World Health Organization , 2020. Ending the Neglect to Attain the Sustainable Development Goals: A Road Map for Neglected Tropical Diseases 2021–2030. Geneva, Switzerland: WHO.
World Health Organization , 2021. Leishmaniasis. Geneva, Switzerland: WHO.
Selvapandiyan A , Croft SL , Rijal S , Nakhasi HL , Ganguly NK , 2019. Innovations for the elimination and control of visceral leishmaniasis. PLoS Negl Trop Dis 13: 1–5.
Castellanos-Gonzalez A , White AC , Melby P , Travi B , 2018. Molecular diagnosis of protozoan parasites by recombinase polymerase amplification. Acta Trop 182: 4–11.
Gunaratna G et al., 2018. Evaluation of rapid extraction and isothermal amplification techniques for the detection of Leishmania donovani DNA from skin lesions of suspected cases at the point of need in Sri Lanka. Parasit Vectors 11: 1–7.
Burza S , Croft SL , Boelaert M , 2018. Leishmaniasis. Lancet 392: 951–970.
Sundar S , Singh OP , 2018. Molecular diagnosis of visceral leishmaniasis. Mol Diagn Ther 22: 443–457.
Al-Hail H , Mirza F , Al Hashemi A , Ahmad MN , Iqbal M , Tang P , Hasan MR , 2021. Evaluation of automated molecular tests for the detection of SARS-CoV-2 in pooled nasopharyngeal and saliva specimens. J Clin Lab Anal 35: 1–6.
Abras A et al., 2018. Introducing automation to the molecular diagnosis of Trypanosoma cruzi infection: a comparative study of sample treatments, DNA extraction methods and real-time PCR assays. PLoS One 13: 1–14.
Galluzzi L , Ceccarelli M , Diotallevi A , Menotta M , Magnani M , 2018. Real-time PCR applications for diagnosis of leishmaniasis. Parasit Vectors 11: 1–13.
Felder RA , Jackson KD , Walter AM , 2014. Process evaluation of an open architecture real-time molecular laboratory platform. J Lab Autom 19: 468–473.
World Health Organization , 2019. Second WHO Model List of Essential in Vitro Diagnostics. WHO Technical Report Series, No. 1017. Geneva, Switzerland: WHO.
World Health Organization , 2018. World Health Organization Model List of Essential in Vitro Diagnostics. WHO Technical Report Series, No. 1017. Geneva, Switzerland: WHO.
World Health Organization , 2021. The Selection and Use of Essential in Vitro Diagnostics. WHO Technical Report Series, No. 1031. Geneva, Switzerland: WHO.
Wolfel R et al., 2015. Mobile diagnostics in outbreak response, not only for Ebola: a blueprint for a modular and robust field laboratory. Euro Surveill 20: 1–9.
World Health Organization , 2019. Consolidated Guidelines on HIV Testing Services. Geneva, Switzerland: WHO.
Fleming KA et al., 2017. An essential pathology package for low- and middle-income countries. Am J Clin Pathol 147: 15–32.
Daar A , Thorsteinsdóttir H , Martin D , Smith A , Nast S , Singer P , 2002. Top ten biotechnologies for improving health in developing countries. Nat Genet 32: 229–232.
Mabey D , Peeling RW , Ustianowski A , Perkins MD , 2004. Diagnostics for the developing world. Nat Rev Microbiol 2: 231–240.
Land KJ , Boeras DI , Chen XS , Ramsay AR , Peeling RW , 2019. REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes. Nat Microbiol 4: 46–54.
Hänscheid T , Rebelo M , Grobusch MP , 2014. Point-of-care tests: where is the point? Lancet Infect Dis 14: 922.
Drain PK , Hyle EP , Noubary F , Freedberg KA , Wilson D , Bishai WR , Rodriguez W , Bassett IV , 2014. Diagnostic point-of-care tests in resource-limited settings. Lancet Infect Dis 14: 239–249.
Schallig H , Hu RVP , Kent AD , van Loenen M , Menting S , Picado A , Oosterling Z , Cruz I , 2019. Evaluation of point of care tests for the diagnosis of cutaneous leishmaniasis in Suriname. BMC Infect Dis 19: 1–6.
Shah K et al., 2017. Field-deployable, quantitative, rapid identification of active Ebola virus infection in unprocessed blood. Chem Sci (Camb) 8: 7780–7797.
Suea-Ngam A , Bezinge L , Mateescu B , Howes PD , deMello AJ , Richards DA , 2020. Enzyme-assisted nucleic acid detection for infectious disease diagnostics: moving toward the point-of-care. ACS Sens 5: 2701–2723.
Kumar A , Saurabh S , Jamil S , Kumar V , 2020. Intensely clustered outbreak of visceral leishmaniasis (kala-azar) in a setting of seasonal migration in a village of Bihar, India. BMC Infect Dis 20: 1–13.
Nassar AA , Abdelrazzaq MH , Almahaqri AH , Al-Amad MA , Al Serouri AA , Khader YS , 2021. Cutaneous leishmaniasis outbreak investigation in Hajjah Governorate, Yemen, in 2018: case-control study. JMIR Public Health Surveill 7: 1–9.
Horrillo L et al., 2019. Clinical aspects of visceral leishmaniasis caused by L. infantum in adults: ten years of experience of the largest outbreak in Europe: what have we learned? Parasit Vectors 12: 1–11.
Bengtson M , Bharadwaj M , Bosch AT , Nyakundi H , Matoke-Muhia D , Dekker C , Diehl JC , 2020. Matching development of point-of-care diagnostic tests to the local context: a case study of visceral leishmaniasis in Kenya and Uganda. Glob Health Sci Pract 8: 549–565.
Archetti C , Montanelli A , Finazzi D , Caimi L , Garrafa E , 2017. Clinical laboratory automation: a case study. J Public Health Res 6: 31–36.
Beal SG , Assarzadegan N , Rand KH , 2016. Sample-to-result molecular infectious disease assays: clinical implications, limitations and potential. Expert Rev Mol Diagn 16: 323–341.
Kulkarni RD , Mishra MN , Mohanraj J , Chandrasekhar A , Ajantha GS , Kulkani S , Bhat S , 2018. Development of a dry-reagent mix-based polymerase chain reaction as a novel tool for the identification of Acinetobacter species and its comparison with conventional polymerase chain reaction. J Lab Physicians 10: 68–72.
Opota O , Brouillet R , Greub G , Jaton K , 2020. Comparison of SARS-CoV-2 RT-PCR on a high-throughput molecular diagnostic platform and the Cobas SARS-CoV-2 test for the diagnostic of COVID-19 on various clinical samples. Pathog Dis 78: 1–6.
Peeling RW , McNerney R , 2014. Emerging technologies in point-of-care molecular diagnostics for resource-limited settings. Expert Rev Mol Diagn 14: 525–534.
Klatser P , Kuijper S , van Ingen C , Kolk A , 1998. Stabilized, freeze-dried PCR mix for detection of mycobacteria. J Clin Microbiol 36: 1798–1800.
Abou Tayoun A , Burchard P , Malik I , Scherer A , Tsongalis G , 2014. Democratizing molecular diagnostics for the developing world. Am J Clin Pathol 141: 17–24.
Mondal D , Ghosh P , Khan MA , Hossain F , Bohlken-Fascher S , Matlashewski G , Kroeger A , Olliaro P , Abd El Wahed A , 2016. Mobile suitcase laboratory for rapid detection of Leishmania donovani using recombinase polymerase amplification assay. Parasit Vectors 9: 1–8.
Ghosh P et al., 2021. A multi-country, single-blinded, phase 2 study to evaluate a point-of-need system for rapid detection of leishmaniasis and its implementation in endemic settings. Microorganisms 9: 1–14.
Hin S et al., 2021. Fully automated point-of-care differential diagnosis of acute febrile illness. PLoS Negl Trop Dis 15: 1–24.
Armstrong M , Harris AR , D’Ambrosio MV , Coulibaly JT , Essien-Baidoo S , Ephraim RKD , Andrews JR , Bogoch II , Fletcher DA , 2022. Point-of-care sample preparation and automated quantitative detection of Schistosoma haematobium using mobile phone microscopy. Am J Trop Med Hyg 106: 1442–1449.
Longoni SS , Pomari E , Antonelli A , Formenti F , Silva R , Tais S , Scarso S , Rossolini GM , Angheben A , Perandin F , 2020. Performance evaluation of a commercial real-time PCR Assay and of an in-house real-time PCR for Trypanosoma cruzi DNA detection in a tropical medicine reference center, northern Italy. Microorganisms 8: 1–12.
Beldi N , Mansouri R , Bettaieb J , Yaacoub A , Souguir Omrani H , Saadi Ben Aoun Y , Saadni F , Guizani I , Guerbouj S , 2017. Molecular characterization of Leishmania parasites in Giemsa-stained slides from cases of human cutaneous and visceral leishmaniasis, eastern Algeria. Vector Borne Zoonotic Dis 17: 416–424.
Nateghi Rostami M , Darzi F , Farahmand M , Aghaei M , Parvizi P , 2020. Performance of a universal PCR assay to identify different Leishmania species causative of Old World cutaneous leishmaniasis. Parasit Vectors 13: 1–12.
Sudarshan M , Singh T , Chakravarty J , Sundar S , 2015. A correlative study of splenic parasite score and peripheral blood parasite load estimation by quantitative PCR in visceral leishmaniasis. J Clin Microbiol 53: 3905–3907.
Taslimi Y , Sadeghipour P , Habibzadeh S , Mashayekhi V , Mortazavi H , Muller I , Lane ME , Kropf P , Rafati S , 2017. A novel non-invasive diagnostic sampling technique for cutaneous leishmaniasis. PLoS Negl Trop Dis 11: 1–12.
Asfaram S , Fakhar M , Mohebali M , Ziaei Hezarjaribi H , Mardani A , Ghezelbash B , Akhoundi B , Zarei Z , Moazeni M , 2022. A convenient and sensitive kDNA-PCR for screening of Leishmania infantum latent infection among blood donors in a highly endemic focus, northwestern Iran. Acta Parasitol 67: 842–850.
Aronson N , Herwaldt BL , Libman M , Pearson R , Lopez-Velez R , Weina P , Carvalho EM , Ephros M , Jeronimo S , Magill A , 2016. Diagnosis and treatment of leishmaniasis: clinical practice guidelines by the Infectious Diseases Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH). Clin Infect Dis 63: e202–e264.
Verrest L et al., 2021. Blood parasite load as an early marker to predict treatment response in visceral leishmaniasis in eastern Africa. Clin Infect Dis 73: 775–782.
Quig K , Wheatley EG , O’Hara M , 2019. Perspectives on blood-based point-of-care diagnostics. Open Access Emerg Med 11: 291–296.
Past two years | Past Year | Past 30 Days | |
---|---|---|---|
Abstract Views | 3038 | 964 | 29 |
Full Text Views | 419 | 116 | 16 |
PDF Downloads | 128 | 10 | 0 |
Neglected tropical diseases affect those in poorer nations disproportionately across the globe. One example of these, leishmaniasis, is a debilitating and potentially fatal parasitic infection. Molecular detection of this disease can provide accurate and fast diagnosis, and with near point-of-care technologies, detection can be provided in many health-care settings. Traditionally, the perceived limitations to such detection methods have hindered their provision to resource-limited nations, but new technologies and techniques are helping to overcome these perceptions. The current pandemic offers an opportunity to maintain and develop further advances, ensuring molecular diagnostics are accessible to all.
Authors’ addresses: Ineka Gow, Nicholas Smith, and John Ellis, School of Life Sciences, Bldg. 4, University of Technology Sydney, PO Box 123 Broadway, NSW, 2007, Australia, E-mails: ineka.c.gow@student.uts.edu.au, nicholas.smith@uts.edu.au, and john.t.ellis@alumni.uts.edu.au. Damien Stark, Department of Microbiology, St Vincent’s Hospital, Xavier Bldg. Level 6, 390 Victoria St., Darlinghurst, NSW, 2010, Australia, damien.stark@svha.org.au.
World Health Organization , 2020. Ending the Neglect to Attain the Sustainable Development Goals: A Road Map for Neglected Tropical Diseases 2021–2030. Geneva, Switzerland: WHO.
World Health Organization , 2021. Leishmaniasis. Geneva, Switzerland: WHO.
Selvapandiyan A , Croft SL , Rijal S , Nakhasi HL , Ganguly NK , 2019. Innovations for the elimination and control of visceral leishmaniasis. PLoS Negl Trop Dis 13: 1–5.
Castellanos-Gonzalez A , White AC , Melby P , Travi B , 2018. Molecular diagnosis of protozoan parasites by recombinase polymerase amplification. Acta Trop 182: 4–11.
Gunaratna G et al., 2018. Evaluation of rapid extraction and isothermal amplification techniques for the detection of Leishmania donovani DNA from skin lesions of suspected cases at the point of need in Sri Lanka. Parasit Vectors 11: 1–7.
Burza S , Croft SL , Boelaert M , 2018. Leishmaniasis. Lancet 392: 951–970.
Sundar S , Singh OP , 2018. Molecular diagnosis of visceral leishmaniasis. Mol Diagn Ther 22: 443–457.
Al-Hail H , Mirza F , Al Hashemi A , Ahmad MN , Iqbal M , Tang P , Hasan MR , 2021. Evaluation of automated molecular tests for the detection of SARS-CoV-2 in pooled nasopharyngeal and saliva specimens. J Clin Lab Anal 35: 1–6.
Abras A et al., 2018. Introducing automation to the molecular diagnosis of Trypanosoma cruzi infection: a comparative study of sample treatments, DNA extraction methods and real-time PCR assays. PLoS One 13: 1–14.
Galluzzi L , Ceccarelli M , Diotallevi A , Menotta M , Magnani M , 2018. Real-time PCR applications for diagnosis of leishmaniasis. Parasit Vectors 11: 1–13.
Felder RA , Jackson KD , Walter AM , 2014. Process evaluation of an open architecture real-time molecular laboratory platform. J Lab Autom 19: 468–473.
World Health Organization , 2019. Second WHO Model List of Essential in Vitro Diagnostics. WHO Technical Report Series, No. 1017. Geneva, Switzerland: WHO.
World Health Organization , 2018. World Health Organization Model List of Essential in Vitro Diagnostics. WHO Technical Report Series, No. 1017. Geneva, Switzerland: WHO.
World Health Organization , 2021. The Selection and Use of Essential in Vitro Diagnostics. WHO Technical Report Series, No. 1031. Geneva, Switzerland: WHO.
Wolfel R et al., 2015. Mobile diagnostics in outbreak response, not only for Ebola: a blueprint for a modular and robust field laboratory. Euro Surveill 20: 1–9.
World Health Organization , 2019. Consolidated Guidelines on HIV Testing Services. Geneva, Switzerland: WHO.
Fleming KA et al., 2017. An essential pathology package for low- and middle-income countries. Am J Clin Pathol 147: 15–32.
Daar A , Thorsteinsdóttir H , Martin D , Smith A , Nast S , Singer P , 2002. Top ten biotechnologies for improving health in developing countries. Nat Genet 32: 229–232.
Mabey D , Peeling RW , Ustianowski A , Perkins MD , 2004. Diagnostics for the developing world. Nat Rev Microbiol 2: 231–240.
Land KJ , Boeras DI , Chen XS , Ramsay AR , Peeling RW , 2019. REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes. Nat Microbiol 4: 46–54.
Hänscheid T , Rebelo M , Grobusch MP , 2014. Point-of-care tests: where is the point? Lancet Infect Dis 14: 922.
Drain PK , Hyle EP , Noubary F , Freedberg KA , Wilson D , Bishai WR , Rodriguez W , Bassett IV , 2014. Diagnostic point-of-care tests in resource-limited settings. Lancet Infect Dis 14: 239–249.
Schallig H , Hu RVP , Kent AD , van Loenen M , Menting S , Picado A , Oosterling Z , Cruz I , 2019. Evaluation of point of care tests for the diagnosis of cutaneous leishmaniasis in Suriname. BMC Infect Dis 19: 1–6.
Shah K et al., 2017. Field-deployable, quantitative, rapid identification of active Ebola virus infection in unprocessed blood. Chem Sci (Camb) 8: 7780–7797.
Suea-Ngam A , Bezinge L , Mateescu B , Howes PD , deMello AJ , Richards DA , 2020. Enzyme-assisted nucleic acid detection for infectious disease diagnostics: moving toward the point-of-care. ACS Sens 5: 2701–2723.
Kumar A , Saurabh S , Jamil S , Kumar V , 2020. Intensely clustered outbreak of visceral leishmaniasis (kala-azar) in a setting of seasonal migration in a village of Bihar, India. BMC Infect Dis 20: 1–13.
Nassar AA , Abdelrazzaq MH , Almahaqri AH , Al-Amad MA , Al Serouri AA , Khader YS , 2021. Cutaneous leishmaniasis outbreak investigation in Hajjah Governorate, Yemen, in 2018: case-control study. JMIR Public Health Surveill 7: 1–9.
Horrillo L et al., 2019. Clinical aspects of visceral leishmaniasis caused by L. infantum in adults: ten years of experience of the largest outbreak in Europe: what have we learned? Parasit Vectors 12: 1–11.
Bengtson M , Bharadwaj M , Bosch AT , Nyakundi H , Matoke-Muhia D , Dekker C , Diehl JC , 2020. Matching development of point-of-care diagnostic tests to the local context: a case study of visceral leishmaniasis in Kenya and Uganda. Glob Health Sci Pract 8: 549–565.
Archetti C , Montanelli A , Finazzi D , Caimi L , Garrafa E , 2017. Clinical laboratory automation: a case study. J Public Health Res 6: 31–36.
Beal SG , Assarzadegan N , Rand KH , 2016. Sample-to-result molecular infectious disease assays: clinical implications, limitations and potential. Expert Rev Mol Diagn 16: 323–341.
Kulkarni RD , Mishra MN , Mohanraj J , Chandrasekhar A , Ajantha GS , Kulkani S , Bhat S , 2018. Development of a dry-reagent mix-based polymerase chain reaction as a novel tool for the identification of Acinetobacter species and its comparison with conventional polymerase chain reaction. J Lab Physicians 10: 68–72.
Opota O , Brouillet R , Greub G , Jaton K , 2020. Comparison of SARS-CoV-2 RT-PCR on a high-throughput molecular diagnostic platform and the Cobas SARS-CoV-2 test for the diagnostic of COVID-19 on various clinical samples. Pathog Dis 78: 1–6.
Peeling RW , McNerney R , 2014. Emerging technologies in point-of-care molecular diagnostics for resource-limited settings. Expert Rev Mol Diagn 14: 525–534.
Klatser P , Kuijper S , van Ingen C , Kolk A , 1998. Stabilized, freeze-dried PCR mix for detection of mycobacteria. J Clin Microbiol 36: 1798–1800.
Abou Tayoun A , Burchard P , Malik I , Scherer A , Tsongalis G , 2014. Democratizing molecular diagnostics for the developing world. Am J Clin Pathol 141: 17–24.
Mondal D , Ghosh P , Khan MA , Hossain F , Bohlken-Fascher S , Matlashewski G , Kroeger A , Olliaro P , Abd El Wahed A , 2016. Mobile suitcase laboratory for rapid detection of Leishmania donovani using recombinase polymerase amplification assay. Parasit Vectors 9: 1–8.
Ghosh P et al., 2021. A multi-country, single-blinded, phase 2 study to evaluate a point-of-need system for rapid detection of leishmaniasis and its implementation in endemic settings. Microorganisms 9: 1–14.
Hin S et al., 2021. Fully automated point-of-care differential diagnosis of acute febrile illness. PLoS Negl Trop Dis 15: 1–24.
Armstrong M , Harris AR , D’Ambrosio MV , Coulibaly JT , Essien-Baidoo S , Ephraim RKD , Andrews JR , Bogoch II , Fletcher DA , 2022. Point-of-care sample preparation and automated quantitative detection of Schistosoma haematobium using mobile phone microscopy. Am J Trop Med Hyg 106: 1442–1449.
Longoni SS , Pomari E , Antonelli A , Formenti F , Silva R , Tais S , Scarso S , Rossolini GM , Angheben A , Perandin F , 2020. Performance evaluation of a commercial real-time PCR Assay and of an in-house real-time PCR for Trypanosoma cruzi DNA detection in a tropical medicine reference center, northern Italy. Microorganisms 8: 1–12.
Beldi N , Mansouri R , Bettaieb J , Yaacoub A , Souguir Omrani H , Saadi Ben Aoun Y , Saadni F , Guizani I , Guerbouj S , 2017. Molecular characterization of Leishmania parasites in Giemsa-stained slides from cases of human cutaneous and visceral leishmaniasis, eastern Algeria. Vector Borne Zoonotic Dis 17: 416–424.
Nateghi Rostami M , Darzi F , Farahmand M , Aghaei M , Parvizi P , 2020. Performance of a universal PCR assay to identify different Leishmania species causative of Old World cutaneous leishmaniasis. Parasit Vectors 13: 1–12.
Sudarshan M , Singh T , Chakravarty J , Sundar S , 2015. A correlative study of splenic parasite score and peripheral blood parasite load estimation by quantitative PCR in visceral leishmaniasis. J Clin Microbiol 53: 3905–3907.
Taslimi Y , Sadeghipour P , Habibzadeh S , Mashayekhi V , Mortazavi H , Muller I , Lane ME , Kropf P , Rafati S , 2017. A novel non-invasive diagnostic sampling technique for cutaneous leishmaniasis. PLoS Negl Trop Dis 11: 1–12.
Asfaram S , Fakhar M , Mohebali M , Ziaei Hezarjaribi H , Mardani A , Ghezelbash B , Akhoundi B , Zarei Z , Moazeni M , 2022. A convenient and sensitive kDNA-PCR for screening of Leishmania infantum latent infection among blood donors in a highly endemic focus, northwestern Iran. Acta Parasitol 67: 842–850.
Aronson N , Herwaldt BL , Libman M , Pearson R , Lopez-Velez R , Weina P , Carvalho EM , Ephros M , Jeronimo S , Magill A , 2016. Diagnosis and treatment of leishmaniasis: clinical practice guidelines by the Infectious Diseases Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH). Clin Infect Dis 63: e202–e264.
Verrest L et al., 2021. Blood parasite load as an early marker to predict treatment response in visceral leishmaniasis in eastern Africa. Clin Infect Dis 73: 775–782.
Quig K , Wheatley EG , O’Hara M , 2019. Perspectives on blood-based point-of-care diagnostics. Open Access Emerg Med 11: 291–296.
Past two years | Past Year | Past 30 Days | |
---|---|---|---|
Abstract Views | 3038 | 964 | 29 |
Full Text Views | 419 | 116 | 16 |
PDF Downloads | 128 | 10 | 0 |