Sample Adequacy Control (SAC) Lowers False Negatives and Increases the Quality of Screening: Introduction of 'Non-Competitive' SAC for qPCR Assays
| Autor: | Matthew Oughton, Alex Resendes, Ivan Brukner, Andreas I. Papadakis, Shaun Eintracht |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
2019-20 coronavirus outbreak sampling Medicine (General) Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) media_common.quotation_subject Sample (material) Clinical Biochemistry Computational biology Negative Test Result clinical 03 medical and health sciences 0302 clinical medicine R5-920 test Medicine Quality (business) 030212 general & internal medicine media_common business.industry Communication screening pandemic false negative assay infection control qPCR 030104 developmental biology embryonic structures Non competitive business control |
| Zdroj: | Diagnostics, Vol 11, Iss 1133, p 1133 (2021) Diagnostics |
| ISSN: | 2075-4418 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|