QCMD 2016 Hepatitis B Virus DNA EQA Programme

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1 //370 NOT E: Summary info rmatio n o nly. Intended Results / Panel Composition Code [1] (All) [2] [3] [4] [] Range (Log ) (n) 10 C101 HBV Type A Plasma D1 Frequently CORE N/A N/A N/A C102 HBV Type D Plasma Frequently CORE N/A N/A N/A C103 HBV Type A Plasma D1 Frequently CORE N/A N/A N/A C1 04 HBV Negative Plasma Negative CORE N/A N/A N/A [1] Re lat ionships: Ind icate s the re latio nship s o f the samp le s within this challe ng e. Dilutio n se rie s are ind icte d b y 'DS1' with e ach p ane l me mb e r in the d ilutio n se rie s re p re se nte d b y a numb e r in o rd e r o f titre, whe re DS1_1 re p re se nts the hig he st titre within that d ilutio n se rie s. Furthe r d ilutio n se rie s are ind icate d b y 'DS2' 'DS3' e tc. If o ne d up licate p air is p re se nt this is ind icate d b y 'D1'. Furthe r d up licate p airs are ind icate d b y 'D2', 'D3' e tc. [2] De t e ct ion : To aid q ualitative analysis e ach p ane l me mb e r is assig ne d a fre q ue ncy o f d e te ctio n. This is b ase d o n the p e e r g ro up co nse nsus o f all q ualitative re sults re turne d fro m p articip ants within the EQ A challe ng e / d istrib utio n. [3] St at us: EQ A samp le s are d e fine d as " CO RE" o r " EDUCATIO NAL". Co re p ro ficie ncy samp le s are re vie we d b y the Q CMD Scie ntific Exp e rt(s). This is o n the b asis o f scie ntific info rmatio n, clinical re le vance, curre nt lite rature and, whe re ap p ro p riate, p ro fe ssio nal clinical g uid e line s. Particip ating lab o rato rie s are e xp e cte d to re p o rt co re p ro ficie ncy samp le s co rre ctly within the EQ A challe ng e / d istrib utio n. [4] (All): Me an co nse nsus (Lo g 10 ) calculate d fro m d ata re turne d b y p articip ants with o utlie rs re mo ve d and numb e r o f q uantitative re sults (n) re turne d fo r e ach p ane l me mb e r. [] Range : Maximum and minimum q uantitative value (All) re p o rte d b y p articip ants within this challe ng e witho ut o utlie rs re mo ve d. For further details please refer to the current participant manual. Your Summary Results Unit s EQ A Asse ssme nt G roup Core Pane l (Q ualitative ) Score Core Pane l Estimation (Q uantitative ) Score [1] [2] [3] N/A N/A N/A N/A Pag e 1 o f 1 Is s u e D ate : 0 M ay 20 16

2 //370 Code Unitage EQ A Asse ssme nt G roup [4] SD Q uantitative Re sult Q ualitative Re sult [] Your Estimation Pe rce ntage Re sult Score [7] Corre ct [6 ] (All) [8] [9 ] Your Re sult Score [10 ] C101 N/A C102 N/A C103 N/A C104 N/A [1] EQ A Asse ssme nt Group: To aid d ata analysis, p articip ant re sults are g ro up e d acco rd ing to the mo le cular amp lificatio n/d e te ctio n me tho d sp e cifie d within the ir mo le cular wo rkflo w fo r this challe ng e / d istrib utio n. Fo r furthe r d e tails re fe r to the Additional Information: Individual Panel Member Analysis se ctio n o f this re p o rt. [2] Core Pane l De t e ct ion (Q ualit at ive ) Score : An o ve rall co re p ane l d e te ctio n sco re p ro vid e d p e r challe ng e / d istrib utio n. [3] Core Pane l Est imat ion (Q uant it at ive ) Score : An o ve rall co re p ane l e stimatio n sco re p ro vid e d p e r challe ng e / d istrib utio n. [4] EQ A Asse ssme nt Group : The me an value fo r all re sults within yo ur EQ A asse ssme nt g ro up. [] SD: The stand ard d e viatio n fo r re sults fro m yo ur EQ A asse ssme nt g ro up. [6 ] Your Q uant it at ive Re sult : The q uantitative re sult yo u re turne d fo r e ach samp le within this EQ A challe ng e. LO D/NR (limit o f d e te ctio n o r no t re p o rte d ). [7] Est imat ion Score : Yo ur e stimatio n (q uantitative ) sco re s are calculate d b ase d o n yo ur variatio n fro m the co nse nsus fo r yo ur EQ A asse ssme nt g ro up. With 0 (ze ro ) sco re d if the q uantitative value yo u re p o rte d is within o ne stand ard d e viatio n (SD) fro m yo ur EQ A asse ssme nt g ro up co nse nsus, 1 (o ne ) if yo ur q uantitative value is b e twe e n o ne and two SDs, 2 (two ) if yo ur q uantitative value is within two and thre e SDs and 3 (thre e ) if yo ur q uantitative value is mo re than thre e SDs fro m the me an o f yo ur EQ A asse ssme nt g ro up. [8 ] Pe rce nt age Corre ct (All): Pe rce ntag e o f d atase ts re p o rting the co rre ct q ualitative re sults fo r e ach p ane l me mb e rs. [9 ] Your Q ualit at ive Re sult : The q ualitative re sult yo u re p o rte d fo r e ach samp le within this EQ A challe ng e / d istrib utio n. [10 ] De t e ct ion Score : Yo ur d e te ctio n (q ualitative ) sco re s are b ase d o n the assig ne d d e te ctio n fre q ue ncy o f e ach p ane l me mb e rs, whe re 0 (ze ro ) is " hig hly satisfacto ry" and 3 (thre e ) is " hig hly unsatisfacto ry". Sco re s are p ro vid e d fo r ind ivid ual p ane l me mb e rs. For further details please refer to the current participant manual. Pag e 2 o f 1 Is s u e D ate : 0 M ay 20 16

3 //370 Core Panel Member Score Breakdown Detection (Qualitative) Number o f Datasets Core Panel Members Score Cumulative Percentage Numbe r of Dat ase t s Cumulat ive Pe rce nt age Estimation (Quantitative) Number o f Datasets Core Panel Members Score Cumulative Percentage Numbe r of Dat ase t s Cumulat ive Pe rce nt age Core Pane l Me mbe r Score Bre akdown De t e ct ion: This fig ure g ive s yo u a b re akd o wn o f the q ualitative d e te ctio n sco re s fo r all q ualitative d atase ts re turne d within this EQ A challe ng e / d istrib utio n ind e p e nd e nt o f the EQ A asse ssme nt g ro up. Pane l d e te ctio n sco re s are g e ne rate d fro m o nly tho se p ane l me mb e rs that are d e fine d as CO RE. Core Pane l Me mbe r Score Bre akdown Est imat ion: This fig ure g ive s yo u a b re akd o wn o f the q uantitative e stimatio n sco re s fo r all q uantitative d atase ts re turne d within this EQ A challe ng e / d istrib utio n ind e p e nd e nt o f the EQ A asse ssme nt g ro up. Pane l e stimatio n sco re s are b ase d o n p o sitive co re p ane l me mb e rs o nly. Tho se d atase ts that d id no t re turn q uantitative value s fo r all co re samp le s are re p re se nte d b y ''. For further details please refer to the current participant manual. Pag e 3 o f 1 Is s u e D ate : 0 M ay 20 16

4 //370 Further Details Number of Participants 331 Number of Countries 37 Number of Respondents 320 Number of Datasets Submitted 336 Quantitative Results Returned (All) 302 (89.9%) Quantitative Results Returned (Copies/ml) 17 (.6%) Quantitative Results Returned (IU/ml) 28 (94.4%) Qualitative Results Returned 169 (0.3%) EQA Aims To assess the proficiency of laboratories in the detection and quantitation of Hepatitis B Virus (HBV) DNA. To assess the proficiency of laboratories in the detection and quantitation in different HBV genotypes. Feedback and Enquiries Participants are encouraged to read the QCMD Participants' Manual, which can be downloaded from the QCMD website. Any queries abo ut this repo rt sho uld be addressed to the QCMD Neutral Office (neutralo ffice@qcmd.o rg). Pag e 4 o f 1 Is s u e D ate : 0 M ay 20 16

5 //370 Additional Information: Individual Panel Member Analysis (Quantitative) Quantitative analysis fo r each panel member is pro vided in relatio n to yo ur EQA assessment gro up. EQA assessment gro ups are established using the mo lecular wo rkflo w info rmatio n repo rted by all participants within this EQA challenge / distribution. The principal level of assessment is at the individual method level which is defined based on your reported amplificatio n/detectio n metho d and o ther labo rato ries using the same o r similar amplificatio n/detectio n metho ds. To allow meaningful assessment at the individual method level the EQA assessment group must consist of or more datasets. If there are not sufficient datasets at the individual method level then your results will be included within a higher EQA assessment group based on whether it is a commercial or in house technology/method. The highest level assessment grouping is all reported results using the same unit of measurement (i.e. Copies/ml or IU/ml). The results below provide a breakdown of participant reported values on each of the panel members within this EQA challenge / distribution. Your result for each panel member is indicated by "your value". You can compare your value to the mean within yo ur EQA assessment gro up and the o verall co nsensus fo r each sample within this EQA challenge / distributio n. Key C101 Quant it at ive Result s Breakdo wn (Co pies/ml) Code (Copie s/ml) Range (Log ) (n) 10 C1 01 HBV Type A Plasma D1 Frequently CORE Copies/ml log Copies/ml ber of Values in Groups Groups be low n=: Ro che (n=2), Ro che Ro che Co b as Taq man (n=2), Alto na Diag no stics (n=1), Alto na Diag no stics Alto na Diag no stics Re alstar (n=1), Q IAG EN (n=4), Q IAG EN Q iag e n Artus Re al Time (n=4), InHo use (n=4), InHo use Re altime InHo use PCR (n=4) Groups Rolle d Up: Ab b o tt Ab b o tt Re altime (n=) Pag e o f 1 Is s u e D ate : 0 M ay 20 16

6 //370 C102 Quant it at ive Result s Breakdo wn (Co pies/ml) Code (Copie s/ml) Range (Log ) (n) 10 C102 HBV Type D Plasma Frequently CORE Copies/ml log Copies/ml ber of Values in Groups Groups be low n=: Ro che (n=2), Ro che Ro che Co b as Taq man (n=2), Alto na Diag no stics (n=1), Alto na Diag no stics Alto na Diag no stics Re alstar (n=1), Q IAG EN (n=4), Q IAG EN Q iag e n Artus Re al Time (n=4), InHo use (n=4), InHo use Re altime InHo use PCR (n=4) Groups Rolle d Up: Ab b o tt Ab b o tt Re altime (n=) C103 Quant it at ive Result s Breakdo wn (Co pies/ml) Code (Copie s/ml) Range (Log ) (n) 10 C1 03 HBV Type A Plasma D1 Frequently CORE Copies/ml log Copies/ml ber of Values in Groups Groups be low n=: Ro che (n=2), Ro che Ro che Co b as Taq man (n=2), Alto na Diag no stics (n=1), Alto na Diag no stics Alto na Diag no stics Re alstar (n=1), Q IAG EN (n=4), Q IAG EN Q iag e n Artus Re al Time (n=4), InHo use (n=4), InHo use Re altime InHo use PCR (n=4) Pag e 6 o f 1 Is s u e D ate : 0 M ay 20 16

7 //370 Groups Rolle d Up: Ab b o tt Ab b o tt Re altime (n=) C101 Quant it at ive Result s Breakdo wn (IU/ml) Code (IU/ml) Range (Log ) (n) 10 C1 01 HBV Type A Plasma D1 Frequently CORE IU/ml Roche Roche Cobas Roche Cobas Taqman Anatolia Geneworks Siemens GeneProof Number of Values in Groups QIAGEN InHouse Realtime InHouse PCR log IU/ml Groups be low n=: LG Life Scie nce (n=1), LG Life Scie nce LG Life Scie nce Ad vansure (n=1), Ho lo g ic (n=1), Ho lo g ic Ho lo g ic Ap tima (n=1), Sacace (n=2), Sacace Sacace Re al TM (n=2), fasttrack DIAGNOSTICS (n=1), fasttrack DIAGNOSTICS Fast Track Diag no stics re al time PCR (n=1), RTA Lab o rato rie s (n=4), RTA Lab o rato rie s RTA Lab o rato rie s Re al time (n=4), Io nte k (n=2), Io nte k Io nte k Fluo rio n (n=2), Prime rde sig n (n=1), Prime rde sig n Prime rde sig n G e ne sig (n=1), InHo use Co nve ntio nal InHo use PCR (n=1) Groups Rolle d Up: Ab b o tt Ab b o tt Re altime (n=6 1), Anato lia G e ne wo rks Anato lia G e ne wo rks Bo sp ho re (n=13), Sie me ns Sie me ns Ve rsant (n=11), G e ne Pro o f G e ne Pro o f Re al Time PCR kit (n=9 ), Q IAG EN Q iag e n Artus Re al Time (n=30 ) Pag e 7 o f 1 Is s u e D ate : 0 M ay 20 16

8 //370 C102 Quant it at ive Result s Breakdo wn (IU/ml) Code (IU/ml) Range (Log ) (n) 10 C1 02 HBV Type D Plasma Frequently CORE IU/ml Roche Roche Cobas Roche Cobas Taqman Anatolia Geneworks Siemens GeneProof Number of Values in Groups QIAGEN InHouse Realtime InHouse PCR log IU/ml Groups be low n=: LG Life Scie nce (n=1), LG Life Scie nce LG Life Scie nce Ad vansure (n=1), Ho lo g ic (n=1), Ho lo g ic Ho lo g ic Ap tima (n=1), Sacace (n=2), Sacace Sacace Re al TM (n=2), fasttrack DIAGNOSTICS (n=1), fasttrack DIAGNOSTICS Fast Track Diag no stics re al time PCR (n=1), RTA Lab o rato rie s (n=4), RTA Lab o rato rie s RTA Lab o rato rie s Re al time (n=4), Io nte k (n=2), Io nte k Io nte k Fluo rio n (n=2), Prime rde sig n (n=1), Prime rde sig n Prime rde sig n G e ne sig (n=1), InHo use Co nve ntio nal InHo use PCR (n=1) Groups Rolle d Up: Ab b o tt Ab b o tt Re altime (n=6 0 ), Anato lia G e ne wo rks Anato lia G e ne wo rks Bo sp ho re (n=13), Sie me ns Sie me ns Ve rsant (n=11), G e ne Pro o f G e ne Pro o f Re al Time PCR kit (n=9 ), Q IAG EN Q iag e n Artus Re al Time (n=31) Pag e 8 o f 1 Is s u e D ate : 0 M ay 20 16

9 //370 C103 Quant it at ive Result s Breakdo wn (IU/ml) Code (IU/ml) Range (Log ) (n) 10 C1 03 HBV Type A Plasma D1 Frequently CORE IU/ml Roche Roche Cobas Roche Cobas Taqman Anatolia Geneworks Siemens GeneProof Number of Values in Groups QIAGEN InHouse Realtime InHouse PCR log IU/ml Groups be low n=: LG Life Scie nce (n=1), LG Life Scie nce LG Life Scie nce Ad vansure (n=1), Ho lo g ic (n=1), Ho lo g ic Ho lo g ic Ap tima (n=1), Sacace (n=2), Sacace Sacace Re al TM (n=2), fasttrack DIAGNOSTICS (n=1), fasttrack DIAGNOSTICS Fast Track Diag no stics re al time PCR (n=1), RTA Lab o rato rie s (n=4), RTA Lab o rato rie s RTA Lab o rato rie s Re al time (n=4), Io nte k (n=2), Io nte k Io nte k Fluo rio n (n=2), Prime rde sig n (n=1), Prime rde sig n Prime rde sig n G e ne sig (n=1), InHo use Co nve ntio nal InHo use PCR (n=1) Groups Rolle d Up: Ab b o tt Ab b o tt Re altime (n=6 1), Anato lia G e ne wo rks Anato lia G e ne wo rks Bo sp ho re (n=13), Sie me ns Sie me ns Ve rsant (n=12), G e ne Pro o f G e ne Pro o f Re al Time PCR kit (n=9 ), Q IAG EN Q iag e n Artus Re al Time (n=31) Pag e 9 o f 1 Is s u e D ate : 0 M ay 20 16

10 //370 Additional Information: Individual Panel Member Analysis (Qualitative) Qualitative analysis fo r each panel member is pro vided in relatio n to yo ur EQA assessment gro up. EQA assessment gro ups are established using the mo lecular wo rkflo w info rmatio n repo rted by all participants within this EQA challenge / distribution. The principal level of assessment is at the individual method level which is defined based on your reported amplificatio n/detectio n metho d and o ther labo rato ries using the same o r similar amplificatio n/detectio n metho ds. To allow meaningful assessment at the individual method level the EQA assessment group must consist of or more datasets. If there are not sufficient datasets at the individual method level then your results will be included within a higher EQA assessment group based on whether it is a commercial or in house technology/method. The highest level assessment gro uping is All participant repo rted qualitative results. A breakdown of qualitative results reported by participants on each of the panel members within this EQA challenge / distribution is provided below. You can compare your results to those within your EQA assessment group and those obtained within other EQA assessment groups or to the overall consensus for each sample within this EQA challenge / distributio n. Pag e 10 o f 1 Is s u e D ate : 0 M ay 20 16

11 //370 C101 Qualit at ive Result s Breakdo wn Code Pe rce ntage Corre ct All (%) (n) C1 01 HBV Type A Plasma D1 Frequently CORE 98.8 All Roche Roche Cobas Taqscreen Roche Cobas Roche Cobas Taqman Grifols GeneProof QIAGEN Number of Values in Groups InHouse Realtime InHouse PCR Inco rrect Co rrect Groups be low n=: Sacace (n=2), Sacace Sacace Re al TM (n=2), G FE Blut (n=2), G FE Blut G FE Blut VSPK (n=2), fasttrack DIAG NO STICS (n=1), fasttrack DIAG NO STICS Fast Track Diag no stics re al time PCR (n=1), RTA Lab o rato rie s (n=2), RTA Lab o rato rie s RTA Lab o rato rie s Re al time (n=2), Inte rlab Se rvice (n=1), Inte rlab Se rvice Inte rlab Se rvice Amp lise ns (n=1), Io nte k (n=1), Io nte k Io nte k Fluo rio n (n=1), Sie me ns (n=2), Sie me ns Sie me ns Ve rsant (n=2), Prime rde sig n (n=1), Prime rde sig n Prime rde sig n G e ne sig (n=1), Alto na Diag no stics (n=1), Alto na Diag no stics Alto na Diag no stics Re alstar (n=1), InHo use Co nve ntio nal InHo use PCR (n=3) Groups Rolle d Up: Ab b o tt Ab b o tt Re altime (n=27), G rifo ls G rifo ls Pro cle ix Ultrio (n=8 ), G e ne Pro o f G e ne Pro o f Re al Time PCR kit (n=6 ), Q IAG EN Q iag e n Artus Re al Time (n=20 ) Pag e 11 o f 1 Is s u e D ate : 0 M ay 20 16

12 //370 C102 Qualit at ive Result s Breakdo wn Code Pe rce ntage Corre ct All (%) (n) C1 02 HBV Type D Plasma Frequently CORE 98.8 All Roche Roche Cobas Taqscreen Roche Cobas Roche Cobas Taqman Grifols GeneProof QIAGEN Number of Values in Groups InHouse Realtime InHouse PCR Inco rrect Co rrect Groups be low n=: Sacace (n=2), Sacace Sacace Re al TM (n=2), G FE Blut (n=2), G FE Blut G FE Blut VSPK (n=2), fasttrack DIAG NO STICS (n=1), fasttrack DIAG NO STICS Fast Track Diag no stics re al time PCR (n=1), RTA Lab o rato rie s (n=2), RTA Lab o rato rie s RTA Lab o rato rie s Re al time (n=2), Inte rlab Se rvice (n=1), Inte rlab Se rvice Inte rlab Se rvice Amp lise ns (n=1), Io nte k (n=1), Io nte k Io nte k Fluo rio n (n=1), Sie me ns (n=2), Sie me ns Sie me ns Ve rsant (n=2), Prime rde sig n (n=1), Prime rde sig n Prime rde sig n G e ne sig (n=1), Alto na Diag no stics (n=1), Alto na Diag no stics Alto na Diag no stics Re alstar (n=1), InHo use Co nve ntio nal InHo use PCR (n=3) Groups Rolle d Up: Ab b o tt Ab b o tt Re altime (n=27), G rifo ls G rifo ls Pro cle ix Ultrio (n=8 ), G e ne Pro o f G e ne Pro o f Re al Time PCR kit (n=6 ), Q IAG EN Q iag e n Artus Re al Time (n=20 ) Pag e 12 o f 1 Is s u e D ate : 0 M ay 20 16

13 //370 C103 Qualit at ive Result s Breakdo wn Code Pe rce ntage Corre ct All (%) (n) C1 03 HBV Type A Plasma D1 Frequently CORE 99.4 All Roche Roche Cobas Taqscreen Roche Cobas Roche Cobas Taqman Grifols GeneProof QIAGEN Number of Values in Groups InHouse Realtime InHouse PCR Inco rrect Co rrect Groups be low n=: Sacace (n=2), Sacace Sacace Re al TM (n=2), G FE Blut (n=2), G FE Blut G FE Blut VSPK (n=2), fasttrack DIAG NO STICS (n=1), fasttrack DIAG NO STICS Fast Track Diag no stics re al time PCR (n=1), RTA Lab o rato rie s (n=2), RTA Lab o rato rie s RTA Lab o rato rie s Re al time (n=2), Inte rlab Se rvice (n=1), Inte rlab Se rvice Inte rlab Se rvice Amp lise ns (n=1), Io nte k (n=1), Io nte k Io nte k Fluo rio n (n=1), Sie me ns (n=2), Sie me ns Sie me ns Ve rsant (n=2), Prime rde sig n (n=1), Prime rde sig n Prime rde sig n G e ne sig (n=1), Alto na Diag no stics (n=1), Alto na Diag no stics Alto na Diag no stics Re alstar (n=1), InHo use Co nve ntio nal InHo use PCR (n=3) Groups Rolle d Up: Ab b o tt Ab b o tt Re altime (n=27), G rifo ls G rifo ls Pro cle ix Ultrio (n=8 ), G e ne Pro o f G e ne Pro o f Re al Time PCR kit (n=6 ), Q IAG EN Q iag e n Artus Re al Time (n=20 ) Pag e 13 o f 1 Is s u e D ate : 0 M ay 20 16

14 //370 C104 Qualit at ive Result s Breakdo wn Code Pe rce ntage Corre ct All (%) (n) C1 04 HBV Negative Plasma Negative CORE 97.6 All Roche Roche Cobas Taqscreen Roche Cobas Roche Cobas Taqman Grifols GeneProof QIAGEN Number of Values in Groups InHouse Realtime InHouse PCR Inco rrect Co rrect Groups be low n=: Sacace (n=2), Sacace Sacace Re al TM (n=2), G FE Blut (n=2), G FE Blut G FE Blut VSPK (n=2), fasttrack DIAG NO STICS (n=1), fasttrack DIAG NO STICS Fast Track Diag no stics re al time PCR (n=1), RTA Lab o rato rie s (n=2), RTA Lab o rato rie s RTA Lab o rato rie s Re al time (n=2), Inte rlab Se rvice (n=1), Inte rlab Se rvice Inte rlab Se rvice Amp lise ns (n=1), Io nte k (n=1), Io nte k Io nte k Fluo rio n (n=1), Sie me ns (n=2), Sie me ns Sie me ns Ve rsant (n=2), Prime rde sig n (n=1), Prime rde sig n Prime rde sig n G e ne sig (n=1), Alto na Diag no stics (n=1), Alto na Diag no stics Alto na Diag no stics Re alstar (n=1), InHo use Co nve ntio nal InHo use PCR (n=3) Groups Rolle d Up: Ab b o tt Ab b o tt Re altime (n=27), G rifo ls G rifo ls Pro cle ix Ultrio (n=8 ), G e ne Pro o f G e ne Pro o f Re al Time PCR kit (n=6 ), Q IAG EN Q iag e n Artus Re al Time (n=20 ) Pag e 14 o f 1 Is s u e D ate : 0 M ay 20 16

15 //370 Q CMD The Q CMD EQ A p ro g ramme samp le s, asso ciate d re p o rts and d ata g e ne rate d d uring this p ro g ramme are inte nd e d fo r Exte rnal Q uality Asse ssme nt (EQ A) and Pro ficie ncy Te sting (PT) p urp o se s o nly. Q CMD o p e rate s acco rd ing to a strict Co d e o f Practice which is in line with ISO /IEC and asso ciate d stand ard s. Data re p o rte d in Q CMD p ro g ramme s is re p re se ntative o f a lab o rato ry's stand ard d iag no stic te sting p ro to co ls irre sp e ctive o f the te chno lo g y the y use. The d ata p ro vid e d in the re p o rts are b ase d o n te chnical info rmatio n p ro vid e d b y the ind ivid ual lab o rato rie s as p art o f the asse ssme nt p ro ce ss, as such it d o e s no t co nstitute a fo rmal te chno lo g y me tho d co mp ariso n. All te xt and imag e s p ro d uce d b y Q CMD are the p ro p e rty o f Q CMD unle ss o the rwise state d. The re p ro d uctio n and use o f the se mate rials is no t p e rmitte d witho ut the e xp re ss writte n co nse nt o f Q CMD. The use o f the info rmatio n p ro vid e d in Q CMD re p o rts fo r co mme rcial p urp o se s is strictly p ro hib ite d. Pag e 1 o f 1 Is s u e D ate : 0 M ay 20 16

Analysis Type : Qualitative. Samp le Re lationships [1] Detected. Detected. Detected. Detected. Detected

Analysis Type : Qualitative. Samp le Re lationships [1] Detected. Detected. Detected. Detected. Detected //1 NOT E: Summary info rmatio n o nly. Intended Results / Panel Composition [1] Corre ct () [2] [3] [4] C1 01 DS1_2 CORE 9.2 C1 02 DS1_3 CORE 93.2 C1 03 DS1_1 CORE 97.2 C1 04 CSF DS2_1 CORE 98.8 C1 0

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