Nanogold Assay Improves Accuracy of Conventional TB Diagnostics
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TB nanodiagnostics have witnessed considerable development. However, most of the published reports did not proceed beyond proof-of-concept. Our objectives are to evaluate the diagnostic accuracy of a novel nanogold assay in detecting patients with active pulmonary TB based on results of BACTEC MGIT (reference test), and to compare its clinical performance to combined use of sputum smear microscopy (SSM) with chest X-ray (CXR).
This is a case–control study that involved 20 active TB patients; 20 non-TB chest patients with a previous history of TB infection; 20 non-TB chest patients without a previous history of TB infection.
Sensitivity and specificity of TB nanogold assay were 95% and 100%, respectively, with diagnostic odds ratio (DOR) of 1053.0. ROC curve analysis yielded an area under curve (AUC) of 0.975. TB nanogold assay generated higher performance than combined use of SSM with CXR. The DOR and AUC differences were 996.0 and 0.125, respectively.
Our study shows that TB nanogold assay is accurate, rapid, and holds the potential for use as an add-on initial test to improve accuracy of SSM and CXR in detecting patients of active pulmonary TB in developing countries. Future studies should involve larger sample size for further assessment of test accuracy.
KeywordsTuberculosis Diagnosis Gold Nanoassay Nanodiagnostics
Area under curve
Chronic obstructive pulmonary disease
Diagnostic odds ratio
Polymerase chain reaction
Receiver operating characteristic
Sputum smear microscopy
United States dollar
World Health Organization
The authors thank Mohamed E. Salem for statistical advices; physicians and nurses at Abbassia Chest Hospital, Ministry of Health, Cairo Egypt, who involved with recruiting study participants and collecting clinical samples; Heba Othman, Amira Mansour, and other members of Novel Diagnostics and Therapeutics Research Group, School of Sciences and Engineering, the American University in Cairo, Egypt, for their technical advice on gold nanoparticles synthesis and characterization, and reading the colorimetric result of TB Nanogold assay for studied patients.
This work was funded by the Arab Company of Drug Industry and Medical Appliances (ACDIMA), Egypt.
Compliance with Ethical Standards
Conflict of interest
HMEA is a co-founder of D-Kimia, LLC, a novel diagnostic solutions company and author of patents on use of gold nanoparticles for detection of infectious agents. Other authors declare no competing interest.
The Research Ethics Committee of the Egyptian Ministry of Health approved study protocol (Approval No. 31-2014/8).
A written informed consent was obtained from all enrolled patients.
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