Performance of a highly sensitive rapid diagnostic test (HS-RDT) for detecting malaria in peripheral and placental blood samples from pregnant women in Colombia

Ana María Vásquez, Ana Catalina Medina, Alberto Tobón-Castaño, Maritza Posada, Gabriel Jaime Vélez, Ana Campillo, Iveth J González, Xavier Ding, Ana María Vásquez, Ana Catalina Medina, Alberto Tobón-Castaño, Maritza Posada, Gabriel Jaime Vélez, Ana Campillo, Iveth J González, Xavier Ding

Abstract

Background: Pregnancy poses specific challenges for the diagnosis of Plasmodium falciparum infection due to parasite sequestration in the placenta, which translates in low circulation levels in peripheral blood. The aim of this study is to assess the performance of a new highly sensitive rapid diagnostic test (HS-RDT) for the detection of malaria in peripheral and placental blood samples from pregnant women in Colombia.

Methods: This is a retrospective study using 737 peripheral and placental specimens collected from pregnant women in Colombian malaria-endemic regions. Light microscopy (LM), conventional rapid diagnostic tests (Pf/Pv RDT and Pf RDT), and HS-RDT testing were performed. Diagnostic accuracy endpoints of LM, HS-RDT and RDTs were compared with nested polymerase chain reaction (nPCR) as the reference test.

Results: In comparison with nPCR, the sensitivity of HS-RDT, Pf RDT, Pf/Pv RDT and LM to detect infection in peripheral samples was 85.7% (95% CI = 70.6-93.7), 82.8% (95% CI = 67.3-91.9), 77.1% (95% CI = 61.0-87.9) and 77.1% (95% CI = 61.0-87.9) respectively. The sensitivity to detect malaria in asymptomatic women, was higher with HS-RDT, where LM and Pf/Pv RDT missed half of infections detected by nPCR, but differences were not significant. Overall, specificity was similar for all tests (>99.0%). In placental blood, the prevalence of infection by P. falciparum by nPCR was 2.8% (8/286), by HS-RDT was 1% and by conventional RDTs (Pf RDT and Pf/Pv RDT) and LM was 0.7%. The HS-RDT detected placental infections in peripheral blood that were negative by LM and Pf/Pv RDT, however the number of positive placentas was low.

Conclusions: The sensitivity of HS-RDT to detect P. falciparum infections in peripheral and placental samples from pregnant women was slightly better compared to routinely used tests during ANC visits and at delivery. Although further studies are needed to guide recommendations on the use of the HS-RDT for malaria case management in pregnancy, this study shows the potential value of this test to diagnose malaria in pregnancy in low-transmission settings.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. Study area.
Fig 1. Study area.
Map of Colombia showing the four study sites in red dots: Apartadó, Bagre, Quibdó and Tumaco.
Fig 2. Study participant flow and testing…
Fig 2. Study participant flow and testing results.
The chart shows the total number of pregnant women recruited during antenatal care visits and at delivery, the number of peripheral and placental blood samples collected, as well as the overall number of malaria infections detected by each test. *Discrepant results when compared with the reference test ANC (antenatal care); Pos. (positive); Neg. (negative); LM (light microscopy); Pf (P. falciparum); Pv (P. vivax); RDT (rapid diagnostic test); HS-RDT (highly sensitive rapid diagnostic test); nPCR (nested polymerase chain reaction).

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