BEIPH Final Report. EQA Programme 2011 Chlamydia trachomatis B (CTDNA11B) Prepared on behalf of QCMD and its Scientific Council October 2011
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1 BEIPH Final Report EQA Programme 2011 Chlamydia trachomatis B (CTDNA11B) Prepared on behalf of QCMD and its Scientific Council October 2011 Not to be reproduced or quoted without permission of QCMD. Any queries about this report should be addressed to the QCMD Neutral Office. Unit 5, Technology Terrace, Todd Campus, West of Scotland Science Park, Glasgow, G20 0XA, Scotland Tel: +44 (0) , Fax: +44 (0) , info@qcmd.org, Web:
2 Contents 1. Programme aims Programme details Panel composition Programme results Qualitative performance on the core proficiency samples Qualitative analysis of the EQA data for all panel samples Qualitative performance scores for all panel samples... 5 Acknowledgements... 5 Appendix A of 6
3 1. Programme aims The primary aims of this External Quality Assessment Programme were to: 1) Determine the qualitative performance of participants testing for Chlamydia trachomatis (C. trachomatis) using molecular technologies. 2) Determine the incidence of false positive results. 3) Determine the performance of participants testing for Swedish variant C. trachomatis. 4) Determine reproducibility on duplicate samples. 5) Compare performance with previous distributions. Participants are encouraged to read the QCMD Participants' Manual, which can be downloaded from the QCMD website. Any queries about this report should be addressed to the QCMD Neutral Office 2. Programme details Table 1: Programme details CTDNA11B Date of panel distribution 27/06/2011 Number of respondents 49 (96%) Number of participants 51 Number of datasets submitted 52 Number of countries 1 Number of qualitative datasets submitted 52 Number of quantitative datasets submitted 0 Two participants did not return results; neither officially withdrew. 3. Panel composition Table 2: Panel composition Sample Sample content Sample * matrix Sample conc. Copies/vial Sample status Sample type CTB11-02 Chlamydia trachomatis Urine 5x10 3 Frequently detected Core CTB11-05 Chlamydia trachomatis Urine 4x10 2 Detected CTB11-01 Chlamydia trachomatis Urine 5x10 1 Infrequently detected CTB11-03 C. trachomatis Swedish Variant Urine 1x10 6 Frequently detected Core CTB11-04 Ct. negative urine Urine Negative Core CTB11-08 Chlamydia trachomatis Swab 6x10 4 Frequently detected Core CTB11-07 Chlamydia trachomatis Swab 3x10 3 Frequently detected Core CTB11-10 Chlamydia trachomatis Swab 3x10 3 Frequently detected Core CTB11-06 Chlamydia trachomatis Swab 5x10 2 Detected CTB11-09 Ct. negative swab Swab Negative Core Key to Table 2 Sample: QCMD panel sample codes for the samples distributed to participants. Sample content: bacterial content of the panel samples. Sample matrix: material used as a matrix in preparation of the panel samples. Sample conc.: sample concentrations estimated by the production laboratory. The values quoted are a mean of two replicates generated using the Abbott RealTime CT/NG test on the Abbott m2000 platform. These values are for QCMD internal purposes only. They should not be used by participants for method comparison or as a target for individual laboratory assessment. Sample status: the sample status assigned to each panel sample. Please see Appendix A for more information. Sample type: panel samples classified as core proficiency samples. C. trachomatis was cultured from a Dutch clinical isolate (LGV L2) obtained in *Urine: Chlamydia trachomatis-negative urine collected from healthy adult volunteers. Swab: 1/10 dilution of TE buffer. 3 of 6
4 Percentage of datasets 2011 Chlamydia trachomatis B 4. Programme results 4.1. Qualitative performance on the core proficiency samples Figure 1 shows performance on the core proficiency samples for BEIPH participants. In this round of the EQA 90.4% of datasets returned to QCMD by BEIPH participants reported all core proficiency samples correctly. Figure 1: Performance on the core proficiency samples for BEIPH participants 100.0% 90.0% 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 90.4% 3.8% 3.8% 1.9% 0.0% 0.0% 0.0% 0.0% 7/7 6/7 5/7 4/7 3/7 2/7 1/7 0/7 Number of core samples correct 4.2. Qualitative analysis of the EQA data for all panel samples The number (percentage) of correct qualitative results are presented in Table 3. Qualitative data were returned by participants as 'positive', 'negative' or 'not determined'. Not determined results were counted as incorrect for all panel samples (positive or negative). Table 3: Number of correct qualitative results per panel member PCR Sample Sample Sample conc. Overall BEIPH Conventional Real time SDA f content Copies/vial datasets datasets Commercial a Commercial c In-house d n=185 n=52 n=4 n=39 n=4 n=5 n % n % n % n % n % n % CTB11-02 Chlamydia trachomatis 5x CTB11-05 Chlamydia trachomatis 4x CTB11-01 Chlamydia trachomatis 5x CTB11-03 C. trachomatis Swedish Variant 1x CTB11-04 Ct. negative urine CTB11-08 Chlamydia trachomatis 6x CTB11-07 Chlamydia trachomatis 3x CTB11-10 Chlamydia trachomatis 3x CTB11-06 Chlamydia trachomatis 5x CTB11-09 Ct. negative swab Key to Table 3 Sample: QCMD panel sample codes for the samples distributed to participants. Sample content: bacterial content of the panel samples. Sample conc.: sample concentrations estimated by the production laboratory. The values quoted are a mean of two replicates generated using the Abbott RealTime CT/NG test on the Abbott m2000 platform. These values are for QCMD internal purposes only. They should not be used by participants for method comparison or as a target for individual laboratory assessment. Overall datasets: number and percentage of datasets in the full EQA programme reporting the correct qualitative result for each panel sample. BEIPH datasets: number and percentage of datasets from BEIPH participants reporting the correct qualitative result for each panel sample. A breakdown of results from BEIPH participants is then presented by technology group. a: Roche Amplicor CT/NG (n=3), Roche COBAS Amplicor CT/NG (n=1). c: Abbott RealTime CT (n=2), Abbott RealTime CT/NG (n=13), Diagenode C. trachomatis real time PCR detection (n=1), Diagenode Dia-CT/NG-050 (n=1), Nanogen Chlamydia tr. Q-PCR Alert Kit (n=1), QIAGEN artus C. trachomatis PCR Kit (TM) (n=1), QIAGEN artus C. trachomatis Plus PCR Kit (RG) (n=4), Roche cobas 4800 CT/NG Test (n=3), Roche COBAS TaqMan CT Test v2.0 (n=13). d: Details not presented. f: BD Diagnostics BD ProbeTec ET System (n=5). 4 of 6
5 4.3. Qualitative performance scores for all panel samples Table 4: Qualitative performance scores per technology type Total PCR All technologies BEIPH only Conventional Real time SDA f Sample Sample status Commercial a Commercial c In-house d n=185 n=52 n=4 n=39 n=4 n= CTB11-02 Frequently detected CTB11-05 Detected CTB11-01 Infrequently detected CTB11-03 Frequently detected CTB11-04 Negative CTB11-08 Frequently detected CTB11-07 Frequently detected CTB11-10 Frequently detected CTB11-06 Detected CTB11-09 Negative Key to Table 4 Sample: QCMD panel sample codes for the samples distributed to participants. Sample status: the sample status assigned to each panel sample. Please see Appendix A for more information. Total. All participants: number of datasets submitted by all participants in the full EQA programme awarded each score (0 to 3). BEIPH only: number of datasets returned by BEIPH participants awarded each score (0 to 3). A breakdown of results for BEIPH participants is then presented by technology group. a: Roche Amplicor CT/NG (n=3), Roche COBAS Amplicor CT/NG (n=1). c: Abbott RealTime CT (n=2), Abbott RealTime CT/NG (n=13), Diagenode C. trachomatis real time PCR detection (n=1), Diagenode Dia-CT/NG-050 (n=1), Nanogen Chlamydia tr. Q-PCR Alert Kit (n=1), QIAGEN artus C. trachomatis PCR Kit (TM) (n=1), QIAGEN artus C. trachomatis Plus PCR Kit (RG) (n=4), Roche cobas 4800 CT/NG Test (n=3), Roche COBAS TaqMan CT Test v2.0 (n=13). d: Details not presented. f: BD Diagnostics BD ProbeTec ET System (n=5). Acknowledgements Programme data analysis and report generation was performed by the QCMD Neutral Office. QCMD The QCMD EQA programme samples, associated reports and data generated during this programme are intended for External Quality Assessment (EQA) and Proficiency Testing (PT) purposes only. QCMD operates according to a strict Code of Practice which is in line with ISO/IEC and associated standards. Data reported in QCMD programmes is representative of a laboratory s standard diagnostic testing protocols irrespective of the technology they use. The data provided in the reports are based on technical information provided by the individual laboratories as part of the assessment process, as such it does not constitute a formal technology method comparison. All text and images produced by QCMD are the property of QCMD unless otherwise stated. The reproduction and use of these materials is not permitted without the express written consent of QCMD. The use of the information provided in QCMD reports for commercial purposes is strictly prohibited. 5 of 6
6 Appendix A Assigning the sample status Sample status is assigned by peer-group consensus, based on the qualitative results returned by all participants in the full EQA programme. It is not a measure of the 'strength' of a positive sample nor is it technology-dependent, and is used solely for the scoring of the EQA data. The rationale for the sample status is: Frequently detected: More than 95% of datasets recorded the correct positive result. Detected: Between 65% and 95% of datasets recorded the correct positive result. Infrequently detected: Less than 65% of datasets recorded the correct positive result. Negative: A panel sample that does not contain the target and produces an unequivocal negative result. Scoring system for qualitative EQA data The scores awarded for qualitative EQA data were based on the sample status. The scoring system is represented in the following table, where 0 is 'highly satisfactory' and 3 is 'highly unsatisfactory'. Colour has been included as an extra visual aid. Scoring system based on the assigned sample status Sample status Participant's result Negative Not determined Positive Frequently detected Detected Infrequently detected Negative of 6
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