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. 2022 Aug;2(3):100088.
doi: 10.1016/j.jcvp.2022.100088. Epub 2022 Jun 2.

Direct comparison of Altona-SARS-CoV-2 dual target RT-qPCR Assay with commercial LAMP Assay using throat washes in health care staff testing

Johannes Wanney  1 , Jessica Lüsebrink  1 , Gina Spölgen  1 , Sabrina Demuth  1 , Verena Schildgen  1 , Oliver Schildgen  1
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Direct comparison of Altona-SARS-CoV-2 dual target RT-qPCR Assay with commercial LAMP Assay using throat washes in health care staff testing

Johannes Wanney et al. J Clin Virol Plus. 2022 Aug.

Abstract

Background: Rapid molecular diagnostics by PCR has a crucial role in handling the global SARS-CoV-2 pandemic. As diagnoses are time-sensitive and global supply chains are susceptible to various factors alternative detection methods would be an important backup.

Objectives: During the study the performance of a commercially available isothermal LAMP method for SARS-CoV-2 detection was compared to a IVD RT-PCR Assays using throat wash specimens that were routinely taken in our hospital setting.

Study design: Throat wash specimens of hospital staff (n = 174) previously tested positive for SARS-CoV-2 by the Altona Diagnostics RealStar SARS-CoV-2 RT-PCR (Altona Diagnostics, Hamburg, Germany) was tested for SARS-CoV-2 also by the SARS-CoV-2 Rapid Colorimetric LAMP Assay (NEB Germany GmbH, Frankfurt a.M., Germany).

Results: The sensitivity of the colorimetric LAMP Assay compared to RT-qPCR was 78.74%, and the specificity was determined to 88.24% with a positive predictive value of 0.986 and a negative predicitve value of 0.882. The positive and negative likelihood ratio for LAMP was 6.693 and 0.241, respectively, while the diagnostic odds ratio was 27.77.

Conclusions: In times of limited PCR test ressources and in settings with limited PCR capacities, the colorimetric LAMP Assay could serve as an alternative, if a calculable loss of sensitivity is acceptable from the Public Health perspective in certain settings.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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