Ongoing Standardisation of Testing for Blood-Borne Pathogens through an Internet-based ApplicationElizabeth M. Dax for the staff of the National Serology Reference Laboratory

NRL’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-Collaborations

Sample characterisation

Panel Distribution Panel Distribution Panel Distribution

Sourcing samples Sourcing samples Sourcing samples

Sample selection

Sample manufacture

Results collection

Results analysis

Reports

KEYAcroMetrix

HealthMetrx

NRL

QC EQASDigital PT

EDCNet

Internet-based QC monitoring system

Laboratories submit data into ‘live’ datagraphically displays data in chartsinstantaneous and confidentialInter- and -intralaboratory variationmonitors performance of instruments, reagents and operators

Facilitating a QC programme in real time

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

* 2 Plasma samples

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 d

ata

entr

ies

01020304050607080

Number of entries Number of laboratories Number of batches of reagent

Monitoring Precision & AccuracyS/

Co

02468

101214

Mean

Mean+2SD

Mean-2SD

A B C D E F G H I J

Performance 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

urac

y - B

ias

(%)

-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 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

1 2 3 4 5 6 7 Laboratory

25201510 5 0

S/C

o

Variation by Batch

Ongoing monitoring of Changes in Performance