnostic tests may reduce malaria-associated adverse pregnancy outcomes. We conducted a diagnostic accuracy study to evaluate new point-of-care tests to screen pregnant women for malaria at their first antenatal visit in western Kenya. METHODS: Consecutively women were tested for Plasmodium infection by expert microscopy, conventional rapid diagnostic test (cRDT), ultra sensitive RDT (usRDT), and loop-mediated isothermal amplification (LAMP). Photoinduced electron-transfer polymerase chain reaction (PET-PCR) served as the reference standard. Diagnostic performance was calculated and modelled at low parasite densities. RESULTS: Between May and September 2018, 172 of 482 screened participants (35.7%) were PET-PCR positive. Relative to PET-PCR, expert microscopy was least sensitive (40.1%; 95% confidence interval [CI], 32.7%-47.9%), followed by cRDT (49.4%; 95% CI, 41.7%-57.1), usRDT (54.7%; 95% CI, 46.9%-62.2%), and LAMP (68.6%; 95% CI, 61.1%-75.5%). Test sensitivities were comparable in febrile women (n = 90). Among afebrile women (n = 392), the geometric-mean parasite density was 29parasites/µL and LAMP (sensitivity = 61.9%) and usRDT (43.2%) detected 1.74 (95% CI, 1.31-2.30) and 1.21 (95% CI, 88-2.21) more infections than cRDT (35.6%). Per our model, tests performed similarly at densities >200parasites/µL. At 50parasites/µL, the sensitivities were 45%, 56%, 62%, and 74% with expert microscopy, cRDT, usRDT, and LAMP, respectively. CONCLUSIONS: This first-generation usRDT provided moderate improvement in detecting low-density infections in afebrile pregnant women compared to cRDTs.
AU  - Samuels,AM
AU  - Towett,O
AU  - Seda,B
AU  - Wiegand,RE
AU  - Otieno,K
AU  - Chomba,M
AU  - Lucchi,N
AU  - Ljolje,D
AU  - Schneider,K
AU  - Walker,PGT
AU  - Kwambai,TK
AU  - Slutsker,L
AU  - Ter,Kuile FO
AU  - Kariuki,SK
DO  - infdis/jiac289
EP  - 707
PY  - 2022///
SP  - 696
TI  - Diagnostic Performance of Loop-Mediated Isothermal Amplification and Ultrasensitive Rapid Diagnostic Tests for Malaria Screening Among Pregnant Women in Kenya.
T2  - J Infect Dis
UR  - http://dx.doi.org/10.1093/infdis/jiac289
UR  - https://www.ncbi.nlm.nih.gov/pubmed/35811308
VL  - 226
ER  -

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