KEY TO THE QCMD EXTERNAL QUALITY ASSESSMENT INDIVIDUAL REPORT The QCMD EQA Individual Reports are divided into sections to assist participants’ navigation of the information presented. One individual report is provided for each dataset submitted by participants. The Sections are: • • • Expected results Analysis of your laboratory’s Qualitative EQA data Analysis of your laboratory’s Quantitative EQA data, where applicable Expected results This section provides participants with the panel composition and expected results. An example is shown in Table 1. Table 1: Example - Expected results of the programme in order of sample content and concentration Sample Sample Content Sample conc. Sample Status Sample Type CMV09-07 CMV (Strain AD 169) 23,174 Frequently detected Core CMV09-12 CMV (Strain AD 169) 4,613 Frequently detected Core CMV09-06 CMV (Strain AD 169) 3,266 Frequently detected Core CMV09-05 CMV (Strain AD 169) 1,028 Frequently detected Core CMV09-02 CMV (Strain AD 169) 1,009 Frequently detected Core CMV09-11 CMV (Strain AD 169) 245 Detected CMV09-10 CMV (Strain AD 169) 238 Detected CMV09-03 CMV (Strain AD 169) 211 Detected CMV09-09 CMV (Strain AD 169) 2,228,435 Frequently detected Core CMV09-04 CMV (Strain AD 169) 252,348 Frequently detected Core CMV09-01 CMV (Strain AD 169) 24,099 Frequently detected Core CMV09-08 Negative Plasma Negative Core Table key: Sample: QCMD panel sample codes for the samples distributed to participants Sample Content: viral or microbial content of the panel samples Sample conc.: Values should not be used by participants for method comparison or as a target for individual laboratory performance assessment Sample Status: the sample status assigned to each panel sample (see below) Sample Type: Panel samples classified as core proficiency samples in the EQA programme. An acceptable level of proficiency is demonstrated by obtaining a correct result on all samples classified as ‘core’ within this EQA programme. Participants are provided with the assigned status for each panel sample. The statuses for panel samples containing the target are ‘Frequently detected’, ‘Detected’ and ‘Infrequently detected’. Panel samples negative for the target are assigned a 'Negative' status. The sample status is defined based on performance in the EQA programme and the expertise of the QCMD Scientific Council. IRK001-04 1/8 QCMD Individual Report Key Version 04 1. Analysis of your laboratory’s Qualitative EQA data Analysis of your laboratory's performance on the core proficiency samples The QCMD EQA panels contain a range of samples, designed to look at different aspects of assay performance. Panel members are designated core proficiency samples on the basis of scientific information, clinical relevance and clinical experience (published literature and professional clinical guidelines) and, where available and appropriate, established target performance limits taken from previous QCMD EQA distributions. Laboratories are expected to correctly analyse and report the core proficiency samples in order to show acceptable proficiency. An example is provided below. Analysis of your laboratory's performance on the core proficiency samples: The core proficiency samples in this EQA programme were: CMV09-07, CMV09-12, CMV09-06, CMV09-05, CMV09-02, CMV09-09, CMV09-04, CMV09-01, CMV09-08. You reported 8/9 (88.9%) of the core proficiency samples correctly. Of the total datasets reported by all participants in this EQA programme, 95% reported correct results for all core proficiency samples. IRK001-04 2/8 QCMD Individual Report Key Version 04 Analysis of your laboratory’s performance on all proficiency samples This section provides participants with their qualitative results and scores for each individual panel sample and an overall performance indicator called the Sum Qualitative Panel Score. An example of the data is given in Table 2 and Figure 1. Table 2: Example – Your laboratory’s qualitative results and performance scores Qualitative Sample Sample Content CMV09-07 CMV (Strain AD 169) CMV09-12 CMV (Strain AD 169) CMV09-06 CMV09-05 CMV09-02 CMV09-11 CMV09-10 CMV (Strain AD 169) CMV (Strain AD 169) CMV (Strain AD 169) CMV (Strain AD 169) CMV (Strain AD 169) Sample Type Your qualitative result Your qualitative score Frequently detected Core Positive 0 Frequently detected Core Negative 3 Core Positive 0 Core Positive 0 Core Positive 0 Detected Positive 0 Detected Positive 0 Negative 2 Core Positive 0 Core Positive 0 Core Positive 0 Core Negative 0 Sample Status Frequently detected Frequently detected Frequently detected CMV09-03 CMV (Strain AD 169) Detected CMV09-09 CMV (Strain AD 169) Frequently detected CMV09-04 CMV09-01 CMV (Strain AD 169) CMV (Strain AD 169) CMV09-08 Negative Plasma Sum Qualitative Panel Score Frequently detected Frequently detected Negative 5 Table key: Sample: QCMD panel sample codes for the samples distributed to participants Sample Content: viral or microbial content of the panel sample Sample Status: the sample status assigned to each panel sample Sample Type: Panel samples classified as core proficiency samples in the EQA programme. An acceptable level of proficiency is demonstrated by obtaining a correct result on all samples classified as ‘core’ within this EQA programme. Your qualitative result: The qualitative results returned by your laboratory for each panel sample Your qualitative score: The qualitative score awarded to your laboratory for each panel sample Sum Qualitative Panel Score: The Sum Qualitative Panel Score awarded to your laboratory IRK001-04 3/8 QCMD Individual Report Key Version 04 Figure 1: Example - Sum Qualitative Panel scores for all participants Graph key: Sum Qualitative Panel Score: the range of Sum Qualitative Panel Scores Number of Datasets: the number of datasets achieving each Sum Qualitative Panel Score Cumulative %: The percentage of datasets achieving each Sum Qualitative Panel Score or better Calculation of your laboratory’s qualitative score for each individual panel sample The following scoring system applies to your laboratory’s qualitative score for each individual panel sample. The scores awarded for qualitative data are based on the sample status 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 Sam ple status Participant's result Negative Not determ ined Frequently detected 3 3 Positive 0 Detected 2 2 0 Infrequently detected 1 1 0 Negative 0 3 3 For example when a participant returns a negative qualitative result for an ‘Infrequently detected’ panel sample they score 1. However a participant would score 3 if they returned a Negative qualitative result for a ‘Frequently detected’ panel sample. IRK001-04 4/8 QCMD Individual Report Key Version 04 Calculation of your laboratory’s Sum Qualitative Panel Score The Sum Qualitative Panel Score is the sum of your qualitative performance scores for all panel samples. The perfect Sum Qualitative Panel Score is zero points. The Sum Qualitative Panel Scores for all participants are presented in graphical form (see Figure 1 for an example). This graph provides participants with the number of datasets achieving each Sum Qualitative Panel Score and the percentage of datasets achieving each Sum Qualitative Panel Score or better. 2. Analysis of your laboratory’s Quantitative EQA data Your laboratory’s quantitative performance on the paired samples Assays may differ relatively in the quantitative values they report. In EQA programmes where sufficient quantitative data are reported, QCMD assesses quantitative proficiency based on the difference reported between paired samples, which provide participants with a measure of proficiency that is independent of assay bias. The median difference between the paired samples is calculated from the log concentration of participants’ results. The choice of paired samples is made on the basis of scientific information, clinical relevance and clinical experience (published literature and professional clinical guidelines) and, where available and appropriate, established target performance limits taken from previous QCMD EQA distributions. An example is provided below: Table 3: Example - Your laboratory’s quantitative performance on the paired samples Paired samples Sample Content CMV09-07 and -12 CMV AD 169 Median difference (log) 0.701 Your difference (log) 0.687 Within 0.5 log units of the median Yes Table key: Paired samples: the samples used for the paired analysis Sample content: viral or microbial content of the paired samples Median difference: The median difference between the two samples in log10 units Your difference: The difference between the sample pair (in log10 units) reported by your laboratory IRK001-04 5/8 QCMD Individual Report Key Version 04 Your laboratory’s quantitative results and performance scores This section provides participants with their quantitative results and scores for each panel sample and an overall performance indicator called the Sum Quantitative Panel Score. An example of the data is given in Table 4. Table 4: Example - Your laboratory’s quantitative results and performance scores CMV09-07 CMV (Strain AD 169) 4.337 Quantitative Your Consensus score 0 CMV09-12 CMV (Strain AD 169) 3.650 0 0 CMV09-06 CMV (Strain AD 169) 3.520 0 0 0 Sample Sample Content Your Result (log) Your Technology score 0 CMV09-05 CMV (Strain AD 169) 2.995 0 CMV09-02 CMV (Strain AD 169) 3.000 0 0 0 CMV09-11 CMV (Strain AD 169) 2.348 0 CMV09-10 CMV (Strain AD 169) 2.381 0 0 CMV09-03 CMV (Strain AD 169) 2.350 0 0 0 CMV09-09 CMV (Strain AD 169) 5.847 1 CMV09-04 CMV (Strain AD 169) 5.404 0 0 4.385 0 0 1 0 CMV09-01 CMV (Strain AD 169) Sum Quantitative Panel Score Table key: Sample: QCMD panel sample codes for the samples distributed to participants Sample content: viral or microbial content of the panel samples Your Result (log): The quantitative results (in log10 units) returned by your laboratory for each panel sample Your Consensus score: The quantitative score awarded to your laboratory for each panel sample Your Technology score: The quantitative score awarded to your laboratory for each panel sample based on the technology concentration Sum Quantitative Panel Score: The Sum Quantitative Panel Score awarded to your laboratory IRK001-04 6/8 QCMD Individual Report Key Version 04 Figure 2: Example - Sum Quantitative Consensus Panel scores for all participants Graph key: Sum Quantitative Consensus Panel Score: the range of Sum Quantitative Consensus Panel Scores Number of datasets: the number of datasets achieving each Sum Quantitative Consensus Panel Score Cumulative %: The percentage of datasets achieving each Sum Quantitative Consensus Panel Score or better Sum Quantitative Panel Scores are only provided to participants that return quantitative data for all panel samples that contain the target agent. Those that return LOD/NR (limit of detection or not reported) for one or more panel samples are represented by the ‘-’ in Figure 2. Calculation of your laboratory’s quantitative score for each individual panel sample The following scoring system applies to your laboratory’s quantitative score for each individual panel sample. Participants are provided with a summary of their performance compared to consensus values for each of the positive panel samples. In order to compare participants’ results within specific technologies or kit methods, where sufficient datasets are reported (5 or more) methods or kits are assigned to a technology group e.g. Real time PCR, bDNA or NASBA etc. Where datasets are reported as 'other' for a technology or kit method this is reviewed by the QCMD Neutral Office and assigned to an appropriate group where possible. The negative panel samples are not included in these analyses. The parameters of the normal distribution are estimated from the log of the positive datasets submitted by participants for each panel sample. Scores are assigned based on the distance from the mean value for each panel sample. The scoring system used for quantitative EQA data ranges from 0 (highly satisfactory) to 3 (highly unsatisfactory). IRK001-04 7/8 QCMD Individual Report Key Version 04 An assigned value is calculated for each panel sample using two methods. These are: 1. Consensus concentration - the mean of the participants' results once outliers have been removed. 2. Technology consensus concentration - the mean of the participants' results per technology group once outliers have been removed. The standard deviation is calculated as the square root of the mean square for error from the ANOVA table where the response is the log concentration of participants’ results with outliers removed. The factor is technology group. Outliers are defined as values with a standardised residual with modulus greater than three. Although outliers are removed for the calculation of the assigned values they are included in the data analysis and scored accordingly. Scores are awarded based on the distance from the calculated mean value for each panel sample. Zero points are awarded if the quantitative value returned is within one standard deviation from the mean. One point is awarded if the quantitative value is between one and two standard deviations, two points if the value is within two and three standard deviations and three points for quantitative values more than three standard deviations from the mean. Where no value (or a limit of detection only) is reported this is assigned as LOD/NR (limit of detection or not reported). Scoring system based on distance from the consensus value 0 1 1 2 2 3 3 Each coloured division represents one standard deviation (SD) from the mean, so that zero points is awarded for quantitative values that are within one standard deviation and three points for quantitative values that are more than three standard deviations from the mean. Calculation of your laboratory’s Sum Quantitative Panel Score The Sum Quantitative Panel Score is the sum of your quantitative performance scores for all panel samples. The perfect Sum Quantitative Panel Score is zero points. The Sum Quantitative Panel Scores for all participants are presented in graphical form (see Figure 2 for an example). This graph provides participants with the number of datasets achieving each Sum Quantitative Panel Score and the percentage of datasets achieving each Sum Quantitative Panel Score or better. A Sum Quantitative Panel Score is provided for the performance of laboratories in relation to the Consensus Concentration only. IRK001-04 8/8 QCMD Individual Report Key Version 04
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