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Assessment of the Quality of Malaria Rapid Diagnostic Test, Adama District, East Shewa Zone, Ethiopia

Received: 21 September 2020     Accepted: 6 October 2020     Published: 23 November 2020
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Abstract

Background: In Ethiopia, smear microscopy is the gold standard for malaria diagnosis however; it is not available in health post. Smear microscopy is time consuming, requires trained personnel and needs careful preparation and application of reagents to ensure quality results. Objective: This study was aimed at testing the diagnostic performance of SD BIOLINE malaria rapid diagnostic test (RDT) with reference to smear microscopy for the diagnosis of falciparum and vivax malaria in Ethiopia. Methods: Blood samples were collected from 402 patients suspected to have malaria in four health facilities in the late minor malaria transmission season from June18-30, 2014. The samples were examined immediately by smear microscopy and the RDT (SD BIOLINE Malaria HRP2/pLDH POCT Test kit). Statistical analysis was performed using Epi-info version 7 and the two-way contingency table analysis. Results: The overall parasite positivity using smear microscopy was 163 (45.6%): 136 (33.8%) for P. falciparum, 25 (6.2%) for P. vivax and two (0.5%) for mixed infections. Using the SD BIOLINE RDT, the overall parasite positivity was 176 (43.7%): 149 (37%) for P. falciparum, 26 (6.5%) for P. vivax and 1 (0.2%) for mixed infections. The overall sensitivity and specificity of SD BIOLINE RDT was found to be 98.2% (97.5–99.9%, 95% CI) and 95.2% (93.9–97.7%, 95% CI), respectively. The sensitivity and specificity of SD BIOLINE RDT was found to be 98.2% (94–99.1%, 95% CI) and 95.4% (93.9–97.1%, 95% CI), respectively. The positive predictive value (PPV) and the negative predictive value (NPV) were found to be 93.6% (88.5–96.1%, 95% CI) and 98.7% (95.3–99.8%, 95% CI), respectively. There was an excellent agreement between the smear microscopy and SD BIOLINE RDT with a Kappa value of 0.965 (0.896–0.988, 95% CI). Conclusion: The SD BIOLINE RDT test showed good sensitivity and specificity with an excellent agreement to the reference smear microscopy. The RDT could therefore be used in place of smear microscopy, at health post where the microscope not applicable.

Published in International Journal of Clinical and Experimental Medical Sciences (Volume 6, Issue 6)
DOI 10.11648/j.ijcems.20200606.11
Page(s) 109-118
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2020. Published by Science Publishing Group

Keywords

Malaria, Rapid Diagnostic Test, East Shoa Zone, Ethiopia

References
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    Merga Gonfa, Daba Mulleta, Wakgari Deresa, Bizuayehu Gurmesa. (2020). Assessment of the Quality of Malaria Rapid Diagnostic Test, Adama District, East Shewa Zone, Ethiopia. International Journal of Clinical and Experimental Medical Sciences, 6(6), 109-118. https://doi.org/10.11648/j.ijcems.20200606.11

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    Merga Gonfa; Daba Mulleta; Wakgari Deresa; Bizuayehu Gurmesa. Assessment of the Quality of Malaria Rapid Diagnostic Test, Adama District, East Shewa Zone, Ethiopia. Int. J. Clin. Exp. Med. Sci. 2020, 6(6), 109-118. doi: 10.11648/j.ijcems.20200606.11

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    AMA Style

    Merga Gonfa, Daba Mulleta, Wakgari Deresa, Bizuayehu Gurmesa. Assessment of the Quality of Malaria Rapid Diagnostic Test, Adama District, East Shewa Zone, Ethiopia. Int J Clin Exp Med Sci. 2020;6(6):109-118. doi: 10.11648/j.ijcems.20200606.11

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  • @article{10.11648/j.ijcems.20200606.11,
      author = {Merga Gonfa and Daba Mulleta and Wakgari Deresa and Bizuayehu Gurmesa},
      title = {Assessment of the Quality of Malaria Rapid Diagnostic Test, Adama District, East Shewa Zone, Ethiopia},
      journal = {International Journal of Clinical and Experimental Medical Sciences},
      volume = {6},
      number = {6},
      pages = {109-118},
      doi = {10.11648/j.ijcems.20200606.11},
      url = {https://doi.org/10.11648/j.ijcems.20200606.11},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijcems.20200606.11},
      abstract = {Background: In Ethiopia, smear microscopy is the gold standard for malaria diagnosis however; it is not available in health post. Smear microscopy is time consuming, requires trained personnel and needs careful preparation and application of reagents to ensure quality results. Objective: This study was aimed at testing the diagnostic performance of SD BIOLINE malaria rapid diagnostic test (RDT) with reference to smear microscopy for the diagnosis of falciparum and vivax malaria in Ethiopia. Methods: Blood samples were collected from 402 patients suspected to have malaria in four health facilities in the late minor malaria transmission season from June18-30, 2014. The samples were examined immediately by smear microscopy and the RDT (SD BIOLINE Malaria HRP2/pLDH POCT Test kit). Statistical analysis was performed using Epi-info version 7 and the two-way contingency table analysis. Results: The overall parasite positivity using smear microscopy was 163 (45.6%): 136 (33.8%) for P. falciparum, 25 (6.2%) for P. vivax and two (0.5%) for mixed infections. Using the SD BIOLINE RDT, the overall parasite positivity was 176 (43.7%): 149 (37%) for P. falciparum, 26 (6.5%) for P. vivax and 1 (0.2%) for mixed infections. The overall sensitivity and specificity of SD BIOLINE RDT was found to be 98.2% (97.5–99.9%, 95% CI) and 95.2% (93.9–97.7%, 95% CI), respectively. The sensitivity and specificity of SD BIOLINE RDT was found to be 98.2% (94–99.1%, 95% CI) and 95.4% (93.9–97.1%, 95% CI), respectively. The positive predictive value (PPV) and the negative predictive value (NPV) were found to be 93.6% (88.5–96.1%, 95% CI) and 98.7% (95.3–99.8%, 95% CI), respectively. There was an excellent agreement between the smear microscopy and SD BIOLINE RDT with a Kappa value of 0.965 (0.896–0.988, 95% CI). Conclusion: The SD BIOLINE RDT test showed good sensitivity and specificity with an excellent agreement to the reference smear microscopy. The RDT could therefore be used in place of smear microscopy, at health post where the microscope not applicable.},
     year = {2020}
    }
    

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  • TY  - JOUR
    T1  - Assessment of the Quality of Malaria Rapid Diagnostic Test, Adama District, East Shewa Zone, Ethiopia
    AU  - Merga Gonfa
    AU  - Daba Mulleta
    AU  - Wakgari Deresa
    AU  - Bizuayehu Gurmesa
    Y1  - 2020/11/23
    PY  - 2020
    N1  - https://doi.org/10.11648/j.ijcems.20200606.11
    DO  - 10.11648/j.ijcems.20200606.11
    T2  - International Journal of Clinical and Experimental Medical Sciences
    JF  - International Journal of Clinical and Experimental Medical Sciences
    JO  - International Journal of Clinical and Experimental Medical Sciences
    SP  - 109
    EP  - 118
    PB  - Science Publishing Group
    SN  - 2469-8032
    UR  - https://doi.org/10.11648/j.ijcems.20200606.11
    AB  - Background: In Ethiopia, smear microscopy is the gold standard for malaria diagnosis however; it is not available in health post. Smear microscopy is time consuming, requires trained personnel and needs careful preparation and application of reagents to ensure quality results. Objective: This study was aimed at testing the diagnostic performance of SD BIOLINE malaria rapid diagnostic test (RDT) with reference to smear microscopy for the diagnosis of falciparum and vivax malaria in Ethiopia. Methods: Blood samples were collected from 402 patients suspected to have malaria in four health facilities in the late minor malaria transmission season from June18-30, 2014. The samples were examined immediately by smear microscopy and the RDT (SD BIOLINE Malaria HRP2/pLDH POCT Test kit). Statistical analysis was performed using Epi-info version 7 and the two-way contingency table analysis. Results: The overall parasite positivity using smear microscopy was 163 (45.6%): 136 (33.8%) for P. falciparum, 25 (6.2%) for P. vivax and two (0.5%) for mixed infections. Using the SD BIOLINE RDT, the overall parasite positivity was 176 (43.7%): 149 (37%) for P. falciparum, 26 (6.5%) for P. vivax and 1 (0.2%) for mixed infections. The overall sensitivity and specificity of SD BIOLINE RDT was found to be 98.2% (97.5–99.9%, 95% CI) and 95.2% (93.9–97.7%, 95% CI), respectively. The sensitivity and specificity of SD BIOLINE RDT was found to be 98.2% (94–99.1%, 95% CI) and 95.4% (93.9–97.1%, 95% CI), respectively. The positive predictive value (PPV) and the negative predictive value (NPV) were found to be 93.6% (88.5–96.1%, 95% CI) and 98.7% (95.3–99.8%, 95% CI), respectively. There was an excellent agreement between the smear microscopy and SD BIOLINE RDT with a Kappa value of 0.965 (0.896–0.988, 95% CI). Conclusion: The SD BIOLINE RDT test showed good sensitivity and specificity with an excellent agreement to the reference smear microscopy. The RDT could therefore be used in place of smear microscopy, at health post where the microscope not applicable.
    VL  - 6
    IS  - 6
    ER  - 

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Author Information
  • Department of Medical Laboratory Science, College of Health Science, Arsi University, Asella, Ethiopia

  • Oromia Public Health Research Capacity Building and Quality Assurance Laboratory, Adama, Ethiopia

  • Oromia Public Health Research Capacity Building and Quality Assurance Laboratory, Adama, Ethiopia

  • Department of Medical Laboratory Science, College of Health Science, Arsi University, Asella, Ethiopia

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