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. 2023 Feb 20;22:60. doi: 10.1186/s12936-023-04445-1

Table 1.

Study design characteristics of the identified studies evaluating the use of the HS-RDT for the detection of MiP

No. Country First Author or PI in clinical trial record Period Malaria transmission Objective of HS-RDT evaluation Study design Participants HS-RDT samples Institution and References
Clinical performance (test accuracy) Clinical impact (benefits and applications Asymptomatic Symptomatic Sample size Mol+ Sample Peripheral Placental Specimen type Testing context
Completed and analyzed
1 Benin V. Briand Dec 2013–Jul 2017 High Y based on PCR Y Association HS-RDT positivity and clinical outcomes Preconceptional cohort, recruitment at community level. HS-RDT testing at 1st/3rd trimester ANC visit and at delivery. X X 942* 172 X X Thawed blood Research Lab

IRD,

FIND [22]

2 Colombia (1) A.M. Vasquez Sept–Dec 2017 Low Y based on PCR N Observational cross-sectional trial. Retrospective study. ANC visits or at delivery. X X 737 35 X X Thawed blood Research Lab Univ. of Antioquia, FIND [26]
3 Colombia (2) A.M. Vasquez May 2017–Jan 2018 Low Y based on PCR N Observational cross-sectional trial. ANC visits. X X 858 39 X Fresh blood POC (ANC clinic) Univ. of Antioquia, FIND [27]
4 Indonesia V.T. Unwin Mar–Jun 2018 Moderate Y based on PCR+LAMP (composite) N ANC visits (participants of a MiP intervention study) X 270 158 X Thawed red blood cells + plasma Research Lab

LSTM [23]

Parent study [24]

5 Kenya (1) A.M. Samuels April–Sept 2018 High Y – [a]based on PCR Y – [b]Correlation HS-RDT-positivity in ANC and Malaria Indicator Surveys (as proxy for surveillance) [a]: First ANC visit.[b]: Community based Malaria Indicator Survey (cMIS) + all ANC visits. X X [a]: 482 [b]: 4000/y 172 X Fresh blood POC (ANC clinic)

LSTM,

CDC,

KEMRI [25]

Completed (analysis ongoing)
6 Papua New Guinea L. Robinson Jun–Dec 2018 Low Y based on PCR N Observational cross-sectional trial. ANC visits. X X 918 X Fresh blood POC (ANC clinic) Burnet Institute, PNG IMR, FIND [36]
7 Kenya (2) E.R. Adams,F.O. ter Kuile Oct 2018–May 2019 High Y based on PCR N ANC visits (participants of a MiP intervention study) X 493 X Fresh blood POC (ANC clinic)

PI E Adams, F ter Kuile

Parent study [37]

8 Malawi D.P. Mathanga, J. Gutman Jan 2017–Dec 2019 Moderate/high Y based on PCR N Population cross-sectional survey: cohort followed from first ANC visit to delivery (participants of a MiP intervention study). HS-RDT testing at delivery. X X 601 X X Fresh blood Field Lab

Univ. of Malawi, CDC [38]

Parent study [39]

Ongoing studies
Diagnostics (in addition to HS-RDT) Testing context Ref
PCR LAMP Co-RDT LM
9 Burkina Faso (1) Tahita M.C,Tinto H. Aug 2020–Feb 2022 High N Y Operational feasibility and impact of additional screening with HS-RDTs ANC visits (16–24 weeks at their first booking) X X qPCR (if budget available) Yes Yes POC (ANC clinic) Institut de Recherche en Sciences de la Santé/Clinical Research Unit of Nanoro (CRUN) [31]
10 Burkina Faso (2) Tahita M.C,Tinto H. Dec 2020–May 2021 High

Y

based on PCRand microscopy

N ANC visits (16–24 weeks at their first booking) X X qPCR Yes Yes Lab conditions Institut de Recherche en Sciences de la Santé/Clinical Research Unit of Nanoro (CRUN)
11 Senegal Programme National de Lutte Contre le Paludisme (PNLP) Dec 2019–TBC ANC visits Yes POC (ANC clinic) Programme National de Lutte Contre le Paludisme (PNLP)
12 Nigeria W. Oyibo Jan–April 2021 Moderate/high Y Compared to co-RDT and LM ANC visits. DBS collected, but not planned in short term YesPf/Pan Yes POC (ANC clinic) University of Lagos PI W Oyibo
13 DRC H Muhindo, V Maketa, H Schallig, PF Mens, K Kayentao Dec 2020–Dec 2022 High Y Compared to qPCR N ANC visits and at time of delivery X X YesqPCR - Yes POC (ANC clinic) University of KinshasaAcademic Medical Centre (Amsterdam)Malaria Research and Training Center (Bamako) [40]

IRD Institut de Recherche pour le Développement; FIND Foundation for Innovative New Diagnostics; CDC Centre for Disease Control; KEMRI Kenya Medical Research Institute; PNG IMR Papua New Guinea Institute of Medical Research; LSTM Liverpool School of Tropical Medicine; ANC antenatal clinic; POC point-of-care; LM light microscopy; Y yes; N no

Malaria transmission determined by P. falciparum prevalence by PCR in the study, or by EIR. Prevalence: Prevalence was determined as low transmission < 9%, moderate 9–25%, and high > 25%. Prevalence by EIR only for high transmission areas, > 5 per year. Samples size: all samples collected in study * study included 327 women, samples collected at multiple timepoints. Mol + sample indicates number of samples positive by molecular methods