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Sample Adequacy Control (SAC) Lowers False Negatives and Increases the Quality of Screening: Introduction of “Non-Competitive” SAC for qPCR Assays

Sample Adequacy Control (SAC) has critical analytical, clinical and epidemiological value that increases confidence in a negative test result. The SAC is an integral qPCR assay control, which ensures that all pre-analytical and analytical steps are adequate for accurate testing and reporting. As suc...

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Autores principales: Brukner, Ivan, Resendes, Alex, Eintracht, Shaun, Papadakis, Andreas I., Oughton, Matthew
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8305439/
https://www.ncbi.nlm.nih.gov/pubmed/34206413
http://dx.doi.org/10.3390/diagnostics11071133
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author Brukner, Ivan
Resendes, Alex
Eintracht, Shaun
Papadakis, Andreas I.
Oughton, Matthew
author_facet Brukner, Ivan
Resendes, Alex
Eintracht, Shaun
Papadakis, Andreas I.
Oughton, Matthew
author_sort Brukner, Ivan
collection PubMed
description Sample Adequacy Control (SAC) has critical analytical, clinical and epidemiological value that increases confidence in a negative test result. The SAC is an integral qPCR assay control, which ensures that all pre-analytical and analytical steps are adequate for accurate testing and reporting. As such, a negative SAC with a negative result on pathogen screen specifies that the result should be reported as inconclusive instead of negative. Despite this, many regulatory approved tests do not incorporate SAC into their assay design. Herein, we emphasize the universal value of SAC and offer for the first time, a simple technical strategy to introduce non-competitive SAC which does not interfere with the limit of detection for the screened pathogen. Integration of SAC can provide key benefits towards identifying, isolating, quarantining and contact tracing infected individuals and in turn can improve worldwide efforts in infection control.
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spelling pubmed-83054392021-07-25 Sample Adequacy Control (SAC) Lowers False Negatives and Increases the Quality of Screening: Introduction of “Non-Competitive” SAC for qPCR Assays Brukner, Ivan Resendes, Alex Eintracht, Shaun Papadakis, Andreas I. Oughton, Matthew Diagnostics (Basel) Communication Sample Adequacy Control (SAC) has critical analytical, clinical and epidemiological value that increases confidence in a negative test result. The SAC is an integral qPCR assay control, which ensures that all pre-analytical and analytical steps are adequate for accurate testing and reporting. As such, a negative SAC with a negative result on pathogen screen specifies that the result should be reported as inconclusive instead of negative. Despite this, many regulatory approved tests do not incorporate SAC into their assay design. Herein, we emphasize the universal value of SAC and offer for the first time, a simple technical strategy to introduce non-competitive SAC which does not interfere with the limit of detection for the screened pathogen. Integration of SAC can provide key benefits towards identifying, isolating, quarantining and contact tracing infected individuals and in turn can improve worldwide efforts in infection control. MDPI 2021-06-22 /pmc/articles/PMC8305439/ /pubmed/34206413 http://dx.doi.org/10.3390/diagnostics11071133 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Communication
Brukner, Ivan
Resendes, Alex
Eintracht, Shaun
Papadakis, Andreas I.
Oughton, Matthew
Sample Adequacy Control (SAC) Lowers False Negatives and Increases the Quality of Screening: Introduction of “Non-Competitive” SAC for qPCR Assays
title Sample Adequacy Control (SAC) Lowers False Negatives and Increases the Quality of Screening: Introduction of “Non-Competitive” SAC for qPCR Assays
title_full Sample Adequacy Control (SAC) Lowers False Negatives and Increases the Quality of Screening: Introduction of “Non-Competitive” SAC for qPCR Assays
title_fullStr Sample Adequacy Control (SAC) Lowers False Negatives and Increases the Quality of Screening: Introduction of “Non-Competitive” SAC for qPCR Assays
title_full_unstemmed Sample Adequacy Control (SAC) Lowers False Negatives and Increases the Quality of Screening: Introduction of “Non-Competitive” SAC for qPCR Assays
title_short Sample Adequacy Control (SAC) Lowers False Negatives and Increases the Quality of Screening: Introduction of “Non-Competitive” SAC for qPCR Assays
title_sort sample adequacy control (sac) lowers false negatives and increases the quality of screening: introduction of “non-competitive” sac for qpcr assays
topic Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8305439/
https://www.ncbi.nlm.nih.gov/pubmed/34206413
http://dx.doi.org/10.3390/diagnostics11071133
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