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Diagnostic performance of loop-mediated isothermal amplification and ultra-sensitive rapid diagnostic tests for malaria screening among pregnant women in Kenya
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9 04 2022
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Source: J Infect Dis. 226(4):696-707
[PDF-1.15 MB]
Details:
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Alternative Title:J Infect Dis
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Personal Author:
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Description: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). Photo-induced 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-September 2018, 172 out of 482 screened participants (35.7%) were PET-PCR positive. Relative to PET-PCR, expert-microscopy was least sensitive (40.1%, 95% CI 32.7–47.9), followed by cRDT (49.4%, 41.7–57.1), usRDT (54.7%, 46.9–62.2), and LAMP (68.6%, 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 (1.31–2.30) and 1.21 (0.88–2.21) 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.
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Source:
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Pubmed ID:35811308
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Pubmed Central ID:PMC9585193
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Funding:
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Volume:226
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Issue:4
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