Ongoing Standardisation of Testing for Blood-Borne Pathogens through an Internet-based Application

Elizabeth M. Dax for the staff of the National Serology Reference Laboratory

NRL’s ActivitiesNRL’s Activities

Evaluations of Test Kits

Quality Management

Performance Monitoring Methods: QC

Monitoring Specificity

Batch

Delivers reports and programsto generate quality in laboratories

EQAS

Reference and QA sample testing

Testing strategy development*Education

I-CollaborationsI-Collaborations

Sample characterisation

Panel DistributionPanel Distribution Panel DistributionPanel Distribution Panel DistributionPanel Distribution

Sourcing samples Sourcing samplesSourcing samples Sourcing samples

Sample selectionSample selection

Sample manufacture

Results collectionResults collection

Results analysisResults analysis

ReportsReports

KEYAcroMetrix

HealthMetrx

NRL

QC EQAS

Digital PT

EDCNet

Internet-based QC monitoring system

Laboratories submit data into ‘live’ data

graphically displays data in charts

instantaneous and confidential

Inter- and -intralaboratory variation

monitors performance of instruments, reagents and operators

Facilitating a QC programme in real timeFacilitating a QC programme in real time

NRL application (https://www.nrlqa.net).

* 2 Plasma samples

Data entered in 2005 for Selected Assays Data entered in 2005 for Selected Assays

0

5000

10000

15000

20000

PanBio EBVVCA IgM

ELISA

Murex anti-HCV (version

4.0)

RocheCOBASAmplicor

Chlamydia

Chiron TMAAssays

AbbottAxSYMHBsAg

Version 2MEIA

AbbottPRISMHBsAgChLIA

Assay type

No

. of

dat

a en

trie

s

01020304050607080

Number of entries Number of laboratories Number of batches of reagent

Monitoring Precision & AccuracyMonitoring Precision & AccuracyS

/Co

0

2

4

6

8

10

12

14

Mean

Mean+2SD

Mean-2SD

A B C D E F G H I J

Performance of QC sample hivspy004Performance of QC sample hivspy004

06/2002 - 10/2003 (7 Laboratories)

Batch N mean SD -2SD +2SD Min Max CV

011701 230 17.75 2.25 13.25 22.25 7.65 29.84 12.68

203159 793 17.34 2.66 12.02 22.66 0.05 23.34 15.34

207123 1288 17.89 2.56 12.77 23.01 0.13 24.24 14.31

208146 1825 17.84 2.55 12.74 22.94 0.39 28.00 14.29

210096 16 18.60 3.67 11.26 25.94 7.29 22.85 19.73

210509 933 18.10 3.08 11.94 24.26 3.26 26.15 17.02

TOTAL 5085 17.82 2.67 12.48 23.16 0.05 29.84 14.98

Precision - CV (%)0 5 10 15 20 25 30

Acc

ura

cy -

Bia

s (%

)

-30

-20

-10

0

10

20

30

instruments testing HCV instruments testing HBsAg instruments testing HIV instruments testing HTLV

Accuracy and Precision of the Abbott PRISMAccuracy and Precision of the Abbott PRISM

Bias - difference between mean ratio for individual laboratory and mean ratio for all laboratories, expressed as % of mean ratio for all laboratories

Variation by Laboratory Variation by Laboratory

1 2 3 4 5 6 7 Laboratory

25

20

15

10

5

0

S/C

o

Variation by BatchVariation by Batch

Ongoing monitoring of Changes in Performance

Ongoing monitoring of Changes in Performance