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

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1 //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 CSF DS2_2 CORE 98.8 [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] Pe rce nt age Corre ct (): Pe rce ntag e o f d atase ts (%) re p o rting the co rre ct q ualitative re sult and the to tal numb e r o f d atase ts (n) re p o rte d fo r e ach p ane l me mb e r. For further details please refer to the current participant manual. Your Summary Results EQ A Asse ssme nt G roup Core Pane l (Q ualitative ) Score [1] [2] N/A N/A Pag e 1 o f 9 Is s u e D ate : 20 J u l 20 1

2 //1 Q ualitative Re sults Your Q uantitative Data (f o r inf o rmat io n o nly) [3] Corre ct () Your Re sult Score [4] [] [ ] Re porte d Value Unit ag e Cycle Thre shold C C C C C [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: 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] Q uant it at ive Dat a (f or inf ormat ion only): This is the q uantitative value, unitag e and cycle thre sho ld yo u p ro vid e d whe n yo u sub mitte d yo ur re sults. Fo r q ualitative p ro g ramme s this info rmatio n is no t use d as p art o f yo ur fo rmal EQ A asse ssme nt. [4] Pe rce nt age Corre ct () 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 r. [] Your 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. [ ] 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. Core Panel Member Score Breakdown Detection () Number o f Datasets Core Panel Members Score Cumulative Percentage Numbe r of Dat ase t s Cumulat ive Pe rce nt age Pag e 2 o f 9 Is s u e D ate : 20 J u l 20 1

3 //1 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. For further details please refer to the current participant manual. Further Programme Details Number of Participants Number of Countries 3 Number of Respondents 239 Number of Datasets Submitted Results Returned (100.0%) EQA Programme Aims To assess the pro ficiency o f labo rato ries in the mo lecular detectio n o f Mycobacterium tuberculosis (M. tuberculosis) (M. Bovis BCG). 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). Additional Information: Panel Member Analysis () 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 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 3 o f 9 Is s u e D ate : 20 J u l 20 1

4 //1 MT BDNA1C101 Qualit at ive Result s Breakdo wn C1 01 DS1_2 CORE 9.2 InHouse Conventional In House PCR Realtime InHouse PCR Groups be low n=: ELITe ch G ro up Elite ch Elite Re al time kit (n=3), ELITe ch G ro up Elite ch Ale rt Re al Time Q PCR kit (n=2), Hain Life scie nce Hain Life scie nce Flo uro Typ e (n=3), Hain Life scie nce Hain Life scie nce G e no Typ e (n=1), Hain Life scie nce Hain Life scie nce G e no Q uick (n=2), Ro che Ro che Co b as Amp lico r (n=1), Ro che Ro che Lig htcycle r (n=1), AB Analitica (n=2), AB Analitica AB Analitica REALQ UALITY RQ (n=2), Ho lo g ic (n=1), Ho lo g ic Ho lo g ic O the r (n=1), Bio G X (n=1), Bio G X Bio G X Re ad y (n=1), BD Mo le cular Diag no stics (n=3), BD Mo le cular Diag no stics BD Re ag e nts (n=1), BD Mo le cular Diag no stics BD Pro b e Te c (n=2), info p ia (n=3), info p ia info p ia Re al Time PCR (n=3), Ab b o tt (n=4), Ab b o tt Ab b o tt Re altime (n=4), Inte rlab Se rvice (n=1), Inte rlab Se rvice Inte rlab Se rvice Amp lise ns (n=1), Diag e no d e (n=4), Diag e no d e Diag e no d e Re al Time kit (n=4), TIB MO LBIO L (n=1), TIB MO LBIO L TIBMo lbio l Lig htmix (n=1), G e ne Pro o f (n=3), G e ne Pro o f G e ne Pro o f Re al Time PCR kit (n=3), Patho Find e r (n=2), Patho Find e r Patho Patho Find e r (n=2), Bio ne e r (n=2), Bio ne e r Bio ne e r Accup o we r (n=2), AnDiaTe c (n=1), AnDiaTe c AnDiaTe c Re al Time PCR (n=1), Pro g e nie Mo le cular (n=1), Pro g e nie Mo le cular Pro g e nie Mo le cular Re alcycle r (n=1) Groups Rolle d Up: Ce p he id Ce p he id Xp e rt kit (n=9 4), Se e g e ne Se e g e ne Re al Time PCR (n=), Q IAG EN Q iag e n Artus Re al Time (n=) Pag e 4 o f 9 Is s u e D ate : 20 J u l 20 1

5 //1 MT BDNA1C102 Qualit at ive Result s Breakdo wn C1 02 DS1_3 CORE 93.2 InHouse Conventional In House PCR Realtime InHouse PCR Groups be low n=: ELITe ch G ro up Elite ch Elite Re al time kit (n=3), ELITe ch G ro up Elite ch Ale rt Re al Time Q PCR kit (n=2), Hain Life scie nce Hain Life scie nce Flo uro Typ e (n=3), Hain Life scie nce Hain Life scie nce G e no Typ e (n=1), Hain Life scie nce Hain Life scie nce G e no Q uick (n=2), Ro che Ro che Co b as Amp lico r (n=1), Ro che Ro che Lig htcycle r (n=1), AB Analitica (n=2), AB Analitica AB Analitica REALQ UALITY RQ (n=2), Ho lo g ic (n=1), Ho lo g ic Ho lo g ic O the r (n=1), Bio G X (n=1), Bio G X Bio G X Re ad y (n=1), BD Mo le cular Diag no stics (n=3), BD Mo le cular Diag no stics BD Re ag e nts (n=1), BD Mo le cular Diag no stics BD Pro b e Te c (n=2), info p ia (n=3), info p ia info p ia Re al Time PCR (n=3), Ab b o tt (n=4), Ab b o tt Ab b o tt Re altime (n=4), Inte rlab Se rvice (n=1), Inte rlab Se rvice Inte rlab Se rvice Amp lise ns (n=1), Diag e no d e (n=4), Diag e no d e Diag e no d e Re al Time kit (n=4), TIB MO LBIO L (n=1), TIB MO LBIO L TIBMo lbio l Lig htmix (n=1), G e ne Pro o f (n=3), G e ne Pro o f G e ne Pro o f Re al Time PCR kit (n=3), Patho Find e r (n=2), Patho Find e r Patho Patho Find e r (n=2), Bio ne e r (n=2), Bio ne e r Bio ne e r Accup o we r (n=2), AnDiaTe c (n=1), AnDiaTe c AnDiaTe c Re al Time PCR (n=1), Pro g e nie Mo le cular (n=1), Pro g e nie Mo le cular Pro g e nie Mo le cular Re alcycle r (n=1) Groups Rolle d Up: Ce p he id Ce p he id Xp e rt kit (n=9 4), Se e g e ne Se e g e ne Re al Time PCR (n=), Q IAG EN Q iag e n Artus Re al Time (n=) Pag e o f 9 Is s u e D ate : 20 J u l 20 1

6 //1 MT BDNA1C103 Qualit at ive Result s Breakdo wn C1 03 DS1_1 CORE 97.2 InHouse Conventional In House PCR Realtime InHouse PCR Groups be low n=: ELITe ch G ro up Elite ch Elite Re al time kit (n=3), ELITe ch G ro up Elite ch Ale rt Re al Time Q PCR kit (n=2), Hain Life scie nce Hain Life scie nce Flo uro Typ e (n=3), Hain Life scie nce Hain Life scie nce G e no Typ e (n=1), Hain Life scie nce Hain Life scie nce G e no Q uick (n=2), Ro che Ro che Co b as Amp lico r (n=1), Ro che Ro che Lig htcycle r (n=1), AB Analitica (n=2), AB Analitica AB Analitica REALQ UALITY RQ (n=2), Ho lo g ic (n=1), Ho lo g ic Ho lo g ic O the r (n=1), Bio G X (n=1), Bio G X Bio G X Re ad y (n=1), BD Mo le cular Diag no stics (n=3), BD Mo le cular Diag no stics BD Re ag e nts (n=1), BD Mo le cular Diag no stics BD Pro b e Te c (n=2), info p ia (n=3), info p ia info p ia Re al Time PCR (n=3), Ab b o tt (n=4), Ab b o tt Ab b o tt Re altime (n=4), Inte rlab Se rvice (n=1), Inte rlab Se rvice Inte rlab Se rvice Amp lise ns (n=1), Diag e no d e (n=4), Diag e no d e Diag e no d e Re al Time kit (n=4), TIB MO LBIO L (n=1), TIB MO LBIO L TIBMo lbio l Lig htmix (n=1), G e ne Pro o f (n=3), G e ne Pro o f G e ne Pro o f Re al Time PCR kit (n=3), Patho Find e r (n=2), Patho Find e r Patho Patho Find e r (n=2), Bio ne e r (n=2), Bio ne e r Bio ne e r Accup o we r (n=2), AnDiaTe c (n=1), AnDiaTe c AnDiaTe c Re al Time PCR (n=1), Pro g e nie Mo le cular (n=1), Pro g e nie Mo le cular Pro g e nie Mo le cular Re alcycle r (n=1) Groups Rolle d Up: Ce p he id Ce p he id Xp e rt kit (n=9 4), Se e g e ne Se e g e ne Re al Time PCR (n=), Q IAG EN Q iag e n Artus Re al Time (n=) Pag e o f 9 Is s u e D ate : 20 J u l 20 1

7 //1 MT BDNA1C104 Qualit at ive Result s Breakdo wn C1 04 CSF DS2_1 CORE 98.8 InHouse Conventional In House PCR Realtime InHouse PCR Groups be low n=: ELITe ch G ro up Elite ch Elite Re al time kit (n=3), ELITe ch G ro up Elite ch Ale rt Re al Time Q PCR kit (n=2), Hain Life scie nce Hain Life scie nce Flo uro Typ e (n=3), Hain Life scie nce Hain Life scie nce G e no Typ e (n=1), Hain Life scie nce Hain Life scie nce G e no Q uick (n=2), Ro che Ro che Co b as Amp lico r (n=1), Ro che Ro che Lig htcycle r (n=1), AB Analitica (n=2), AB Analitica AB Analitica REALQ UALITY RQ (n=2), Ho lo g ic (n=1), Ho lo g ic Ho lo g ic O the r (n=1), Bio G X (n=1), Bio G X Bio G X Re ad y (n=1), BD Mo le cular Diag no stics (n=3), BD Mo le cular Diag no stics BD Re ag e nts (n=1), BD Mo le cular Diag no stics BD Pro b e Te c (n=2), info p ia (n=3), info p ia info p ia Re al Time PCR (n=3), Ab b o tt (n=4), Ab b o tt Ab b o tt Re altime (n=4), Inte rlab Se rvice (n=1), Inte rlab Se rvice Inte rlab Se rvice Amp lise ns (n=1), Diag e no d e (n=4), Diag e no d e Diag e no d e Re al Time kit (n=4), TIB MO LBIO L (n=1), TIB MO LBIO L TIBMo lbio l Lig htmix (n=1), G e ne Pro o f (n=3), G e ne Pro o f G e ne Pro o f Re al Time PCR kit (n=3), Patho Find e r (n=2), Patho Find e r Patho Patho Find e r (n=2), Bio ne e r (n=2), Bio ne e r Bio ne e r Accup o we r (n=2), AnDiaTe c (n=1), AnDiaTe c AnDiaTe c Re al Time PCR (n=1), Pro g e nie Mo le cular (n=1), Pro g e nie Mo le cular Pro g e nie Mo le cular Re alcycle r (n=1) Groups Rolle d Up: Ce p he id Ce p he id Xp e rt kit (n=9 4), Se e g e ne Se e g e ne Re al Time PCR (n=), Q IAG EN Q iag e n Artus Re al Time (n=) Pag e 7 o f 9 Is s u e D ate : 20 J u l 20 1

8 //1 MT BDNA1C10 Qualit at ive Result s Breakdo wn C1 0 CSF DS2_2 CORE 98.8 InHouse Conventional In House PCR Realtime InHouse PCR Groups be low n=: ELITe ch G ro up Elite ch Elite Re al time kit (n=3), ELITe ch G ro up Elite ch Ale rt Re al Time Q PCR kit (n=2), Hain Life scie nce Hain Life scie nce Flo uro Typ e (n=3), Hain Life scie nce Hain Life scie nce G e no Typ e (n=1), Hain Life scie nce Hain Life scie nce G e no Q uick (n=2), Ro che Ro che Co b as Amp lico r (n=1), Ro che Ro che Lig htcycle r (n=1), AB Analitica (n=2), AB Analitica AB Analitica REALQ UALITY RQ (n=2), Ho lo g ic (n=1), Ho lo g ic Ho lo g ic O the r (n=1), Bio G X (n=1), Bio G X Bio G X Re ad y (n=1), BD Mo le cular Diag no stics (n=3), BD Mo le cular Diag no stics BD Re ag e nts (n=1), BD Mo le cular Diag no stics BD Pro b e Te c (n=2), info p ia (n=3), info p ia info p ia Re al Time PCR (n=3), Ab b o tt (n=4), Ab b o tt Ab b o tt Re altime (n=4), Inte rlab Se rvice (n=1), Inte rlab Se rvice Inte rlab Se rvice Amp lise ns (n=1), Diag e no d e (n=4), Diag e no d e Diag e no d e Re al Time kit (n=4), TIB MO LBIO L (n=1), TIB MO LBIO L TIBMo lbio l Lig htmix (n=1), G e ne Pro o f (n=3), G e ne Pro o f G e ne Pro o f Re al Time PCR kit (n=3), Patho Find e r (n=2), Patho Find e r Patho Patho Find e r (n=2), Bio ne e r (n=2), Bio ne e r Bio ne e r Accup o we r (n=2), AnDiaTe c (n=1), AnDiaTe c AnDiaTe c Re al Time PCR (n=1), Pro g e nie Mo le cular (n=1), Pro g e nie Mo le cular Pro g e nie Mo le cular Re alcycle r (n=1) Groups Rolle d Up: Ce p he id Ce p he id Xp e rt kit (n=9 4), Se e g e ne Se e g e ne Re al Time PCR (n=), Q IAG EN Q iag e n Artus Re al Time (n=) Pag e 8 o f 9 Is s u e D ate : 20 J u l 20 1

9 //1 Q CMD 201. 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. 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 9 o f 9 Is s u e D ate : 20 J u l 20 1

QCMD 2016 Hepatitis B Virus DNA EQA Programme

QCMD 2016 Hepatitis B Virus DNA EQA Programme //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