Implementation of an Extraction-Free COVID Real-Time PCR Workflow in a Pediatric Hospital Setting.
J Appl Lab Med
; 6(6): 1441-1451, 2021 11 01.
Article
in English
| MEDLINE | ID: covidwho-1493844
ABSTRACT
BACKGROUND:
This study outlines the development, implementation, and impact of a laboratory-developed, extraction-free real-time PCR assay as the primary diagnostic test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in a pediatric hospital.METHODS:
Clinical specimens from both upper and lower respiratory tract sources were validated, including nasopharyngeal aspirates, nasopharyngeal swabs, anterior nares swabs, and tracheal aspirates (n = 333 clinical samples). Testing volumes and laboratory turnaround times were then compared before and after implementation to investigate effects of the workflow changes.RESULTS:
Compared to magnetic-bead extraction platforms, extraction-free real-time PCR demonstrated ≥95% positive agreement and ≥97% negative agreement across all tested sources. Implementation of this workflow reduced laboratory turnaround time from an average of 8.8 (+/-5.5) h to 3.6 (+/-1.3) h despite increasing testing volumes (from 1515 to 4884 tests per week over the reported period of testing).CONCLUSIONS:
The extraction-free workflow reduced extraction reagent cost for SARS-CoV-2 testing by 97%, shortened sample handling time, and significantly alleviated supply chain scarcities due to the elimination of specialized extraction reagents for routine testing. Overall, this assay is a viable option for laboratories to increase efficiency and navigate reagent shortages for SARS-CoV-2 diagnostic testing.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
COVID-19 Testing
/
COVID-19
Type of study:
Diagnostic study
/
Experimental Studies
/
Prognostic study
Limits:
Child
/
Humans
Language:
English
Journal:
J Appl Lab Med
Year:
2021
Document Type:
Article
Affiliation country:
Jalm
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