Evidence map›Paper›PMID 35331251›Full record

Trial reportMalaria journal2022

Diagnostic performance and comparison of ultrasensitive and conventional rapid diagnostic test, thick blood smear and quantitative PCR for detection of low-density Plasmodium falciparum infections during a controlled human malaria infection study in Equatorial Guinea.

Maxmillian Mpina, Thomas C Stabler, Tobias Schindler, Jose Raso, Anna Deal, Ludmila Acuche Pupu, Elizabeth Nyakarungu, Maria Del Carmen Ovono Davis, Vicente Urbano, Ali Mtoro and 21 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Malaria journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03590340 (Randomized, Double-Blind, Placebo-Controlled, Regimen Optimization Study of a Radiation-Attenuated Plasmodium Falciparum), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03590340 phase1completednot on this map

Randomized, Double-Blind, Placebo-Controlled, Regimen Optimization Study of a Radiation-Attenuated Plasmodium Falciparum (Pf) Sporozoite Vaccine (PfSPZ Vaccine) in Equatoguinean Adults

TypeinterventionalSponsorSanaria Inc.Ran2018 to 2019Enrolled104ConditionsMalariaArmsPfSPZ Vaccine, Normal saline, PfSPZ Challenge (for CHMI)
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Article
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  5. Ultrasensitive ELISA for Accurate Detection ofOpen forum infectious diseases · 2025
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  12. Detection ofDiagnostics (Basel, Switzerland) · 2023
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  17. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors at 6 institutions in 4 countries.

Maxmillian MpinaSwiss Tropical and Public Health Institute, Basel, Switzerland. mmpina@ihi.or.tz.ORCID http://orcid.org/0000-0002-9300-6430
Thomas C StablerSwiss Tropical and Public Health Institute, Basel, Switzerland.
Tobias SchindlerSwiss Tropical and Public Health Institute, Basel, Switzerland.
Jose RasoMedical Care Development International, Malabo, Equatorial Guinea.
Anna DealSwiss Tropical and Public Health Institute, Basel, Switzerland.
Ludmila Acuche PupuMedical Care Development International, Malabo, Equatorial Guinea.
Elizabeth NyakarunguIfakara Health Institute, Ifakara, Tanzania.
Maria Del Carmen Ovono DavisMedical Care Development International, Malabo, Equatorial Guinea.
Vicente UrbanoMedical Care Development International, Malabo, Equatorial Guinea.
Ali MtoroIfakara Health Institute, Ifakara, Tanzania.
Ali HamadIfakara Health Institute, Ifakara, Tanzania.
Maria Silvia A LopezMedical Care Development International, Malabo, Equatorial Guinea.
Beltran PasialoMedical Care Development International, Malabo, Equatorial Guinea.
Marta Alene Owono EyangMedical Care Development International, Malabo, Equatorial Guinea.
Matilde Riloha RivasEquatorial Guinea Ministry of Health and Social Welfare, Malabo, Equatorial Guinea.
Carlos Cortes FallaMedical Care Development International, Malabo, Equatorial Guinea.
Guillermo A GarcíaMedical Care Development International, Silver Spring, MD, USA.
Juan Carlos MomoMedical Care Development International, Malabo, Equatorial Guinea.
Raul ChuquiyauriMedical Care Development International, Malabo, Equatorial Guinea.
Elizabeth SaverinoSanaria Inc., 9800 Medical Center Drive, Rockville, MD, 20850, USA.
L W Preston ChurchSanaria Inc., 9800 Medical Center Drive, Rockville, MD, 20850, USA.
B Kim Lee SimSanaria Inc., 9800 Medical Center Drive, Rockville, MD, 20850, USA.
Bonifacio ManguireMarathon EG production Ltd., Houston, USA.
Marcel TannerSwiss Tropical and Public Health Institute, Basel, Switzerland.
Carl MaasMarathon EG production Ltd., Houston, USA.
Salim AbdullaIfakara Health Institute, Ifakara, Tanzania.
Peter F BillingsleySanaria Inc., 9800 Medical Center Drive, Rockville, MD, 20850, USA.
Stephen L HoffmanSanaria Inc., 9800 Medical Center Drive, Rockville, MD, 20850, USA.
Said JongoIfakara Health Institute, Ifakara, Tanzania.
Thomas L Richie *Sanaria Inc., 9800 Medical Center Drive, Rockville, MD, 20850, USA.
Claudia A Daubenberger *Swiss Tropical and Public Health Institute, Basel, Switzerland. claudia.daubenberger@swisstph.ch.
Medical Care Development International · USSanaria · USIfakara Health Institute · TZSwiss Tropical and Public Health Institute · CHMarathon Oil (United States) · USNational University of Equatorial Guinea · GQ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProgress towards malaria elimination has stagnated, partly because infections persisting at low parasite densities comprise a large reservoir contributing to ongoing malaria transmission and are difficult to detect. This study compared the performance of an ultrasensitive rapid diagnostic test (uRDT) designed to detect low density infections to a conventional RDT (cRDT), expert microscopy using Giemsa-stained thick blood smears (TBS), and quantitative polymerase chain reaction (qPCR) during a controlled human malaria infection (CHMI) study conducted in malaria exposed adults (NCT03590340).

methodsBlood samples were collected from healthy Equatoguineans aged 18-35 years beginning on day 8 after CHMI with 3.2 × 10

results279 samples were collected from 24 participants; 123 were positive by qPCR. TBS detected 24/123 (19.5% sensitivity [95% CI 13.1-27.8%]), uRDT 21/123 (17.1% sensitivity [95% CI 11.1-25.1%]), cRDT 10/123 (8.1% sensitivity [95% CI 4.2-14.8%]); all were 100% specific and did not detect any positive samples not detected by qPCR. TBS and uRDT were more sensitive than cRDT (TBS vs. cRDT p = 0.015; uRDT vs. cRDT p = 0.053), detecting parasitaemias as low as 3.7 parasites/µL (p/µL) (TBS and uRDT) compared to 5.6 p/µL (cRDT) based on TBS density measurements. TBS, uRDT and cRDT did not detect any of the 70/123 samples positive by qPCR below 5.86 p/µL, the qPCR density corresponding to 3.7 p/µL by TBS. The median prepatent periods in days (ranges) were 14.5 (10-20), 18.0 (15-28), 18.0 (15-20) and 18.0 (16-24) for qPCR, TBS, uRDT and cRDT, respectively; qPCR detected parasitaemia significantly earlier (3.5 days) than the other tests.

conclusionsTBS and uRDT had similar sensitivities, both were more sensitive than cRDT, and neither matched qPCR for detecting low density parasitaemia. uRDT could be considered an alternative to TBS in selected applications, such as CHMI or field diagnosis, where qualitative, dichotomous results for malaria infection might be sufficient.

Indexed as

MalariaPlasmodium falciparumAdolescentAdultDiagnostic Tests, RoutineEquatorial GuineaHumansReal-Time Polymerase Chain ReactionYoung AdultControlled human malaria infectionLow parasite density infectionsMalariaMalaria pre-exposureRapid diagnostic testThick blood smear

Identifiers

PMID35331251
PMCPMC8943516
OpenAlexW4226218142

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.