Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                
Skip to main content

Advertisement

Springer Nature Link
Log in

Diagnostic Performances of an in-House Immunochromatography Test Based on the Monoclonal Antibody 18B7 to Glucuronoxylomannan for Clinical Suspected Cryptococcosis: a Large-Scale Prototype Evaluation in Northern Thailand

  • Original Article
  • Published:
Mycopathologia Aims and scope Submit manuscript

Abstract

Objective

Cryptococcosis predominantly presents as a meningoencephalitis in Thailand. Early and expeditious diagnosis is essential for reducing both mortality and morbidity associated with cryptococcal meningitis. We aim to define and establish the diagnostic performances between the benchmark commercially available diagnostic kit (CrAg® LFA) and the large-scale prototype of an inexpensive in-house immunochromatographic test (ICT) based on monoclonal antibody (MAb) 18B7.

Methods

We have developed the large-scale prototype for the rapid detection of cryptococcal polysaccharide antigens by utilizing a single antibody sandwich ICT format employing MAb 18B7, which is highly specific to Cryptococcus neoformans glucuronoxylomannan (GXM) antigens. An in-house MAb18B7 ICT was manufactured in accordance with industry standards under the control of the International Organization for Standardization (ISO) 13485.

Results

The diagnostic sensitivity, specificity, and accuracy for the in-house MAb 18B7 ICT were 99.10%, 97.61%, and 97.83%, respectively. The agreement kappa (κ) coefficient was 0.968 based on the retrospective evaluation of 580 specimens from patients living in northern Thailand with clinically suspected cryptococcosis.

Conclusion

The data suggest that this in-house MAb 18B7 ICT will be highly beneficial for addressing the issue of cryptococcal infection in Thailand. Moreover, it is anticipated that this inexpensive ICT can play a pivotal role in various global strategies aimed at eradicating cryptococcal meningitis among individuals living with HIV by 2030.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Subscribe and save

Springer+ Basic
$34.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or eBook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Rajasingham R, Smith RM, Park BJ, Jarvis JN, Govender NP, Chiller TM, Denning DW, Loyse A, Boulware DR. Global burden of disease of HIV-associated cryptococcal meningitis: an updated analysis. Lancet Infect Dis. 2017;17(8):873–81. https://doi.org/10.1016/S1473-3099(17)30243-8.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Alastruey-Izquierdo A. (2022) WHO fungal priority pathogens list to guide research, development and public health action. World Health Organization: Geneva, Switzerland

  3. Oladele RO, Bongomin F, Gago S, Denning DW. HIV-associated cryptococcal disease in resource-limited settings: a case for “prevention is better than cure”? J Fungi (Basel). 2017;3(4):67. https://doi.org/10.3390/jof3040067.

    Article  PubMed  CAS  Google Scholar 

  4. Ahmad MM, Saqib SE. Pandemic in the land of the smile: the case of COVID-19 outbreak in Thailand in 2020. In: Pal I, Shaw R, editors. Pandemic Risk, Response, and Resilience. Amsterdam: Elsevier; 2022. pp. 41–49.

    Article  Google Scholar 

  5. Otoo JA, Schlappi TS. Reassured multiplex diagnostics: a critical review and forecast. Biosensors (Basel). 2022;12(2):124. https://doi.org/10.3390/bios12020124.

    Article  PubMed  CAS  Google Scholar 

  6. Garcia PJ, You P, Fridley G, Mabey D, Peeling R. Point-of-care diagnostic tests for low-resource settings. Lancet Glob Health. 2015;3(5):e257–8. https://doi.org/10.1016/S2214-109X(15)70089-6.

    Article  PubMed  Google Scholar 

  7. World Health Organization. (2011) Rapid advice: diagnosis, prevention and management of cryptococcal disease in HIV-infected adults, adolescents and children. World Health Organization; 2011. https://iris.who.int/handle/10665/44786

  8. World Health Organization. (2022) Guidelines for diagnosing, preventing and managing cryptococcal disease among adults, adolescents and children living with HIV. World Health Organization; 2022. https://www.ncbi.nlm.nih.gov/books/NBK581832

  9. Wake RM, Govender NP, Omar T, Nel C, Mazanderani AH, Karat AS, Ismail NA, Tiemessen CT, Jarvis JN, Harrison TS. Cryptococcal-related mortality despite fluconazole preemptive treatment in a cryptococcal antigen screen-and-treat program. Clin Infect Dis. 2020;70(8):1683–90. https://doi.org/10.1093/cid/ciz485.

    Article  PubMed  CAS  Google Scholar 

  10. Wake RM, Molloy SF, Jarvis JN, Harrison TS, Govender NP. Cryptococcal antigenemia in advanced human immunodeficiency virus disease: pathophysiology, epidemiology, and clinical implications. Clin Infect Dis. 2023;76(4):764–70. https://doi.org/10.1093/cid/ciac675.

    Article  PubMed  CAS  Google Scholar 

  11. Casadevall A, Cleare W, Feldmesser M, Glatman-Freedman A, Goldman DL, Kozel TR, Lendvai N, Mukherjee J, Pirofski LA, Rivera J. Characterization of a murine monoclonal antibody to Cryptococcus neoformans polysaccharide that is a candidate for human therapeutic studies. Antimicrob Agents Chemother. 1998;42(6):1437–46. https://doi.org/10.1128/AAC.42.6.1437.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  12. Sathongdejwisit P, Pruksaphon K, Intaramat A, Aiumurai P, Sookrung N, Ratanabanangkoon K, Nosanchuk JD, Youngchim S. A Novel, Inexpensive in-house immunochromatographic strip test for cryptococcosis based on the Cryptococcal glucuronoxylomannan specific monoclonal antibody 18B7. Diagnostics (Basel). 2021;11(5):758. https://doi.org/10.3390/diagnostics11050758.

    Article  PubMed  CAS  Google Scholar 

  13. Nimrichter L, Frases S, Cinelli LP, Viana NB, Nakouzi A, Travassos LR, Casadevall A, Rodrigues ML. Self-aggregation of Cryptococcus neoformans capsular glucuronoxylomannan is dependent on divalent cations. Eukaryot Cell. 2007;6(8):1400–10. https://doi.org/10.1128/EC.00122-07.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  14. Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J BioMed Inform. 2014;48:193–204. https://doi.org/10.1016/j.jbi.2014.02.013.

    Article  PubMed  Google Scholar 

  15. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33(1):159–74.

    Article  PubMed  CAS  Google Scholar 

  16. Chayakulkeeree M, Wangchinda P. Clinical characteristics and outcomes of patients with cryptococcal meningoencephalitis in a resource-limited setting. J Med Assoc Thai. 2014;97(Suppl 3):S26-34.

    PubMed  Google Scholar 

  17. Gangcuangco LMA, Sawada I, Tsuchiya N, Do CD, Pham TTT, Rojanawiwat A, Alejandria M, Leyritana K, Yokomaku Y, Pathipvanich P. Regional differences in the prevalence of major opportunistic infections among antiretroviral-naive human immunodeficiency virus patients in Japan, Northern Thailand, Northern Vietnam, and the Philippines. Am J Trop Med Hyg. 2017;97(1):49–56. https://doi.org/10.4269/ajtmh.16-0783.

    Article  PubMed  PubMed Central  Google Scholar 

  18. Johnstone A, Thorpe R. Immunoassays. In: Johnstone A, Thorpe R, editors. Immunochemistry in Practice, 2nd ed, Blackwell Scientific Pub, London; 1988. pp. 257–260.

    Google Scholar 

  19. Chayakulkeeree M, Denning D. Serious fungal infections in Thailand. Eur J Clin Microbiol Infect Dis. 2017;36(6):931–5. https://doi.org/10.1007/s10096-017-2927-6.

    Article  PubMed  CAS  Google Scholar 

  20. Ruxrungtham K, Chokephaibulkit K, Chetchotisakd P, Chariyalertsak S, Kiertburanakul S, Putcharoen O.Thailand national guidelines on HIV/AIDS treatment and prevention 2021/2022. 2023; Nonthaburi: Division of AIDS and STIs, Department of Disease Control, Thailand

  21. Chan-o-Cha P. Thailand’s commitment to global cooperation on NCDs: acting together now. Lancet (London, England). 2019;393(10166):11–3. https://doi.org/10.1016/S0140-6736(18)32347-X.

    Article  PubMed  Google Scholar 

  22. Jarvis JN, Percival A, Bauman S, Pelfrey J, Meintjes G, Williams GN, Longley N, Harrison TS, Kozel TR. Evaluation of a novel point-of-care cryptococcal antigen test on serum, plasma, and urine from patients with HIV-associated cryptococcal meningitis. Clin Infect Dis. 2011;53(10):1019–23. https://doi.org/10.1093/cid/cir613.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  23. Percival A, Thorkildson P, Kozel TR. Monoclonal antibodies specific for immunorecessive epitopes of glucuronoxylomannan, the major capsular polysaccharide of Cryptococcus neoformans, reduce serotype bias in an immunoassay for cryptococcal antigen. Clin Vaccine Immunol. 2011;18(8):1292–6. https://doi.org/10.1128/CVI.05052-11.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  24. Donnelly JP, Chen SC, Kauffman CA, Steinbach WJ, Baddley JW, Verweij PE, Clancy CJ, Wingard JR, Lockhart SR, Groll AH, Sorrell TC, Bassetti M, Akan H, Alexander BD, Andes D, Azoulay E, Bialek R, Bradsher RW, Bretagne S, Calandra T, Caliendo AM, Castagnola E, Cruciani M, Cuenca-Estrella M, Decker CF, Desai SR, Fisher B, Harrison T, Heussel CP, Jensen HE, Kibbler CC, Kontoyiannis DP, Kullberg BJ, Lagrou K, Lamoth F, Lehrnbecher T, Loeffler J, Lortholary O, Maertens J, Marchetti O, Marr KA, Masur H, Meis JF, Morrisey CO, Nucci M, Ostrosky-Zeichner L, Pagano L, Patterson TF, Perfect JR, Racil Z, Roilides E, Ruhnke M, Prokop CS, Shoham S, Slavin MA, Stevens DA, Thompson GR, Vazquez JA, Viscoli C, Walsh TJ, Warris A, Wheat LJ, White PL, Zaoutis TE, Pappas PG. Revision and update of the consensus definitions of invasive fungal disease from the European organization for research and treatment of cancer and the mycoses study group education and research consortium. Clin Infect Dis. 2020;71(6):1367–76. https://doi.org/10.1093/cid/ciz1008.

    Article  PubMed  Google Scholar 

  25. Cano EJ, Yetmar ZA, Razonable RR. Cryptococcus species other than Cryptococcus neoformans and Cryptococcus gattii: are they clinically significant? Open Forum Infect Dis. 2020;7(12):ofaa527. https://doi.org/10.1093/ofid/ofaa527.

    Article  PubMed  PubMed Central  Google Scholar 

  26. Martinez LR, Moussai D, Casadevall A. Antibody to Cryptococcus neoformans glucuronoxylomannan inhibits the release of capsular antigen. Infect Immun. 2004;72(6):3674–9. https://doi.org/10.1128/IAI.72.6.3674-3679.2004.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  27. Messina F, Santiso G, Arechavala A, Romero M, Depardo R, Marin E. Preemptive therapy in cryptococcosis adjusted for outcomes. J Fungi (Basel). 2023;9(6):631. https://doi.org/10.3390/jof9060631.

    Article  PubMed  CAS  Google Scholar 

  28. Meya DB, Manabe YC, Castelnuovo B, Cook BA, Elbireer AM, Kambugu A, Kamya MR, Bohjanen PR, Boulware DR. Cost-effectiveness of serum cryptococcal antigen screening to prevent deaths among HIV-infected persons with a CD4+ cell count ≤ 100 cells/μL who start HIV therapy in resource-limited settings. Clin Infect Dis. 2010;51(4):448–55. https://doi.org/10.1086/655143.

    Article  PubMed  Google Scholar 

  29. Limper AH, Adenis A, Le T, Harrison TS. Fungal infections in HIV/AIDS. Lancet Infect Dis. 2017;17(11):e334–43. https://doi.org/10.1016/S1473-3099(17)30303-1.

    Article  PubMed  Google Scholar 

  30. Sloan DJ, Parris V. Cryptococcal meningitis: epidemiology and therapeutic options. Clin Epidemiol. 2014;6:169–82. https://doi.org/10.2147/CLEP.S38850.

    Article  PubMed  PubMed Central  Google Scholar 

  31. Harris JR, Lindsley MD, Henchaichon S, Poonwan N, Naorat S, Prapasiri P, Chantra S, Ruamcharoen F, Chang LS, Chittaganpitch M. High prevalence of cryptococcal infection among HIV-infected patients hospitalized with pneumonia in Thailand. Clin Infect Dis. 2012;54(5):e43-50. https://doi.org/10.1093/cid/cir903.

    Article  PubMed  Google Scholar 

  32. Frases S, Nimrichter L, Viana NB, Nakouzi A, Casadevall A. Cryptococcus neoformans capsular polysaccharide and exopolysaccharide fractions manifest physical, chemical, and antigenic differences. Eukaryot Cell. 2008;7(2):319–27. https://doi.org/10.1128/EC.00378-07.

    Article  PubMed  CAS  Google Scholar 

  33. McFadden DC, Fries BC, Wang F, Casadevall A. Capsule structural heterogeneity and antigenic variation in Cryptococcus neoformans. Eukaryot Cell. 2007;6(8):1464–73. https://doi.org/10.1128/EC.00162-07.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  34. Poonwan N, Mikami Y, Poosuwan S, Boon-Long J, Mekha N, Kusum M, Yazawa K, Tanaka R, Nishimura K, Konyama K. Serotyping of Cryptococcus neoformans strains isolated from clinical specimens in Thailand and their susceptibility to various antifungal agents. Eur J Epidemiol. 1997;13(3):335–40. https://doi.org/10.1023/a:1007376917836.

    Article  PubMed  CAS  Google Scholar 

  35. Sriburee P, Khayhan S, Khamwan C, Panjaisee S, Tharavichitkul P. Serotype and PCR-fingerprints of clinical and environmental isolates of Cryptococcus neoformans in Chiang Mai. Thailand Mycopathologia. 2004;158(1):25–31. https://doi.org/10.1023/b:myco.0000038435.14281.f4.

    Article  PubMed  CAS  Google Scholar 

  36. Kuroki M, Phichaichumpon C, Yasuoka A, Chiranairadul P, Chosa T, Sirinirund P, Miyazaki T, Kakeya H, Higashiyama Y, Miyazaki Y. Environmental isolation of Cryptococcus neoformans from an endemic region of HIV-associated cryptococcosis in Thailand. Yeast. 2004;21(10):809–12. https://doi.org/10.1002/yea.1112.

    Article  PubMed  CAS  Google Scholar 

  37. Khayhan K, Hagen F, Pan W, Simwami S, Fisher MC, Wahyuningsih R, Chakrabarti A, Chowdhary A, Ikeda R, Taj-Aldeen SJ. Geographically structured populations of Cryptococcus neoformans variety grubii in Asia correlate with HIV status and show a clonal population structure. PLoS ONE. 2013;8(9):e72222. https://doi.org/10.1371/journal.pone.0072222.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  38. Tangwattanachuleeporn M, Somparn P, Poolpol K, Gross U, Weig M, Bader O. Prevalence and antifungal susceptibility of Cryptococcus neoformans isolated from pigeon excreta in Chon Buri Province. Eastern Thailand Med Mycol J. 2013;54(3):303–7. https://doi.org/10.3314/mmj.54.303.

    Article  PubMed  Google Scholar 

  39. Raviglione M, Maher D. Ending infectious diseases in the era of the sustainable development goals. Porto Biomed J. 2017;2(5):140–2. https://doi.org/10.1016/j.pbj.2017.08.001.

    Article  PubMed  Google Scholar 

  40. Shroufi A, Chiller T, Jordan A, Denning DW, Harrison TS, Govender NP, Loyse A, Baptiste S, Rajasingham R, Boulware DR. Ending deaths from HIV-related cryptococcal meningitis by 2030. Lancet Infect Dis. 2021;21(1):16–8. https://doi.org/10.1016/S1473-3099(20)30909-9.

    Article  PubMed  Google Scholar 

  41. Sati H, Alastruey-Izquierdo A, Perfect J, Govender NP, Harrison TS, Chiller T, Sorrell TC, Bongomin F, Oladele R, Chakrabarti A. HIV and fungal priority pathogens. Lancet HIV. 2023;10(11):e750–4. https://doi.org/10.1016/S2352-3018(23)00174-1.

    Article  PubMed  CAS  Google Scholar 

  42. Nanthaprut P, Manojai N, Chanlearn P, Mattawanon N, Chiawkhun P, Homkham N, Traisathit P. Comparison of HIV-positive incidence among transgender women and men who have sex with men at stand-alone and mobile voluntary counseling and testing facilities in Chiang Mai province. Thailand AIDS Patient Care STDs. 2021;35(4):116–25. https://doi.org/10.1089/apc.2020.0258.

    Article  PubMed  Google Scholar 

  43. Chariyalertsak S, Kosachunhanan N, Saokhieo P, Songsupa R, Wongthanee A, Chariyalertsak C, Visarutratana S, Beyrer C. HIV incidence, risk factors, and motivation for biomedical intervention among gay, bisexual men, and transgender persons in Northern Thailand. PLoS ONE. 2011;6(9):e24295. https://doi.org/10.1371/journal.pone.0024295.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

Download references

Acknowledgements

We are grateful to the Microbiology Unit, Diagnostic Laboratory of Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, for supplying clinical samples.

Funding

This research was funded by Chiang Mai University (Grant No. TGCMU 2566P009/2566). This work is supported by Walailak University under the New Researcher Development scheme (Contract Number WU67202). Joshua D. Nosanchuk is supported in part by US NIH AI171093, AI183314, and AI156104.

Author information

Authors and Affiliations

  1. Department of Medical Technology, School of Allied Health Sciences, Walailak University, Nakhon Si Thammarat, 80160, Thailand

    Kritsada Pruksaphon

  2. Center of Excellence Research for Melioidosis and Microorganisms (CERMM), Walailak University, Nakhon Si Thammarat, 80160, Thailand

    Kritsada Pruksaphon

  3. Office of Research Administration, Chiang Mai University, Chiang Mai, 50200, Thailand

    Artid Amsri

  4. Department of Microbiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand

    Artid Amsri, Patcharin Thammasit & Sirida Youngchim

  5. Department of Medicine (Division of Infectious Diseases), Department of Microbiology and Immunology, Albert Einstein College of Medicine, Bronx, NY, 10461, USA

    Joshua D. Nosanchuk

  6. Center of Research Excellence in Allergy and Immunology, Research Department, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, 10700, Thailand

    Pisinee Aiumurai

Authors
  1. Kritsada Pruksaphon
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Artid Amsri
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Patcharin Thammasit
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Joshua D. Nosanchuk
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Pisinee Aiumurai
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Sirida Youngchim
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

Kritsada Pruksaphon: Conceptualization; Funding acquisition; Methodology; Investigation; Validation; Formal analysis; Data curation; Writing—original draft. Artid Amsri: Conceptualization; Methodology; Investigation; Formal analysis; Visualization Data curation; Writing—original draft. Patcharin Thammasit: Data curation; Visualization; Formal analysis. Joshua D. Nosanchuk: Writing—review & editing; Data curation; Funding acquisition; Resources. Pisinee Aiumurai: Methodology; Data curation. Sirida Youngchim: Conceptualization; Funding acquisition; Writing—review & editing; Project administration; Formal analysis; Data curation; Supervision; Visualization.

Corresponding author

Correspondence to Sirida Youngchim.

Ethics declarations

Conflict of interest

All authors declare no conflict of interest. Neither of the diagnostic test manufacturing companies were involved in the design of the experiment, data collection or analysis, or the manuscript’s writing.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Handling Editor: Min Chen.

Supplementary Information

Below is the link to the electronic supplementary material.

11046_2024_882_MOESM1_ESM.tif

Supplementary file1 Supplementary Figure 1. Region in upper Northern Thailand from which clinical samples were evaluated. Maharaj Nakorn Chiang Mai Hospital (red pinpoint) is a tertiary care, regional-level hospital responsible for public health management within the upper northern region of Thailand (the deep gray zone), encompassing 9 provinces. Additionally, the northern region of Thailand, particularly Chiang Mai province, has one of the highest incidence rates of HIV, second only to Bangkok, the capital city of Thailand [42,43]. (TIF 1716 KB)

11046_2024_882_MOESM2_ESM.tif

Supplementary file2 Figure 2. The confusion matrix of 580 patients with suspected cryptococcosis investigated with the in-house MAb18B7 ICT. (TIF 583 KB)

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Pruksaphon, K., Amsri, A., Thammasit, P. et al. Diagnostic Performances of an in-House Immunochromatography Test Based on the Monoclonal Antibody 18B7 to Glucuronoxylomannan for Clinical Suspected Cryptococcosis: a Large-Scale Prototype Evaluation in Northern Thailand. Mycopathologia 189, 75 (2024). https://doi.org/10.1007/s11046-024-00882-x

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1007/s11046-024-00882-x

Keywords

Search

Navigation