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HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory, Australia and Indonesian Collaborators
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HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

Apr 17, 2018

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Page 1: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

HIV EQAS -Novel Perspectives

Elizabeth M. Dax for the staff of the National Serology Reference Laboratory, Australia and Indonesian Collaborators

Page 2: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

Objectives of an EQAS

Monitoring of laboratory and assay performances

To compare results between participantsTo review testing processes

Facilitation of information exchange between participants

On assays and testing strategies usedTo identify problems and their possible causesTo obtain information to offer advice, solutions and targeted training.

Page 3: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

Participants Gain…

Risk ManagementDetermination of the accuracy of results

Comparison of results Review of performances of assays in useInformation to minimise their errorsSelf appraisalObjective evidence of quality Identification of training needsContinual improvement

Page 4: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

2. Develop Sample Bank

1B. Questionnaire

5. Data Collection

3. Preparation of Panels

6. Preliminary report

4. Panel Distribution

7. Data Analysis

8. Final report

1A. New Participants

Process of EQAS

Page 5: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

Review feedback;Improve processes

External Quality Assessment Scheme (EQAS)

Provider Participants

Sends samplesTest samples;Submit results

Analyses resultsProvide feedback

Workshops

Large volumes of well- characterised plasma or other samples

Page 6: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

Chris Chiu

Page 7: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

Pathologists, Laboratory (trained), VCT staff (trained)

N=34 N=22 N=19

Page 8: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

78.18%

96.36%

81.11%

99.47%

84.17%95.90%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

VCT Lab senior Pathologist

Training improved the interpretation of Determine for all groups

Other

Invalid

False Negative

False Positive

Correct

Page 9: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

75.45%

98.64%

80.00%

94.21%87.50%

97.95%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

VCT Lab Senior Pathologist

Training improved the interpretation of Advanced Quality for all groups

Other

Invalid

False Negative

False Positive

Correct

Page 10: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

72.73%

98.64%

79.44%

100.00%91.94%

97.44%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

VCT Lab senior Pathologist

Training improved the interpretation of Insti for all groups

Other

Invalid

False Negative

False Positive

Correct

Page 11: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

12.73%

71.36%

28.95%

85.26%

49.44%

75.90%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

VCT Lab senior Pathologist

Training improved the interpretation of SD Bioline for all groups

Other

Invalid

False negative

False positive

Wrong subtyping

Can't differentiate

Correct

Page 12: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

Bottom Line

Photographs may be used to assess operators’ interpretation skillsMay be used for trainingSelf Appraisal was enabled and was revealing

Page 13: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

How effective is EQAS?

How often to administer?

How many samples?

Page 14: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

The Model compared with the Data

Page 15: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

How many samples to detect errors?

Page 16: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,
Page 17: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

How often to send panels of what size?

EQAS 1 panel 1 year 2 years 3 years

6 x 2 samples 1.0 % 5.0 % 8.3 % 10.7 %

3 x 5 samples 2.4 % 6.0 % 9.6 % 11.9 %

4 x 5 samples 2.4 % 7.4 % 11.3 % 13.3 %

3 x 10 samples 4.3 % 9.6 % 13.3 % 14.6 %

EQAS 1 panel 1 year 2 years 3 years

6 x 2 samples 1.0 % 5.0 % 8.3 % 10.7 %

3 x 5 samples 2.4 % 6.0 % 9.6 % 11.9 %

4 x 5 samples 2.4 % 7.4 % 11.3 % 13.3 %

3 x 10 samples 4.3 % 9.6 % 13.3 % 14.6 %

Page 18: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

Conclusions

According to the described model, large numbers of EQAS samples are required before all errors can be detected with confidence.

If errors are not detected in a given number of samples, to be 95% confident of the results considerable testing needs to be carried out to detect low error rates.

Over time, increasingly errors will be detected through EQAS.

Addition of an ongoing quality assurance tool such as quality control measures will assist in error detection.

Page 19: HIV EQAS - Novel Perspectives - 2019 HIV Diagnostics … ·  · 2010-05-11HIV EQAS - Novel Perspectives Elizabeth M. Dax for the staff of the National Serology Reference Laboratory,

Thank you!