“Infectious Diseases Laboratory Quality Control – Essential

Component for Public Health Improvement.”

Kalashnikova T.(GISK RF; CDC/CAR)Musabaev E. (Ref. Lab .Uzbekistan)Usmanov R. (Ref. Lab. Kyrgyztan)Kuchuk T.(Ref. Lab. Kyrgyztan)

Ongarbaev A. (Ref. Lab .Uzbekistan)Mustafaeva E. (Ref. Lab .Uzbekistan)Suleymenova S.(Ref. Lab. Kazakhstan )Jumagulova A. ( CDC/CAR)Favorov M. (CDC/CAR)

Actuality

High level ofInfectious Disease

Objective Results ofLaboratory Diagnosis

Necessity of further improving current public health measures for control and

prophylaxis of infectious disease.

Main issues of laboratory work in countries of the former Soviet Union

•Increase in the number and type of laboratories

• Progress in using highly effective laboratory methods ( ELISA , PCR)

•Absence of Quality Control measures for laboratory investigations

There is mismatch between clinical-epidemiological

diagnoses and the results of

serological tests.

Goals

• To develop a training module for quality control (QC) measures and implement QC program in the laboratory servises of Central Asia countries.

Objectives Knowledge :

Training course for establishing the proper laboratory conditions and quality control measures for laboratory investigations

Teach on screening and other blood banks related lab issues Use quality control manual developed by USAID/CDC

Improve Skills: Conduct a “wet” day, part of the training course Conduct ELIZA testing Group to group results comparison in order to mistakes

identification and problems solving technique. Competence:

Establish of the Reference laboratories Comprehensive laboratory documentation Reference panels for various markers Introduction of external quality control for the countries

Methods

Four-day courses for teaching with focus on:Quality control methodology for pre-analytical stage and analytical assay for laboratory investigation; principles for making and using biological standards; laboratory safety; demonstrate epidemiological and prevention principles using viral hepatitis A through E as models.

Wet lab day: conduct ELIZA tests using CDC design reference panel; compare results among groups of participants; find out the mistakes made by participants

Reference laboratory on site training: develop laboratory guideline documents; develop reference panels for markers for different infectious diseases; monitor quality of laboratories in Republics

Develop knowledge Seven quality control training seminars were held in various

regions of Central Asia Kirgyzia (1998) Uzbekistan (1999, 2000 and 2001) Kazakhstan (2000 and 2001) Turkmenistan (2000)

196 participants attended from the laboratories of various Republic oblasts.

Blood banks Infection hospitals Private laboratories Sanitary Epidemiological Stations

Lectures for quality control measures were included in seminars for epidemiologists and clinicians from Central Asia.

Establish the proper conditions and quality control measures for the stages of laboratory investigations

Pre-analytical stage• Ways to prevent clerical mistakes

– The forms of direction– The forms of marking for samples– The forms of the registration

• Standards for handling samples– obtaining– serum extraction– transportation – storage

Analytical stage• Conditions

– checking equipment– checking each lot of

laboratory test kit• Quality Control

– develop reference samples panel of markers for different infectious disease

– how to utilize reference samples for quality control of tests

Frequency of ‘good’ and ‘excellent’. Pre and Post course tests

20 21,5 23,7

10

46,2

31

7

75

90,4 95,2

65

95 97

56

0102030405060708090

100

Kyrgyzstan 1998

Uzbekistan 1999

Uzbekistan 2000

Turkmenistan-2000

Kazazhstan-2000

Kazazhstan-2001

Uzbekistan 2001Pre-testPost-test

Establishing of Reference Laboratory Laboratory staff• Chief• Laboratory workers• Assistants

Laboratory Procedures Guidelines

• Quality assurance of pre-analytical stage of laboratory research (Kyrgyztan , 2000)

• Instructions for pre-analytical stage (Kazakstan ,2000)

• Quality Control guidelines (Kyrgyztan, 2001)

• Instructions for in-house laboratory quality control (Uzbekistan, 2001)

Laboratory Layout• Rooms for Serology

• Rooms for receiving samples

• Rooms for staff

• Utility and Autoclave rooms

Equipment • Refrigerators

• Incubators

• Computers

• Plate washers

• Readers

• Automatic pipetmen

• Backup generators

Backup Honda generator

Don’t use expensive kits for confirmation before you purchase generator

Locally available kits evaluation with CDC desing panel.

3

2

Anti-HAV IgM

Anti-HCV

98751

HBsAg

Predictive value posit.

SpecificitySensitivity Name of marker

4

9681 100 100 89

100 69 68 10097 82 77

77

97

1

34

2

Lot №

100100

100

100

66

94829996

100

98

94

539382

100

100

75

70

10097

100

100

98

100

100

1

2

3

1

100100

100

100 100

Anti-HBc IgM

Predictive value negat.

87

First-round external quality control assesment in Uzbekistan

86% 86%

43%

95%

38%

86%90%

65%

95%

29%

95%86%

71%81%

100% 100% 95%

Layout

Equipment

Stock

Utensils

Resourcesof safety

Laboratory Evaluations in Uzbekistan

0%10%20%30%40%50%60%70%80%90%

100%

AquaPast Pospon Pospon Pospon VectorBestVectorBestPospon Pospon Pospon Pospon Pospon Pospon Pospon Pospon Pospon Pospon AquaPast Pospon AquaPast

Average of accuracy on the data of reference -laboratory( 84+2%)

СonclusionThe training module to establish quality control principles in

the region has been developed

Building quality control for infection diseases laboratories in: – Sentinal surveillance for viral hepatitis in Kyrgyztan.

– Control of diagnostic reagents (kits) for viral hepatitis under national licensing praktices in Uzbekistan and Kyrgyzstan.

– The outside quality assessment on the state level in Uzbekistan

Establishing the system of quality control laboratory procedure in Kyrgyzstan and Uzbekistan extending program to Kazakhstan and Turkmenistan

Recommendations:

Promote training of trainers program for quality control project in Central Asia.

Strengthen reference laboratory role in establishing external and internal laboratory control within countries of the region.

Training module adoption to HIV diagnostic laboratories.

Establishing quality control program for Polymerize Cheng Reaction technology laboratories.