Dharap's Diagnostic Center, Mumbai, India.
HORIBA Medical, Montpellier, France.
Malar J. 2020 Nov 23;19(1):429. doi: 10.1186/s12936-020-03502-3.
Automated detection of malaria and dengue infection has been actively researched for more than two decades. Although many improvements have been achieved, these solutions remain too expensive for most laboratories and clinics in developing countries. The low range HORIBA Medical Haematology Analyzer, Yumizen H550, now provides dedicated flags 'vivax malaria' and 'dengue fever' in routine blood testing, developed through machine learning methods, to be used as a screening tool for malaria and dengue fever in endemic areas. This study sought to evaluate the effectiveness of these flags under real clinical conditions.
A total of 1420 samples were tested using the Yumizen H550 Haematology Analyzer, including 1339 samples from febrile patients among whom 202 were infected with malaria parasites (Plasmodium vivax only: 182, Plasmodium falciparum only: 18, both: 2), 210 were from febrile dengue infected patients, 3 were from afebrile dengue infected patients and 78 were samples from healthy controls, in an outpatient laboratory clinic in Mumbai, India. Microscopic examination was carried out as the confirmatory reference method for detection of malarial parasite, species identification and assessing parasitaemia based on different stages of parasite life cycle. Rapid diagnostic malarial antigen tests were used for additional confirmation. For dengue infection, NS1 antigen detection by ELISA was used as a diagnostic marker.
For the automated vivax malaria flag, the original manufacturer's cut off yielded a sensitivity and specificity of 65.2% and 98.9% respectively with the ROC AUC of 0.9. After optimization of cut-off value, flag performance improved to 72% for sensitivity and 97.9% specificity. Additionally it demonstrated a positive correlation with increasing levels of parasitaemia. For the automated dengue fever flag it yielded a ROC AUC of 0.82 with 79.3% sensitivity and 71.5% specificity.
The results demonstrate a possibility of the effective use of automated infectious flags for screening vivax malaria and dengue infection in a clinical setting.
自动化检测疟疾和登革热感染已经被研究了二十多年。尽管已经取得了许多进展，但这些解决方案对发展中国家的大多数实验室和诊所来说仍然过于昂贵。现在，堀场医疗的常规血液检测专用仪器 HORIBA Medical Haematology Analyzer，Yumizen H550 通过机器学习方法提供了专门的“间日疟原虫疟疾”和“登革热”标志，作为流行地区疟疾和登革热的筛查工具。本研究旨在评估这些标志在实际临床条件下的有效性。
共对 1420 个样本使用 Yumizen H550 血液分析仪进行了测试，包括来自发热患者的 1339 个样本，其中 202 个样本感染了疟原虫（仅间日疟原虫：182 个，仅恶性疟原虫：18 个，两者均有：2 个），210 个样本来自发热登革热感染患者，3 个样本来自无发热登革热感染患者，78 个样本来自健康对照者，这些样本均来自印度孟买的一个门诊实验室诊所。显微镜检查作为检测疟原虫、物种鉴定和根据寄生虫生命周期不同阶段评估寄生虫血症的确认参考方法。使用快速诊断疟原虫抗原检测法进行额外确认。登革热感染采用 ELISA 检测 NS1 抗原作为诊断标志物。
对于自动化间日疟原虫标志，原始制造商的截止值分别产生了 65.2%的敏感性和 98.9%的特异性，ROC AUC 为 0.9。在优化截止值后，标志性能提高到 72%的敏感性和 97.9%的特异性。此外，它还与寄生虫血症水平的升高呈正相关。对于自动化登革热标志，ROC AUC 为 0.82，敏感性为 79.3%，特异性为 71.5%。
结果表明，在临床环境中，自动化传染病标志可有效用于筛查间日疟原虫和登革热感染。
