External Quality Assurance Scheme in a National Reference Laboratory for HIV Testing in South India


Background: The Department of Experimental Medicine functions as the National Reference Laboratory (NRL) for HIV testing covering 11 Medical Colleges (State Reference Laboratories SRL) & 723 subcenters i.e. Integrated Counseling & Testing Centres and Blood Banks. The External Quality Assurance Scheme (EQAS) in NRL implements Quality Control (QC) Testing, Proficiency panel testing and training programs. Materials & Method: 9419 samples (4393 HIV negative/5026 HIV positive) were tested for QC. All the samples were tested using HIV rapid test (CombAids) and HIV positives alone were tested using Tridot and EIA Comb. The QC samples consisted of 20% negative and all positives. All the 723 subcenters were provided with 5 coded plasma samples (3 reactive & 2 negative) for proficiency testing using rapid tests. The aliquot panel (500 μl) were provided twice a year for testing to monitor the laboratory performance. Results: Out of 9419 samples tested for QC, 9371 (99.49%) reported correct results and 48 (0.50%) discordant results. Out of 48 samples 26 (0.27%) were false positives and 22 (0.23%) false negative. Mislabeling, sample contamination, leaking vials, transcriptional errors, tests that were not performed correctly were identified. For proficiency testing 91.8% reported test results. 645 (97.13%) reported correct results & 19 (2.86%) incorrect results. Out of 19 samples 7 (1.05%) were false positive & 12 (1.80%) were false negative. Hands on training were provided and the 19 discordant centers reported correct results on retesting. Conclusion: Significant progress in establishing a well coordinated HIV Laboratory network of NRL and SRLs had been developed. However the HIV testing and Quality Assurance needs to be strengthened towards certification.

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K. Mary Sushi, T. Gopal, S. Mini Jacob, G. Arumugam and A. Durairaj, "External Quality Assurance Scheme in a National Reference Laboratory for HIV Testing in South India," World Journal of AIDS, Vol. 2 No. 3, 2012, pp. 222-225. doi: 10.4236/wja.2012.23028.

Conflicts of Interest

The authors declare no conflicts of interest.


[1] E. M. Dax, “ External Quality Assurance Scheme in HIV testing Guidelines,” National Reference Laboratory, Melbourne, 2000. www.nrl.gov.au
[2] Centers for Disease Control and Prevention, “Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived under the Clinical Laboratory Improvement Amendments of 1988,” 2007. http:www.cdc.gov/hiv/topics/testing/resources/guidelines/pdf/QA_Guidlines.pdf
[3] National AIDS Control Organization, “Guidelines for HIV Testing,” 2007. www.nacoonline.org
[4] D. E. Dwyer, “Advances in HIV Laboratory Testing,” NSW Public Health Bulletin, Vol. 21, No. 3-4, 2010, pp. 86-88. doi:10.1071/NB10018
[5] D. W. Tholen, L. M. Berte, D. J. Boone, W. G. Cooper, J. Gun-Munro, M. A. Noble, S. J. Sarewitz and M. L. Williams, “Using Proficiency Testing to Improve the Clinical Laboratory, Approved Guideline,” CLSI/NCCLS GP27-A, Vol. 27, No. 8, 1999.
[6] G. B. Clarke, S. J. Sarewitz, K. J. Aziz, K Castaneda-Mendez, L. K. Miller. E. Simson and D. W. Tholen, “Continuous Quality Improvement: Essential Management Approaches: Approved Guideline,” CLSI/NCCLS GP22-A, Vol. 19, No. 13, 1999.
[7] M. Fearon, “The Laboratory Diagnosis of HIV Infections,” The Canadian Journal of Infectious Diseases and Medical Microbiology, Vol. 16, No. 1, 2005, pp. 26-30.
[8] M. J. Casado, A. Rovira, C. Blanch and J. Casabona, “Survey of the Performance of Anti-HIV Antibody Detection Tests in Laboratories in Catalonia (Spain),” Gac Sanit Journal, Vol. 18, No. 1, 2004, pp. 68-71. doi:10.1157/13057982
[9] Y. Jiang, M. Qiu, G. Zhang, W. Xing, Y. Xiao, P. Pan, J. Yao, C. Y. Ou and X. Su, “Quality Assurance in the HIV/AIDS Laboratory Network of China,” International Journal of Epidemiology, Vol. 39, Suppl. 2, 2010, pp. 72-78. doi:10.1093/ije/dyq224
[10] M. Parczewski, K. Madalinski, M. Leszozyszyn-Pynka and A. Boron-Kaczmarska, “Evaluation of Quality of HIV Diagnostic Procedures in Poland,” Przegi Epidemiol Journal, Vol. 64, No. 1, 2010, pp. 47-53.
[11] S. Kant, K. Goswami, S. K. Rai, L. Dar and P. Misra, “Quality Assurance of Annual HIV Sentinel Surveillance: Experience of Regional Institute, Central Zone,” Indian Journal of Public Health, Vol. 51, No. 1, 2007, pp. 28-32.

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