Diagnostic performance of HRP2-only malaria rapid diagnostic test in Ghanaian pregnant women with asymptomatic peripheral blood infection: the case of First Response® test kit

Abstract

Background: The use of malaria rapid diagnostic test(RDT) enables targeted treatment that mitigates against the development of parasite drug resistance. With detection thresholds at ≥200 parasites/μL, their diagnostic performance in pregnant women may be challenging as asymptomatic infections with low parasite densities are common. Few data exist on the performance of histidine-rich protein-2 (HRP2) RDTs in Ghanaian pregnant women considering commonly occurring low parasite densities. Objective: The study sought to contribute more knowledge on test performance on First Response® test kit to guide the continuous evaluation of HRP2 RDTs in pregnancy. Methods: As part of an antimalarial drug trial in pregnancy, First Response® RDT results were compared to microscopy of peripheral blood slides in 1664 women. The diagnostic performance indicators were computed as proportions with 95% confidence intervals. The risk of having a positive RDT result was computed for age, gravidity and parasite density using binomial regression methods. Results: Parasitaemia prevalence by microscopy was 5.71%(n =95/1664) while that by RDT was 21.57%(n = 359/1664). Sensitivity was 82.11% (n=78/95), specificity was 82.09% (n=1288/1569), positive predictive value was 21.73% (n=78/359), and the likelihood ratio for a positive test was 4.58. False-negative RDT results were recorded for low parasite densities as well as densities ≥ 200/ μL while false-positive results were recorded in 281of 1664 tests. Primigravidae and younger aged women were more likely to have positive RDT results compared to multigravidae and women aged ≥ 30 yr. Conclusion: The moderate sensitivity, specificity and other diagnostic parameters reported suggest the First Response® malaria RDT is useful for detecting peripheral parasitaemia in pregnant women but the use of HRP2-only RDTs is limited by the existence of parasites with HRP2 gene deletion. The use of RDTs based on combined antigens continues to be recommended. Further research is needed on RDT performance in pregnant women with declining malaria transmission.