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Nanogold Assay Improves Accuracy of Conventional TB Diagnostics

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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.

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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

References

  1. World Health Organization (2017) Global tuberculosis report. WHO, Geneva

    Google Scholar 

  2. World Health Organization (2016) Framework of indicators and targets for laboratory strengthening under the End TB Strategy. WHO, Geneva

    Google Scholar 

  3. World Health Organization (2017) Tuberculosis diagnostics technology landscape. UNITAID Secretariat

  4. World Health Organization (2010) Treatment of tuberculosis: guidelines. WHO, Geneva

    Google Scholar 

  5. Liu W-T (2006) Nanoparticles and their biological and environmental applications. J Biosci Bioeng 102:1–7. https://doi.org/10.1263/jbb.102.1

    Article  CAS  PubMed  Google Scholar 

  6. Azzazy H, Mansour M, Kazmierczak S (2006) Nanodiagnostics: a new frontier for clinical laboratory medicine. Clin Chem 52:1238–1246

    Article  CAS  PubMed  Google Scholar 

  7. El-samadony H, Althani A, Tageldin M, Azzazy H (2017) Nanodiagnostics for tuberculosis detection. Expert Rev Mol Diagn 17:427–443. https://doi.org/10.1080/14737159.2017.1308825

    Article  CAS  PubMed  Google Scholar 

  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)

  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 170:713–716

    Article  Google Scholar 

  10. Siddiqi S, Rüsch-Gerdes S (2006) MGIT™ Procedure Manual

  11. TB Care I (2014) International standards for tuberculosis care, 3rd edn. TB Care I, The Hague

    Google Scholar 

  12. Egyptian Ministry of Health and Poulation-National Tuberculosis Control Program (2017) Tuberculosis Control Guidelines

  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. https://doi.org/10.1093/jac/dkm025

    Article  CAS  PubMed  Google Scholar 

  14. World Health Organization (2014) Mycobacteriology Laboratory Manual, 1st edn. Stop TB Partnership

  15. Shinkins B, Thompson M, Mallett S, Perera R (2013) Diagnostic accuracy studies: how to report and analyse inconclusive test results. BMJ 346:f2778. https://doi.org/10.1136/bmj.f2778

    Article  PubMed  Google Scholar 

  16. Pai M, Schito M (2015) Tuberculosis diagnostics in 2015: landscape, priorities, needs, and prospects. J Infect Dis 211:S21–S28. https://doi.org/10.1093/infdis/jiu803

    Article  PubMed  PubMed Central  Google Scholar 

  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 11:55

    Article  Google Scholar 

  18. Balasubramanian SK, Yang L, Yung LYL et al (2010) Characterization, purification, and stability of gold nanoparticles. Biomaterials 31:9023–9030. https://doi.org/10.1016/j.biomaterials.2010.08.012

    Article  CAS  PubMed  Google Scholar 

  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. https://doi.org/10.5588/ijtld.11.0392

    Article  PubMed  Google Scholar 

  20. World Health Organisation (2014) Xpert MTB/RIF implementation manual

  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:e0131701

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  22. World Health Organization (2012) Public-private partnership announces immediate 40 percent cost reduction for rapid TB test. http://www.who.int/tb/features_archive/GeneXpert_press_release_final.pdf

  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. https://doi.org/10.11604/pamj.2014.18.277.3906

    Article  PubMed  PubMed Central  Google Scholar 

  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. https://doi.org/10.2217/fmb.11.84

    Article  PubMed  PubMed Central  Google Scholar 

  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. https://www.theglobalfund.org/en/portfolio/country/grant/?k=06de34c5-8218-4494-9aea-0eb6fb02d08b&grant=EGY-607-G02-T

  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. https://doi.org/10.1186/1472-6874-11-7

    Article  PubMed  PubMed Central  Google Scholar 

  27. Gill P, Ghaemi A (2008) Nucleic acid isothermal amplification technologies—a review. Nucleosides Nucleotides Nucleic Acids 27:224–243. https://doi.org/10.1080/15257770701845204

    Article  CAS  PubMed  Google Scholar 

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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.

Author information

Author notes

  1. Hesham El-Samadony and Hassan M. E. Azzazy have contributed equally to this work.

Authors and Affiliations

  1. Abbassia Chest Hospital, Ministry of Health, 6 El-Sekka El-Baydaa St, Nasr City, Cairo, 11759, Egypt

    Hesham El-Samadony

  2. Department of Chest Diseases, Faculty of Medicine, Al-Azhar University, Cairo, Egypt

    Hesham El-Samadony, Mahmoud E. Ashour & Ibrahim M. Deraz

  3. Department of Chemistry, School of Sciences & Engineering, The American University in Cairo, P.O. Box 74, New Cairo, 11835, Egypt

    Hassan M. E. Azzazy

  4. Department of Chest Diseases, Faculty of Medicine, Ain Shams University, Cairo, Egypt

    Mohamed Awad Tageldin

  5. Department of Molecular Biology, National Center for Radiation Research and Technology, Atomic Energy Authority, Cairo, Egypt

    Tarek Elmaghraby

Authors
  1. Hesham El-Samadony
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  2. Hassan M. E. Azzazy
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  3. Mohamed Awad Tageldin
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  4. Mahmoud E. Ashour
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  5. Ibrahim M. Deraz
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  6. Tarek Elmaghraby
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Corresponding authors

Correspondence to Hesham El-Samadony or Hassan M. E. Azzazy.

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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.

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El-Samadony, H., Azzazy, H.M.E., Tageldin, M.A. et al. Nanogold Assay Improves Accuracy of Conventional TB Diagnostics. Lung 197, 241–247 (2019). https://doi.org/10.1007/s00408-018-00194-0

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  • DOI: https://doi.org/10.1007/s00408-018-00194-0

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