背景:半乳甘露聚糖酶免疫分析(GM-EIA)被证明是诊断COVID-19相关肺曲霉病(CAPA)的基石,它在中低收入国家的使用有限,其中应用简单快速的测试,包括半乳甘露聚糖侧流测定(GM-LFA),高度赞赏。尽管有这些优点,有限的研究直接比较了GM-LFA和GM-EIA。在这里,我们比较了GM-LFA的诊断特征,GM-EIA和支气管肺泡灌洗(BAL)培养用于伊朗CAPA诊断,一个发展中国家。
方法:GM-LFA和GM-EIA对BAL(GM指数≥1)和血清(GM指数>0.5)的诊断性能,即灵敏度,特异性,阳性预测值(PPV)和阴性预测值(NPV)以及曲线下面积(AUC),使用重症监护病房机械通气COVID-19患者的BAL(n=105)和血清(n=101)样本进行评估。根据宿主因素的存在对患者进行分类,根据2020年ECMM/ISHAMCAPA诊断共识标准的放射学发现和真菌学证据。
结果:曲霉GM-LFA对血清和BAL样品的敏感性分别为56.3%和60.6%,特异性为94.2%和88.9%,PPV为81.8%和71.4%,净现值分别为82.3%和83.1%,与BAL文化相比,分别。GM-EIA的敏感性分别为46.9%和54.5%,100%和91.7%的特异性,100%和75%的PPV,血清和BAL样本的NPV分别为80.2%和81.5%,分别。
结论:我们的研究发现GM-LFA是一种可靠的简单快速的诊断工具,这可以避免培养和GM-EIA的缺点,并在及时开始抗真菌治疗中至关重要。
BACKGROUND: Galactomannan Enzyme Immunoassay (GM-EIA) is proved to be a cornerstone in the diagnosis of COVID-19-associated pulmonary aspergillosis (CAPA), its use is limited in middle and low-income countries, where the application of simple and rapid test, including Galactomannan Lateral Flow Assay (GM-LFA), is highly appreciated. Despite such merits, limited studies directly compared GM-LFA with GM-EIA. Herein we compared the diagnostic features of GM-LFA, GM-EIA and bronchoalveolar lavage (BAL) culture for CAPA diagnosis in Iran, a developing country.
METHODS: Diagnostic performances of GM-LFA and GM-EIA in BAL (GM indexes ≥1) and serum (GM indexes >0.5), i.e. sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) and areas under the curve (AUC), were evaluated using BAL (n = 105) and serum (n = 101) samples from mechanically ventilated COVID-19 patients in intensive care units. Patients were classified based on the presence of host factors, radiological findings and mycological evidences according to 2020 ECMM/ISHAM consensus criteria for CAPA diagnosis.
RESULTS: The Aspergillus GM-LFA for serum and BAL samples showed a sensitivity of 56.3% and 60.6%, specificity of 94.2% and 88.9%, PPV of 81.8% and 71.4%, NPV of 82.3% and 83.1%, when compared with BAL culture, respectively. GM-EIA showed sensitivities of 46.9% and 54.5%, specificities of 100% and 91.7%, PPVs of 100% and 75%, NPVs of 80.2% and 81.5% for serum and BAL samples, respectively.
CONCLUSIONS: Our study found GM-LFA as a reliable simple and rapid diagnostic tool, which could circumvent the shortcomings of culture and GM-EIA and be pivotal in timely initiation of antifungal treatment.