Cargando…
Clinical Evaluation of the Torq Zero Delay Centrifuge System for Decentralized Blood Collection and Stabilization
Blood sample collection and rapid separation—critical preanalytical steps in clinical chemistry—can be challenging in decentralized collection settings. To address this gap, the Torq™ zero delay centrifuge system includes a lightweight, hand-portable centrifuge (ZDrive™) and a disc-shaped blood coll...
Autores principales: | , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8226604/ https://www.ncbi.nlm.nih.gov/pubmed/34199408 http://dx.doi.org/10.3390/diagnostics11061019 |
_version_ | 1783712326341361664 |
---|---|
author | Hong, Kyungjin Iacovetti, Gabriella Rahimian, Ali Hong, Sean Epperson, Jon Neal, Clara Pan, Tifany Le, Angela Kendall, Eric Melton, Kory Sommer, Greg J. Schaff, Ulrich Y. |
author_facet | Hong, Kyungjin Iacovetti, Gabriella Rahimian, Ali Hong, Sean Epperson, Jon Neal, Clara Pan, Tifany Le, Angela Kendall, Eric Melton, Kory Sommer, Greg J. Schaff, Ulrich Y. |
author_sort | Hong, Kyungjin |
collection | PubMed |
description | Blood sample collection and rapid separation—critical preanalytical steps in clinical chemistry—can be challenging in decentralized collection settings. To address this gap, the Torq™ zero delay centrifuge system includes a lightweight, hand-portable centrifuge (ZDrive™) and a disc-shaped blood collection device (ZDisc™) enabling immediate sample centrifugation at the point of collection. Here, we report results from clinical validation studies comparing performance of the Torq System with a conventional plasma separation tube (PST). Blood specimens from 134 subjects were collected and processed across three independent sites to compare ZDisc and PST performance in the assessment of 14 analytes (K, Na, Cl, Ca, BUN, creatinine, AST, ALT, ALP, total bilirubin, albumin, total protein, cholesterol, and triglycerides). A 31-subject precision study was performed to evaluate reproducibility of plasma test results from ZDiscs, and plasma quality was assessed by measuring hemolysis and blood cells from 10 subject specimens. The ZDisc successfully collected and processed samples from 134 subjects. ZDisc results agreed with reference PSTs for all 14 analytes with mean % biases well below clinically significant levels. Results were reproducible across different operators and ZDisc production lots, and plasma blood cell counts and hemolysis levels fell well below clinical acceptance thresholds. ZDiscs produce plasma samples equivalent to reference PSTs. Results support the suitability of the Torq System for remotely collecting and processing blood samples in decentralized settings. |
format | Online Article Text |
id | pubmed-8226604 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-82266042021-06-26 Clinical Evaluation of the Torq Zero Delay Centrifuge System for Decentralized Blood Collection and Stabilization Hong, Kyungjin Iacovetti, Gabriella Rahimian, Ali Hong, Sean Epperson, Jon Neal, Clara Pan, Tifany Le, Angela Kendall, Eric Melton, Kory Sommer, Greg J. Schaff, Ulrich Y. Diagnostics (Basel) Article Blood sample collection and rapid separation—critical preanalytical steps in clinical chemistry—can be challenging in decentralized collection settings. To address this gap, the Torq™ zero delay centrifuge system includes a lightweight, hand-portable centrifuge (ZDrive™) and a disc-shaped blood collection device (ZDisc™) enabling immediate sample centrifugation at the point of collection. Here, we report results from clinical validation studies comparing performance of the Torq System with a conventional plasma separation tube (PST). Blood specimens from 134 subjects were collected and processed across three independent sites to compare ZDisc and PST performance in the assessment of 14 analytes (K, Na, Cl, Ca, BUN, creatinine, AST, ALT, ALP, total bilirubin, albumin, total protein, cholesterol, and triglycerides). A 31-subject precision study was performed to evaluate reproducibility of plasma test results from ZDiscs, and plasma quality was assessed by measuring hemolysis and blood cells from 10 subject specimens. The ZDisc successfully collected and processed samples from 134 subjects. ZDisc results agreed with reference PSTs for all 14 analytes with mean % biases well below clinically significant levels. Results were reproducible across different operators and ZDisc production lots, and plasma blood cell counts and hemolysis levels fell well below clinical acceptance thresholds. ZDiscs produce plasma samples equivalent to reference PSTs. Results support the suitability of the Torq System for remotely collecting and processing blood samples in decentralized settings. MDPI 2021-06-02 /pmc/articles/PMC8226604/ /pubmed/34199408 http://dx.doi.org/10.3390/diagnostics11061019 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 | Article Hong, Kyungjin Iacovetti, Gabriella Rahimian, Ali Hong, Sean Epperson, Jon Neal, Clara Pan, Tifany Le, Angela Kendall, Eric Melton, Kory Sommer, Greg J. Schaff, Ulrich Y. Clinical Evaluation of the Torq Zero Delay Centrifuge System for Decentralized Blood Collection and Stabilization |
title | Clinical Evaluation of the Torq Zero Delay Centrifuge System for Decentralized Blood Collection and Stabilization |
title_full | Clinical Evaluation of the Torq Zero Delay Centrifuge System for Decentralized Blood Collection and Stabilization |
title_fullStr | Clinical Evaluation of the Torq Zero Delay Centrifuge System for Decentralized Blood Collection and Stabilization |
title_full_unstemmed | Clinical Evaluation of the Torq Zero Delay Centrifuge System for Decentralized Blood Collection and Stabilization |
title_short | Clinical Evaluation of the Torq Zero Delay Centrifuge System for Decentralized Blood Collection and Stabilization |
title_sort | clinical evaluation of the torq zero delay centrifuge system for decentralized blood collection and stabilization |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8226604/ https://www.ncbi.nlm.nih.gov/pubmed/34199408 http://dx.doi.org/10.3390/diagnostics11061019 |
work_keys_str_mv | AT hongkyungjin clinicalevaluationofthetorqzerodelaycentrifugesystemfordecentralizedbloodcollectionandstabilization AT iacovettigabriella clinicalevaluationofthetorqzerodelaycentrifugesystemfordecentralizedbloodcollectionandstabilization AT rahimianali clinicalevaluationofthetorqzerodelaycentrifugesystemfordecentralizedbloodcollectionandstabilization AT hongsean clinicalevaluationofthetorqzerodelaycentrifugesystemfordecentralizedbloodcollectionandstabilization AT eppersonjon clinicalevaluationofthetorqzerodelaycentrifugesystemfordecentralizedbloodcollectionandstabilization AT nealclara clinicalevaluationofthetorqzerodelaycentrifugesystemfordecentralizedbloodcollectionandstabilization AT pantifany clinicalevaluationofthetorqzerodelaycentrifugesystemfordecentralizedbloodcollectionandstabilization AT leangela clinicalevaluationofthetorqzerodelaycentrifugesystemfordecentralizedbloodcollectionandstabilization AT kendalleric clinicalevaluationofthetorqzerodelaycentrifugesystemfordecentralizedbloodcollectionandstabilization AT meltonkory clinicalevaluationofthetorqzerodelaycentrifugesystemfordecentralizedbloodcollectionandstabilization AT sommergregj clinicalevaluationofthetorqzerodelaycentrifugesystemfordecentralizedbloodcollectionandstabilization AT schaffulrichy clinicalevaluationofthetorqzerodelaycentrifugesystemfordecentralizedbloodcollectionandstabilization |