Tablado Alonso Sara, Biéler Sylvain, Inocêncio da Luz Raquel, Verlé Paul, Büscher Philippe, Hasker Epco
Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.
Neglected Tropical Diseases Program, Foundation for Innovative New Diagnostics, Geneva, Switzerland.
Trop Med Int Health. 2025 Feb;30(2):135-142. doi: 10.1111/tmi.14077. Epub 2024 Dec 23.
Rapid diagnostic tests for the serological detection of gambiense human African trypanosomiasis (gHAT) have been developed to overcome the limitations of the traditional screening method, CATT/T. b. gambiense. The Abbott Bioline human African trypanosomiasis (HAT) 2.0 rapid diagnostic test has recently been developed by Abbott using only recombinant antigens. The objective of this study was to evaluate its clinical sensitivity and specificity, in comparison with the other available rapid diagnostic tests and CATT.
METHODOLOGY/PRINCIPAL FINDINGS: For this study, archived plasma samples from 150 gHAT cases and 150 endemic controls originating from Chad, Guinea, the Democratic Republic of the Congo and Uganda were analysed on the following tests: CATT/T. b. gambiense, the HAT Sero K-SeT, SD BIOLINE HAT and Abbott Bioline HAT 2.0 rapid diagnostic tests, and the immune trypanolysis test. The sensitivity and specificity of Abbott Bioline HAT 2.0 were 96.7% and 78.4%, respectively, and the sensitivity and specificity of SD BIOLINE HAT were 99.3% and 74.1%. The sensitivity and specificity of CATT were 98.7% and 89.2%. The sensitivity and specificity of HAT Sero K-SeT were 99.3% and 81.3%.
CONCLUSIONS/SIGNIFICANCE: The sensitivity and specificity of the Abbott Bioline HAT 2.0 are comparable to those of its predecessors HAT Sero K-SeT and SD BIOLINE HAT. However, considering the decreasing prevalence of gHAT, a higher specificity of the tests used for screening is desirable to improve their positive predictive value.
为克服传统筛查方法——冈比亚布氏锥虫环状抗原卡片试验（CATT/T. b. gambiense）的局限性，已开发出用于血清学检测冈比亚型人类非洲锥虫病（gHAT）的快速诊断检测方法。雅培生物线人类非洲锥虫病（HAT）2.0快速诊断检测方法是雅培公司最近仅使用重组抗体制备的。本研究的目的是将其与其他可用的快速诊断检测方法及CATT相比较，评估其临床敏感性和特异性。
方法/主要发现：在本研究中，对来自乍得、几内亚、刚果民主共和国和乌干达的150例gHAT病例和150例流行区对照的存档血浆样本进行了以下检测：CATT/T. b. gambiense、HAT血清K-SeT、SD生物线HAT和雅培生物线HAT 2.0快速诊断检测方法以及免疫锥虫溶解试验。雅培生物线HAT 2.0的敏感性和特异性分别为96.7%和78.4%，SD生物线HAT的敏感性和特异性分别为99.3%和74.1%。CATT的敏感性和特异性分别为98.7%和89.2%。HAT血清K-SeT的敏感性和特异性分别为99.3%和81.3%。
结论/意义：雅培生物线HAT 2.0的敏感性和特异性与其前身HAT血清K-SeT和SD生物线HAT相当。然而，考虑到gHAT的流行率不断下降，用于筛查的检测方法需要更高的特异性以提高其阳性预测值。
