quality assessment service of the institute for quality ... · quality assessment service of the...

IfQ-LübeckI n s t i t u t f ü rQ u a l i t ä t s s i c h e r u n gL ü b e c k

Quality assessment

service of the

Institute for

Quality Assurance

IfQ-Lübeck · Institut für Qualitätssicherung Lübeck · Seekamp 31 · 23560 Lübeck (Germany) · Tel +49 451 29288 233 · Fax +49 451 5855 591 · E-mail [email protected]

33

Table of contents

Institute for Quality Assurance Lübeck (IfQ-Lübeck) ........................................................5IfQ staff ....................................................................................................................................6Quality assessment parameters ...........................................................................................8Characteristics of the IfQ-Lübeck quality assessment .....................................................8Participation process .............................................................................................................9Example of an evaluation report ........................................................................................10Quality assessment schemes for autoimmunity..............................................................12

Autoantibodies against thyroid gland ........................................................................12Autoantibodies against granulocytes .........................................................................14Antibodies in autoimmune kidney diseases ..............................................................15Antibodies in autoimmune liver diseases ..................................................................16Autoantibodies in pernicious anaemia .......................................................................17Autoantibodies against structural proteins of the skin.............................................18Antibodies against CCP ................................................................................................19Autoantibodies against cell nuclei ..............................................................................20Antibodies in autoimmune myopathies .....................................................................21Autoantibodies against phospholipids .......................................................................22Antibodies against tissue transglutaminase (tTG),endomysium and gliadin ..............................................................................................23

Quality assessment schemes for infectious serology .....................................................24Antibodies against Borrelia burgdorferi sensu lato ..................................................24Antibodies against hepatitis E virus ...........................................................................25Antibodies against herpes simplex virus ...................................................................26Antibodies against parvovirus B19 .............................................................................27Antibodies against Epstein-Barr virus ........................................................................28Antibodies against arboviruses ...................................................................................29

Quality assessment schemes for allergology ...................................................................30Total IgE, specifi c IgE ....................................................................................................30

Terms and conditions for participation and information on the QA schemes .............31Price list and timetable ........................................................................................................35

Autoimmunity schemes ...............................................................................................35Infectious serology schemes .......................................................................................36Allergology schemes ....................................................................................................36

55

The Institute for Quality Assurance Lübeck was founded as an affi liated institution of EUROIMMUN Medizinische Labor diagnos-tika AG (hereinafter called EUROIMMUN AG) in 2005. It belongs 100 % to EURO-IMMUN AG, Lübeck (umbrella organisa-tion). The Institute for Quality Assurance Lübeck is responsible for the organisa-tion, management and evaluation of quali-ty assessment schemes and the provision of professional support to participants. In December 2008 the Institute for Quality Assurance Lübeck received accreditation.The quality assessment service is de-signed to evaluate the capabilities of participating laboratories, based on per-formed analyses in comparison to refer-ence values and results from other par-ticipating laboratories. It aims to provide an objective aid for assessing and deter-mining the reliability of data obtained, for evaluating results and recognising prob-lems. Great value is placed on the use of clinically and serologically well character-

ised samples. The reference values are determined by independent external ref-erence laboratories, which use reagents from different manufacturers for analysis and share their test results. Our quality assessment schemes are not restricted to specifi c test systems. Based on the re-sults, participating laboratories should introduce corrective measures, if neces-sary, to improve the quality of their ser-vices. The Institute for Quality Assurance Lübeck supports participants with com-petent scientifi c advice. Quality assess-ment schemes are held regularly in order to give the participating laboratories the chance to monitor their performance ca-pabilities continuously.

Further information can be found atwww.ifq-portal.de

Institute for Quality Assurance

Lübeck (IfQ-Lübeck)

IfQ staff Lübeck. Back row: Mareen Zimmermann-Ahmari, Dr. Monika Probst, Michaela Pfeiffer; front row: Jessica Nehlsen, Juliane Eggert, Anne Kahl

66

Michaela PfeifferTel: +49 451 5855 25761E-mail: [email protected]

Juliane EggertTel: +49 451 5855 25731E-mail: [email protected]

Dr. Monika ProbstTel: +49 451 5855 25751E-mail: [email protected]

QA coordination

Technical support and administration

77

Mareen Zimmermann-AhmariTel: +49 451 5855 24624E-mail: [email protected]

Jessica NehlsenTel.: +49 451 5855 25732E-mail: [email protected]

Anne KahlTel.: +49 451 5855 25736E-mail: [email protected]

88

Quality assessment parameters

Autoimmunity

Thyroid gland Neuronal antigens ANCA Kidney Liver Structural proteins of the skin CCP Cell nuclei Autoimmune myopathies Phospholipids Coeliac disease Pernicious anaemia

Infectious serology

Borrelia Hepatitis E virus Herpes simplex virus Parvovirus B19 Epstein-Barr virus Arboviruses (Zika virus,

dengue virus, chikungunya virus)

Allergology

Total IgE, specifi c IgE

Characteristics of the IfQ-Lübeck quality assessment Online registration, entry of results and evaluation No restriction to specifi c test systems Target values established by external reference laboratories Clinically characterised sera Two quality assessment schemes per year for each parameter Evaluation contains images (IFA, Westernblot) and results fromreference labs

Certifi cates for successful participation High number of participantsfrom over 50 countries

30 June

for schemes during the second half-year30 November

for schemes during the fi rst half-year

Registration possible until:

Timetableon pages 35

and 36!

Numbers of participants I/2017

0

100

200

300

500

400

600

Myopath

iesHEV

Arbo-

viruses

ANCA

Neuronal

Liver

KidneySkin

CCPANA

Coeliac

diseaseBorre

liaHSV

Parvoviru

s

B19EBV

Allerg

ology

Phospho-

lipids

Thyroid

gland

Nu

mb

er

of

part

icip

an

ts (

I/2017)

Autoimmunity Infectious serology Allergology

Participants other countries (light)

Participants Germany (dark)

99

Participation process

General registration at

www.ifq-portal.de

Registration for the

individual schemes

Shipment of samples

as indicated

Data entry

Evaluation available on

the internet

Certifi cates sent by

postal mail

1010

Dear Ms./Mr. ...,

wwe thank you for your participation in the interlaboratory test. A total of 440 labo-ratories participated. The rate of correct results was 98 %.

Characterisation of samples

Clinical expressionTarget value

(cANCA)

Target value

(anti-PR3)

Target value

(pANCA)

Target value

(anti-MPO)

Sample 1 Wegener‘s granulomatosis pos pos neg neg

Sample 2 Healthy blood donor neg neg neg neg

Sample 3 Wegener‘s granulomatosis pos pos neg neg

Rate of correct results per test method (IgG)

Test methods Frequency of use Correct single results

IIFT 404 98 %

ELISA (PR3 and MPO) 261 99 %

Lineblot (PR3 and MPO) 123 98 %

Westernblot (PR3 and MPO) 2 100 %

Other (PR3 and MPO) 78 100 %

The reference values from reference laboratories, immunofl uorescence images of the interlaboratory samples and details about the performance and evaluation of EUROIMMUN interlaboratory test schemes are available through our qualityassessment portal. The next interlaboratory test for the investigation of “Autoan-ttibodies against granulocytes” will take place in October 2017. We hope you will participate again!

Sincerely yours

Dr. rer.nat. Monika ProbstQuality Assessment Service Coordinator

Example of an evaluation report

QA report

1111

Individual evaluation

Participant: Represented by:

Test system used in your lab (class IgG):

EUROIMMUN Anti-PR3-hn-hr ELISAAll users of this test system

ParameterIntended

resultYour result Median [U/ml]

Interval of 68 %

of resultsn

Correct

[%]

Sample 1 anti-PR3 positive positive 428.0 U/ml 282.9 200.0 - 546.0 75 98.7

Sample 2 anti-PR3 negative negative 2.0 U/ml 2,0 1,7 - 4,2 75 98.7

Sample 3 anti-PR3 positive positive 1009.0 U/ml 318.5 200.0 - 916.0 75 98.7

Certifi cate: yes October 2016: yes May 2016: yes November 2015: yes May 2015: yes

Rate of correct results of the different test systems

2. Anti-PR3 Correct results

Test system ManufacturerTest

method

Number of

partici-

pants

Sample 1

target:

anti-PR3 pos

Sample 2

target:

anti-PR3 neg

Sample 3

target:

anti-PR3 pos

Aeskulisa PR3 sensitiveAnti-PR3-ELISAAnti-PR3-ELISAAnti-PR3-ELISAAnti-PR3-hn-hr ELISA

Aesku.DiagnosticsBioradDiesseEurodiagnosticaEUROIMMUN

ELISAELISAELISAELISAELISA

5224

104

100 %100 %100 %100 %99 %

100 %100 %100 %100 %98 %

100 %100 %100 %100 %98 %

ANCA-Profi le ELISAQuanta Lite PR3

EUROIMMUNInova Diagnostics

ELISAELISA

258

96 %100 %

96 %88 %

92 %88 %

Anti-proteinase 3Antibodies againstMPO and PR3

Other

Other

Other

Other

1

2

100 %

100 %

100 %

100 %

100 %

100 %

All anti-PR3 test systems 371 99 % 97 % 98 %

Results of reference laboratories

Anti-PR3 Units Cut-off Sample

External ref.

laboratoryTest system (manufacturer) 1 2 3

Laboratory 1 Anti-PR3-hn-hr ELISA (EUROIMMUN) U/ml 20 769 < 2 1,302

Laboratory 2 Anti-PR3-hn-hr ELISA (EUROIMMUN) U/ml 20 594 1 1,054

Laboratory 5 PR3 ANCA capture ELISA (Eurodiagnostica) IU/ml 7 pos neg pos

Laboratory 5 PR3 ANCA direct ELISA (Phadia) IU/ml 3 63 < 2 599

Laboratory 7 Anti-PR3-hn-hr ELISA (EUROIMMUN) U/ml 20 457 2 1,100

Target value pos neg pos

1212

Shipment: April and October

Number of samples: 3

Evaluated parameters: TG, TPO, TRAb

Sample volume: 300 µl (double set available)

Quality assessment no: QV 1010

Evaluation: The test systems are evaluated individually. A certifi cate is only awarded upon correct analysis of all three samples.

Dilution 1:10

Test substrate:

Thyroid gland (monkey)

Test substrate:

Thyroglobulin BIOCHIP

Further available fi gures to complement the QA report (examples)QA report

Autoantibodies against thyroid gland

positive: anti-TPO, anti-TG

1313

QA report



Evaluated parameters:Amphiphysin, aquaporin 4, CASPR2, CV2, GAD, Hu, LGI1, Ma/Ta, NMDA receptor, Ri, Yo




Autoantibodies against neuronal antigens

Cerebellum

(monkey)

Transfected

cells

Control-

transfected cells

Dilution 1:10

Hippocampus

(rat)

positive: anti-NMDAR

QV 1111-151013 Sample 2

Test method: PNS Profi le 12 Ag EUROLINE (EUROIMMUN) positive: anti-Hu

0

10

20

30

40

50

8

1

32

3

11

15

1

Titerpos.neg. bdl. 1:10 1:32 1:100 1:320 1:1,000

Further available fi gures to complement the QA report (examples)

Nu

mb

er o

f p

arti

cip

ants

outside target range

within target range

no target range

1414



Evaluated parameters: ANCA, MPO, PR3



Evaluation: If immunofl uorescence is used, only borderline and positive sam-ples in the immunofl uorescence must be confi rmed by monospe-cifi c test systems to obtain a certifi cate.

0

50

100

150

200

250

300

350

7

327

3

pc

41

0

27

0

66

1

79

1

33

0 2 0

10 32 100 320 1,000pc pc pc pc pc

3,200pc

Nu

mb

er o

f p

arti

cip

ants

Qualitative Quantitativedominant pattern (titer)-1


pANCA

cANCA

p

c

inside target range

Test substrate:Ethanol-fi xed

granulocytes

Test substrate:Formalin-fi xed

granulocytes

Test substrate:PR3 BIOCHIP

Test substrate:HEp-2/ethanol-fi xed

granulocytes

Dilution 1:10

positive: cANCA


Autoantibodies against granulocytes

QV 1200-160419 Sample 1

Test method: ANCA Profi le EUROLINE (EUROIMMUN) positive: anti-PR3

neg. pos.

1515

QA report

Shipment: April und October


Evaluated parameters: GBM, PLA2R, THSD7A




KidneyPLA2R-trans-

fected cells

THSD7A-trans-

fected cells

Dilution 1:10

Antigen spots

GBM

Antibodies in autoimmune kidney diseases

positive: anti-GBM

QV 1250-161011 Sample 1

Test method: ANCA/-GBM Profi le EUROLINE (EUROIMMUN) positive: anti-GBM


Nu

mb

er o

f p

arti

cip

ants

0

50

100

150

200

2

55

189 16

211

1

Qualitative Titer

pos.neg. 1:10 1:32 1:100 1:320 1:1,000 1:3,200


within target range

no target range

1616

Shipment: March and September

Numbers of samples: 3

Evaluated parameters:AMA, ASMA, F-actin, gp210, LC-1, LKM-1, M2, nuclear dots, nuclear membrane, SLA/LP, Sp100




QV 1300-140325 Sample 1

Test method: Liver Profi le EUROLINE (EUROIMMUN) positive: anti-gp210, anti-M2-3E, anti-M2

HEp-2 cells Liver Kidney

Dilution 1:100

Antibodies in autoimmune liver diseases

Nu

mb

er

of

pa

rtic

ipa

nts

nuclear

dots

cellular

membrane


Antigen spotspos: Anti-M2

positive: AMA

Pattern

0

20

40

60

80

100100

1

87

20

3 24

28

41

16

Qualitative

neg AMA ASMA 100 320 1,000 3,200 10,000pos

Quantitativedominant pattern (titer)-1


within target range

no target range

1717



Evaluated parameters: Intrinsic factor, parietal cells (PCA)




Autoantibodies in pernicious anaemia

QA report

Dilution 1:10

0

10

20

30

40

50

2 1

29

3

10

15

1

Qualitative Titer

pos.neg. bdl. 1:10 1:32 1:100 1:320 1:1,000

Nu

mb

er o

f p

arti

cip

ants


within target range

no target range

positive: anti-PCA, anti-intrinsic faktor

Test substrate:

Stomach (monkey)

Test substrate:

Intrinsic faktor BIOCHIP


1818


Numbers of samples: 3

Evaluated parameters:BP180, BP230, desmoglein 1, desmoglein 3, desmosomes,epidermal basement membrane,



Evaluation: The test systems are evaluated individually. A certifi cate is onlyawarded upon correct analysis of all three samples.

0

10

D EBM

20

30

40

50

0

47

4

D EBM D EBM D DEBM EBM D EBM

10

1

15

1

11

1 2000

10 32 100 320 1,000

Nu

mb

er o

f p

arti

cpan

ts

Quantitativedominant pattern (titer) -1

Qualitative

neg. pos.


desmosomes

epidermal basement membrane

D

EBM

inside target range

Oesophagus Anti-Dsg 1 Anti-Dsg 3

Dilution 1:10 Dilution 1:10Dilution 1:100 Dilution 1:10

positive: anti-desmosomes, anti-Dsg 1, anti-Dsg 3


Autoantibodies against structural proteins of the skin

1919



Evaluated parameter: CCP



Evaluation: The test systems are evaluated individually. A certifi cate is only awarded upon correct analysis of all three samples. Only test sys-tems that detect antibodies against CCP will be accepted.

QA report without further fi guresQA report

Antibodies against CCP

2020

neg 100 320 1,000 3,200 10,000

34

140

210

497

Pattern

0

100

200

300

400

500508

1pos

Nu

mb

er

of

pa

rtic

ipa

nts

Qualitative

463

100

23 13 6

granular nucleolar nuclear

dots

homo-

genous

cytoplasm

granular



Evaluated parameters: Cell nuclei, centromeres, CENP A, CENP B, dsDNA, nucleosomes, RNP, RNP / Sm, Scl-70, Sm, SS-A, SS-B

Sample volume: 400 µl


Evaluation: If immunofl uorescence is used, only borderline and positive sam-ples in the immunofl uorescence must be confi rmed by monospe-cifi c test systems to obtain a certifi cate.

Antigen spotspos: SS-A;

neg: nRNP/Sm, Sm

Antigen spotspos: SS-B;

neg: Scl-70, Jo-1

QV 1510-130319 Sample 1

Test method: ANA Profi le 5 EUROLINE (EUROIMMUN) positive: anti-SS-B, anti-SS-A, anti-Ro-52

HEp-2 cells Liver

Dilution 1:100


Autoantibodies against cell nuclei

positive: ANA (pattern: granular / nucleolar)

Quantitativedominant pattern (titer)-1


within target range

no target range

2121

QA report

QV 1530-170319 Sample 1

Test method: Myositis Profi le 3 EUROLINE (EUROIMMUN)

QV 1530-170319 Sample 2

Test method: Myositis Profi le 3 EUROLINE (EUROIMMUN)

positive: anti-Jo-1, anti-Ro-52

positive: anti-Ku

Antibodies in autoimmune myopathies



Evaluated parameters: cN-1A, EJ, Jo-1, Ku, Mi-2, Mi-2α, Mi-2�, OJ, PL-7, PL-12, PM-Scl,

SRP





2222



Evaluated parameters: Cardiolipin (IgG, IgM, IgAGM); �2-Glykoprotein (IgG, IgM, IgAGM)




QA report without further fi guresQA report

Autoantibodies against phospholipids

2323

positive



Evaluated parameters: Tissue transglutaminase (tTG), endomysium, gliadin (IgA, IgG)



Evaluation: Certifi cates will only be awarded to participants who use a test system that determines antibodies against tTG (IgA) or EMA (IgA) in combination with a coeliac-disease-specifi c IgG test system. The latter may be for the analysis of transglutaminase (IgG) or EMA (IgG), or an IgG test system based on deamidated gliadin. Test systems using native gliadin will not be certifi ed.

Test substrate:Liver

Test substrate:Oesophagus

Test substrate:Gliadin (deamidated)

positive

Test substrate:Intestine

IgA

negative

IgG

positive

Dilution 1:10


Antibodies against tissue transglutaminase (tTG),

endomysium and gliadin

0

50

100

150

200

6 1

115

2012 17

2111

Qualitative Titerposneg bdl. 1:10 1:32 1:100 1:320 1:1,000 1:3,200


within target range

no target range

positive: anti-endomysium (IgA), anti-gliadin (IgA, IgG)

2424



Evaluated parameters: Borrelia (IgG, IgM), serological complete diagnosis



Evaluation: If a screening assay is used only borderline or positive samples have to be confi rmed in a confi rmation assay to obtain a certifi cate.

QV 2132-130319 Sample 2 Test method: EUROLINE-WB (IgG)

QV 2132-130319 Sample 2 Test method: EUROLINE-RN-AT (IgG)

QV 2132-130319 Sample 2 Test method: EUROLINE-WB (IgM) positive

QV 2132-130319 Sample 2 Test method: EUROLINE-RN-AT (IgM)


Antibodies against Borrelia burgdorferi sensu lato

negative

negative

positive

2525

QA report

Shipment March and September


Evaluated parameter: Hepatitis E virus (IgG, IgM, IgAGM)


QA number: QV 2525


Antibodies against hepatitis E virus

QA report without further fi gures

2626



Evaluated parameters: HSV-1, HSV-2, HSV-1 / 2 (IgG, IgM)




QV 2531-130319 Sample 2 Test method: EUROLINE-WB (IgM) negative

QV 2531-130319 Sample 2 Test method: EUROLINE-WB (IgG) positive: anti-HSV-1


Antibodies against herpes simplex virus

2727



Evaluated parameter: Parvovirus (IgG, IgM)


QA number: QV 2580


QV 2580-130319 Sample 2 Test method: EUROLINE (IgG)

QV 2580-130319 Sample 2 Test method: EUROLINE (IgM)

positive

positive


Antibodies against parvovirus B19

2828



Evaluated parameters:EBV-CA (IgG, IgM), EBNA-1(IgG), avidity, serological completediagnosis


QA number: QV 2790

Evaluation: The test systems are evaluated individually. A certifi cate is onlyawarded upon correct analysis of all three samples.

QV 2580-130319 Sample 2

Test method: EUROLINE Profi le 2 EBV (IgG)

QV 2580-130319 Sample 2

Test method: EUROLINE Profi le 2 EBV (IgM)

positive: anti-EBV-CA, anti-EBNA-1

positive: anti-EBV-EA, anti-EBV-CA


Antibodies against Epstein-Barr virus

positive: anti-EBV-CA (IgG), anti-EBNA (IgG); high avidity

EBV-CA (IgG)EBV-CA (IgG)treated with urea

EBV-CA (IgM)

Dilution 1:10

EBNA (IgG)

2929



Evaluated parameters:Chikungunya virus, dengue virus, Zika virus (IgG, IgM)dengue virus NS1 antigen


QA number: QV 2668



Antibodies against arboviruses

positive: anti-Zika virus (IgG, IgM)

Zika virus Dengue virus Chikungunya virus

IgG

IgM

Dilution 1:10

3030

Allergology



Evaluated parameters: Total IgE, specifi c IgE

Sample volume:Total IgE 1 x 500 µlTotal IgE / specifi c IgE 2 x 1000 µl

QA number: QV 3000

Evaluation: The test systems are evaluated individually. One certifi cate is beawarded for the correct analysis of total IgE and one for the correctanalysis of specifi c IgE in each case.


QA report

Test method: EUROLINE Profi le Inhalation

Test method: EUROLINE Profi le Food

Test method: EUROLINE Profi le Insect Venoms

Test systems employed at your lab (class IgE):EUROIMMUNAllercoat 6 system (EAST class [0-6])ELISA

ParameterIntended result

(EAST class [0-6]) Your Result

Sample 2 w1 (common ragweed) 0-1 0 kU/l: <0,35

Sample 3 w1 (common ragweed) 2-6 3 kU/l: 6,11

Quality Assessment Report QV 3000-150922, II/2015"Allergology": Evaluation of your results

Participants:

Represented by:

Certificate: yes April 2015 -

0123456

EA

ST

clas

s(0-

6)

0 2 4 6 8 1 0 1 2 1 4 1 6 1 8 2 0 2 2 2 4 2 6 2 8 3 0Sample 3 (Number of participants)

* *

Legend** Your Result result accepted: All assay Your assay result not accepted: All assay Your assay

3131

Terms and conditions for participation

and information on the QA schemes

The Institute for Quality Assurance Lübeck

(henceforth called IfQ Lübeck) organises qual-

ity assessment schemes for laboratory external

quality control.

Purpose of the quality assessment service

The quality assessment service is designed to

evaluate the performance capabilities of partici-

pating laboratories, based on performed labora-

tory tests in comparison to reference values and

results from other participating laboratories.

It provides an objective aid for assessing and de-

termining the reliability of data obtained and for

recognising problems. Based on the results, par-

ticipating laboratories should introduce correc-

tive measures, if necessary, to improve the qual-

ity of their services. Quality assessment schemes

are held regularly in order to give the participat-

ing laboratories the chance to monitor their per-

formance capabilities continuously. Participation

in the quality assessment schemes should estab-

lish additional confi dence for customers of par-

ticipating laboratories.

Quality assessment schemes are not aimed at

evaluating the products (test systems) used

and should not be drawn on to assess the per-

formance of the products. The use of the qual-

ity assessment samples, certifi cates, participa-

tions certifi cates, reports and other information

provided by the IfQ is only permitted within the

framework of this intended use.

Costs

The participation fees for the quality assess-

ment schemes are to be taken from the relevant

valid price list (for Switzerland, please refer to

the responsible EUROIMMUN subsidiary for

information on the costs). Participants bear the

costs for their reagents, time expenditure, etc.

Quality assessment samples

Quality assessment schemes take place twice

a year, each time with three samples. “Real” clin-

ically characterised samples are used preferably.

These are obtained in collaboration with doctors

or sample donors. The origin of each sample is

known. The samples can be serum or plasma.

Methods used by the participants must therefore

be validated for both serum and plasma.

Determination of expected resultsp

Expected results for quality assessment samples

are determined before delivery of the samples

in cooperation with competent external labo-

ratories. A list of the reference laboratories is

available on the quality assessment portal. For

each quality assessment scheme at least one

reference laboratory is commissioned which

is accredited for performance of the respective

analysis according to the corresponding labora-

tory norm (e.g. DIN EN ISO 15189, DIN EN ISO/

IEC 17025, DIN EN ISO 15195). The samples are

measured and assessed by the appropriate ref-

erence laboratories. The qualitative result of the

reference laboratories is taken as the expected

result.

Stability/preservationy p

The quality assessment scheme samples are

preserved, usually with sodium azide (< 1%). In

individual cases, also other preservatives may

be used. Avoid contact with the skin. Occasion-

ally the used preservatives can interfere with

certain test methods. To exclude such interfer-

ence, consult the instructions in the test system

used. Every quality assurance sample undergoes

a stability check. In this check, transport and stor-

age of the samples are simulated in stress tests.

The stability check establishes that the sample is

stable at the given storage temperature for the

duration of the quality assessment round (gener-

ally 4 weeks).

3232

Homogeneityg y

Quality assurance samples are fl uid and are

mixed before and during fi lling to ensure

homogeneity. The homogeneity of the samples

is determined during process validation of the

fi lling process.

Safety warningsy g

No antibodies against HCV, HIV-1 or HIV-2 are

detected in quality assessment samples using

CE-registered or FDA-approved test systems.

Nevertheless, samples should be handled as

carefully as infectious material.

Registration of participants

Any interested laboratory that routinely car-

ries out the respective laboratory analyses can

take part in the quality assessment. Partici-

pants are required to register on the internet at

www.ifq-portal.de. The quality assessment ser-

vice portal allows participants to register for the

different quality assessment schemes and later

enter their results online. The e-mail address

provided by the participant is used to provide

effective communication between the IfQ Lübeck

and the participants. Participants have to ensure

availability via this e-mail address. Participants

are required to notify the IfQ Lübeck via the por-

tal of any changes in their personal details (e.g.

e-mail or delivery address) and to keep their

details up to date. If the provided address is in-

correct, participants are not entitled to a new

delivery or refund.

Registration for quality assessment schemes,

signing up for subscription, and procedure

Registration, entering of results and issuing of

reports take place online via the quality assess-

ment portal. There, the dates for every quality

assessment scheme are announced. Participants

can apply to the quality assessment schemes

during the registration period. The registered

participants are informed on the start and end

dates of the registration phase via e-mail. By

registering to the quality assessment schemes,

the participant agrees to the terms and condi-

tions of the IfQ in its relevant valid version, to be

found in the quality assessment portal.

Registration for the quality assessment schemes

can also be made via subscription. With registra-

tion via subscription, the participants are regis-

tered for all future quality assessment schemes

offered by the IfQ until further notice. The partici-

pants can cancel the participation in the respec-

tive quality assessment scheme until the end of

the registration period or cancel the subscription

by this date. Revocation and cancellation can be

done via e-mail. The conditions of participation

apply in their relevant valid version. If the con-

ditions of participation change, the participants

are expressly informed about the change on the

website (“Infobox: Changes in the conditions of

participation”). Changed conditions of participa-

tion are published at the latest two weeks before

the end of the registration period on the web-

site and communicated via e-mail. An isolated

revocation is not possible. The revocation always

applies to the participation in the quality assess-

ment scheme.

Despite careful planning it may happen that the

sample contingent is used up before the end of

the registration phase. There is no entitlement

to the number of samples being extended. Early

registration ensures participation.

After the end of the registration period, the

quality assessment samples are sent by the IfQ

Lübeck at the date announced in the portal. If

samples are lost or damaged and the IfQ Lübeck

is informed straightaway, replacements will be

sent if possible. However, participants are not

entitled to replacements. If a new delivery results

in lateness or delayed service, there is no entitle-

ment to the participant’s results being taken into

account in the evaluation of the quality assess-

ment round. The participants commit to handle

3333

and store the quality assessment samples in the

same way as routine samples and measure them

in their own laboratory. Participants must state

their method(s) used (routine method) together

with the results. Results obtained under rou-

tine conditions must be entered online in the

portal by the respective deadline. No additional

determinations or further methods that are not

used for routine samples may be used to obtain

results. It is not permitted to enter test results

which are consolidated from different methods.

If a test procedure consists of a screening test fol-

lowed by a confi rmatory test, both methods must

be entered during registration on the portal, and

results for the two methods must be given sepa-

rately. If the confi rmatory test is performed by an

external laboratory this should be indicated. The

certifi cate is only valid for tests performed by the

participating laboratory; externally performed

tests are therefore marked in the certifi cate.

Falsifi cation and secret communication between

participating laboratories contradicts the goal

of external quality control and is therefore not

permitted. It is recommended that participants

double-check that their results are entered cor-

rectly in the portal. Participants should also fi le

a printout of their entry with their documenta-

tion. Errors in data entry can be corrected up until

the deadline for entering the results. After the

deadline no changes may be made to the entered

results. In cases of necessity, for example faulty

internet connection, results can be submitted to

the IfQ Lübeck in writing (e.g. e-mail, fax). These

will be entered into the portal by the quality

assurance team, as long as the deadline is met.

If results are not entered or transmitted within

the time limit, no evaluation can be made. In this

case, the costs are not refunded.

Evaluation, quality assurance report and issuing

of certifi cates

The IfQ Lübeck evaluates the data promptly

and places the evaluation online on the qual-

ity assessment portal. This includes the results

of every participant (only available for the cor-

responding participant), a statistical total evalu-

ation with anonymous and summarised results

of all participating laboratories, and further help-

ful information (e.g. images from immunofl uo-

rescence tests, blot strips). Participants receive

a message when the evaluation is available.

Qualitative evaluation is crucial for the granting

of a certifi cate. If the qualitative results of the par-

ticipant for all samples is in agreement with the

expected values, the quality assessment scheme

has been passed and a certifi cate will be issued.

Particularities of individual quality assessment

schemes are to be found in detail in the respec-

tive information in the quality assessment portal.

If a quality assessment scheme is not passed,

the participant receives a participation confi rma-

tion instead of a certifi cate. In the result evalua-

tion for each participant, the following statistical

information is given alongside a comparison of

the participant’s results and the expected results.

These values are based on all participants who

participated in the scheme using the same test

system.

• Median of results*

• 68 % result range*

• Number of participants

• Number of correct results (pass rate)

*if at least 6 participants gave a quantitative result

The median is the middle value of all measure-

ment values when sorted by size, so that half of

the values lie under the median and half over.

If the number of measurement values is even,

the arithmetic mean of the two middle values is

taken as the median. The median rather than the

arithmetic mean is used as a statistical param-

eter to reduce the infl uence of extreme values.

Outlier tests are not performed.The 68 % result

range gives the distribution range of quantitative

results, within which the measurement values of

3434

68 % of the participants lie. In the total evalua-

tion the following information is given for each

test that was used by participants in the quality

assessment scheme:

• Number of participants

• Number of correct results (pass rate)

The certifi cates and participation confi rmations of

the IfQ Lübeck are sent to the participants via mail

to the address provided. The complete quality

assessment scheme reports are provided in the

quality assessment portal. Certifi cates, confi rma-

tions of participation and reports may be used

within the framework of the intended used of the

quality assessment schemes as described above.

Misuse or tampering, or meaningful changes

through manipulation of the documents, or

by relating them with other documents is not

allowed.

Queries

Complaints about the quality assessment carried

out by the IfQ Lübeck should be sent in written

form to the institute within 4 weeks of receiving

the quality assessment report. After this dead-

line, complaints can no longer be considered.

If it should happen that a quality assessment

scheme becomes invalid through a mistake by

the IfQ Lübeck, an additional scheme will be

offered free of charge (with the same conditions

for participation). Further claims on the IfQ

Lübeck are excluded.

Declaration of confi dentiality

The IfQ Lübeck treats all participant data as con-

fi dential. Merely the data required for invoicing

are passed on to the responsible departments. In

the quality assessment portal, the anonymised

results of each quality assessment scheme are

made accessible to the participants.

Miscellaneous

Further information about the quality assess-

ment service can be found in the quality assess-

ment portal. The IfQ Lübeck reserves the right

to exclude a laboratory if it repeatedly does not

return results or if a participant has falsifi ed data

or has made secret consultations or has tried

to. This also applies to attempts to infl uence

employees of the IfQ Lübeck. The IfQ reserves the

right to introduce participant fees and to change

individual quality assessment schemes with

regard to their scope or to discontinue them com-

pletely.

For further issues the general terms and condi-

tions of EUROIMMUN AG apply.

Please address any questions about the in-

dividual quality assessment schemes or the

quality assessment service to the IfQ Lübeck at

E-mail: [email protected]

Tel: +49 451 29288 233

3535

Autoimmunity

Scheme FormatDates QAS

2018/I

Dates QAS

2018/II

Autoantibodies against cell nuclei

Cell nuclei, centromeres, CENP A, CENP B,dsDNA, nucleosomes, RNP, RNP / Sm, Scl-70, Sm, SS-A, SS-B

1 set of specimen 3 x 400 µl Registrationguntil:

November 30,2017

Shipment:pMarch 20,

2018

Deadline:April 17,

2018

Registrationguntil:

June 30, 2018

Shipment:pSeptember 18,

2018

Deadline:October 16,

2018

Antibodies in autoimmunemyopathies

cN-1A, EJ, Jo-1, Ku, Mi-2, Mi-2α, Mi-2�, OJ, PL-7,

PL-12, PM-Scl, SRP

1 set of specimen2 sets of specimen

3 x 200 µl3 x 400 µl

Antibodies in autoimmune liver diseasesAMA, ASMA, F-actin, gp210, LC-1, LKM-1, M2, nuclear dots, nuclear membrane, SLA/LP, Sp100


3 x 200 µl3 x 400 µl

Autoantibodies against thyroid gland

TG, TPO, TRAb1 set of specimen2 sets of specimen

3 x 300 µl3 x 600 µl

Registrationguntil:

November 30,2017

Shipment:pApril 24,

2018

Deadline:May 22,

2018

Registrationguntil:

June 30, 2018

Shipment:pOctober 16,

2018

Deadline:November 13,

2018

Autoantibodies against neuronal

antigens

Amphiphysin, aquaporin 4, CASPR2, CV2, GAD, Hu, LGI1, Ma/Ta, NMDA receptor, Ri, Yo


3 x 200 µl3 x 400 µl

Autoantibodies against granulocytes

ANCA, MPO, PR31 set of specimen2 sets of specimen

3 x 200 µl3 x 400 µl

Autoantibodies against structural proteins of

the skin

BP180, BP230, desmoglein 1 and 3, desmosomes,epidermal basement membrane


3 x 200 µl3 x 400 µl

Antibodies against CCP1 set of specimen2 sets of specimen

3 x 200 µl3 x 400 µl

Autoantibodies against phospholipids

Cardiolipin (IgG, IgM, IgAGM);�2-glycoprotein (IgG, IgM, IgAGM)


3 x 150 µl3 x 300 µl

Antibodies against tissue transglutaminase,

endomysium and gliadin

(IgA, IgG)


3 x 200 µl3 x 400 µl

Antibodies in autoimmune kidney diseasesGBM, PLA2R, THSD7A


3 x 200 µl3 x 400 µl

Autoantibodies in pernicious anaemiaIntrinsic factor, parietal cells


3 x 200 µl3 x 400 µl

Time schedule 2018

3636

Infectious serology


2018/I

Dates QAS

2018/II

Antibodies against Borrelia burgdorferi

sensu lato

(IgG, IgM), serological complete diagnosis


3 x 250 µl3 x 500 µl

Registrationguntil:

November 30,2017

Shipment:pMarch 20,

2018

Deadline:April 17,

2018

Registrationguntil:

June 30,2018


2018


2018

Antibodies against hepatitis E virus

(IgG, IgM, IgAGM)1 set of specimen2 sets of specimen

3 x 200 µl3 x 400 µl

Antibodies against herpes simplex virus

HSV-1, HSV-2, HSV-1/2 (IgG, IgM)


3 x 200 µl3 x 400 µl

Antibodies against parvovirus B19

(IgG, IgM)1 set of specimen2 sets of specimen

3 x 200 µl3 x 400 µl

Antibodies against Epstein-Barr virus

EBV-CA (IgG, IgM), EBNA-1 (IgG),avidity, serological complete diagnosis


3 x 200 µl3 x 400 µl

Antibodies against arboviruses

Chikungunya virus, dengue virus, Zika virus(IgG, IgM)


3 x 300 µl3 x 600 µl


2018/I

Dates QAS

2018/II

Allergology

Total IgE, specifi c IgE

1 set of specimen consisting of Registrationguntil:

November 30,2017

Shipment:pMarch 20,

2018

Deadline:April 17,

2018

Registrationguntil:

June 30,2018


2018


2018

Total IgE

Total IgE/

specifi c IgE

1 x 500 µl

2 x 1000 µl

Allergology

Time schedule 2018

Please ask your local distributor for prices.

3737

Notes

3838

Notes

3939

Notes

IfQ-LübeckI n s t i t u t f ü rQ u a l i t ä t s s i c h e r u n gL ü b e c k

IfQ-Lübeck

Institut für Qualitätssicherung LübeckSeekamp 31, 23560 Lübeck, Germany

Tel: +49 451 29288 233Fax: +49 451 5855 591

E-mail: [email protected]

YV_0000_I_UK_B10, 09/2017

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