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Clinical and economic impact of the introduction of a nucleic acid amplification assay for Clostridium difficile

机译:难辨梭菌核酸扩增法的引入对临床和经济的影响

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The clinical outcomes and cost implications of a diagnostic shift from an EIA- to PCR-based assay for Clostridium difficile infection (CDI) have not been completely described in the literature. The impact of the PCR-based assay on the incidence and duration of CDI therapy was compared to the EIA assay for patients with a negative CDI diagnostic result. Secondary clinical and economic outcomes were also evaluated. Independent predictors of receipt of antibiotic therapy were assessed via logistic regression. 141 EIA and 140 PCR patients were included. Significantly more patients were started or continued on anti-CDI antibiotic therapy after a known negative assay result in the EIA group (26 patients vs. 8 patients, P?=?0.002). Duration of antibiotic therapy after a known negative result was significantly shorter in the PCR group (1 vs. 4?days, P?=?0.029) and a 23% reduction in the number of tests obtained per patient was observed (1.41?±?0.86 vs. 1.82?±?1.35, P?=?0.007). The over fourfold difference in per-test cost of the EIA assay ($8.33 vs. $42.86, P?
机译:艰难梭菌感染(CDI)诊断从EIA到PCR的诊断转变的临床结果和成本影响尚未在文献中完整描述。对于那些CDI诊断结果为阴性的患者,将基于PCR的检测对CDI治疗的发生率和持续时间的影响与EIA检测进行了比较。次要临床和经济结果也进行了评估。通过logistic回归评估接受抗生素治疗的独立预测因素。包括141位EIA和140位PCR患者。在EIA组中,已知的阴性结果导致明显更多的患者开始或继续接受抗CDI抗生素治疗(26例vs. 8例,P = 0.002)。在PCR组中,已知阴性结果后的抗生素治疗时间显着缩短(1天比4天,P = 0.029),观察到每位患者的检测数量减少了23%(1.41±±3)。 0.86 vs.1.82±1.35,P = 0.007)。 EIA分析每次测试成本的四倍差异($ 8.33比$ 42.86,P 0.0001)被EIA组增加治疗所需的总体药物成本所抵消($ 546.60比$ 188.96,P == 0.191)。阴性试验后,使用基于EIA的CDI测定与CDI治疗的几率增加相关(aOR 4.71,95%CI 1.93-11.46,P <= 0.001)。从EIA过渡到用于诊断CDI的基于PCR的检测方法的转变,导致治疗结果显着下降,并且治疗结果阴性。治疗的显着减少导致成本降低,从而抵消了对CDI诊断结果阴性的患者使用更昂贵的分子测试的费用。

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