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© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B4-2014-str.doc Report Issued Monday, 28 July 2014 Page Page 1 of 14
RCPA Quality Phone +61 2 9045 6000
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au
Survey B4:2014: 4G & 4H
Final Generic Report Bacterial Program
Streptococcal Serology Report prepared and collated by: RCPAQAP Serology Comments provided by: Robert Gibb on behalf of RCPAQAP Serology Microbiology, Pathology Queensland, QLD, Australia
Report prepared by
RCPAQAP Serology Suite 201, 8 Herbert Street St Leonards NSW 2065 AUSTRALIA Phone +61 2 9045 6070 Facsimile +61 2 9356 2003 Email [email protected] Web http://www.rcpaqap.com.au/serology
Contact
Susan Badman Group Manager Infectious Diseases & Immunology | Manager - Serology
The completed report has been authorised for issue by
Professor Alison Kesson Program Chair - Serology
Copyright
This material is copyright and may not be used in any form for advertising, sales promotion or publicity. The material may not be reproduced in whole or in part for any purpose whatsoever (including presentations at meetings and conferences), without the prior written permission of the RCPA Quality Assurance Programs Pty Limited. Permission must be sought in writing from the Program but will not be unreasonably refused.
Confidentiality
RCPA Quality Assurance Programs Pty Limited keeps all participant details confidential. No information related to any of the participants will be divulged to a third party, unless required by legislation, without the express written consent of the participant. General information may be discussed at meetings or presented as papers to journals.
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B4-2014-str.doc Report Issued Monday, 28 July 2014 Page Page 2 of 14
RCPA Quality Phone +61 2 9045 6000
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au
Kit Performance
It is up to all users to form their own opinion or conclusions on each kit's performance based on the accumulation of data and information that is supplied by this survey, and other information available to the participant. A variety of samples are used in this Program (undiluted, diluted and pooled serum and plasma) and this can sometimes impact on results and performance of some kits. With serum specimens, occasional artefactual problems are encountered with some kits due to changes in the matrix caused by rethrombinisation of plasma or dilution.
Clinical Notes
The “Clinical Notes” were created so as to highlight particular issues relating to interpretation of serological results. They do not necessarily reflect the clinical history of the patient from whom the sample was obtained. 4G A 20 year old male presents with malaise, sore throat, rash and fever over the past two weeks. Recent
streptococcal infection is suspected.
4H A 25 year old male presents to his doctor with migratory polyarthritis. He has had a recent sore throat and a
sample is submitted for investigation.
Request
Please test sera for antibodies to streptococcal exotoxins. Elevated titres should be extended to the end-point. Please test in the same manner as patient specimens.
Specimen Details
Specimens are of human origin and tested negative for hepatitis B surface antigen, hepatitis C antibody and HIV. (Ref. 2014 RCPAQAP Serology Program Plan section B4:2014) 4G is a serum sample that tested positive for ASOT and negative to Anti-DNase B.
Source: SEALS, Prince of Wales Hospital, NSW. 4H is a pooled serum sample that tested positive for ASOT and negative to Anti-DNase B.
Source: Laverty Pathology, North Ryde, NSW.
Pre-issue testing: Princess Alexandra Hospital, Pathology Queensland, QLD.
Analysis of Results
For information on “Analysis of Results” please refer to your RCPAQAP Serology Participation Handbook for the current year. The Participant Performance Table is an indicator for participants to review their results and evaluate their own performance as ‘Satisfactory’ or ‘Unsatisfactory’.
Robust Statistics
Analysis of Results using Robust Statistics is performed on user groups of five (5) or more participants using the same units and is now available on your personalised Assessment Report. In order to calculate the statistics as accurately as possible, results that are presented as < or > are entered into the calculations as the next whole number. For example, <10 is entered into the calculation as 9 and >500 is entered as 501. To view robust statistics of user groups other than your own, use the RCPAQAP Serology website http://www.rcpaqap.com.au/serology Log into the ‘Member Services’ section and go to ‘Dynamic Graphs of Results’.
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B4-2014-str.doc Report Issued Monday, 28 July 2014 Page Page 3 of 14
RCPA Quality Phone +61 2 9045 6000
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au
Results 62 participants returned results for Streptococcal Serology.
Survey Results B4:2014 Streptococcus
Streptococcus Anti-DNase B - Specimen 4G NS: 34 = 97.14% S: 1 = 2.86% Total Results =35 Consensus: NS
Streptococcus Anti-DNase B - Specimen 4H ind: 3 = 8.57% NS: 19 = 54.29% S: 13 = 37.14% Total Results =35 Consensus: No
Streptococcus ASOT - Specimen 4G NS: 38 = 63.33% S: 22 = 36.67% Total Results =60 Consensus: No
Streptococcus ASOT - Specimen 4H ind: 1 = 1.67% NS: 9 = 15.00% S: 50 = 83.33% Total Results =60 Consensus: S
Streptococcus Streptozyme - Specimen 4G S: 2 = 100.00% Total Results =2 Consensus: Insufficient data (less than 5 results)
Streptococcus Streptozyme - Specimen 4H S: 2 = 100.00% Total Results =2 Consensus: Insufficient data (less than 5 results)
Inconsistencies in this Survey
Anti-DNase B Participant Comment
Specimen 4G 91317 Result inconsistent with the consensus. An error appears to have occurred when transcribing the result.
Specimen 4H 31252 Result assigned is inconsistent with the cut-off and result value provided.
41018 Result assigned is inconsistent with the cut-off and result value provided.
Test Group 1000 Edit - Re-assigned kit according to lot number provided.
89072 A transcription error appears to have been made with the cut-off value.
89173 Cut-off value not provided.
92014 A transcription error appears to have been made with the cut-off value.
ASOT Participant Comment
Specimens 4G & 4H 89144 Result value in incorrect format. Please see instructions on results sheet.
Specimen 4G 21439 Result assigned is inconsistent with the cut-off and result value provided.
21763 Result value not provided.
89002 Result value not provided.
89028 Result higher than majority of participants performing this test.
89055 Result higher than majority of participants performing this test.
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B4-2014-str.doc Report Issued Monday, 28 July 2014 Page Page 4 of 14
RCPA Quality Phone +61 2 9045 6000
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au
Inconsistencies in this Survey continued (continued) .
ASOT Participant Comment
Specimen 4G 89319 Result assigned is inconsistent with the cut-off and result value provided.
Specimen 4H 21229 Result inconsistent with the consensus.
21267 Result inconsistent with the consensus.
21347 Result inconsistent with the consensus.
21375 Result inconsistent with the consensus.
21439 Result inconsistent with the consensus.
21500 Result inconsistent with the consensus.
41018 Result inconsistent with the consensus.
51063 Result inconsistent with the consensus.
61247 Result inconsistent with the consensus.
83909 Result assigned is inconsistent with the cut-off and result value provided.
89096 Result higher than majority of participants performing this test.
91487
Result inconsistent with the consensus. An error appears to have occurred when transcribing the result.
Test Group 61253 Other users of the same lot number have a different expiry date.
80030 Other users of the same lot number have a different expiry date.
83555 A transcription error appears to have been made with the cut-off value.
83909 Cut-off in incorrect format. Please see instructions on results sheet.
89002 Cut-off value not provided.
89055 Cut-off value not provided.
89144 Cut-off value not provided.
89173 Cut-off value not provided.
92014 A transcription error appears to have been made with the cut-off value.
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B4-2014-str.doc Report Issued Monday, 28 July 2014 Page Page 5 of 14
RCPA Quality Phone +61 2 9045 6000
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au
0
100
200
300
400
500
600
700
800
Val
ue
s
Participants
ASOT Values - Specimen 4H (n=60)
Abbott Diagnostics TURB
Beckman Coulter Immage
Biokit
bioMerieux ASL-Kit
ELITech
Human
Omega Diagnostics
Plasmatec
Roche Diagnostics Anti-Streptolysin O
Roche Diagnostics Tinaquant Anti-Streptolysin O
Siemens Healthcare Diagnostics TURB
Siemens Healthcare Diagnostics Neph
Siemens Healthcare Diagnostics Latex
The Binding Site
Veda Lab
Graphical Representation of Anti-DNaseB Values for Specimen 4H (n=35)
Graphical Representation of ASOT Values for Specimen 4H (n=60)
0
50
100
150
200
250
300
350
400
Val
ue
s
Participants
Anti-DNase B Values - Specimen 4H (n=35)
Beckman Coulter Abbott
Beckman Coulter Immage
bioMerieux ASD-Kit
ELITech DYE
Siemens DNase B DYE
Siemens Neph BN Prospec-BN11
Siemens Latex Cobas Integra
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B4-2014-str.doc Report Issued Monday, 28 July 2014 Page Page 6 of 14
RCPA Quality Phone +61 2 9045 6000
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au
Interpretative Comments
Combination responses have been split into their appropriate option – for example, if a participant chose 3 & 5, they are counted once in each of those options. % is based on the total number of participants and not the total number of comments. Therefore, the total % adds to more than 100%. Extra Comments
41302 4G/H: peak levels are achieved 3-6 weeks after onset, following uncomplicated infection
Comments provided by: Robert Gibb, Microbiology, Pathology Queensland, QLD, Australia, on behalf of the RCPAQAP Serology
SPECIMEN 4G
ASOT (60 Participants)
Most participants (38, 63%) reported a non-significant ASOT result whilst 22 participants (37%) reported the results as significant. There was no consensus for the ASOT with this specimen. All Beckman Coulter Immage participants reported the result as not significant with a small spread of values. One result of <50 IU/mL was discarded to give a mean of 154 IU/mL and a CV of 14%. Most of the Roche Diagnostics Integra/Cobas and Siemens Healthcare Diagnostics BNII participants reported a significant result. The mean of each assay was 248 IU/mL (CV 16%) and 223 IU/mL (CV 4.6%) respectively, which was significantly higher than mean of the Beckman Coulter Immage participants (154 IU/mL). All ten bioMerieux ASL assay participants reported the result as not significant, with values of 100 and 200 IU/mL. All the Siemens Healthcare Diagnostics RapiTex ASL results were either <200 or 200, with 63% of participants reporting the specimen as not significant.
Anti-DNase B (35 Participants)
34 of the 35 participants (97%) returned results interpreted as not significant. All participants (except one) reported results of less than 100 IU/mL. There was excellent consistency for this specimen amongst all participants and manufacturers. Streptozyme (2 Participants) Both participants using Streptozyme assay reported the result as Significant.
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B4-2014-str.doc Report Issued Monday, 28 July 2014 Page Page 7 of 14
RCPA Quality Phone +61 2 9045 6000
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au
Discussion There was good consensus amongst most participants, particularly for the anti-DNase B assay. Comment 2 “Result is not consistent with recent streptococcal infection” was chosen by 56% of participants and 36% chose Comment 3 “Serum taken early in course of illness, suggest repeat testing in 1 week”. The patient presented with acute symptoms of sore throat and fever. As this is early in the acute phase of the illness, this could be indicative of a recent streptococcal infection without detectable streptococcal antibodies and a follow-up specimen should be collected.
SPECIMEN 4H
ASOT (60 Participants)
Most participants (50, 83%) reported a significant ASOT result whilst nine participants (15%) reported results as not significant. Beckman Coulter Immage participants showed a range of values from 146 to 238 IU/mL. With the low outlier (146 IU/mL) removed, the mean was 224 IU/mL and the CV 6.4%. Two participants reporting the higher values interpreted this as not significant, whilst three participants with lower values reported the results as significant. The difference was based on the cut-off applied by the laboratory. All of the Roche Diagnostics Integra/Modular and Siemens Healthcare Diagnostics BNII participants reported a significant result. The mean of the assays were 365 IU/mL (CV 3.5%) and 352 IU/mL (CV 5.4%) respectively, which was significantly higher than mean of the Beckman Coulter Immage participants (224 IU/mL). Six participants of the bioMerieux ASL assay (60%) reported values of 100 IU/mL as not significant, whilst four participants reported a value of 200 IU/mL as significant. All participants using the Siemens Healthcare Diagnostics RapiTex ASL gave results between 200 and 400 IU/mL with only one participant reporting the specimen as not significant.
Anti-DNase B (35 Participants)
There was no consensus for the anti-DNase B assay for this specimen with 19/35 participants (54%) reporting their result as not significant and 13 participants (37%) reporting the result as significant. Beckman Coulter Immage participants showed a range of values from 153 to 199 IU/mL with a mean of 167 IU/mL and a CV of 11%. Excluding one low result, the six Siemens Healthcare Diagnostics BNII participants reported a mean of 201 IU/mL (CV 18%). The Siemens Healthcare Diagnostics results were opposite to the Beckman Coulter Immage where all participants except one reported the result as not significant. Participants of the bioMerieux ASD assay reported values from 100 to 200 IU/mL, with the cut-off ranging from 50 to 680, giving a range of interpretations. Streptozyme (2 Participants) Both participants using Streptozyme assay reported the result as Significant. Discussion This specimen contained moderately elevated levels of ASOT and slightly raised levels of anti-DNase B. There were 67% of participants that correctly used Comment 1 “Result is elevated and consistent with current or recent streptococcal infection” and 43% suggested repeat testing in 1 week. The initial site of infection is known to influence the antibody response. The ASOT is usually elevated following throat infection and skin infection usually causes a raised anti-DNase B level. The sensitivity of the ASOT in rheumatic fever and post streptococcal glomerulonephritis is around 85%. In this case, polyarthritis following a throat infection with slightly elevated ASOT results may be consistent with a recent streptococcal infection. Repeat testing should be performed in one week to determine rising titres.
CONCLUSIONS
As many participants determine their own reference range based on local population, detailed analysis of absolute values is difficult. This is particularly evident in the ASOT levels of Specimen 4G and the anti-DNase B results of Specimen 4H where consensus could not be reached.
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B4-2014-str.doc Report Issued Monday, 28 July 2014 Page Page 8 of 14
RCPA Quality Phone +61 2 9045 6000
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au
Streptococcal Summary for Survey B4:2014:4G & 4H
Part
Specimen 4G Specimen 4H
Anti-Dnase B ASOT Streptozyme INTERP Anti-Dnase B ASOT Streptozyme INTERP
1000 NS S 3 S S 1
21092 NS S 1,3 S S 1
21229 NS NS 2 S NS 1
21267 NS NS 2 NS NS 2,3
21292 S 1 S 1
21347 NS NS 2,3 NS NS 2,3
21375 NS NS S 1 S NS S 2,3
21398 NS S 3 NS S 1,3
21401 NS S 1,3 ind S 1,3
21412 NS 2,3 NS 2,3
21439 NS NS 2,3 NS NS 2,3
21500 NS NS 2 NS NS 2,3
21763 NS 2 S 3
31008 NS NS 2 NS S 1
31171 S S
31252 NS NS 2,3 NS S 1
31293 NS NS NS S
31342 NS NS 2,3 NS S 1,3
31369 S 1 S 1
41018 NS NS 2 ind NS 3
41133 NS S 1,3 NS S 1,3
41183 NS S 1 S S 1
41302 NS NS 2,3 NS S 1,3
51063 NS NS 3 NS NS 3
61247 NS NS 2,3 NS NS 2
61253 NS S 2 S S 1
80030 NS 2 S 1,3
80500 S 3 S 1
80780 S 1,3 S 1
81325 NS 2 S 3
82216 NS 2,3 S 1,3
83555 S 1 S 1
83618 NS 2 S 1
83667 NS 2 S 3
83909 NS 3 S 1
89002 NS 2 S 1
89028 NS S NS S
89036 S 1 S 1
89041 NS S 1 NS S 1
89055 S 1 S 1
89057 S 4 S 4
89061 NS NS 3 S S 3
89072 NS NS S S
89074 NS 2 S 3
89096 S 1 S 1
89104 NS 2 S 1
89114 S 1 S 1
89123 NS 2 S 4
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B4-2014-str.doc Report Issued Monday, 28 July 2014 Page Page 9 of 14
RCPA Quality Phone +61 2 9045 6000
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au
Streptococcal Summary for Survey B4:2014:4G & 4H
Part
Specimen 4G Specimen 4H
Anti-Dnase B ASOT Streptozyme INTERP Anti-Dnase B ASOT Streptozyme INTERP
89144 S S
89151 S 4 S 4
89173 NS NS 2 S S 2
89176 NS S
89177 NS S
89319 NS NS 4 S S 4
89325 NS 2 S 1
91119 NS NS 2 S S 3
91180 NS S 1 S S 1
91317 S NS 1 S S 1
91461 NS NS 2 NS S 1
91487 NS NS 4 NS ind 4
92010 NS NS 2 NS S 1
92014 NS NS 4 ind S 4
RCPA Quality Phone +61 2 9045 6000
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B4-2014-str.doc Report Issued Monday, 28 July 2014 Page Page 10 of 14
Streptozyme Results for Survey B4:2014:4G & 4H
Part Manufacturer Kit Name Method Lot No. Expiry Date Units Value
4G Value
4G Result
4G Cut-Off
4G Value
4H Result
4H Cut-Off
4H
21375 Alere Wampole Colorcard Streptozyme Latex 1113262 Jul-15 N/A N/A N/A S N/A S
89057 Alere Wampole Colorcard Streptozyme Latex 0114063 Nov-15 titre 400 400 S 100 400 S 100
ASOT Results for Survey B4:2014:4G & 4H
Part Manufacturer Kit Name Method Automation Lot No. Expiry Date Units
Value 4G
Result 4G
Cut-Off 4G
Value 4H
Result 4H
Cut-Off 4H
89176 Abbott Diagnostics Quantia ASO TURB Architect 03713D000 Oct-14 IU/mL 133 NS 200 216 S 200
89177 Abbott Diagnostics Quantia ASO TURB Architect 03713D000 Oct-14 IU/mL 125.9 NS 200 207.7 S 200
92010 Abbott Diagnostics Quantia ASO TURB Architect 03713D000 Oct-14 IU/mL 134 NS 150 219 S 150
21500 Beckman Coulter Anti-Streptolysin O Neph Immage M309293 Oct-15 IU/mL 147 NS 300 224 NS 300
61247 Beckman Coulter Anti-Streptolysin O Neph Immage M309293 Oct-15 IU/mL 157 NS 400 238 NS 400
89072 Beckman Coulter Anti-Streptolysin O Neph Immage M307152 Sep-15 IU/mL 130 NS 200 204 S 200
91317 Beckman Coulter Anti-Streptolysin O Neph Immage M303308 May-15 IU/mL <50 NS 116 146 S 116
91461 Beckman Coulter Anti-Streptolysin O Neph Immage M303308 May-15 IU/mL 183 NS 200 228 S 200
89002 Biokit Rheumajet ASO Latex - B23203 Dec-14 titre N/A NS 400 S
89151 Biokit Rheumajet ASO Latex - B23203 Dec-14 IU/mL 200 S 100 400 S 100
21229 bioMerieux ASL-Kit Haem - 1002841440 Dec-14 IU/mL 100 NS 200 100 NS 200
21267 bioMerieux ASL-Kit Haem - 1002781150 Jul-14 IU/mL 100 NS >200 100 NS >200
21347 bioMerieux ASL-Kit Haem - 1002841440 Dec-14 titre 100 NS 300 100 NS 300
21375 bioMerieux ASL-Kit Haem - 1002841440 Dec-14 titre 100 NS 300 100 NS 300
21439 bioMerieux ASL-Kit Haem - 1002781150 Jul-14 IU/mL 200 NS 200 100 NS 200
31293 bioMerieux ASL-Kit Haem - 1002891330 Jan-15 titre 100 NS 200 200 S 200
41018 bioMerieux ASL-Kit Haem - 1002841440 Dec-14 titre 100 NS 200 100 NS 200
89173 bioMerieux ASL-Kit Haem - 1003019060 Feb-15 IU/mL <200 NS 200 S
89319 bioMerieux ASL-Kit Haem - 1002891330 Jan-15 IU/mL 100 NS 50 200 S 50
91119 bioMerieux ASL-Kit Haem - 1002503830 Jun-16 titre 100 NS 200 200 S 200
RCPA Quality Phone +61 2 9045 6000
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B4-2014-str.doc Report Issued Monday, 28 July 2014 Page Page 11 of 14
ASOT Results for Survey B4:2014:4G & 4H
Part Manufacturer Kit Name Method Automation Lot No. Expiry Date Units
Value 4G
Result 4G
Cut-Off 4G
Value 4H
Result 4H
Cut-Off 4H
89061 ELITech Group ASO-BAR Haem - 130130 Sep-14 IU/mL 300 NS 400 400 S 400
82216 Human Humatex ASO Latex - 12005 Oct-14 IU/mL <200 NS 200 200 S 200
89036 Omega Diagnostics Avitex ASO Latex - 7042512 Apr-16 titre 200 S 200 400 S 200
89074 Omega Diagnostics Avitex ASO Latex - 7042512 Apr-16 titre <200 NS 200 200 S 200
89104 Omega Diagnostics Avitex ASO Latex - 7041287 Nov-15 titre N/A NS 1 1 S 1
89144 Omega Diagnostics Avitex ASO Latex - 7037838 Jan-15 IU/mL 1/200 S N/A 1/200 S N/A
83667 Plasmatec ASO Latex Test Kit Latex - 016084 Jan-16 titre <200 NS 200 200 S 200
21092 Roche Diagnostics Anti-Streptolysin O ITA Integra 682278-01 Sep-14 IU/mL 199 S 100 356 S 100
21292 Roche Diagnostics Anti-Streptolysin O ITA Modular Analytics E170 689479 Nov-14 IU/mL 278 S 200 356 S 200
31252 Roche Diagnostics Anti-Streptolysin O ITA Integra 682278 Sep-14 IU/mL 185 NS 200 377 S 200
41183 Roche Diagnostics Anti-Streptolysin O ITA Integra 682278-01 Sep-14 IU/mL 205 S 200 372 S 200
1000 Roche Diagnostics Tinaquant Antistreptolysin O ITA Cobas c 501 69417701 Mar-15 IU/mL 271 S 200 358 S 200
31171 Roche Diagnostics Tinaquant Antistreptolysin O ITA Cobas c 501 689476 Nov-14 IU/mL 256 S 200 334 S 200
31369 Roche Diagnostics Tinaquant Antistreptolysin O ITA Cobas c 501 687404 Sep-14 IU/mL 265 S 240 347 S 240
89114 Roche Diagnostics Tinaquant Antistreptolysin O ITA Cobas c 501 694239 Nov-15 IU/mL 280.2 S 200 359.9 S 200
91180 Roche Diagnostics Tinaquant Antistreptolysin O ITA Cobas c 501 692131 Jan-15 IU/mL 289 S 200 356 S 200
92014 Siemens Healthcare Diagnostics Anti-Streptolysin O 2 TURB Advia 2400 090 Dec-14 IU/mL 187 NS <240 324 S <240
21398 Siemens Healthcare Diagnostics N Latex ASL Neph BN Prospec-BN11 110738 Oct-14 IU/mL 225 S 200 353 S 200
41133 Siemens Healthcare Diagnostics N Latex ASL Neph BN Prospec-BN11 110741 Apr-15 IU/mL 229 S 200 369 S 200
41302 Siemens Healthcare Diagnostics N Latex ASL Neph BN Prospec-BN11 110741A Apr-15 IU/mL <90 NS 250 327 S 250
61253 Siemens Healthcare Diagnostics N Latex ASL Neph BN Prospec-BN11 110738 Oct-18 IU/mL 205 S 200 351 S 200
89028 Siemens Healthcare Diagnostics N Latex ASL Neph BN Prospec-BN11 110739 Jan-15 IU/mL 853 S 200 348 S 200
89041 Siemens Healthcare Diagnostics N Latex ASL Neph BN Prospec-BN11 110739B Jan-15 IU/mL 228 S 200 335 S 200
89123 Siemens Healthcare Diagnostics N Latex ASL Neph BN Prospec-BN11 110738 Oct-14 IU/mL 229 NS 230 383 S 230
RCPA Quality Phone +61 2 9045 6000
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B4-2014-str.doc Report Issued Monday, 28 July 2014 Page Page 12 of 14
ASOT Results for Survey B4:2014:4G & 4H
Part Manufacturer Kit Name Method Automation Lot No. Expiry Date Units
Value 4G
Result 4G
Cut-Off 4G
Value 4H
Result 4H
Cut-Off 4H
21401 Siemens Healthcare Diagnostics RapiTex ASL Latex - 194375 Sep-14 IU/mL 200 S 200 400 S 200
21763 Siemens Healthcare Diagnostics RapiTex ASL Latex - 43152 Nov-14 IU/mL NA NS 200 200 S 200
31008 Siemens Healthcare Diagnostics RapiTex ASL Latex - 43152 Nov-14 IU/mL <200 NS 200 200 S 200
31342 Siemens Healthcare Diagnostics RapiTex ASL Latex - 43495 Mar-15 IU/mL 200 NS 400 400 S 400
51063 Siemens Healthcare Diagnostics RapiTex ASL Latex - 194375 Sep-14 IU/mL 200 NS 201 200 NS 201
80500 Siemens Healthcare Diagnostics RapiTex ASL Latex - 43048 Nov-14 IU/mL 200 S 200 400 S 200
80780 Siemens Healthcare Diagnostics RapiTex ASL Latex - 43048 Nov-14 titre 200 S 200 400 S 200
81325 Siemens Healthcare Diagnostics RapiTex ASL Latex - 43048 Nov-14 titre <200 NS 200 200 S 200
83555 Siemens Healthcare Diagnostics RapiTex ASL Latex - 194375 Sep-14 IU/mL 200 S <200 400 S <200
83618 Siemens Healthcare Diagnostics RapiTex ASL Latex - 43388 Mar-15 IU/mL <200 NS 200 200 S 200
91487 The Binding Site Antistreptolysin O Turbidimetry SpaPlus 342471 Jan-15 IU/mL 225 NS 240 342 ind 240
80030 Veda Lab ASO Direct Latex Latex - 02093-08 Jun-15 IU/mL <200 NS 200 200 S 200
83909 Veda Lab ASO Direct Latex Latex - 2803-05 Mar-15 titre N/A NS Negative 1 S 200
89055 Veda Lab ASO Direct Latex Latex - 02093-08 Aug-15 IU/mL 800 S 400 S
89096 Veda Lab ASO Direct Latex Latex - 02093-08 Aug-15 IU/mL 400 S 200 800 S 200
89325 Veda Lab ASO Direct Latex Latex - 14024-05 Oct-15 IU/mL <200 NS 200 200 S 200
Anti-DNase B Results for Survey B4:2014:4G & 4H
Part Manufacturer Kit Name Method Automation Lot No. Expiry Date Units
Value 4G
Result 4G
Cut-Off 4G
Value 4H
Result 4H
Cut-Off 4H
21500 Beckman Coulter ADNase B Neph Immage M309316 May-15 U/mL <50 NS 188 163 NS 188
61247 Beckman Coulter ADNase B Neph Immage M309316 May-15 U/mL 50 NS 600 162 NS 600
89072 Beckman Coulter ADNase B Neph Immage M309316 Jun-15 IU/mL <50 NS <75 157 S <75
91317 Beckman Coulter ADNase B Neph Immage M301001 Jul-14 U/mL 152 S 187 199 S 187
91461 Beckman Coulter ADNase B Neph Immage M301001 Jun-14 U/mL <50 NS 200 153 NS 200
92010 Beckman Coulter ADNase B Turb Abbott Ci8000 M301315 Jan-15 IU/mL <150 NS 160 152 NS 160
RCPA Quality Phone +61 2 9045 6000
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B4-2014-str.doc Report Issued Monday, 28 July 2014 Page Page 13 of 14
Anti-DNase B Results for Survey B4:2014:4G & 4H
Part Manufacturer Kit Name Method Automation Lot No. Expiry Date Units
Value 4G
Result 4G
Cut-Off 4G
Value 4H
Result 4H
Cut-Off 4H
21092 bioMerieux ASD-Kit DYE - 1002864740 Nov-14 titre <100 NS 100 200 S 100
21229 bioMerieux ASD-Kit DYE - 1002864740 Nov-14 titre <100 NS 200 200 S 200
21267 bioMerieux ASD-Kit DYE - 1002805640 Nov-14 U/mL <100 NS >200 200 NS >200
21347 bioMerieux ASD-Kit DYE - 1002817910 Nov-14 titre <100 NS 300 100 NS 300
21401 bioMerieux ASD-Kit DYE - 1002766970 Oct-14 U/mL <100 NS >200 200 ind >200
21412 bioMerieux ASD-Kit DYE - 1002805640 Nov-14 titre <100 NS 300 100 NS 300
21439 bioMerieux ASD-Kit DYE - 1002664090 Oct-14 U/mL 100 NS 200 100 NS 200
31008 bioMerieux ASD-Kit DYE - 1002817910 Nov-14 IU/mL <100 NS 300 100 NS 300
31252 bioMerieux ASD-Kit DYE - 1002864740 Nov-14 U/mL <100 NS 200 200 NS 200
31293 bioMerieux ASD-Kit DYE - 1002732870 Oct-14 titre <100 NS 200 100 NS 200
31342 bioMerieux ASD-Kit DYE - 1002864740 Nov-14 U/mL <100 NS 300 200 NS 300
41018 bioMerieux ASD-Kit DYE - 1002866090 Jun-14 titre <100 NS 200 200 ind 200
51063 bioMerieux ASD-Kit DYE - 1002866090 Jan-15 U/mL <100 NS >200 200 NS >200
89173 bioMerieux ASD-Kit DYE - 1002962020 Feb-15 U/mL 100 NS 200 S
89319 bioMerieux ASD-Kit DYE - 1002930210 Feb-15 U/mL <50 NS 50 200 S 50
91487 bioMerieux ASD-Kit DYE - 1002766970 Oct-14 IU/mL <100 NS 680 200 NS 680
92014 bioMerieux ASD-Kit DYE - 1002817910 Nov-14 U/mL <100 NS <200 200 ind <200
89061 ELITech Group DOR-BAR DYE - 130114 Sep-14 IU/mL <100 NS 200 300 S 200
21375 Siemens Healthcare Diagnostics Anti-streptococcal DNase B DYE - 43511 Oct-15 titre 100 NS 600 800 S 600
91119 Siemens Healthcare Diagnostics Anti-streptococcal DNase B DYE - 43511 Oct-15 titre 75 NS 200 200 S 200
91180 Siemens Healthcare Diagnostics Anti-streptococcal DNase B DYE - 43511 Oct-15 titre 40 NS 160 320 S 160
1000 Beckman Coulter ADNase B Neph Immage 43625 Nov-14 IU/mL 45 NS 200 245 S 200
41183 Siemens Healthcare Diagnostics N Latex ADNase B Latex Cobas Integra 43625 Nov-14 U/mL 60 NS 200 230 S 200
21398 Siemens Healthcare Diagnostics N Latex ADNase B Neph BN Prospec-BN11 195309 Sep-14 IU/mL <78 NS 200 194 NS 200
41133 Siemens Healthcare Diagnostics N Latex ADNase B Neph BN Prospec-BN11 43236 Jul-14 U/mL 82 NS 200 98 NS 200
41302 Siemens Healthcare Diagnostics N Latex ADNase B Neph BN Prospec-BN11 43241 Jul-14 U/mL 194 NS 250 237 NS 250
61253 Siemens Healthcare Diagnostics N Latex ADNase B Neph BN Prospec-BN11 195309 Sep-14 U/mL <80 NS 187 237 S 187
RCPA Quality Phone +61 2 9045 6000
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B4-2014-str.doc Report Issued Monday, 28 July 2014 Page Page 14 of 14
Anti-DNase B Results for Survey B4:2014:4G & 4H
Part Manufacturer Kit Name Method Automation Lot No. Expiry Date Units
Value 4G
Result 4G
Cut-Off 4G
Value 4H
Result 4H
Cut-Off 4H
89028 Siemens Healthcare Diagnostics N Latex ADNase B Neph BN Prospec-BN11 43684 Nov-14 U/mL 90.6 NS 200 178 NS 200
89041 Siemens Healthcare Diagnostics N Latex ADNase B Neph BN Prospec-BN11 43269 Jul-14 U/mL <82 NS 200 157 NS 200