Clinical utility and cost-effectiveness of bacterial 16S rRNA and targeted PCR based diagnostic testing in a UK microbiology laboratory network

16S ribosomal-ribonucleic acid polymerase chain reaction (PCR) and targeted PCR aid microbiological diagnosis in culture-negative clinical samples. Despite routine clinical use, there remains a paucity of data on their effectiveness across a variety of clinical sample types, and cost-effectiveness....

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Bibliographic Details
Published in:Scientific reports Vol. 10; no. 1; p. 7965
Main Authors: Aggarwal, Dinesh, Kanitkar, Tanmay, Narouz, Michael, Azadian, Berge S., Moore, Luke S. P., Mughal, Nabeela
Format: Journal Article
Language:English
Published: London Nature Publishing Group UK 14.05.2020
Nature Publishing Group
Subjects:
692/4017
692/699/255
692/700/139
Bacterial Typing Techniques
Communicable Diseases - diagnosis
Communicable Diseases - etiology
Cost analysis
Cost control
Cost-Benefit Analysis
Diagnosis
Diagnostic tests
Humanities and Social Sciences
Humans
Laboratories
London
Microbiological Techniques - economics
Microbiological Techniques - methods
Microbiology
Molecular Diagnostic Techniques - economics
Molecular Diagnostic Techniques - methods
multidisciplinary
Observational studies
Patients
Polymerase chain reaction
Polymerase Chain Reaction - economics
Polymerase Chain Reaction - methods
Procedures and Techniques Utilization - economics
Procedures and Techniques Utilization - statistics & numerical data
Reproducibility of Results
Retrospective Studies
RNA, Ribosomal, 16S - genetics
rRNA 16S
Science
Science (multidisciplinary)
Sensitivity and Specificity
United Kingdom
London
United Kingdom
ISSN:2045-2322, 2045-2322
Online Access:Get full text
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Summary:16S ribosomal-ribonucleic acid polymerase chain reaction (PCR) and targeted PCR aid microbiological diagnosis in culture-negative clinical samples. Despite routine clinical use, there remains a paucity of data on their effectiveness across a variety of clinical sample types, and cost-effectiveness. In this 4 year multicentre retrospective observational study, all clinical samples referred for 16S PCR and/or targeted PCR from a laboratory network serving seven London hospitals were identified. Laboratory, clinical, prescribing, and economic variables were analysed. 78/607 samples were 16S PCR positive; pus samples were most frequently positive (29/84; p < 0.0001), and CSF least (8/149; p = 0.003). 210/607 samples had targeted PCR (361 targets requested across 23 organisms) with 43/361 positive; respiratory samples (13/37; p = 0.01) had the highest detection rate. Molecular diagnostics provided a supportive microbiological diagnosis for 21 patients and a new diagnosis for 58. 14/91 patients with prescribing information available and a positive PCR result had antimicrobial de-escalation. For culture-negative samples, mean cost-per-positive 16S PCR result was £568.37 and £292.84 for targeted PCR, equating to £4041.76 and £1506.03 respectively for one prescription change. 16S PCR is more expensive than targeted PCR, with both assisting in microbiological diagnosis but uncommonly enabling antimicrobial change. Rigorous referral pathways for molecular tests may result in significant fiscal savings.
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ISSN:2045-2322
2045-2322
DOI:10.1038/s41598-020-64739-1