Evaluation of Fungitell (1,3)-β-D-glucan assay in tear samples for rapid diagnosis of fungal keratitis.

IF 6.1 2区 医学 Q1 MICROBIOLOGY Journal of Clinical Microbiology Pub Date : 2024-11-06 DOI:10.1128/jcm.01200-24
Yamini Tawde, Sourav Das, Shreya Singh, Soham Basak, Savitri Sharma, Amit Gupta, Shivaprakash M Rudramurthy, Geetika Yadav, Anup Ghosh
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Abstract

Fungal keratitis (FK) is a serious suppurative and ulcerative corneal infection leading to blindness and vision loss. Rapid diagnosis of FK can contribute to prompt clinical management with early recovery. The study aimed to standardize the detection of (1,3)-β-D-glucan (BDG) and establish the diagnostic cut-off concentration in tears of suspected FK patients along with non-infected controls. This prospective multicentric study was conducted between the period of August 2022 and April 2024. Samples were collected from three tertiary eye-care facilities across India. All suspected FK patients were enrolled in the study. Prior to tear collection, the eye and eyelid were gently cleansed using sterile normal saline (NS) and lint-free tissue paper. Subsequently, 50 µL of sterile NS was instilled into the eye, followed by tear sample collection after 60 s using sterile fine microtips. Tear samples were collected from the contralateral eyes of the FK patients, and those from healthy volunteers served as controls. The concentration of BDG in tears in varying dilutions was quantitatively measured using the Fungitell Assay Kit (Associates of Cape Cod, East Falmouth, Massachusetts). A total of 53 tear samples were analyzed at 1:10 and 1:20 dilutions. The receiver operating curve revealed an area under the curve (AUC) of 0.919 for the 1:10 dilution, with a cut-off value of 123 pg/mL, yielding a sensitivity of 100% and specificity of 84.85%. The corresponding Youden Index was 0.798. At the 1:20 dilution, the AUC was 0.898 with a cut-off of 84 pg/mL, achieving a sensitivity of 70% and specificity of 96.88% with a Youden Index of 0.670. Given the higher specificity at the 1:20 dilution, it was further validated in 145 tear samples. The validation cohort demonstrated a sensitivity of 95.56%, specificity of 83%, positive predictive value (PPV) of 71.67%, negative predictive value (NPV) of 97.65%, and diagnostic odds ratio of 112.4. Notably, a significantly higher BDG concentration (P < 0.0001) was observed in infected tear samples compared to controls (270.6 ± 128.5 vs 37.31 ± 31.32). Detection of BDG in tear samples is a new, non-invasive, and rapid technique showing excellent performance and can be effectively implemented for diagnosing FK in laboratories.

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评估用于快速诊断真菌性角膜炎的泪液样本中 Fungitell (1,3)-β-D 葡聚糖测定法。
真菌性角膜炎(FK)是一种严重的化脓性和溃疡性角膜感染,可导致失明和视力下降。快速诊断 FK 有助于及时进行临床治疗,使患者早日康复。该研究旨在对疑似 FK 患者和非感染对照者泪液中的(1,3)-β-D-葡聚糖(BDG)进行标准化检测,并确定诊断临界浓度。这项前瞻性多中心研究于 2022 年 8 月至 2024 年 4 月期间进行。样本采集自印度的三家三级眼科医疗机构。所有疑似 FK 患者都参加了这项研究。采集泪液前,使用无菌生理盐水(NS)和无绒面纸轻轻清洁眼球和眼睑。随后,将 50 µL 无菌 NS 注入眼球,60 秒后使用无菌细微吸头采集泪液样本。从 FK 患者的对侧眼和健康志愿者的对侧眼采集泪液样本作为对照。使用 Fungitell 分析试剂盒(Associates of Cape Cod,East Falmouth,Massachusetts)定量检测不同稀释度泪液中的 BDG 浓度。共分析了 53 份 1:10 和 1:20 稀释度的泪液样本。接收器工作曲线显示,1:10 稀释度的曲线下面积(AUC)为 0.919,临界值为 123 pg/mL,灵敏度为 100%,特异性为 84.85%。相应的尤登指数为 0.798。在 1:20 稀释度下,AUC 为 0.898,临界值为 84 pg/mL,灵敏度为 70%,特异度为 96.88%,尤登指数为 0.670。鉴于 1:20 稀释度的特异性更高,该方法在 145 份泪液样本中进行了进一步验证。验证队列显示灵敏度为 95.56%,特异性为 83%,阳性预测值 (PPV) 为 71.67%,阴性预测值 (NPV) 为 97.65%,诊断几率比为 112.4。值得注意的是,与对照组(270.6 ± 128.5 vs 37.31 ± 31.32)相比,受感染泪液样本中的 BDG 浓度明显更高(P < 0.0001)。检测泪液样本中的 BDG 是一种新型、非侵入性、快速的技术,具有卓越的性能,可有效用于实验室诊断 FK。
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来源期刊
Journal of Clinical Microbiology
Journal of Clinical Microbiology 医学-微生物学
CiteScore
17.10
自引率
4.30%
发文量
347
审稿时长
3 months
期刊介绍: The Journal of Clinical Microbiology® disseminates the latest research concerning the laboratory diagnosis of human and animal infections, along with the laboratory's role in epidemiology and the management of infectious diseases.
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