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 | Â | ||||||
Completed and analyzed | Â | Â | Â | Â | Â | Â | ||||||||||
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 | ||||||||||||||||
| Â | Â | 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] | |