Shah Malay Ilesh, Joseph Jayaraj, Sanne Ujwal Sriharsha, Sivaprakasam Mohanasankar
Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:4247-4250. doi: 10.1109/EMBC.2017.8037794.
There is a vital need for portable and cost-effective point-of-care (PoC) testing technologies that provide reliable and rapid results. Lateral Flow Immunoassays (LFIA) are suitable PoC diagnostic tools with the potential for use in a wide variety of field applications ranging from uses in clinical diagnostics to aiding law enforcement. Quick and reliable diagnosis of non-communicable diseases (NCD) like diabetes is vital especially in developing countries like India where the burden of these diseases is very high and is increasing day by day. In this paper, we have presented the design of smartphone-based fully quantitative LFIA analyser, An automatic image processing algorithm is also described. A repeatability study was done with stable fluorescence reference cartridges. The Coefficient of Variation (CoV) for repeatability study was calculated and it was found to be good (<; 1.5%). The instrument was tested with blood samples to generate a calibration curve for Glycated Haemoglobin (HbA1c) with respect to standard lab instrument. Three different set of settings parameters were used in smartphone camera their calibration curve formed. All three curves were linearly correlated with R-value greater than 0.985. Finally, the calibration curve was validated through three HbA1c blood sample tests- for each sample, CoV was less than 5%. The PhoneQuant analyser is the portable cost-effective solution to traditional bulky LFIA analysers and it has good potential to be deployed at physician's desk or for in-home PoC testing for quick and reliable diagnosis.
迫切需要便携式且经济高效的即时检测(PoC)技术,以提供可靠且快速的结果。侧向流动免疫分析(LFIA)是适用的即时诊断工具,有潜力用于从临床诊断到协助执法等广泛的现场应用。对糖尿病等非传染性疾病(NCD)进行快速可靠的诊断至关重要,特别是在印度等发展中国家,这些疾病的负担非常高且日益加重。在本文中,我们展示了基于智能手机的全定量LFIA分析仪的设计,还描述了一种自动图像处理算法。使用稳定的荧光参考试剂盒进行了重复性研究。计算了重复性研究的变异系数(CoV),发现结果良好(<1.5%)。用血液样本对该仪器进行测试,以生成相对于标准实验室仪器的糖化血红蛋白(HbA1c)校准曲线。在智能手机相机中使用了三组不同的设置参数来形成其校准曲线。所有三条曲线均呈线性相关,R值大于0.985。最后,通过三次HbA1c血液样本测试对校准曲线进行了验证——对于每个样本,CoV均小于5%。PhoneQuant分析仪是传统笨重LFIA分析仪的便携式经济高效解决方案,具有很好的潜力可部署在医生办公桌旁或用于家庭即时检测,以实现快速可靠的诊断。