Mallepaddi Prudhvi Chand, Maity Soumendra Nath, Poonati Revathi, Pyadala Nagababu, Polavarapu Rathnagiri, Mangamuri Usha Kiranmayi, Poda Sudhakar
1Department of Biotechnology, Acharya Nagarjuna University, Guntur, Andhra Pradesh India.
Genomix Molecular Diagnostics Pvt. Ltd, 5-36/207, Prashanthinagar, Kukatpally, Hyderabad, Andhra Pradesh 500072 India.
3 Biotech. 2019 Jan;9(1):36. doi: 10.1007/s13205-018-1566-7. Epub 2019 Jan 5.
Malaria is a fatal life-threatening parasitic infection and a leading cause of morbidity and mortality. The present study was aimed to evaluate simple, inexpensive, accurate, reliable, easily available better diagnostic for rapid detection of malaria at point of care (POC). The study includes 1403 samples collected from the patients, of which 1227 were clinically suspected cases and 176 from consecutive feverish patients. Among the suspected cases only 338 samples were confirmed positive and 889 samples were negative for species by PCR. All the 889 samples showed negative result for species by microscopy, Malarial Ag rapid kits but only 867 samples were confirmed negative with malarial Ab rapid kits. Of the 338 PCR positive samples, 337 samples were confirmed positive by microscopy and Malarial Ag rapid kits, but only 284 samples were confirmed positive using malarial Ab rapid kits. Overall the microscopy and the malaria antigen-based lateral flow assay exhibited similar sensitivity, specificity, PPV, NPV and efficiency, respectively, whereas the PCR assay had 100% sensitivity, specificity, PPV, NPV and efficiency. But the evolutionary data for malaria antibody lateral flow assay has 92.81% sensitivity, 94.13% specificity, 84.02% PPV, 97.52% NPV and 93.80% efficiency. The developed Malaria / antigen and antibody field-deployable kits are simple, rapid, accurate, reliable, inexpensive, user friendly, POC. In addition the kits are highly sensitive and species-specific. The / antigen kit is found to be more accurate with 99.7% sensitivity and 100% specificity than to Malaria / antibody rapid kits. Of the two rapid kits developed, Malaria / antigen kit is found be more accurate with 99.7% sensitivity and 100% specificity than to Malaria / antibody rapid kits.
疟疾是一种致命的、威胁生命的寄生虫感染,是发病和死亡的主要原因。本研究旨在评估简单、廉价、准确、可靠、易于获得的更好诊断方法,用于在护理点(POC)快速检测疟疾。该研究包括从患者收集的1403份样本,其中1227份为临床疑似病例,176份来自连续发热患者。在疑似病例中,通过PCR仅338份样本被确认为阳性,889份样本为阴性。所有889份样本通过显微镜检查、疟疾抗原快速检测试剂盒检测均显示为阴性,但使用疟疾抗体快速检测试剂盒仅867份样本被确认为阴性。在338份PCR阳性样本中,337份样本通过显微镜检查和疟疾抗原快速检测试剂盒被确认为阳性,但使用疟疾抗体快速检测试剂盒仅284份样本被确认为阳性。总体而言,显微镜检查和基于疟疾抗原的侧向流动分析分别表现出相似的敏感性、特异性、阳性预测值、阴性预测值和效率,而PCR检测具有100%的敏感性、特异性、阳性预测值、阴性预测值和效率。但疟疾抗体侧向流动分析的进化数据具有92.81%的敏感性、94.13%的特异性、84.02%的阳性预测值、97.52%的阴性预测值和93.80%的效率。所开发的疟疾/抗原和抗体现场可部署试剂盒简单、快速、准确、可靠、廉价、用户友好,适用于护理点。此外,这些试剂盒高度敏感且具有种特异性。发现/抗原试剂盒比疟疾/抗体快速检测试剂盒更准确,敏感性为99.7%,特异性为100%。在所开发的两种快速检测试剂盒中,发现疟疾/抗原试剂盒比疟疾/抗体快速检测试剂盒更准确,敏感性为99.7%,特异性为100%。