Korean J Clin Microbiol.  2009 Dec;12(4):147-153.

Quality Assurance of Laboratory Tests for Tuberculosis

• Kim CK
• Chang CL

Abstract

Clinical microbiology laboratories play a critical role in diagnosing tuberculosis (TB) and monitoring its treatment. Poor quality laboratory services remain a major barrier to diagnosis by microscopy and culture, and may complicate the interpretation of drug susceptibility testing (DST) results. External quality assessment (EQA) for microscopy is an important component of quality assurance, and includes panel testing, slide rechecking, and on-site supervision. Periodic panel testing is the simplest way to assess the performance of laboratories. Rechecking of a sample of routine smears by a higher-level laboratory is the method of choice for evaluation and continuous motivation of peripheral laboratories. On-site supervision allows the observation of workers' performance under actual conditions, including equipment handling, laboratory safety, adequacy of supplies, and the processes used for smearing, staining, reading, recording, and reporting. Culture performance is not easily measured, and existing EQA programs are not sensitive enough to estimate the sensitivity of the process. Therefore, laboratory regulations and accreditation programs are critical to assure the quality of cultures. The Supranational Reference Laboratory Network (SRLN) was organized in 1994 to ensure optimal performance of laboratories conducting DST. A panel of 30 pretested and coded isolates is exchanged annually within the network for proficiency testing. It has been demonstrated that education and an EQA program can improve the proficiency of TB laboratories. However, quality programs in Korea are still weak. Expanded and strengthened laboratory quality improvement systems are necessary to achieve TB control in this country.

Keyword

Tuberculosis; Microbiology laboratory; Quality assurance; External quality assessment

MeSH Terms

Accreditation
Dietary Sucrose
Equipment and Supplies
Handling (Psychology)
Korea
Microscopy
Motivation
Organization and Administration
Quality Improvement
Social Control, Formal
Tuberculosis
Dietary Sucrose

Reference

1. World Health Organization. Global Tuberculosis Control 2009. http://www.who.int/tb/publications/global_report/2009/pdf/full_report.pdf. [Online] (last visitd on 10 December 2009).

2. Hong YP, Kim SJ, Lew WJ, Lee EK, Han YC. The seventh nationwide tuberculosis prevalence survey in Korea, 1995. Int J Tuberc Lung Dis. 1998; 2:27–36.

3. David HL. Probability distribution of drug-resistant mutants in unselected populations of Mycobacterium tuberculosis. Applied microbiology. 1970; 20:810–4.

4. Kim SJ. Drug-susceptibility testing in tuberculosis: methods and reliability of results. Eur Respir J. 2005; 25:564–9.

5. Laszlo A, Rahman M, Espinal M, Raviglione M. Quality assurance programme for drug susceptibility testing of Mycobacterium tuberculosis in the WHO/IUATLD Supranational Reference Laboratory Network: five rounds of proficiency testing, 1994-1998. Int J Tuberc Lung Dis. 2002; 6:748–56.

6. Shah NS, Wright A, Bai GH, Barrera L, Boulahbal F, Martín-Casabona N, et al. Worldwide emergence of extensively drug-resistant tuberculosis. Emerg Infect Dis. 2007; 13:380–7.

7. Kim DH, Kim HJ, Park SK, Kong SJ, Kim YS, Kim TH, et al. Treatment outcomes and longterm survival in patients with extensively drug-resistant tuberculosis. Am J Respir Crit Care Med. 2008; 178:1075–82.

8. Bai GH, Park YK, Choi YW, Bai JI, Kim HJ, Chang CL, et al. Trend of anti-tuberculosis drug resistance in Korea, 1994-2004. Int J Tuberc Lung Dis. 2007; 11:571–6.

9. Aziz M, Ba F, Becx-Bleumink , Bretzel G, Humes R, Ladermarco MF. External Quality Assessment for AFB Smear Microscopy. Geneva, Switzerland: World Health Organization,. 2002.

10. Rieder HL, Van Deun A, Kam KM, Kim DH, Chonde TM, Trébucq A, et al. Priorities for Tuberculosis Bacteriology Services in Low-Income Countries. 2nd ed.Paris: International Union Against Tuberculosis and Lung Disease;2007.

11. Selvakumar N, Murthy BN, Prabhakaran E, Sivagamasundari S, Vasanthan S, Perumal M, et al. Lot quality assurance sampling of sputum acid-fast bacillus smears for assessing sputum smear microscopy centers. J Clin Microbiol. 2005; 43:913–5.

12. Aziz M, Bretzel G. Use of a standardised checklist to assess peripheral sputum smear microscopy laboratories for tuberculosis diagnosis in Uganda. Int J Tuberc Lung Dis. 2002; 6:340–9.

13. World Health Organization and Regional Office for the Western Pacific. Quality Assurance of Sputum Microscopy in DOTS Programmes: Regional Guidelines for Countries in the Western Pacific. Geneva, Switzerland: World Health Organization,. 2003.

14. Siddiqi S, Rüsch-Gerdes S. MGIT Procedure Manual. http://www.finddiagnostics.org/resource-centre/reports_brochures/071130_mgit_manual.html. [Online] (last visitd on 10 December 2009).

15. Ridderhof JC, van Deun A, Kam KM, Narayanan PR, Aziz MA. Roles of laboratories and laboratory systems in effective tuberculosis programmes. Bull World Health Organ. 2007; 85:354–9.

16. Walton C, Hawkey PM, James VL. Examination of specimens for mycobacteria in clinical laboratories in 21 countries: a 10-year review of the UK National Quality Assessment Scheme for Mycobacteria Culture. Clin Microbiol Infect. 2005; 11:1016–21.

17. Yamada H, Mitarai S, Aguiman L, Matsumoto H, Fujiki A. Preparation of mycobacteria-containing artificial sputum for TB panel testing and microscopy of sputum smears. Int J Tuberc Lung Dis. 2006; 10:899–905.

18. World Health Organization. Anti-tuberculosis drug resistance in the world: fourth global report. The WHO/UNION Global Project on Anti-Tuberculosis Drug Resistance Surveillance, 2002-2007. WHO/HTM/TB/2008.394.http://whqlibdoc.who.int/hq/2008/WHO_HTM_TB_2008.394_eng.pdf. [Online] (last visitd on 10 December 2009).

19. Bai GH, Kim SJ, Chang CL. Proficiency analysis of drug susceptibility testing by national-level tuberculosis reference laboratories from 1995 to 2003. J Clin Microbiol. 2007; 45:3626–30.

20. Migliori GB, Ambrosetti M, Fattorini L, Penati V, Vaccarino P, Besozzi G, et al. Surveillance of anti-tuberculosis drug resistance: results of the 1998/1999 proficiency testing in Italy. SMIRA (Italian Multicentre Study on Antituberculosis Drug Resistance) Study Group. Int J Tuberc Lung Dis. 2000; 4:940–6.

21. Migliori GB, Centis R, Fattorini L, Besozzi G, Saltini C, Orefici G, et al. Monitoring the quality of laboratories and the prevalence of resistance to antituberculosis drugs: Italy, 1998-2000. Eur Respir J. 2003; 21:129–34.

22. Fattorini L, Iona E, Cirillo D, Migliori GB, Orefici G, Aziz M, et al. External quality control of Mycobacterium tuberculosis drug susceptibility testing: results of two rounds in endemic countries. Int J Tuberc Lung Dis. 2008; 12:214–7.

23. Laszlo A, Rahman M, Raviglione M, Bustreo F. Quality assurance programme for drug susceptibility testing of Mycobacterium tuberculosis in the WHO/IUATLD Supranational Laboratory Network: first round of proficiency testing. Int J Tuberc Lung Dis. 1997; 1:231–8.

24. Van Deun A, Wright A, Zignol M, Rieder HL. Proficiency in drug susceptibility testing in the international network of supranational reference laboratories Proficiency Rounds 6 through 14 TSRU Meeting. Seoul, Korea. 2009.

25. Woods GL, Long TA, Witebsky FG. Mycobacterial testing in clinical laboratories that participate in the college of American pathologists mycobacteriology surveys. Changes in practices based on responses to 1992, 1993, and 1995 questionnaires. Arch Pathol Lab Med. 1996; 120:429–35.

26. Center for Disease Control and Prevention. Analyses of June 2008 M. tuberculosis and Nontuberculous Mycobacteria Drug Susceptibility Test Results Reported by Participating Laboratories. http://wwwn.cdc.gov/mpep/pdf/mtb/TB%20DST200806.pdf. [Online] (last visitd on 10 December 2009).

27. Evolution of an external quality assessment program in Canadian Mycobacteriology Laboratories: three years of proficiency testing data. Am J Clin Pathol. 2004; 121:566–73.

28. Wu MH, Chiang CY, Jou R, Chang SY, Luh KT. External quality assessment of sputum smear microscopy in Taiwan. Int J Tuberc Lung Dis. 2009; 13:606–12.

29. Mitarai S. External quality assessment of drug susceptibility testing for Mycobacterium tuberculosis. Kekkaku. 2006; 81:501–9.

30. Kobayashi I, Abe C, Mitarai S. BACTEC MGIT 960 system for drug susceptibility testing of Mycobacterium tuberculosis: a study using external quality assessment strains. Kekkaku. 2006; 81:57–62.

31. Martinez-Guarneros A, Balandrano-Campos S, Solano-Ceh MA, Gonzalez-Dominguez F, Lipman HB, Ridderhof JC, et al. Implementation of proficiency testing in conjunction with a rechecking system for external quality assurance in tuberculosis laboratories in Mexico. Int J Tuberc Lung Dis. 2003; 7:516–21.

32. Siddiqi K, Newell JN, Van der Stuyft P, Gotuzzo E, Torrico F, Van Deun A, et al. Improving sputum microscopy services for the diagnosis of tuberculosis in Peru and Bolivia. Int J Tuberc Lung Dis. 2007; 11:665–70.