Zamil Md Fahad, Hasan Anamul, Trina Afrida Tabassum, Hossain Mohammad Sharif, Afreen Sajia, Kumkum Asifa, Ahmed Dilruba, Alam Mohammad Shafiul
Infectious Diseases Division, International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.
Clinical and Diagnostic Services, Office of Executive Director, International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.
BMC Infect Dis. 2025 Aug 7;25(1):991. doi: 10.1186/s12879-025-11411-6.
Dengue fever poses an extreme public health risk in the tropical and subtropical zones around the world. Prompt and correct diagnosis is critical for dengue case management and control. Dengue NS1 antigen detection is the basic diagnostic method for dengue. Although PCR is the gold standard for detecting dengue, it is expensive, equipment-intensive, and requires skilled personnel posing major challenges for many healthcare facilities. A rapid and affordable diagnostic method for dengue is essential to address these limitations.
This study examine the clinical performance of OnSite Dengue Ag Rapid Test (developed by CTK Biotech Inc., Poway, CA, USA) utilizing 316 symptomatic patients from three outreach centers of icddr, b diagnostic unit of Dhaka, Bangladesh. RT-PCR was used as the gold standard and Bioline™ Dengue NS1 Ag (developed by Abbott Laboratories, Illinois, U.S.) was used as comparator.
The Overall sensitivity and specificity of OnSite Dengue Ag Rapid Test were 96.93% (95% CI: 95.03%- 98.83%) and 99.35% (95% CI: 98.46-100.23%) respectively against RT-PCR. These values were slightly higher than those of comparator device, which demonstrated sensitivity and specificity of 93.87% (95% CI: 91.22%-96.51%) and 96.73% (95% CI: 94.77%-98.69%) respectively. Between two and five days following the onset of fever, the RDT kit can detect patients and is able to detect dengue NS1 even in samples with very low viral load (high RT-PCR Ct values ≤ 36.96), indicating its high sensitivity and accuracy.
OnSite Dengue Ag Rapid Test demonstrated substantial potential for clinical diagnosis of symptomatic dengue patients, providing a fast, cheap and reliable detection method. Its simplicity, ease of use and minimal equipment requirements make it highly suitable for use in diverse healthcare settings, particularly in resource-limited areas around the world.
登革热在全球热带和亚热带地区构成了极其严重的公共卫生风险。及时、正确的诊断对于登革热病例的管理和控制至关重要。登革热NS1抗原检测是登革热的基本诊断方法。虽然聚合酶链反应（PCR）是检测登革热的金标准，但它成本高昂、设备要求高，且需要技术熟练的人员，这给许多医疗机构带来了重大挑战。因此，一种快速且经济实惠的登革热诊断方法对于克服这些局限性至关重要。
本研究利用来自孟加拉国达卡icddr，b诊断单位三个外展中心的316例有症状患者，检测了现场登革热抗原快速检测试剂盒（由美国加利福尼亚州波威市的CTK生物技术公司开发）的临床性能。以逆转录聚合酶链反应（RT-PCR）作为金标准，以雅培公司（美国伊利诺伊州）开发的Bioline™登革热NS1抗原检测试剂盒作为对照。
与RT-PCR相比，现场登革热抗原快速检测试剂盒的总体灵敏度和特异性分别为96.93%（95%置信区间：95.03%-98.83%）和99.35%（95%置信区间：98.46-100.23%）。这些数值略高于对照设备，对照设备的灵敏度和特异性分别为93.87%（95%置信区间：91.22%-96.51%）和96.73%（95%置信区间：94.77%-98.69%）。在发热开始后的两到五天内，该快速检测试剂盒能够检测出患者，甚至在病毒载量非常低（RT-PCR Ct值高≤36.96）的样本中也能检测到登革热NS1，表明其具有高灵敏度和准确性。
现场登革热抗原快速检测试剂盒在有症状登革热患者的临床诊断中显示出巨大潜力，提供了一种快速、廉价且可靠的检测方法。其简单性、易用性和对设备要求极低，使其非常适合在各种医疗环境中使用，特别是在全球资源有限的地区。
