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Diagnostic Performance of Loop-Mediated Isothermal Amplification and Ultrasensitive Rapid Diagnostic Tests for Malaria Screening Among Pregnant Women in Kenya.

Authors :
Samuels, Aaron M
Towett, Oliver
Seda, Brian
Wiegand, Ryan E
Otieno, Kephas
Chomba, Miriam
Lucchi, Naomi
Ljolje, Dragan
Schneider, Kammerle
Walker, Patrick G T
Kwambai, Titus K
Slutsker, Laurence
Kuile, Feiko O ter
Kariuki, Simon K
Ter Kuile, Feiko O
Source :
Journal of Infectious Diseases; 8/15/2022, Vol. 226 Issue 4, p696-707, 12p
Publication Year :
2022

Abstract

<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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 29 parasites/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 >200 parasites/µL. At 50 parasites/µL, the sensitivities were 45%, 56%, 62%, and 74% with expert microscopy, cRDT, usRDT, and LAMP, respectively.<bold>Conclusions: </bold>This first-generation usRDT provided moderate improvement in detecting low-density infections in afebrile pregnant women compared to cRDTs. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
00221899
Volume :
226
Issue :
4
Database :
Complementary Index
Journal :
Journal of Infectious Diseases
Publication Type :
Academic Journal
Accession number :
158908531
Full Text :
https://doi.org/10.1093/infdis/jiac289