TY - JOUR
T1 - Diagnostic Performance of Loop-Mediated Isothermal Amplification and Ultrasensitive Rapid Diagnostic Tests for Malaria Screening Among Pregnant Women in Kenya
AU - Samuels, Aaron M.
AU - Towett, Oliver
AU - Seda, Brian
AU - Wiegand, Ryan E.
AU - Otieno, Kephas
AU - Chomba, Miriam
AU - Lucchi, Naomi
AU - Ljolje, Dragan
AU - Schneider, Kammerle
AU - Walker, Patrick G.T.
AU - Kwambai, Titus K.
AU - Slutsker, Laurence
AU - Ter Kuile, Feiko
AU - Kariuki, Simon
PY - 2022/7/11
Y1 - 2022/7/11
N2 - BackgroundScreen-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. MethodsConsecutively 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. ResultsBetween 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. ConclusionsThis first-generation usRDT provided moderate improvement in detecting low-density infections in afebrile pregnant women compared to cRDTs.
AB - BackgroundScreen-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. MethodsConsecutively 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. ResultsBetween 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. ConclusionsThis first-generation usRDT provided moderate improvement in detecting low-density infections in afebrile pregnant women compared to cRDTs.
KW - diagnostic sensitivity in malaria in pregnancy
KW - loop-mediated isothermal amplicification for malaria
KW - malaria in pregnancy
KW - malaria screening at first antenatal care clinic visit
KW - ultrasensitive rapid diagnostic tests for malaria
U2 - 10.1093/infdis/jiac289
DO - 10.1093/infdis/jiac289
M3 - Article
SN - 0022-1899
VL - 226
SP - 696
EP - 707
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 4
ER -
