Assay Integrity of a PCR Influenza Point-of-Care Test Remains Following Artificial System Contamination.


Journal

The journal of applied laboratory medicine
ISSN: 2576-9456
Titre abrégé: J Appl Lab Med
Pays: England
ID NLM: 101693884

Informations de publication

Date de publication:
11 2019
Historique:
received: 10 12 2018
accepted: 08 04 2019
entrez: 30 10 2019
pubmed: 30 10 2019
medline: 20 9 2020
Statut: ppublish

Résumé

Healthcare providers who have access to tests at the point of care (POC) are increasingly requesting the same performance from the POC test as they expect from the laboratory. With the introduction of the cobas To assess the likelihood of system contamination contributing to the generation of false-positive results, in this study we contaminated a cobas Liat System with flu A/B-positive control material. The system contamination was then assessed by swabbing exposed surfaces. Following confirmed system contamination, negative control samples were processed to determine whether system contamination had an impact on the expected negative results. Instrument contamination was confirmed, and no detectable flu A/B signal was observed for any of the negative control tubes run immediately following confirmation of system contamination. Environmental contamination of the Liat instrument does not have an impact on the integrity of the result.

Sections du résumé

BACKGROUND
Healthcare providers who have access to tests at the point of care (POC) are increasingly requesting the same performance from the POC test as they expect from the laboratory. With the introduction of the cobas
METHODS
To assess the likelihood of system contamination contributing to the generation of false-positive results, in this study we contaminated a cobas Liat System with flu A/B-positive control material. The system contamination was then assessed by swabbing exposed surfaces. Following confirmed system contamination, negative control samples were processed to determine whether system contamination had an impact on the expected negative results.
RESULTS
Instrument contamination was confirmed, and no detectable flu A/B signal was observed for any of the negative control tubes run immediately following confirmation of system contamination.
CONCLUSION
Environmental contamination of the Liat instrument does not have an impact on the integrity of the result.

Identifiants

pubmed: 31659080
pii: jalm.2018.028639
doi: 10.1373/jalm.2018.028639
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

422-426

Informations de copyright

© 2019 American Association for Clinical Chemistry.

Auteurs

Jamie E Phillips (JE)

Roche Diagnostics Corporation, Indianapolis, IN.

Stephen McCune (S)

Roche Diagnostics Corporation, Indianapolis, IN.

Corinne R Fantz (CR)

Roche Diagnostics Corporation, Indianapolis, IN.

Julia Engstrom-Melnyk (J)

Roche Diagnostics Corporation, Indianapolis, IN.

John C Osiecki (JC)

Roche Diagnostics Corporation, Indianapolis, IN. john.osiecki@roche.com.

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