| Peer-Reviewed

Ethiopian National Tuberculosis Reference Laboratory Ten Year External Quality Assurance-Panel Test Performance Review

Received: 11 September 2015     Accepted: 20 August 2016     Published: 7 September 2016
Views:       Downloads:
Abstract

The Objective of this review was to see the ten year EQA performance trend from 2005 till 2014 at Ethiopian national tuberculosis Reference laboratory. The finding shows that 81.3% and 11.2%of participation were ZN-AFB and of phenotypic DST respectively. The remaining participation was for LPA-PT with proportion of 4.6% and 2.3% for GeneXpert. Most of EQA-PT performance of NTRL scored above 80% and above 90% for Phenotypic DST of 1st and 2nd line Anti-TB drug. DST efficiency reveal that most tested drugs at NTRL were achieved acceptable performance and good agreement result compared to SRLN laboratory test with record data of above 90% for all 1st line and 2nd line drugs with the exception of Ethambutol. Over all TAT record were acceptable with the exception of phenotypic DST which is Critical TAT findings that ranges from 100 to 841 days from total 4 round 1ST and 2nd line DST -PT participation With the median TAT of 205 days. The most frequently committed error type were High false Negative, which accounts 3% contribution for total loss of PT score. The review finding shows there were some gaps on Critical TAT therefore a periodic review and evidence based corrective action has to be made in short time interval after feedback obtained since laboratory error will have devastating impact on clinical management of Patients and laboratory information.

Published in American Journal of Laboratory Medicine (Volume 1, Issue 2)
DOI 10.11648/j.ajlm.20160102.11
Page(s) 5-8
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), 2016. Published by Science Publishing Group

Keywords

AFB-PT, NTRL, NICD, DST, EQA, TAT

References
[1] Guideline for External quality assessment of AFB smears microscopy. 2002. WHO press.
[2] ISO Standard document for Medical laboratories — Requirements for quality and competence. ISO 15189:2012Third edition2012.
[3] Sekadde M, Wobudeya E, Joloba M L, Sengooba W, Harriet K, at el. Evaluation of the Xpert MTB/RIF Test for the Diagnosis of Childhood Pulmonary Tuberculosis in Uganda: a cross sectional diagnostic study. BMC Infectious Diseases 2013; 13:133. Available: http://www.biomedcentral.com
[4] John C Ridderhof, Armand van Deun, Kai Man Kam, PR Narayanand and Mohamed Abdul Aziz. Roles of laboratories and laboratory systems in effective tuberculosis programmes. WHO. 2007; 85:354-359. doi: 10.2471/BLT.06.039081
[5] Wayne, PA., Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality. 2009. CLSI Proposed Guideline.
[6] Treatment of tuberculosis Guidelines World Health Organization. Forth Editions WHO.2010.
[7] Guidelines for the programmatic management of drug-resistant tuberculosis. WHO. 2008.
[8] Federal Ministry of Health of Ethiopia: Guideline for program and clinical management of drug resistant tuberculosis. 5th edition. Addis Ababa, Ethiopia: FMOH; 2009.
[9] Nikolayevskyy V, Hillemann D, Richter E, Ahmed N, van der Werf MJ, Kodmon C, et al. (2016)External Quality Assessment for Tuberculosis Diagnosis and Drug Resistance in the European Union: A Five Year Multicentre Implementation Study. PLoS ONE 11(4): e0152926. doi:10.1371/journal.pone.0152926.
[10] Hillemann D, Hoffner S, Cirillo D, Drobniewski F, Richter E, et al. (2013) First Evaluation after Implementation of a Quality Control System for the Second Line Drug Susceptibility Testing of Mycobacterium tuberculosis Joint Efforts in Low and High Incidence Countries. PLoS One 8: e76765. doi:10.1371/journal.pone.0076765PMID:24146924.
[11] Shulgina MV, Malakhov VN, Hoffner SE, Haile M, Wright A (2009) Results of the external quality assessment of Mycobacterium tuberculosis drug susceptibility testing in Russia, 20052007. Int J Tuberc Lung Dis 13: 12941300. PMID: 19793436.
Cite This Article
  • APA Style

    Mengistu Tadesse K., Getahun M., Kebede A., Yaregal Z., Meaza A., et al. (2016). Ethiopian National Tuberculosis Reference Laboratory Ten Year External Quality Assurance-Panel Test Performance Review. American Journal of Laboratory Medicine, 1(2), 5-8. https://doi.org/10.11648/j.ajlm.20160102.11

    Copy | Download

    ACS Style

    Mengistu Tadesse K.; Getahun M.; Kebede A.; Yaregal Z.; Meaza A., et al. Ethiopian National Tuberculosis Reference Laboratory Ten Year External Quality Assurance-Panel Test Performance Review. Am. J. Lab. Med. 2016, 1(2), 5-8. doi: 10.11648/j.ajlm.20160102.11

    Copy | Download

    AMA Style

    Mengistu Tadesse K., Getahun M., Kebede A., Yaregal Z., Meaza A., et al. Ethiopian National Tuberculosis Reference Laboratory Ten Year External Quality Assurance-Panel Test Performance Review. Am J Lab Med. 2016;1(2):5-8. doi: 10.11648/j.ajlm.20160102.11

    Copy | Download

  • @article{10.11648/j.ajlm.20160102.11,
      author = {Mengistu Tadesse K. and Getahun M. and Kebede A. and Yaregal Z. and Meaza A. and Dagne Z. and Moga S. and Addise D. and Tesfaye E. and Yenew B. and Mollalign H. and Diriba G. and Girmachew F. and Dimssea D. and Marondera B.},
      title = {Ethiopian National Tuberculosis Reference Laboratory Ten Year External Quality Assurance-Panel Test Performance Review},
      journal = {American Journal of Laboratory Medicine},
      volume = {1},
      number = {2},
      pages = {5-8},
      doi = {10.11648/j.ajlm.20160102.11},
      url = {https://doi.org/10.11648/j.ajlm.20160102.11},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajlm.20160102.11},
      abstract = {The Objective of this review was to see the ten year EQA performance trend from 2005 till 2014 at Ethiopian national tuberculosis Reference laboratory. The finding shows that 81.3% and 11.2%of participation were ZN-AFB and of phenotypic DST respectively. The remaining participation was for LPA-PT with proportion of 4.6% and 2.3% for GeneXpert. Most of EQA-PT performance of NTRL scored above 80% and above 90% for Phenotypic DST of 1st and 2nd line Anti-TB drug. DST efficiency reveal that most tested drugs at NTRL were achieved acceptable performance and good agreement result compared to SRLN laboratory test with record data of above 90% for all 1st line and 2nd line drugs with the exception of Ethambutol. Over all TAT record were acceptable with the exception of phenotypic DST which is Critical TAT findings that ranges from 100 to 841 days from total 4 round 1ST and 2nd line DST -PT participation With the median TAT of 205 days. The most frequently committed error type were High false Negative, which accounts 3% contribution for total loss of PT score. The review finding shows there were some gaps on Critical TAT therefore a periodic review and evidence based corrective action has to be made in short time interval after feedback obtained since laboratory error will have devastating impact on clinical management of Patients and laboratory information.},
     year = {2016}
    }
    

    Copy | Download

  • TY  - JOUR
    T1  - Ethiopian National Tuberculosis Reference Laboratory Ten Year External Quality Assurance-Panel Test Performance Review
    AU  - Mengistu Tadesse K.
    AU  - Getahun M.
    AU  - Kebede A.
    AU  - Yaregal Z.
    AU  - Meaza A.
    AU  - Dagne Z.
    AU  - Moga S.
    AU  - Addise D.
    AU  - Tesfaye E.
    AU  - Yenew B.
    AU  - Mollalign H.
    AU  - Diriba G.
    AU  - Girmachew F.
    AU  - Dimssea D.
    AU  - Marondera B.
    Y1  - 2016/09/07
    PY  - 2016
    N1  - https://doi.org/10.11648/j.ajlm.20160102.11
    DO  - 10.11648/j.ajlm.20160102.11
    T2  - American Journal of Laboratory Medicine
    JF  - American Journal of Laboratory Medicine
    JO  - American Journal of Laboratory Medicine
    SP  - 5
    EP  - 8
    PB  - Science Publishing Group
    SN  - 2575-386X
    UR  - https://doi.org/10.11648/j.ajlm.20160102.11
    AB  - The Objective of this review was to see the ten year EQA performance trend from 2005 till 2014 at Ethiopian national tuberculosis Reference laboratory. The finding shows that 81.3% and 11.2%of participation were ZN-AFB and of phenotypic DST respectively. The remaining participation was for LPA-PT with proportion of 4.6% and 2.3% for GeneXpert. Most of EQA-PT performance of NTRL scored above 80% and above 90% for Phenotypic DST of 1st and 2nd line Anti-TB drug. DST efficiency reveal that most tested drugs at NTRL were achieved acceptable performance and good agreement result compared to SRLN laboratory test with record data of above 90% for all 1st line and 2nd line drugs with the exception of Ethambutol. Over all TAT record were acceptable with the exception of phenotypic DST which is Critical TAT findings that ranges from 100 to 841 days from total 4 round 1ST and 2nd line DST -PT participation With the median TAT of 205 days. The most frequently committed error type were High false Negative, which accounts 3% contribution for total loss of PT score. The review finding shows there were some gaps on Critical TAT therefore a periodic review and evidence based corrective action has to be made in short time interval after feedback obtained since laboratory error will have devastating impact on clinical management of Patients and laboratory information.
    VL  - 1
    IS  - 2
    ER  - 

    Copy | Download

Author Information
  • National Tuberculosis Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia

  • National Tuberculosis Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia

  • National Tuberculosis Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia

  • National Tuberculosis Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia

  • National Tuberculosis Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia

  • National Tuberculosis Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia

  • National Tuberculosis Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia

  • National Tuberculosis Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia

  • National Tuberculosis Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia

  • National Tuberculosis Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia

  • National Tuberculosis Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia

  • National Tuberculosis Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia

  • National Tuberculosis Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia

  • National Tuberculosis Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia

  • FIND Diagnostics/Expand TB Project, EPHI, Addis Ababa, Ethiopia

  • Sections