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Biomarker Development Trial to test the diagnostic accuracy of EUA approved RT-PCR assay and a Laboratory Developed LAMP SARS-CoV-2 test in paired nasopharyngeal, saliva, and urine samples
  • +13
  • Ana Purcell-Wiltz,
  • Fernando Tadeu Zamuner,
  • Karem Caraballo,
  • Lorena De Jesus,
  • Yaima Miranda,
  • Denise Ortiz,
  • Amanda García Negrón,
  • Andrea Cortés,
  • Adriana Baez,
  • Josefina Romaguera,
  • Ivonne Jiménez-Velázquez,
  • Alberto Ortiz,
  • Jorge Acevedo Canabal,
  • Liliana Viera,
  • David Sydranski,
  • Rafael Guerrero-Preston
Ana Purcell-Wiltz
LifeGene BioMarks Inc Puerto Rico
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Fernando Tadeu Zamuner
Johns Hopkins Medical Institutions Campus
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Karem Caraballo
LifeGene BioMarks Inc Puerto Rico
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Lorena De Jesus
LifeGene BioMarks Inc Puerto Rico
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Yaima Miranda
LifeGene BioMarks Inc Puerto Rico
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Denise Ortiz
LifeGene BioMarks Inc Puerto Rico
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Amanda García Negrón
LifeGene BioMarks Inc Puerto Rico
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Andrea Cortés
LifeGene BioMarks Inc Puerto Rico
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Adriana Baez
University of Puerto Rico School of Medicine
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Josefina Romaguera
University of Puerto Rico Medical Sciences Campus
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Ivonne Jiménez-Velázquez
University of Puerto Rico Medical Sciences Campus
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Alberto Ortiz
University of Puerto Rico Medical Sciences Campus
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Jorge Acevedo Canabal
University of Puerto Rico Medical Sciences Campus
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Liliana Viera
University of Puerto Rico Medical Sciences Campus
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David Sydranski
Johns Hopkins School of Medicine
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Rafael Guerrero-Preston
LifeGene BioMarks Inc Puerto Rico

Corresponding Author:[email protected]

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Abstract

As the SARS-CoV-2 pandemic virus has spread throughout the world, millions of positive cases of COVID-19 have been 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. Given the difficulty of massive sample collection in Puerto Rico and the restrictions to perform the molecular test to detect SARS-CoV-2, this study aims to evaluate the diagnostic accuracy of the TaqPath RT-PCR COVID-19 kit and a LAMP SARS-CoV-2 Laboratory Developed Test in paired nasopharyngeal, saliva, and urine samples. Automated RNA extraction was performed in the KingFisher Flex instrument, whilst PCR quantification of SARS-CoV-2 on the 7500 Fast Dx RT-PCR instrument using the TaqPath RT-PCR COVID-19 molecular test. The PCR 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 was found to be 0.52, showing moderate agreement. Nasal and saliva samples displayed concordance and it was determined that saliva samples had a higher viral load. Another objective was to compare the positive or negative result of the RT-PCR with the positive or negative result of LifeGene-Biomarks SARS-CoV-2 Rapid Colorimetric LAMP LDT, which resulted in 90% concordance. Due to this, the use of saliva and LifeGene-Biomarks SARS-CoV-2 Rapid Colorimetric LAMP test is suggested for further evaluation as an alternative to nasal, urine, and RT-PCR tests for the detection of SARS-CoV-2, since it can be easily used in clinics, hospitals, the workplace, and at home, optimizing the surveillance and collection process, which helps mitigate the global public health and socioeconomic damage caused by airborne pandemics.
16 Jul 2023Submitted to Immunity, Inflammation and Disease
19 Jul 2023Assigned to Editor
19 Jul 2023Submission Checks Completed
19 Jul 2023Review(s) Completed, Editorial Evaluation Pending
26 Jul 2023Reviewer(s) Assigned
22 Nov 2023Editorial Decision: Revise Major