Molecular point-of-care devices for the diagnosis of infectious diseases in resource-limited settings - A review of the current landscape, technical challenges, and clinical impact
Copyright © 2023. Published by Elsevier B.V..
Molecular point-of-care (POC) tests offer high sensitivity, rapid turnaround times, relative ease of use, and the convenience of laboratory-grade testing in the absence of formal laboratory spaces and equipment, making them appealing options for infectious disease diagnosis in resource-limited settings. In this review, we discuss the role and potential of molecular POC tests in resource-limited settings and their associated logistical challenges. We discuss U.S. Food and Drug Administration approval, Clinical Laboratory Improvement Amendments complexity levels, and the REASSURED criteria as a starting point for assessing options currently available inside and outside of the United States. We then present POC tests currently in research and development phases that have potential for commercialization and implementation in limited-resource settings. Finally, we review published studies that have assessed the clinical impact of molecular POC testing in limited- and moderate-resource settings.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:169 |
|---|---|
| Enthalten in: |
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology - 169(2023) vom: 11. Dez., Seite 105613 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Gavina, Kenneth [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Infectious disease |
|---|
| Anmerkungen: |
Date Completed 16.12.2023 Date Revised 02.04.2024 published: Print-Electronic ClinicalTrials.gov: NCT05048472 Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.jcv.2023.105613 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM363584188 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM363584188 | ||
| 003 | DE-627 | ||
| 005 | 20240402235833.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.jcv.2023.105613 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1361.xml |
| 035 | |a (DE-627)NLM363584188 | ||
| 035 | |a (NLM)37866094 | ||
| 035 | |a (PII)S1386-6532(23)00236-6 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Gavina, Kenneth |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Molecular point-of-care devices for the diagnosis of infectious diseases in resource-limited settings - A review of the current landscape, technical challenges, and clinical impact |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 16.12.2023 | ||
| 500 | |a Date Revised 02.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT05048472 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023. Published by Elsevier B.V. | ||
| 520 | |a Molecular point-of-care (POC) tests offer high sensitivity, rapid turnaround times, relative ease of use, and the convenience of laboratory-grade testing in the absence of formal laboratory spaces and equipment, making them appealing options for infectious disease diagnosis in resource-limited settings. In this review, we discuss the role and potential of molecular POC tests in resource-limited settings and their associated logistical challenges. We discuss U.S. Food and Drug Administration approval, Clinical Laboratory Improvement Amendments complexity levels, and the REASSURED criteria as a starting point for assessing options currently available inside and outside of the United States. We then present POC tests currently in research and development phases that have potential for commercialization and implementation in limited-resource settings. Finally, we review published studies that have assessed the clinical impact of molecular POC testing in limited- and moderate-resource settings | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Review | |
| 650 | 4 | |a Infectious disease | |
| 650 | 4 | |a Point-of-care device | |
| 650 | 4 | |a Point-of-care test | |
| 650 | 4 | |a Real-time PCR | |
| 650 | 4 | |a Resource-limited settings | |
| 700 | 1 | |a Franco, Lauren C |e verfasserin |4 aut | |
| 700 | 1 | |a Khan, Haseeba |e verfasserin |4 aut | |
| 700 | 1 | |a Lavik, John-Paul |e verfasserin |4 aut | |
| 700 | 1 | |a Relich, Ryan F |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology |d 1997 |g 169(2023) vom: 11. Dez., Seite 105613 |w (DE-627)NLM097223964 |x 1873-5967 |7 nnns |
| 773 | 1 | 8 | |g volume:169 |g year:2023 |g day:11 |g month:12 |g pages:105613 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.jcv.2023.105613 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 169 |j 2023 |b 11 |c 12 |h 105613 | ||