Cost Consequences for the NHS of Using a Two-Step Testing Method for the Detection of Clostridium difficile with a Point of Care, Polymerase Chain Reaction Test as the First Step.

William S Jones,Mark H Wilcox,Stephen Rice,Gregory Maniatopoulos,A John Simpson,Michelle Permain,Fiona Beyer,H Michael Power,Jana Suklan,D Ashley Price,A Joy Allen

doi:10.3390/diagnostics10100819

William S Jones, Mark H Wilcox + Show 9 more

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https://doi.org/10.3390/diagnostics10100819

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Abstract

Clostridium difficile infection (CDI) is a common healthcare-associated infection. Current practice for diagnosing CDI in the Newcastle upon Tyne Hospitals NHS Foundation Trust involves a three-step, laboratory testing strategy using glutamate dehydrogenase (GDH) enzyme immunoassay (EIA), followed by a polymerase chain reaction (PCR) test then a toxin EIA. However, a PCR point of care test (POCT) for the C. difficile tcdB gene for screening suspected CDI cases, may provide a more efficient way of facilitating an equally effective, two-step, testing strategy with a toxin EIA. This study evaluated the cost consequences of changing from the three-step to a two-step testing strategy. A cost-consequences model was developed to compare the costs and consequences of the two strategies. Uncertainties in the model inputs were investigated with one- and two-way sensitivity analysis. The two-step, POCT strategy was estimated to save £283,282 per 1000 hospitalized NHS patients with suspected infectious diarrhea. Sensitivity analysis indicated that the turnaround time for the POCT was the largest driver for cost savings. Providing the POCT has sufficiently high diagnostic accuracy for detecting C. difficile, the two-step, POCT strategy for CDI identification is likely to be cost saving for NHS hospitals with an offsite laboratory.

Highlights

Clostridium difficile can be carried without symptoms but is highly transmissible, and in its infectious form (i.e., C. difficile infection (CDI)) can result in severe disease and death
Clostridium difficile can be carried without symptoms but is highly transmissible, and in its (NuTH)—have anform adapted of first(CDI))
Adaptation justified by a service (EIA) or a test for the tcdB gene of C. diff encoding for toxin B; if the screening test is positive, a evaluation performed by the NuTH laboratories, in which they demonstrated that performing polymerase chain reaction (PCR)

Summary

Introduction

Clostridium difficile can be carried without symptoms but is highly transmissible, and in its infectious form (i.e., C. difficile infection (CDI)) can result in severe disease and death. UK [1], and European guidelines [2,3], recommend, as a minimum, a two-step testing protocol using laboratory tests: First a screening test with either a glutamate dehydrogenase (GDH) enzyme immunoassay (EIA) or a test for the tcdB gene of C. diff encoding for toxin B; if the screening test is positive, a toxin assay. REVIEWstep to test for the tcdB gene may be added for 2patients of 8 for toxin B (often2020, an10,EIA). Adaptation justified by a service (EIA) or a test for the tcdB gene of C. diff encoding for toxin B; if the screening test is positive, a evaluation performed by the NuTH laboratories, in which they demonstrated that performing PCR toxin assay for toxin B (often an EIA). EIAatesting ensures thatnegative any toxin positive results are due to theisproduction who have positive GDH

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