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

Samuels, Aaron, Towett, Oliver, Seda, Brian, Wiegand, Ryan E, Otieno, Kephas, Chomba, Miriam, Lucchi, Naomi, Ljolje, Dragan, Schneider, Kammerle, Walker, Patrick G T, Kwambai, Titus, Slutsker, Laurence, terKuile, Feiko ORCID: https://orcid.org/0000-0003-3663-5617 and Kariuki, Simon K (2022) 'Diagnostic Performance of Loop-Mediated Isothermal Amplification and Ultrasensitive Rapid Diagnostic Tests for Malaria Screening Among Pregnant Women in Kenya'. The Journal of Infectious Diseases, Vol 226, Issue 4, pp. 696-707.

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Abstract

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 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.

Conclusions
This first-generation usRDT provided moderate improvement in detecting low-density infections in afebrile pregnant women compared to cRDTs.

Item Type:	Article
Subjects:	WA Public Health > Health Problems of Special Population Groups > WA 309 Women's health WC Communicable Diseases > Tropical and Parasitic Diseases > WC 750 Malaria WQ Obstetrics > Pregnancy > WQ 200 General works
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):	https://doi.org/10.1093/infdis/jiac289
SWORD Depositor:	JISC Pubrouter
Depositing User:	JISC Pubrouter
Date Deposited:	20 Jul 2023 10:25
Last Modified:	07 Aug 2023 14:09
URI:	https://archive.lstmed.ac.uk/id/eprint/21132

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