Evidence map›Paper›PMID 40580991›Full record

ArticleThe Lancet. Global health2025

Colorimetric RT-LAMP for SARS-CoV-2 detection from nasopharyngeal swabs or crude saliva: a multicountry diagnostic accuracy study in Africa.

Urša Šušnjar, Molalegne Bitew, Samuele Ayele, Tina Uršič, Miroslav Petrovec, Tea Carletti, Erica Bussani, Laura De Conti, Feleke Mekonnen, Marycelin Mandu Baba and 14 more

Abstract readMulticenter Study
In one paragraph

Article in The Lancet. Global health, 2025. 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. Review
  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

24 authors.

Urša ŠušnjarInternational Centre for Genetic Engineering and Biotechnology, Trieste, Italy.
Molalegne BitewBio and Emerging Technology Institute, Addis Ababa, Ethiopia.
Samuele AyeleArmauer Hansen Research Institute, Addis Ababa, Ethiopia.
Tina UršičInstitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Miroslav PetrovecInstitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Tea CarlettiInternational Centre for Genetic Engineering and Biotechnology, Trieste, Italy.
Erica BussaniInternational Centre for Genetic Engineering and Biotechnology, Trieste, Italy.
Laura De ContiInternational Centre for Genetic Engineering and Biotechnology, Trieste, Italy.
Feleke MekonnenInternational Centre for Genetic Engineering and Biotechnology, Trieste, Italy; College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia.
Marycelin Mandu BabaUniversity of Maiduguri Teaching Hospital, Maiduguri, Nigeria.
Eric Lelo AgolaKenya Medical Research Institute, Nairobi, Kenya.
Maria Madalena ChimpoloFaculdade de Medicina da Universidade Agostinho Neto, Luanda, Angola.
Joaquim Carlos Vicente Van-DúnemFaculdade de Medicina da Universidade Agostinho Neto, Luanda, Angola.
Zékiba TarnagdaInstitut de Recherche en Sciences de la Santé, Ouagadougou, Burkina Faso.
Solange Kakou-NgazoaInstitut Pasteur de Côte d'Ivoire (IPCI), Abidjan, Côte d'Ivoire.
Djibril WadeInstitute for Health Research-Epidemiological Surveillance and Training, Dakar, Senegal.
Kenneth Kudzai MaekaNational Microbiology Reference Laboratory, Harare, Zimbabwe.
Mubarak MustafaTropical Medical Research Institute, National Centre for Research, Khartoum, Sudan.
Ralitsa RaychevaMedical University Plovdiv, Plovdiv, Bulgaria.
Jean KaseyaAfrica Centres for Disease Control and Prevention, Addis Ababa, Ethiopia.
Nicaise NdembiAfrica Centres for Disease Control and Prevention, Addis Ababa, Ethiopia; Institute of Human Virology, Baltimore, MD, USA.
Joseph FokamChantal Biya International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaounde, Cameroon; Department of Medical Laboratory Science, Faculty of Health Sciences, University of Buea, Buea, Cameroon. Electronic address: josephfokam@gmail.com.
Alessandro MarcelloInternational Centre for Genetic Engineering and Biotechnology, Trieste, Italy. Electronic address: marcello@icgeb.org.
EXPANDIA Working Group

Funding

Ethiopia-Emory TB Research Training ProgramD43TW009127 · FIC · EMORY UNIVERSITY · PI HENRY M BLUMBERG, Kidist Bobosha · 2013 to 2026
$3.4M
FIC NIH HHS D43 TW009127Gates Foundation INV-034799
6 · The paper itself

Abstract

backgroundReverse-transcription loop-mediated isothermal amplification (RT-LAMP) with colorimetric readout is a rapid, robust, and cost-effective one-step amplification assay that we previously trialled for the identification of SARS-CoV-2 in nasopharyngeal swabs in four countries. Here, we expanded our assessment of RT-LAMP for SARS-CoV-2 detection to several other African countries and evaluated its operational performance with crude saliva as a pragmatic approach for outbreak surveillance and response in resource-limited settings.

methodsWe conducted a multicountry diagnostic accuracy study of RT-LAMP for the detection of SARS-CoV-2 in different types of clinical samples. A preliminary study was conducted in Slovenia and Italy to establish the analytical performance (limit of detection) of RT-LAMP and optimise this assay before its deployment in Africa. Subsequently, we tested RT-LAMP with RNA extracted from nasopharyngeal swabs in seven countries in Africa (Angola, Burkina Faso, Côte d'Ivoire, Ethiopia, Senegal, Sudan, and Zimbabwe), and, in parallel, with crude saliva samples (ie, without RNA extraction) in an additional four countries (Cameroon, Ethiopia, Kenya, and Nigeria; paired nasopharyngeal swabs were collected at the same time). In both contexts, quantitative RT-PCR (RT-qPCR) with RNA extracted from nasopharyngeal swabs was used as the gold-standard benchmarking assay to evaluate performance. For RT-qPCR testing, each laboratory followed their own standard diagnostic procedure, whereas a standardised protocol was used for RT-LAMP. Saliva test standardisation was ensured through centralised reagent distribution. We calculated diagnostic parameters (sensitivity, specificity, and accuracy) using a 2 × 2 contingency table.

findingsThe preliminary study reported 87% sensitivity and 98% specificity for RT-LAMP. Between Sept 1, 2021, and June 30, 2022, we collected 2774 nasopharyngeal swabs and 577 crude saliva samples. For RNA extracted from nasopharyngeal swabs, the sensitivity and specificity of RT-LAMP for detection of SARS-CoV-2 (relative to the standard of diagnostics-ie, the RT-qPCR assay used in each participating laboratory) were 89% (95% CI 87-90) and 95% (93-96), respectively. Similarly, RT-LAMP tested on saliva without RNA extraction showed 80% (75-84) sensitivity and 99% (96-100) specificity (relative to the results obtained with the standard of diagnostics for RNA extracted from paired nasopharyngeal samples).

interpretationColorimetric RT-LAMP is a reliable assay for SARS-CoV-2 detection in both extracted RNA and crude saliva samples. The demonstrably acceptable performance on crude saliva samples (without RNA extraction) underscores the scalability of this method for efficient outbreak surveillance in resource-limited settings.

fundingGates Foundation.

Indexed as

ColorimetryCOVID-19COVID-19 Nucleic Acid TestingMolecular Diagnostic TechniquesNasopharynxNucleic Acid Amplification TechniquesSalivaSARS-CoV-2AfricaHumansRNA, ViralSensitivity and SpecificityRNA, Viral

Identifiers

PMID40580991
PMCPMC12208784

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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 OpenQuestion graph.