Evidence map›Paper›PMID 36989731›Full record

Trial reportJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2023

A multi-country phase 2 study to evaluate the suitcase lab for rapid detection of SARS-CoV-2 in seven Sub-Saharan African countries: Lessons from the field.

Arianna Ceruti, Ndongo Dia, Adeleye Solomon Bakarey, Judah Ssekitoleko, Soa Fy Andriamandimby, Padra Malwengo-Kasongo, Rasheeda H A Ahmed, Rea Maja Kobialka, Jean Michel Heraud, Moussa Moise Diagne and 56 more

Abstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
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

66 authors.

Arianna CerutiInstitute of Animal Hygiene and Veterinary Public Health, Leipzig University, Germany. Electronic address: arianna.ceruti@uni-leipzig.de.
Ndongo DiaVirology Department, Institut Pasteur de Dakar, Dakar 12900, Senegal.
Adeleye Solomon BakareyInstitute for Advanced Medical Research and Training (IAMRAT), College of Medicine, University of Ibadan, Nigeria.
Judah SsekitolekoCollege of Veterinary Medicine, Animal Resources and Biosecurity, Makerere University, P.o.Box 7062 Uganda.
Soa Fy AndriamandimbyVirology Unit, Institut Pasteur de Madagascar, Republic of Madagascar.
Padra Malwengo-KasongoDepartment of Virology at the Institut National de Recherche Biomédicale (INRB), Kinshasa, Democratic Republic of the Congo (DRC); Faculty of Medicine, University of Kinshasa, Democratic Republic of the Congo (DRC).
Rasheeda H A AhmedTuberculosis National Reference Laboratory, National Public Health Laboratory, El Qasr Avenue, Federal Ministry of Health, Khartoum, Sudan.
Rea Maja KobialkaInstitute of Animal Hygiene and Veterinary Public Health, Leipzig University, Germany.
Jean Michel HeraudVirology Department, Institut Pasteur de Dakar, Dakar 12900, Senegal.
Moussa Moise DiagneVirology Department, Institut Pasteur de Dakar, Dakar 12900, Senegal.
Marie Henriette Dior DioneVirology Department, Institut Pasteur de Dakar, Dakar 12900, Senegal.
Idrissa DiengVirology Department, Institut Pasteur de Dakar, Dakar 12900, Senegal.
Martin FayeVirology Department, Institut Pasteur de Dakar, Dakar 12900, Senegal.
Ousmane FayeVirology Department, Institut Pasteur de Dakar, Dakar 12900, Senegal.
Jean Théophile RafisandratantsoaVirology Unit, Institut Pasteur de Madagascar, Republic of Madagascar.
Jean-Pierre RavaloheryVirology Unit, Institut Pasteur de Madagascar, Republic of Madagascar.
Claudio RaharinandrasanaVirology Unit, Institut Pasteur de Madagascar, Republic of Madagascar.
Tsiry H RandriambolamanantsoaVirology Unit, Institut Pasteur de Madagascar, Republic of Madagascar.
Norosoa RazanajatovoVirology Unit, Institut Pasteur de Madagascar, Republic of Madagascar.
Iony RazanatovoVirology Unit, Institut Pasteur de Madagascar, Republic of Madagascar.
Joelinotahina H RabarisonVirology Unit, Institut Pasteur de Madagascar, Republic of Madagascar.
Phillipe DussartVirology Unit, Institut Pasteur de Madagascar, Republic of Madagascar.
Louis Kyei-TuffuorKumasi Centre for Collaborative Research, Kwame Nkrumah University of Science and Technology, Ghana.
Abigail AgbanyoKumasi Centre for Collaborative Research, Kwame Nkrumah University of Science and Technology, Ghana.
Olubusuyi Moses AdewumiDepartment of Virology, College of Medicine, University of Ibadan, Nigeria.
Adeola FowotadeDepartment of Medical Microbiology and Parasitology, College of Medicine, University of Ibadan, Nigeria.
Muideen Kolawole RaifuInstitute for Advanced Medical Research and Training (IAMRAT), College of Medicine, University of Ibadan, Nigeria.
Patient Okitale-TalundaDepartment of Virology at the Institut National de Recherche Biomédicale (INRB), Kinshasa, Democratic Republic of the Congo (DRC); Faculty of Medicine, University of Kinshasa, Democratic Republic of the Congo (DRC).
Gracia Kashitu-MujingaDepartment of Virology at the Institut National de Recherche Biomédicale (INRB), Kinshasa, Democratic Republic of the Congo (DRC); Faculty of Medicine, University of Kinshasa, Democratic Republic of the Congo (DRC).
Christelle Mbelu-KabongoDepartment of Virology at the Institut National de Recherche Biomédicale (INRB), Kinshasa, Democratic Republic of the Congo (DRC); Faculty of Medicine, University of Kinshasa, Democratic Republic of the Congo (DRC).
Steve Ahuka-MundekeDepartment of Virology at the Institut National de Recherche Biomédicale (INRB), Kinshasa, Democratic Republic of the Congo (DRC); Faculty of Medicine, University of Kinshasa, Democratic Republic of the Congo (DRC).
Anguy Makaka-MutondoDepartment of Virology at the Institut National de Recherche Biomédicale (INRB), Kinshasa, Democratic Republic of the Congo (DRC); Faculty of Medicine, University of Kinshasa, Democratic Republic of the Congo (DRC).
Enas M AbdallaUnit of Animal Health and Safety of Animal Products, Institute for Studies and Promotion of Animal Exports, University of Khartoum, 13314 Khartoum North, Sudan.
Sanaa M IdrisUnit of Animal Health and Safety of Animal Products, Institute for Studies and Promotion of Animal Exports, University of Khartoum, 13314 Khartoum North, Sudan.
Wisal A ElmagzoubUnit of Animal Health and Safety of Animal Products, Institute for Studies and Promotion of Animal Exports, University of Khartoum, 13314 Khartoum North, Sudan.
Rahma H AliTuberculosis National Reference Laboratory, National Public Health Laboratory, El Qasr Avenue, Federal Ministry of Health, Khartoum, Sudan.
Eman O M NourTuberculosis National Reference Laboratory, National Public Health Laboratory, El Qasr Avenue, Federal Ministry of Health, Khartoum, Sudan.
Rasha S M EbraheemTuberculosis National Reference Laboratory, National Public Health Laboratory, El Qasr Avenue, Federal Ministry of Health, Khartoum, Sudan.
Huda H H AhmedTuberculosis National Reference Laboratory, National Public Health Laboratory, El Qasr Avenue, Federal Ministry of Health, Khartoum, Sudan.
Hamadelniel E AbdallaTuberculosis National Reference Laboratory, National Public Health Laboratory, El Qasr Avenue, Federal Ministry of Health, Khartoum, Sudan.
Musab ElnegoumiTuberculosis National Reference Laboratory, National Public Health Laboratory, El Qasr Avenue, Federal Ministry of Health, Khartoum, Sudan.
Izdihar MukhtarTuberculosis National Reference Laboratory, National Public Health Laboratory, El Qasr Avenue, Federal Ministry of Health, Khartoum, Sudan.
Muatsim A M AdamTuberculosis National Reference Laboratory, National Public Health Laboratory, El Qasr Avenue, Federal Ministry of Health, Khartoum, Sudan.
Nuha Y I MohamedTuberculosis National Reference Laboratory, National Public Health Laboratory, El Qasr Avenue, Federal Ministry of Health, Khartoum, Sudan.
Shahinaz A BedriTuberculosis National Reference Laboratory, National Public Health Laboratory, El Qasr Avenue, Federal Ministry of Health, Khartoum, Sudan.
Hamdan Mustafa HamdanMDR Focal Point, El Qasr Avenue, Federal Ministry of Health, Khartoum, Sudan.
Magid KisekkaCollege of Veterinary Medicine, Animal Resources and Biosecurity, Makerere University, P.o.Box 7062 Uganda.
Monica MpumwiireCollege of Veterinary Medicine, Animal Resources and Biosecurity, Makerere University, P.o.Box 7062 Uganda.
Sharley Melissa AloyoDepartment of Immunology and Molecular Biology, College of Health Sciences, Makerere University, Uganda.
Joanita Nabwire WanderaDepartment of Immunology and Molecular Biology, College of Health Sciences, Makerere University, Uganda.
Andrew AgabaDepartment of Immunology and Molecular Biology, College of Health Sciences, Makerere University, Uganda.
Rogers KamulegeyaDepartment of Immunology and Molecular Biology, College of Health Sciences, Makerere University, Uganda.
Hosea KiprotichDepartment of Immunology and Molecular Biology, College of Health Sciences, Makerere University, Uganda.
David Patrick KateeteDepartment of Immunology and Molecular Biology, College of Health Sciences, Makerere University, Uganda.
Paul KadetzInstitute for Global Health and Development, Queen Margaret University, United Kingdom.
Uwe TruyenInstitute of Animal Hygiene and Veterinary Public Health, Leipzig University, Germany.
Kamal H EltomUnit of Animal Health and Safety of Animal Products, Institute for Studies and Promotion of Animal Exports, University of Khartoum, 13314 Khartoum North, Sudan.
Anavaj SakuntabhaiFunctional Genetics of Infectious Diseases Unit, Institut Pasteur, France.
Julius Boniface OkuniCollege of Veterinary Medicine, Animal Resources and Biosecurity, Makerere University, P.o.Box 7062 Uganda.
Sheila Makiala-MandandaDepartment of Virology at the Institut National de Recherche Biomédicale (INRB), Kinshasa, Democratic Republic of the Congo (DRC); Faculty of Medicine, University of Kinshasa, Democratic Republic of the Congo (DRC).
Vincent LacosteVirology Unit, Institut Pasteur de Madagascar, Republic of Madagascar.
George Olusegun AdemowoInstitute for Advanced Medical Research and Training (IAMRAT), College of Medicine, University of Ibadan, Nigeria.
Michael FrimpongDepartment of Molecular Medicine, School of Medicine and Dentistry, Kwame Nkrumah University of Science and Technology, Ghana; Kumasi Centre for Collaborative Research, Kwame Nkrumah University of Science and Technology, Ghana.
Amadou Alpha SallVirology Department, Institut Pasteur de Dakar, Dakar 12900, Senegal.
Manfred WeidmannInstitute of Microbiology and Virology, Medizinische Hochschule Brandenburg Theodor Fontane, Germany.
Ahmed Abd El WahedInstitute of Animal Hygiene and Veterinary Public Health, Leipzig University, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe COVID-19 pandemic led to severe health systems collapse, as well as logistics and supply delivery shortages across sectors. Delivery of PCR related healthcare supplies continue to be hindered. There is the need for a rapid and accessible SARS-CoV-2 molecular detection method in low resource settings.

objectivesTo validate a novel isothermal amplification method for rapid detection of SARS-CoV-2 across seven sub-Sharan African countries. STUDY

designIn this multi-country phase 2 diagnostic study, 3,231 clinical samples in seven African sites were tested with two reverse transcription Recombinase-Aided Amplification (RT-RAA) assays (based on SARS-CoV-2 Nucleocapsid (N) gene and RNA-dependent RNA polymerase (RdRP) gene). The test was performed in a mobile suitcase laboratory within 15 min. All results were compared to a real-time RT-PCR assay. Extraction kits based on silica gel or magnetic beads were applied.

resultsFour sites demonstrated good to excellent agreement, while three sites showed fair to moderate results. The RdRP gene assay exhibited an overall PPV of 0.92 and a NPV of 0.88. The N gene assay exhibited an overall PPV of 0.93 and a NPV 0.88. The sensitivity of both RT-RAA assays varied depending on the sample Ct values. When comparing sensitivity between sites, values differed considerably. For high viral load samples, the RT-RAA assay sensitivity ranges were between 60.5 and 100% (RdRP assay) and 25 and 98.6 (N assay).

conclusionOverall, the RdRP based RT-RAA test showed the best assay accuracy. This study highlights the challenges of implementing rapid molecular assays in field conditions. Factors that are important for successful deployment across countries include the implementation of standardized operation procedures, in-person continuous training for staff, and enhanced quality control measures.

Indexed as

COVID-19SARS-CoV-2Africa South of the SaharaHumansNucleic Acid Amplification TechniquesPandemicsReal-Time Polymerase Chain ReactionRNA, ViralSensitivity and SpecificityRNA, ViralDiagnostics-in-a-suitcaseRecombinase polymerase amplification assaySARS-CoV-2

Identifiers

PMID36989731
PMCPMC9981265

What Socratic holds

Textmetadata
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Registered trials

None linked

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.