Evidence map›Paper›PMID 35878801›Full record

ArticleInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2022

An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour.

Gonçalo Doria, Carla Clemente, Eduardo Coelho, João Colaço, Rui Crespo, Andrei Semikhodskii, Helder Mansinho, Magno Dinis, Maria Fernanda Carvalho, Manuela Casmarrinha and 10 more

Open access · goldAbstract read
In one paragraph

Article in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 23% 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.

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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. 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

20 authors at 4 institutions in 3 countries.

Gonçalo DoriaSTAB VIDA Lda, Rua dos Inventores, Caparica, Portugal. Electronic address: goncalo.doria@stabvida.com.
Carla ClementeSTAB VIDA Lda, Rua dos Inventores, Caparica, Portugal.
Eduardo CoelhoSTAB VIDA Lda, Rua dos Inventores, Caparica, Portugal.
João ColaçoSTAB VIDA Lda, Rua dos Inventores, Caparica, Portugal.
Rui CrespoSTAB VIDA Lda, Rua dos Inventores, Caparica, Portugal.
Andrei SemikhodskiiMedical Genomics Ltd, London, United Kingdom; King Saud Bin Abdulaziz's University for Health Sciences (KSAU-HS), Riyadh, Saudi Arabia.
Helder MansinhoOncology Service, Garcia de Orta Hospital, Almada, Portugal.
Magno DinisOncology Service, Garcia de Orta Hospital, Almada, Portugal.
Maria Fernanda CarvalhoOncology Service, Garcia de Orta Hospital, Almada, Portugal.
Manuela CasmarrinhaOncology Service, Garcia de Orta Hospital, Almada, Portugal.
Cátia SaminaOncology Service, Garcia de Orta Hospital, Almada, Portugal.
Ana Cristina VidalGarcia de Orta Center, Garcia de Orta Hospital, Almada, Portugal; Escola Superior de Saúde Egas Moniz, Caparica, Portugal.
Francisca DelarueInternal Medicine Service - Garcia de Orta Center, Garcia de Orta Hospital, Almada, Portugal.
Susana GraúdoInternal Medicine Service - Garcia de Orta Center, Garcia de Orta Hospital, Almada, Portugal.
Ana Catarina SantosInternal Medicine Service - Garcia de Orta Center, Garcia de Orta Hospital, Almada, Portugal.
David PeçasInternal Medicine Service - Garcia de Orta Center, Garcia de Orta Hospital, Almada, Portugal.
Olga CarreiraClinical Pathology Service, Garcia de Orta Hospital, Almada, Portugal.
Raquel MarquesClinical Pathology Service, Garcia de Orta Hospital, Almada, Portugal.
Carina GasparClinical Pathology Service, Garcia de Orta Hospital, Almada, Portugal.
Orfeu FloresSTAB VIDA Lda, Rua dos Inventores, Caparica, Portugal.
Hospital Garcia de Orta · PTStab Vida (Portugal) · PTEscola Superior de Saúde Egas Moniz · PTKing Saud bin Abdulaziz University for Health Sciences · SA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe performance of a new point-of-care CE-IVD-marked isothermal lab-on-phone COVID-19 assay was assessed in comparison to a gold standard real-time reverse transcriptase-PCR method.

methodsThe study was conducted following a nonprobability sampling of ≥16-year-old volunteers from three different laboratories, using direct mouthwash (N = 24) or nasopharyngeal (N = 191) clinical samples.

resultsThe assay demonstrated 95.19% sensitivity and 100% specificity for detection of SARS-CoV-2 in direct nasopharyngeal crude samples and 78.95% sensitivity and 100% specificity in direct mouthwash crude samples. It also successfully detected currently predominant SARS-CoV-2 variants of concern (Beta B.1.351, Delta B.1.617.2, and Omicron B.1.1.529) and demonstrated to be inert against potential cross-reactions of other common respiratory pathogens that cause infections that present similar symptoms to COVID-19.

conclusionThis lab-on-phone pocket-sized assay relies on an isothermal amplification of SARS-CoV-2's N and E genes, taking just 50 minutes from sample to result, with only 2 minutes of hands-on time. It presents good performance when using direct nasopharyngeal crude samples, enabling a low-cost, real-time, rapid, and accurate identification of SARS-CoV-2 infections at the point of care, which is important for both clinical management and population screening, as a tool to break the chain of transmission of COVID-19 pandemic, especially in low-resources environments.

Indexed as

COVID-19SARS-CoV-2AdolescentCOVID-19 TestingHumansLaboratoriesMolecular Diagnostic TechniquesMouthwashesNucleic Acid Amplification TechniquesPandemicsRNA-Directed DNA PolymeraseRNA, ViralSensitivity and SpecificityMouthwashesRNA-Directed DNA PolymeraseRNA, ViralCOVID-19LAMP assayNucleic acid amplification techniquesPoint-of-care testingReal-time PCRSARS-CoV-2

Identifiers

PMID35878801
PMCPMC9307284
OpenAlexW4286639492

What OpenQuestion holds

Textmetadata
Read underepoch 390

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 OpenQuestion graph.