Evidence map›Paper›PMID 38888444›Full record

ArticleImmunity, inflammation and disease2024

Evaluation of self-collected nasal, urine, and saliva samples for molecular detection of SARS-CoV-2 using an EUA approved RT-PCR assay and a laboratory developed LAMP SARS-CoV-2 test.

Ana Purcell-Wiltz, Fernando Tadeu Zamuner, Karem Caraballo, Lorena De Jesus, Yaima Miranda, Denise Ortiz, Amanda García Negrón, Andrea Cortés Ortiz, Adriana Baez, Josefina Romaguera and 6 more

Abstract read
In one paragraph

Article in Immunity, inflammation and disease, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

16 authors.

Ana Purcell-WiltzBiomarker Discovery and Validation Laboratory, LifeGene-Biomarks, Toa Baja, Puerto Rico.ORCID 0009-0009-7264-460X
Fernando Tadeu ZamunerOtolaryngology Department, Head and Neck Cancer Research Division, Johns Hopkins University, School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-6106-4361
Karem CaraballoBiomarker Discovery and Validation Laboratory, LifeGene-Biomarks, Toa Baja, Puerto Rico.
Lorena De JesusBiomarker Discovery and Validation Laboratory, LifeGene-Biomarks, Toa Baja, Puerto Rico.
Yaima MirandaBiomarker Discovery and Validation Laboratory, LifeGene-Biomarks, Toa Baja, Puerto Rico.
Denise OrtizBiomarker Discovery and Validation Laboratory, LifeGene-Biomarks, Toa Baja, Puerto Rico.
Amanda García NegrónBiomarker Discovery and Validation Laboratory, LifeGene-Biomarks, Toa Baja, Puerto Rico.
Andrea Cortés OrtizBiomarker Discovery and Validation Laboratory, LifeGene-Biomarks, Toa Baja, Puerto Rico.
Adriana BaezOtolaryngology Department, University of Puerto Rico School of Medicine, San Juan, Puerto Rico.
Josefina RomagueraObstetrics and Gynecology Department, University of Puerto Rico School of Medicine, San Juan, Puerto Rico.
Ivonne JiménezInternal Medicine Department, University of Puerto Rico School of Medicine, San Juan, Puerto Rico.
Alberto OrtizInternal Medicine Department, University of Puerto Rico School of Medicine, San Juan, Puerto Rico.
Jorge AcevedoInternal Medicine Department, University of Puerto Rico School of Medicine, San Juan, Puerto Rico.ORCID 0000-0003-2153-3415
Liliana VieraDepartment of Surgery, University of Puerto Rico School of Medicine, San Juan, Puerto Rico.
David SidranskyOtolaryngology Department, Head and Neck Cancer Research Division, Johns Hopkins University, School of Medicine, Baltimore, Maryland, USA.
Rafael Guerrero-PrestonBiomarker Discovery and Validation Laboratory, LifeGene-Biomarks, Toa Baja, Puerto Rico.ORCID 0000-0002-3069-9583

Funding

Precision methylation biomarkers for cervical cancer prevention in low resource settings in Latin AmericaR44CA254690 · NCI · LIFEGENE-BIOMARKS, INC. · PI GUERRERO-PRESTON, RAFAEL · 2021 to 2023
$2.4M
Precision methylation biomarkers linked to cancer disparitiesR44MD014911 · NIMHD · LIFEGENE-BIOMARKS, INC. · PI GUERRERO-PRESTON, RAFAEL · 2019 to 2021
$1.7M
Division of Cancer Prevention, National Cancer Institute R44CA254690National Institute of Minority Health and Health Disparities R44MD014911NCI NIH HHS R44 CA254690NCI NIH HHS R44CA254690NIMHD NIH HHS R44 MD014911SBIR/STTR Matching Grant Program of the Puerto Rico Science, Technology and Research Trust
6 · The paper itself

Abstract

As the SARS-CoV-2 virus spread throughout the world, millions of positive cases of COVID-19 were registered and, even though there are millions of people already vaccinated against SARS-CoV-2, a large part of the global population remains vulnerable to contracting the virus. Massive nasopharyngeal sample collection in Puerto Rico at the beginning of the pandemic was limited by the scarcity of trained personnel and testing sites. To increase SARS-CoV-2 molecular testing availability, we evaluated the diagnostic accuracy of self-collected nasal, saliva, and urine samples using the TaqPath reverse transcription polymerase chain reaction (RT-PCR) COVID-19 kit to detect SARS-CoV-2. We also created a colorimetric loop-mediated isothermal amplification (LAMP) laboratory developed test (LDT) to detect SARS-CoV-2, as another strategy to increase the availability of molecular testing in community-based laboratories. Automated RNA extraction was performed in the KingFisher Flex instrument, followed by PCR quantification of SARS-CoV-2 on the 7500 Fast Dx RT-PCR using the TaqPath RT-PCR COVID-19 molecular test. Data was interpreted by the COVID-19 Interpretive Software from Applied Biosystems and statistically analyzed with Cohen's kappa coefficient (k). Cohen's kappa coefficient (k) for paired nasal and saliva samples showed moderate agreement (0.52). Saliva samples exhibited a higher viral load. We also observed 90% concordance between LifeGene-Biomarks' SARS-CoV-2 Rapid Colorimetric LAMP LDT and the TaqPath RT-PCR COVID-19 test. Our results suggest that self-collected saliva is superior to nasal and urine samples for COVID-19 testing. The results also suggest that the colorimetric LAMP LDT is a rapid alternative to RT-PCR tests for the detection of SARS-CoV-2. This test can be easily implemented in clinics, hospitals, the workplace, and at home; optimizing the surveillance and collection process, which helps mitigate global public health and socioeconomic upheaval caused by airborne pandemics.

Indexed as

COVID-19Molecular Diagnostic TechniquesNucleic Acid Amplification TechniquesSalivaSARS-CoV-2Specimen HandlingCOVID-19 Nucleic Acid TestingCOVID-19 TestingHumansPuerto RicoReverse Transcriptase Polymerase Chain ReactionRNA, ViralSensitivity and SpecificityRNA, ViralCOVID‐19invasiveLAMPLDTnasal swabsRT‐PCRsalivaSARS‐CoV‐2urine

Identifiers

PMID38888444
PMCPMC11184932

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.