Evidence map›Paper›PMID 34476394›Full record

ArticleEClinicalMedicine2021

Diagnostic performance of a colorimetric RT -LAMP for the identification of SARS-CoV-2: A multicenter prospective clinical evaluation in sub-Saharan Africa.

Marycelin Mandu Baba, Molalegne Bitew, Joseph Fokam, Eric Agola Lelo, Ahmed Ahidjo, Kominist Asmamaw, Grace Angong Beloumou, Wallace Dimbuson Bulimo, Emanuele Buratti, Collins Chenwi and 21 more

Abstract read
In one paragraph

Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
–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

27 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. 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.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2023
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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.

Marycelin Mandu BabaDepartment of Medical Laboratory Science, College of Medical Sciences, University of Maiduguri, Borno State P.M.B.1069, Nigeria.
Molalegne BitewEthiopian Biotechnology Institute (EBTI), Addis Ababa, Ethiopia.
Joseph FokamThe Chantal Biya International Reference Center (CIRCB), Yaounde, Cameroon.
Eric Agola LeloCenter for Biotechnology Research, Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.
Ahmed AhidjoDepartment of Medical Laboratory Science, College of Medical Sciences, University of Maiduguri, Borno State P.M.B.1069, Nigeria.
Kominist AsmamawEthiopian Biotechnology Institute (EBTI), Addis Ababa, Ethiopia.
Grace Angong BeloumouThe Chantal Biya International Reference Center (CIRCB), Yaounde, Cameroon.
Wallace Dimbuson BulimoCenter for Biotechnology Research, Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.
Emanuele BurattiInternational Center for Genetic Engineering and Biotechnology (ICGEB), Padriciano 99, Trieste 34149, Italy.
Collins ChenwiThe Chantal Biya International Reference Center (CIRCB), Yaounde, Cameroon.
Hailu DadiEthiopian Biotechnology Institute (EBTI), Addis Ababa, Ethiopia.
Pierlanfranco D'AgaroAzienda Sanitaria Universitaria Integrata di Trieste, UCO Igiene e Sanità Pubblica, Trieste, Italy.
Laura De ContiInternational Center for Genetic Engineering and Biotechnology (ICGEB), Padriciano 99, Trieste 34149, Italy.
Nadine FainguemThe Chantal Biya International Reference Center (CIRCB), Yaounde, Cameroon.
Galadima GadzamaDepartment of Medical Laboratory Science, College of Medical Sciences, University of Maiduguri, Borno State P.M.B.1069, Nigeria.
Paolo MaiuriIFOM, the FIRC Institute of Molecular Oncology, Via Adamello 16, Milano 20139, Italy.
Janet MajanjaCenter for Biotechnology Research, Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.
Wadegu MeshackCenter for Biotechnology Research, Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.
Alexis NdjoloThe Chantal Biya International Reference Center (CIRCB), Yaounde, Cameroon.
Celine NkenfouThe Chantal Biya International Reference Center (CIRCB), Yaounde, Cameroon.
Bamidele Soji OderindeDepartment of Medical Laboratory Science, College of Medical Sciences, University of Maiduguri, Borno State P.M.B.1069, Nigeria.
Silvanos Mukunzi OpandaCenter for Biotechnology Research, Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.
Ludovica SegatAzienda Sanitaria Universitaria Integrata di Trieste, UCO Igiene e Sanità Pubblica, Trieste, Italy.
Cristiana StuaniInternational Center for Genetic Engineering and Biotechnology (ICGEB), Padriciano 99, Trieste 34149, Italy.
Samwel L SymekherCenter for Biotechnology Research, Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.
Desire TakouThe Chantal Biya International Reference Center (CIRCB), Yaounde, Cameroon.
Kassahun TesfayeEthiopian Biotechnology Institute (EBTI), Addis Ababa, Ethiopia.
Gianluca TrioloInternational Center for Genetic Engineering and Biotechnology (ICGEB), Padriciano 99, Trieste 34149, Italy.
Keyru TukiEthiopian Biotechnology Institute (EBTI), Addis Ababa, Ethiopia.
Serena ZacchignaInternational Center for Genetic Engineering and Biotechnology (ICGEB), Padriciano 99, Trieste 34149, Italy.
Alessandro MarcelloInternational Center for Genetic Engineering and Biotechnology (ICGEB), Padriciano 99, Trieste 34149, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundManagement and control of the COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus SARS-CoV-2 is critically dependent on quick and reliable identification of the virus in clinical specimens. Detection of viral RNA by a colorimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP) is a simple, reliable and cost-effective assay, deployable in resource-limited settings (RLS). Our objective was to evaluate the intrinsic and extrinsic performances of RT-LAMP in RLS.

methodsThis is a multicenter prospective observational study of diagnostic accuracy, conducted from October 2020 to February 2021 in four African Countries: Cameroon, Ethiopia, Kenya and Nigeria; and in Italy. We enroled 1657 individuals who were either COVID-19 suspect cases, or asymptomatic and presented for screening. RNA extracted from pharyngeal swabs was tested in parallel by a colorimetric RT-LAMP and by a standard real time polymerase chain reaction (RT-PCR).

findingsThe sensitivity and specificity of index RT LAMP compared to standard RT-PCR on 1657 prospective specimens from infected individuals was determined. For a subset of 1292 specimens, which underwent exactly the same procedures in different countries, we obtained very high specificity (98%) and positive predictive value (PPV = 99%), while the sensitivity was 87%, with a negative predictive value NPV = 70%, Stratification of RT-PCR data showed superior sensitivity achieved with an RT-PCR cycle threshold (Ct) below 35 (97%), which decreased to 60% above 35.

interpretationIn this field trial, RT-LAMP appears to be a reliable assay, comparable to RT-PCR, particularly with medium-high viral loads (Ct < 35). Hence, RT-LAMP can be deployed in RLS for timely management and prevention of COVID-19, without compromising the quality of output.

Identifiers

PMID34476394
PMCPMC8401528

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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.