Bayer MolecularBayer Molecular

Customer HIV-1 Quantitation QA SchemeCustomer HIV-1 Quantitation QA Scheme

Bayer Molecular/NIBSC HIV QA SchemeBayer Molecular/NIBSC HIV QA Scheme

• AimsAims– To provide a pair of externally manufactured HIV-1 Controls

for Inclusion in Bayer HIV-1 Quant bDNA assays– Provide Regular Reporting demonstrating Intra and Intersite

reproducibility– Provide Continuous Monitoring of End User Results as an

Early Indicator of Potential Problems• MaterialsMaterials

– NIBSC Code 01/544: Medium copy number subtype A virus (92UG037)

• Approximate 20,000 copies/ml

– NIBSC Code 02/110: A low copy number subtype B virus. Based on WHO HIV-1 International Standard

• Approximately 1000 copies/ml

Bayer Molecular/NIBSC HIV QA SchemeBayer Molecular/NIBSC HIV QA Scheme

• Participant LaboratoriesParticipant Laboratories– Hospital

– Health Protection Agency

– Virus Reference Laboratories

QA Scheme ReportingQA Scheme Reporting

• Reported results compiled and analysed in a biannual report provided to all UK Versant HIV Version 3.0 bDNA customers.

• Reports Formatted to Permit Comparisons between

– Reagent Lots

– Instruments

– Operators

– Different Sites

Reporting ResultsReporting ResultsAll results NIBSC A

0

5000

10000

15000

20000

25000

30000

35000

40000

45000

0 20 40 60 80 100 120 140 160 180

HIV 3.0 bDNA Run

Result (copies/ml) NIBSC A

26 31 20 29 21 24 23 25 22

Reporting ResultsReporting Results

All Results NIBSC B

0

1,000

2,000

3,000

4,000

5,000

0 20 40 60 80 100 120 140 160 180

HIV 3.0 bDNA Run

Result (copies/ml) NIBSC B

Site 26 Site 31 Site 20 Site 29 Site 21 Site 24 Site 23 Site 25 Site 22

Results Analysis – NIBSC A ReagentResults Analysis – NIBSC A ReagentSite: Median: Mean: Standard Deviation:

20 12211 32668 23043 21941 5004.2

21 8124 20583 13062 13051 3171.8

22 11150 28549 18311 18052 3814.2

23 9407 24850 13574 14970 3888.9

24 3784 28258 17036 17372 4320.7

25 10854 27692 15004 15723 3600.0

26 11218 25437 17604 17613 3521.2

29 5913 40602 16323 17294 4816.1

31 10284 44432 16995 19509 9587.4

Median: Mean: Standard Deviation:

All Sites: 3784 44432 16344 17196 4813

Low and High (Range):

Low and High (Range):

Results Analysis – NIBSC B ReagentResults Analysis – NIBSC B Reagent

Site: Median: Mean: Standard Deviation:

20 639 2869 1134 1239 521.3

21 487 1321 867 934 255.6

22 541 1685 976 993 225.4

23 336 1333 823 880 323.6

24 253 5046 1276 1339 601.0

25 743 1746 977 1048 256.0

26 361 1747 1021 1061 264.8

29 394 2739 899 929 306.1

31 600 3508 1083 1302 667.3

Median: Mean: Standard Deviation:

All Sites: 253 5046 992 1053 412

Low and High (Range):

Low and High (Range):

Results – By Site/By LotResults – By Site/By Lot

Results obtained Lot X025 NIBSC A

0

5000

10000

15000

20000

25000

30000

Site 22: Site 23: Site 24: Site 21: Site 29: Site 20: Site 26:

QA scheme site no. / HIV 3.0 bDNA runs

Results NIBSC A (copies/ml)

Results – By Site/By LotResults – By Site/By Lot

Results obtained Lot X025 NIBSC B

0

500

1000

1500

2000

2500

3000

3500

Site 22: Site 23: Site 24: Site 21: Site 29: Site 20: Site 26:

QA scheme site no. / HIV 3.0 bDNA runs

Results NIBSC B (copies/ml)

Results Analysis - By Site/By LotResults Analysis - By Site/By Lot

Statistics: 14563 All Sites:

Range: 14020-24126 11505-24850 13465-20935 9273-10825 11699-22956 16902-23047 12409-14133 9273-24850

Median: 18299 18745 15990 10049 15459 19975 13271 15586

Mean: 18815 18367 17009 10049 15714 19975 13271 16357

SD: 5073 6681 2732 1097 2750 4345 1219 3829

No. of runs: 3 3 9 2 12 2 2

Site 22: Site 23: Site 24: Site 21: Site 29: Site 20: Site 26:

Statistics: 907 All Sites:

Range: 976-1223 336-1273 600-2904 487-1056 608-1224 991-1134 NA 336-2904

Median: 1067 1270 1193 772 870 1063 1085 1044

Mean: 1089 960 1312 772 877 1063 1085 1038

SD: 125 540 662 402 178 101 NA 433

Site 22: Site 23: Site 24: Site 21: Site 29: Site 20: Site 26:

No. of runs: 3 3 9 2 12 2 1

NIBSC A Reagent

NIBSC B Reagent

SummarySummary

• Provision of External StandardsProvision of External Standards– Permits End-Users to Verify Manufacturer Claims

– Allows a partnership between customer and manufacturer in the management of continuous good results quality

• Instrument and Operator Monitoring

– Permits Cross-Site Comparability

• Continuous Improvement Project to benefit Continuous Improvement Project to benefit Manufacturers and End-UsersManufacturers and End-Users

• Bayer and UK Customers have agreed Intervention Bayer and UK Customers have agreed Intervention Mechanisms for Corrective and Preventative Actions Mechanisms for Corrective and Preventative Actions to be Undertakento be Undertaken

Special ThanksSpecial Thanks

• Clare DavisClare Davis NIBSCNIBSC• Harvey HolmesHarvey Holmes NIBSCNIBSC• Vicki Wilson Vicki Wilson Bayer UKBayer UK• Mike PottenMike Potten Bayer UKBayer UK