Budget Impact Analysis of Adopting a One-Step Nucleic Acid Amplification Testing (NAAT) Alone Diagnostic Pathway for Clostridioides difficile in Japan Compared to a Two-Step Algorithm with Glutamate Dehydrogenase/Toxin Followed by NAAT

Abstract

Clostridioides difficile infection (CDI) is a major healthcare-associated infection that leads to a significant health economic burden in Japan. Using a decision tree model, we evaluated the budget impact of adopting a one-step nucleic acid amplification test (NAAT) alone pathway compared to a two-step diagnostic algorithm with glutamate dehydrogenase (GDH) and toxin antigen, followed by NAAT. The analysis was conducted from the government payer’s perspective for 100,000 symptomatic, hospitalized adults requiring a CDI diagnostic test. One-way sensitivity analysis was conducted for all data inputs. The NAAT alone strategy costed JPY 225,886,360 (USD 2,424,714) more, but was more effective, resulting in 1749 more patients accurately diagnosed and 91 fewer deaths compared to the two-step algorithm. Additionally, the NAAT alone pathway costed JPY 26,146 (USD 281) less per true positive CDI diagnosed. The total budget impact, and cost per CDI diagnosed was most sensitive to GDH sensitivity in one-way sensitivity analysis, where a lower GDH sensitivity resulted in greater cost savings with the NAAT alone pathway. Findings from this budget impact analysis can guide the adoption of a NAAT alone pathway for CDI diagnosis in Japan.

Experience with PCR Testing for Enteric Bacteria and Viruses of Emergency Department Patients with Acute Gastroenteritis: Are There Implications for the Early Treatment of Clostridioides difficile Infection?

“…The use of PCR as a stand-alone test has not been defined as an optimal approach to differentiate between colonization and infection [ 9 ]. On the other hand, there are studies in which the use of one-step PCR testing results in more patients being accurately diagnosed and fewer deaths, indicating that suboptimal analytical sensitivity in two-step algorithms may miss cases that should be treated [ 12 , 13 , 14 ]. It has been shown that about 70% of PCR-positive but toxin antigen-negative patients were found to have probable or possible CDI [ 13 ].…”

Rapid, Point-of-Care Microwave Lysis and Electrochemical Detection of Clostridioides difficile Directly from Stool Samples

“…Diagnostic laboratories regularly employ algorithms to detect toxigenic C. difficile in symptomatic hospitalized patients. This usually involves rapid immunogenic screening for the presence of the glutamate dehydrogenase antigen (GDH) on C. difficile vegetative bacteria, in conjunction with an enzyme immunoassay (EIA) to detect the presence of TcdA and TcdB [ 9 , 10 ]. These algorithms have yet to be standardized globally; therefore, the performances of differing diagnostic test algorithms are directly compared to the gold standard cell culture neutralization assay (CCTA) in studies, often generating conflicting results and high operation costs [ 11 , 12 ].…”