Laboratory aspects of acute diseases surveillance and the needs for QA/QC

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Laboratory aspects of acute diseases surveillance and the needs for QA/QC Kalashnikova T. ( DIH, EPO, CDC/CAR) Ongarbaev A. (Ref. Lab.Uzbekistan) Musabaev E. (Ref. Lab.Uzbekistan) Kuchuk T.(Ref. Lab. Kyrgyztan) Usmanov R.

1 Laboratory aspects of acute diseases surveillance and the needs for QA/QC Kalashnikova T. ( DIH, EPO, CDC/CAR) Ongarbaev A. (Ref. Lab.Uzbekistan) Musabaev E. (Ref. Lab.Uzbekistan) Kuchuk T.(Ref. Lab. Kyrgyztan) Usmanov R. (Ref. Lab. Kyrgyztan) Mustafaeva E. (Ref. Lab.Uzbekistan) Kovtunenko N ( RL RC AIDS Kazazhstan) Jumagulova A. (DIH, EPO, CDC/CAR) Suleymenova S.(Ref. Lab Kazazhstan) Drobeniuk J. (DVH, NCID, CDC) Golovchenko N.I.(RL RC AIDS Kyrgyzstan) Favorov M. (DIH, EPO, CDC/CAR)

2 The Quality Assurance Cycle Reporting Patient/Client Prep Sample Collection Data and Lab Management Safety Customer Service Personnel Competency Test Evaluations Sample Receipt and Accessioning Record Keeping Quality Control Testing Sample Transport 2

3 Features of laboratory service in Central Asia region Absence of continuously postgraduate education for laboratory specialists Short supply with technical facilities Absence of laboratory control of test kits Absence of steady monitoring for analysis quality in every single laboratory (IQCl) and state (EQC) 3

4 GOAL Establishing and implementation of laboratorial quality assurance system for HIV and viral hepatitis diagnosing in states of Central Asia 4

5 OBJECTIVES Training of Central Asia specialist of rules of quality assurance and quality control (QA/QC) Establishing national referencelaboratories (NRL) for implementation of basis of QA Internal Quality Control and program of External Quality Control 3. Creation of background for further development of QA through integration of NRL to present laboratory service system 5

6 TRAINING 18 QA and HIV and hepatitis laboratory diagnostics training courses were held in different regions of Central Asia: Kyrgyzstan (1998, 2002, 2003) Uzbekistan (1999, 2000, 2001, 2002, 2003(2),2004) Kazakhstan (2000, 2001, 2002(2), 2003(2) Turkmenia (2000,2004) 438 of participants representatives of laboratory service system from several regions of republics Blood Donor Centers Infectious diseases hospitals Private laboratories SSC (sanitarian surveillance centers) Lecturing in quality control have been included to workshops for epidemiologists and practitioners in Central Asia 6

7 Distribution of participants with over 70% of successful examination rate Before training After training Uzbekistan-2000 Uzbekistan-1999 Kirgizia-1998 Uzbekistan-2001(HV) Kazakhstan-2001(HV) Kazakhstan-2000(HV) Turkmenia-2000(HV) Uzbekistan (HIV) Kirgizia (QAT HIV) Uzbekistan-2001 (HIV) Kazakhstan-2000 (HIV) Kazakhstan-2001 (HV) Kirgizia (QAT HIV) 7

8 16.00 Res ults of laboratorial day of quality control works hop in Tashkent (June 2002) Reference (V-0,3-1,7) Group 1 (V=3,2-5,6) Group 2 (V=16,0-35,8) Group 3 (V=6,8-10,6) Group 4 (V=4,2-4,3)

9 Reference laboratories for HIV and viral hepatitis were established in four states of Central Asia Kyrgyzstan ( 1998) Uzbekistan*( 1999) Kazakhstan ( 2000) Turkmenistan ( 2000) * Joint project with Swiss agency of emergent events and CDC/USAID 9

10 JURAL BASIS OF NRL The principals of establishing of assurance of quality control system are fixed in «Regulation of activity of reference laboratories» and approved by Ministry of Health 10

11 Implementation QA program in acute viral hepatitis sentinel surveillance in Kyrgyzstan 11

12 Organizational Scheme of preanalytical step of the research Obl. hospital for children, Naryn Lab Obl. hospital for adults, Naryn City SES, Bishkek RL Obl. Hospital for children, Zhalal- Abad Lab Lab Obl. Hospital for adults, Zhalal- Abad Hospital for infectious diseases, Bishkek 12

13 Quality Performance of test-system system on HBsAg ( 2000 ) SHORT NAME OF THE TEST- SYSTEMS HBs антиген-ифа» Sensitivity Sample Correlation 31/31 % 100 Specificity Sample Correlation 0/37 % 0 «Рекоматгеп В- стрип» 23/31 74,1 49/50 98 Вектогеп В- HBsAg-стрип» 25/31 80,6 50/ «Рекоматгеп В- стрип» 31/ /50 66 «ИФА-HBsAg/м» 30/ / HBsAg-ИФА 22/31 70,9 50/

14 The evaluation of the quality assurance systems effectiveness for the laboratory researches in Sentinel Epidemiologic Surveillance of Kyrgyzia was conducted by repeated research of 25% of the samples in the reference- laboratory for virus hepatitis diagnosis in CDC Atlanta 14

15 Results of data comparison from RL of Kyrgyzia and RL of CDC Atlanta ( 2002 ) Marker anti-вга IgM Presence of the marker positive negative CDC Data Number of correct RL data Number of errors 3 15 total ( 3,0%) 15

16 Results of data comparison from RL of Kyrgyzia and RL of CDC Atlanta ( 2002 ) Marker Anti-HCV Presence of the marker positive CDC Data 59 Number of correct 46 RL data Number of errors 13 negative total ( 3,8%) 16

17 Results of data comparison from RL of Kyrgyzia and RL of CDC Atlanta ( 2002 ) Marker anti- HBcor IgM Presence of the marker positive negative CDC Data Number of correct RL data Number of errors 34 7 total ( 9,8%) 17

18 Results of data comparison from RL of Kyrgyzia and RL of CDC Atlanta ( 2002 ) Marker HBsAg Presence of the marker positive CDC Data 243 Number of correct 172 RL data Number of errors 71 negative total ( 12,7%) 18

19 EQC Results of 19 laboratories of AIDS Centers of Kazakhstan ( 2002 ) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% negative HBsAg 5 ng/ml. HBsAg 1 ng/ml HBsAg 0,25 ng/ml negative High positive Weak positive negative High positive Midlle positive Weak positive HBsAg Anti-HCV Anti-HIV 19

20 Conclusion (1) The program of quality assurance of laboratory diagnosing of HIV and viral hepatitis has been developed and implemented in Uzbekistan, Kazakhstan and Kyrgyzstan The realization of program allowed: Training the rules of quality assurance to laboratory experts of Central Asia Obtaining the objective results of monitoring of viral hepatitis in Kyrgyzstan Organization of quality control of test kits while licensing and further production in Uzbekistan and Kirhizia Monitor the quality of testing of HBsAg, anti-hcv, anti-hiv while EQC in Uzbekistan, Kazakhstan and Kyrgyzstan 20

21 Conclusion (2) The QA will be improved by: Implementation of the national External Quality Control programs on the regular basis (Kazakhstan, Uzbekistan) Realization of the interregional EQC programs (NRL of AIDS Centers of Kazakhstan and Kyrgyzstan, 2003) Participation in the international EQC programs МPEP, Atlanta CDC, 2004 (Kazakhstan 6: Uzbekistan-10: Kyrgyzia -1) PTP anti-hiv DBS, CDC Atlanta, 2004 (Kazakhstan -6 lab, Uzbekistan -1 lab, Kyrgyzia- 1 lab 21

22 Thank you for your attention 22

Integrating Surveillance - Essential Constituent for HIV/AIDS, Viral Hepatitis, and STDs Control and Prevention

Integrating Surveillance - Essential Constituent for HIV/AIDS, Viral Hepatitis, and STDs Control and Prevention Michael Favorov MD, Ph.D., D.Sc., Harold Margolis MD, CDC Central Asia Program, DIH, EPO;