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Preanalytical issues affecting the diagnosis of COVID-19
  1. Daniel Payne1,
  2. Darren Newton2,
  3. Paul Evans1,
  4. Husam Osman3,
  5. Richard Baretto4,5
  1. 1 Haematology, Leeds Teaching Hospitals NHS Trust, Leeds, UK
  2. 2 Haematology and Immunology, University of Leeds, Leeds, West Yorkshire, UK
  3. 3 Virology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
  4. 4 Immunology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
  5. 5 Immunology, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK
  1. Correspondence to Dr Richard Baretto, Immunology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, B9 5SS, UK; richard.baretto{at}nhs.net

https://doi.org/10.1136/jclinpath-2020-206751

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    Introduction

    Significant challenges exist to develop sensitive and specific tests to diagnose COVID-19 caused by infection with the RNA virus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).1

    Diagnosis of COVID-19 in the acute stage relies on detecting SARS-CoV-2 genomic RNA in naso/oropharyngeal (NOP) swabs. The swab is transferred to the laboratory in either viral or universal transport medium (VTM/UTM) and reverse transcriptase PCR (RT-PCR) performed to detect SARS-CoV-2 RNA.1

    This same algorithm is used in the diagnosis of seasonal flu caused by the RNA virus, influenza with few false-positive and false-negative results leading to specificity and sensitivity greater than 95%, respectively.2

    Issues with SARS-CoV-2 RT-PCR testing

    The false-negative rate for RT-PCR in COVID-19 has been reported to be as high as 41%3 and there are several reports of swab negative patients, who are subsequently positive on repeat testing.4 It is possible that the amount of virion present in NOP in COVID-19 is much less than that in influenza …

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    Footnotes

    • Handling editor Tahir S Pillay.

    • Contributors DP conceived the study. DN and PE provided expert advice about molecular biology. HO provided expert advice about virology. All authors reviewed and contributed to the manuscript. DP and RB wrote the manuscript.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; internally peer reviewed.