pp 1–7 | Cite as

Nanogold Assay Improves Accuracy of Conventional TB Diagnostics

  • Hesham El-SamadonyEmail author
  • Hassan M. E. AzzazyEmail author
  • Mohamed Awad Tageldin
  • Mahmoud E. Ashour
  • Ibrahim M. Deraz
  • Tarek Elmaghraby



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.


Tuberculosis Diagnosis Gold Nanoassay Nanodiagnostics 



Area under curve


Gold nanoparticles


Confidence interval


Chronic obstructive pulmonary disease


Chest X-ray


Deoxyribonucleic acid


Diagnostic odds ratio


Egyptian pound






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.

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)


  1. 1.
    World Health Organization (2017) Global tuberculosis report. WHO, GenevaGoogle Scholar
  2. 2.
    World Health Organization (2016) Framework of indicators and targets for laboratory strengthening under the End TB Strategy. WHO, GenevaGoogle Scholar
  3. 3.
    World Health Organization (2017) Tuberculosis diagnostics technology landscape. UNITAID SecretariatGoogle Scholar
  4. 4.
    World Health Organization (2010) Treatment of tuberculosis: guidelines. WHO, GenevaGoogle Scholar
  5. 5.
    Liu W-T (2006) Nanoparticles and their biological and environmental applications. J Biosci Bioeng 102:1–7. CrossRefGoogle Scholar
  6. 6.
    Azzazy H, Mansour M, Kazmierczak S (2006) Nanodiagnostics: a new frontier for clinical laboratory medicine. Clin Chem 52:1238–1246CrossRefGoogle Scholar
  7. 7.
    El-samadony H, Althani A, Tageldin M, Azzazy H (2017) Nanodiagnostics for tuberculosis detection. Expert Rev Mol Diagn 17:427–443. CrossRefGoogle Scholar
  8. 8.
    El-Samadony H, Ashour M, Deraz I et al (2017) Sensitivity and specificity of a novel nanogold assay in detecting patients with active pulmonary TB. In: 48th World Conference on Lung Health of the International Union Against Tuberculosis and Lung Disease (The Union)Google Scholar
  9. 9.
    Kennedy N, Gillespie SH, Saruni AOS et al (1995) Polymerase chain reaction for assessing treatment response in patients with pulmonary tuberculosis. J Infect Dis 170:713–716CrossRefGoogle Scholar
  10. 10.
    Siddiqi S, Rüsch-Gerdes S (2006) MGIT™ Procedure ManualGoogle Scholar
  11. 11.
    TB Care I (2014) International standards for tuberculosis care, 3rd edn. TB Care I, The HagueGoogle Scholar
  12. 12.
    Egyptian Ministry of Health and Poulation-National Tuberculosis Control Program (2017) Tuberculosis Control GuidelinesGoogle Scholar
  13. 13.
    Fortun J, Martıin-Davila P, Molina A et al (2007) Sputum conversion among patients with pulmonary tuberculosis: are there implications for removal of respiratory isolation ? J Antimicrob Chemother 59:794–798. CrossRefGoogle Scholar
  14. 14.
    World Health Organization (2014) Mycobacteriology Laboratory Manual, 1st edn. Stop TB PartnershipGoogle Scholar
  15. 15.
    Shinkins B, Thompson M, Mallett S, Perera R (2013) Diagnostic accuracy studies: how to report and analyse inconclusive test results. BMJ 346:f2778. CrossRefGoogle Scholar
  16. 16.
    Pai M, Schito M (2015) Tuberculosis diagnostics in 2015: landscape, priorities, needs, and prospects. J Infect Dis 211:S21–S28. CrossRefGoogle Scholar
  17. 17.
    Turkevich J, Stevenson PC, Hillier J (1951) A study of the nucleation and growth processes in the synthesis of colloidal gold. Discuss Faraday Soc 11:55CrossRefGoogle Scholar
  18. 18.
    Balasubramanian SK, Yang L, Yung LYL et al (2010) Characterization, purification, and stability of gold nanoparticles. Biomaterials 31:9023–9030. CrossRefGoogle Scholar
  19. 19.
    Trébucq A, Enarson DA, Chiang CY et al (2011) Xpert® MTB/RIF for national tuberculosis programmes in low-income countries: when, where and how? Int J Tuberc Lung Dis 15:1567–1571. CrossRefGoogle Scholar
  20. 20.
    World Health Organisation (2014) Xpert MTB/RIF implementation manualGoogle Scholar
  21. 21.
    Wong G, Wong I, Chan K et al (2015) A rapid and low-cost PCR thermal cycler for low resource settings. PLoS ONE 10:e0131701CrossRefGoogle Scholar
  22. 22.
    World Health Organization (2012) Public-private partnership announces immediate 40 percent cost reduction for rapid TB test.
  23. 23.
    Abdurrahman ST, Emenyonu N, Obasanya OJ et al (2014) The hidden costs of installing xpert machines in a Tuberculosis [TB] high-burden country: experiences from Nigeria. Pan Afr Med J 18:277. CrossRefGoogle Scholar
  24. 24.
    Lawn S, Nicol M (2011) Xpert® MTB/RIF assay: development, evaluation and implementation of a new rapid molecular diagnostic for tuberculosis and rifampicin resistance. Future Microbiol 6:1067–1082. CrossRefGoogle Scholar
  25. 25.
    THE GLOBAL FUND (2008) Support of National plan for control of Tuberculosis, EGY-607-G02-T. In: Glob. Fund to Fight AIDS, Tuberc. Malar.
  26. 26.
    Morris RK, Selman TJ, Zamora J, Khan KS (2011) Methodological quality of test accuracy studies included in systematic reviews in obstetrics and gynaecology: sources of bias. BMC Womens Health 11:7. CrossRefGoogle Scholar
  27. 27.
    Gill P, Ghaemi A (2008) Nucleic acid isothermal amplification technologies—a review. Nucleosides Nucleotides Nucleic Acids 27:224–243. CrossRefGoogle Scholar

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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