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.
Humans
Saliva
/ virology
SARS-CoV-2
/ genetics
COVID-19
/ diagnosis
Nucleic Acid Amplification Techniques
/ methods
Specimen Handling
/ methods
Molecular Diagnostic Techniques
/ methods
Reverse Transcriptase Polymerase Chain Reaction
/ methods
RNA, Viral
/ analysis
COVID-19 Nucleic Acid Testing
/ methods
Sensitivity and Specificity
Puerto Rico
/ epidemiology
COVID-19 Testing
/ methods
COVID‐19
LAMP
LDT
RT‐PCR
SARS‐CoV‐2
invasive
nasal swabs
saliva
urine
Journal
Immunity, inflammation and disease
ISSN: 2050-4527
Titre abrégé: Immun Inflamm Dis
Pays: England
ID NLM: 101635460
Informations de publication
Date de publication:
Jun 2024
Jun 2024
Historique:
revised:
23
04
2024
received:
18
07
2023
accepted:
12
05
2024
medline:
18
6
2024
pubmed:
18
6
2024
entrez:
18
6
2024
Statut:
ppublish
Résumé
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.
Substances chimiques
RNA, Viral
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e1285Subventions
Organisme : National Institute of Minority Health and Health Disparities
ID : R44MD014911
Organisme : Division of Cancer Prevention, National Cancer Institute
ID : R44CA254690
Organisme : NCI NIH HHS
ID : R44CA254690
Pays : United States
Organisme : SBIR/STTR Matching Grant Program of the Puerto Rico Science, Technology and Research Trust
Informations de copyright
© 2024 LifeGene Biomarks. Immunity, Inflammation and Disease published by John Wiley & Sons Ltd.
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