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Nanogold Assay Improves Accuracy of Conventional TB Diagnostics

  • Hesham El-Samadony
  • Hassan M. E. Azzazy
  • Mohamed Awad Tageldin
  • Mahmoud E. Ashour
  • Ibrahim M. Deraz
  • Tarek Elmaghraby
RESPIRATORY INFECTIONS
  • 182 Downloads

Abstract

Purpose

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).

Methods

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.

Results

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.

Conclusions

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.

Keywords

Tuberculosis Diagnosis Gold Nanoassay Nanodiagnostics 

Abbreviations

AUC

Area under curve

AuNPs

Gold nanoparticles

CI

Confidence interval

COPD

Chronic obstructive pulmonary disease

CXR

Chest X-ray

DNA

Deoxyribonucleic acid

DOR

Diagnostic odds ratio

EGP

Egyptian pound

NP

Nanoparticle

PA

Posterior–anterior

PCR

Polymerase chain reaction

ROC

Receiver operating characteristic

SSM

Sputum smear microscopy

TB

Tuberculosis

US$

United States dollar

WHO

World Health Organization

Notes

Acknowledgements

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.

Funding

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.

Ethical Approval

The Research Ethics Committee of the Egyptian Ministry of Health approved study protocol (Approval No. 31-2014/8).

Informed Consent

A written informed consent was obtained from all enrolled patients.

Supplementary material

408_2018_194_MOESM1_ESM.docx (94 kb)
Supplementary material 1 (DOCX 93 KB)

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Abbassia Chest HospitalMinistry of HealthCairoEgypt
  2. 2.Department of Chest Diseases, Faculty of MedicineAl-Azhar UniversityCairoEgypt
  3. 3.Department of Chemistry, School of Sciences & EngineeringThe American University in CairoNew CairoEgypt
  4. 4.Department of Chest Diseases, Faculty of MedicineAin Shams UniversityCairoEgypt
  5. 5.Department of Molecular Biology, National Center for Radiation Research and TechnologyAtomic Energy AuthorityCairoEgypt

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