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.

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.

Diagnostic utilities of a fully automated molecular test for toxigenic Clostridium difficile.

Laboratory underdiagnosis of toxigenic Clostridium difficile can lead to inappropriate management of C. difficile infection (CDI). A fully automated molecular test (FAMT), BD MAX, and enzyme immunoassays for C. difficile glutamate dehydrogenase (GDH) and for toxin A/B antigen test were evaluated using clinical specimens. Laboratory analysis of 231 fecal specimens from patients suspected with CDI, indicated that the sensitivity (Sn), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV) of FAMT was 98.1%, 98.9%, 96.3%, and 99.4%, while that of toxin A/B antigen was 52.8%, 100.0%, 100.0%, and 87.7%, respectively, compared to toxigenic culture. Sn, Sp, PPV, and NPV of GDH test compared to toxigenic culture was 92.5%, 94.4%, 83.1%, and 97.7%, respectively. FAMT can support the accurate laboratory diagnosis of toxigenic C. difficile and be an effective tool for appropriate treatment of CDI.

Unfavorable peripheral intravenous catheter replacements can be reduced using an integrated closed intravenous catheter system.

PURPOSE: To evaluate the clinical usefulness of an integrated closed intravenous catheter system (CICS) with a preattached stabilization platform and extension tube (BD Nexiva™; Becton, Dickinson and Company) in Japanese patients. METHODS: In this open, single-center study, patients who required peripheral intravenous (PIV) catheterization for ≥72 hours were quasi-randomized to receive a CICS or a conventional intravenous catheter. Study outcomes included adverse events during catheter insertion, catheter replacements during the initial 72 hours, catheter survival rate at 72 hours after insertion and costs of initial catheterization and catheter replacement. RESULTS: Of 359 patients enrolled, 194 received the CICS and 165 received the conventional catheter. The incidence rates of ≥1 failed insertion attempts, blood leakage and blood exposure were similar in both groups. The survival rate of the CICS group (83.7%) was significantly higher than that of the conventional catheter group (62.6%) in the intention-to-treat analysis (p=0.0085). There were significantly fewer catheter replacements due to catheter-related complications (e.g., catheter failure or extravasation) in the CICS group (p=0.0056). Although the initial cost per patient was greater for the CICS group (US$17.07 vs. US$13.26), the total cost per patient over 72 hours was similar (US$21.00 vs. US$20.30) because of the cost of unplanned replacements of conventional catheters. CONCLUSIONS: Although rates of adverse events at insertion were similar for both catheters, significantly fewer patients required unplanned reinsertion with the CICS. The results suggest that the longer survival rate for the CICS can offset the higher initial catheterization costs.

Detection of norovirus antigens from recombinant virus-like particles and stool samples by a commercial norovirus enzyme-linked immunosorbent assay kit.

The commercial norovirus enzyme-linked immunosorbent assay kit was evaluated for its reactivity to recombinant virus-like particles and the detection of natural viruses from stool samples of Japanese infants and children with sporadic acute gastroenteritis compared to reverse transcription-PCR. The kit had a sensitivity of 76.3% and a specificity of 94.9%. Our results clearly indicated that the kit allows the detection of the most prevalent genotype, GII/4. In order to increase the sensitivity of the kit, the reactivity with norovirus of GII/3 and GII/6 genotypes needs to be improved.