quality assessment service of the ifq-lübeck · chikungunya virus dengue virus zika virus...

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 AssuranceLübeck

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]

mailto:[email protected]?subject=

tel:+4945129288 233

tel:+494515855 591

33

Table of contents

Institute for Quality Assurance Lübeck (IfQ-Lübeck) ........................................................5Quality assessment parameters ...........................................................................................6Characteristics of the IfQ-Lübeck quality assessment .....................................................6Participation process .............................................................................................................7Example of an evaluation report ..........................................................................................8Quality assessment schemes for autoimmunity..............................................................10

Autoantibodies against thyroid gland ........................................................................10Autoantibodies against neuronal antigens ................................................................11Autoantibodies against granulocytes .........................................................................12Antibodies in autoimmune kidney diseases ..............................................................13Antibodies in autoimmune liver diseases ..................................................................14Autoantibodies in pernicious anaemia .......................................................................15Autoantibodies against structural proteins of the skin.............................................16Antibodies against CCP ................................................................................................17Autoantibodies against cell nuclei ..............................................................................18Antibodies in autoimmune myopathies .....................................................................19Autoantibodies against phospholipids .......................................................................20Antibodies against tissue transglutaminase (tTG), endomysium and gliadin ..............................................................................................21

Quality assessment schemes for infectious serology .....................................................22Antibodies against Borrelia burgdorferi sensu lato ..................................................22Antibodies against hepatitis E virus ...........................................................................23Antibodies against herpes simplex virus ...................................................................24Antibodies against parvovirus B19 .............................................................................25Antibodies against Epstein-Barr virus ........................................................................26Antibodies against chikungunya virus .......................................................................27Antibodies against dengue virus ................................................................................28Antibodies against Zika virus ......................................................................................29

Quality assessment schemes for allergology ...................................................................30Total IgE..........................................................................................................................30Specific IgE ....................................................................................................................31

Terms and conditions for participation and information on the QA schemes .............32Price list and timetable ........................................................................................................36

Autoimmunity schemes ...............................................................................................36Infectious serology schemes .......................................................................................37Allergology schemes ....................................................................................................37

55

The Institute for Quality Assurance Lübeck was founded as an affiliated 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 specific 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 scientific 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-Lübeck staff. From the left: Jessica Nehlsen, Anne Kahl, Juliane Eggert, Mareen Zimmermann-Ahmari, Dr. Monika Probst, Michaela Pfeiffer, Yasemin Koc, Sybille Kubald

http://www.ifq-portal.de./

66

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 Chikungunya virus Dengue virus Zika virus

Allergology Total IgE Specific IgE

Characteristics of the IfQ-Lübeck quality assessment Online registration, entry of results and evaluation

No restriction to specific 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 from reference labs

Certificates for successful participation

High number of participants from over 40 countries

30 Junefor schemes during the second half-year

30 Novemberfor schemes during the first half-year

Registration possible until:

Timetableon pages 36

and 37!

Numbers of participants II/2017

0

100

200

300

400

500

600

Num

ber

of p

arti

cipa

nts

(II/2

017)

MyopathiesHEV

Arbo-

viruses

ANCA

NeuronalLiver

KidneySkin

CCPANA

Coeliac

diseaseBorre

liaHSV

Parvovirus

B19EBV

Allergology

Phospho-

lipidsThyroid

gland

Autoimmunity Infectious serology Allergology

Participants other countries (light)

Participants Germany (dark)

Pernicious

anaemia

77

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

Certificates sent by postal mail

http://www.ifq-portal.de./

88

Dear Ms./Mr. ...,

we 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, immunofluorescence images of the interlaboratory samples and details about the performance and evaluation of EUROIMMUN interlaboratory test schemes are available through our quality assessment portal. The next interlaboratory test for the investigation of “Autoan-tibodies 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

99

Individual evaluationParticipant: Represented by:

Test system used in your lab (class IgG):EUROIMMUN Anti-PR3-hn-hr ELISA All users of this test system

ParameterIntended

resultYour result Median [U/ml]

Interval of 68 % of results

nCorrect

[%]

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

Certificate: yes October 2016: yes May 2016: yes November 2015: yes May 2015: yes

Rate of correct results of the different test systems2. Anti-PR3 Correct results

Test system ManufacturerTest

method

Number of partici-pants

Sample 1target:

anti-PR3 pos

Sample 2target:

anti-PR3 neg

Sample 3target:

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-Profile ELISAQuanta Lite PR3

EUROIMMUNInova Diagnostics

ELISAELISA

258

96 %100 %

96 %88 %

92 %88 %

Anti-proteinase 3Antibodies against MPO 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 laboratoriesAnti-PR3 Units Cut-off Sample

External ref. laboratory

Test 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

1010

Shipment: April and October

Number of samples: 2

Evaluated parameters: TG, TPO, TRAb

Sample volume: 300 µl

Order no:QV 1010-0203 (1 set of specimen)QV 1010-0206-1 (2 sets of specimen)

Evaluation: The test systems are evaluated individually. A certificate is only awarded upon correct analysis of both samples.

Dilution 1:10

Test substrate: Thyroid gland (monkey)

Test substrate: Thyroglobulin BIOCHIP

Further available figures to complement the QA report (examples)QA report

Autoantibodies against thyroid gland

positive: anti-TPO, anti-TG

1111



Evaluated parameters:Amphiphysin, aquaporin 4, CASPR2, CV2, GAD, Hu, LGI1, Ma/Ta, MOG, NMDA receptor, recoverin, Ri, SOX1, titin, Yo, ZIC4

Order no: 200 µl

Quality assessment no:QV 1111-0202 (1 set of specimen)QV 1111-0204-1 (2 sets of specimen)


Autoantibodies against neuronal antigens

Cerebellum (monkey)

Transfected cells

Control-transfected cells

Dilution 1:10

Hippocampus (rat)

positive: anti-NMDAR

QV 1111-151013 Sample 2Test method: PNS Profile 12 Ag EUROLINE (EUROIMMUN)

positive: anti-Hu

QA report

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

Further available figures to complement the QA report (examples)

Nu

mb

er o

f p

arti

cip

ants

outside target range

within target range

no target range

1212



Evaluated parameters: ANCA, MPO, PR3



Evaluation: If immunofluorescence is used, only borderline and positive sam-ples in the immunofluorescence must be confirmed by monospe-cific test systems to obtain a certificate.

Test substrate:Ethanol-fixed granulocytes

Test substrate:Formalin-fixedgranulocytes

Test substrate:PR3 BIOCHIP

Test substrate:HEp-2/ethanol-fixed

granulocytes

Dilution 1:10

positive: cANCA

Autoantibodies against granulocytes

QV 1200-160419 Sample 1Test method: ANCA Profile EUROLINE (EUROIMMUN)

positive: anti-PR3

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327

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Nu

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cip

ants

Qualitative Quantitativedominant pattern (titer)-1


pANCA

cANCA

p

c

inside target range


neg. pos.

1313

QA report



Evaluated parameters: GBM, PLA2R, THSD7A




KidneyPLA2R-transfected cells

THSD7A-transfected cells

Dilution 1:10

Antigen spotsGBM

Antibodies in autoimmune kidney diseases

positive: anti-GBM

QV 1250-161011 Sample 1Test method: ANCA/-GBM Profile EUROLINE (EUROIMMUN)

positive: anti-GBM


Nu

mb

er o

f p

arti

cip

ants

0

50

100

150

200

2

55

189 16

211

10

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

1414

Shipment: March and September

Numbers of samples: 2

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




QV 1300-140325 Sample 1Test method: Liver Profile EUROLINE (EUROIMMUN) positive: anti-gp210, anti-M2-3E, anti-M2

HEp-2 cells Liver Kidney

Dilution 1:100

Antibodies in autoimmune liver diseases

Antigen spotspos: Anti-M2

positive: AMA

Num

ber

of p

arti

cip

ants

nuclear dots

cellularmembrane


Pattern

0

20

40

60

80

100100

14

28

41

16

87

20

3 20

20

40

60

80

100100

14

28

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16

87

20

3 20

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60

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100100

14

28

41

16

87

20

3 2

Qualitative

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

Quantitativedominant pattern (titer)-1


within target range

no target range

1515



Evaluated parameters: Intrinsic factor, parietal cells (PCA)


Ordner no:QV 1360-0202 (1 set of specimen)QV 1360-0204-1 (2 sets of specimen)


Autoantibodies in pernicious anaemia

Dilution 1:10

positive: anti-PCA, anti-intrinsic factor

Test substrate: Stomach (monkey)

Test substrate: Intrinsic factor BIOCHIP

QA report

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10

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30

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50

2 1

29

3

10

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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


1616


Numbers of samples: 2

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




0

10

D EBM D EBM D EBM D DEBM EBM D EBM

20

30

40

50

0

47

4

10

1

15

1

11

1 2000

10 32 100 320 1.000

0

10

D EBM D EBM D EBM D DEBM EBM D EBM

20

30

40

50

0

47

4

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 1:10 Dilution 1:100 Dilution 1:10

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


Autoantibodies against structural proteins of the skin

1717



Evaluated parameter: CCP


Qrder no: QV 1505-0202 (1 set of specimen)QV 1505-0204-1 (2 sets of specimen)

Evaluation: The test systems are evaluated individually. A certificate is only awarded upon correct analysis of both samples. Only test systems that detect antibodies against CCP will be accepted.

QA report without further figuresQA report

Antibodies against CCP

1818

neg 100 320 1,000 3,200 10,0000

100

200

300

400

500508

134

140

210

497

Pattern

100 320 1.000 3.200 10.0000

100

200

300

400

500508

134

140

210

497

pos

Num

ber

of p

arti

cip

ants

Qualitative granul nucleolar homogen Zytoplasma granul nuclear dot

0

100

200

300

400

500463

100

23 13 6

granular nucleolar nuclear dots

homo-genous

cytoplasm granular



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


Order no: QV 1510-0204 (1 set of specimen)

Evaluation: If immunofluorescence is used, only borderline and positive sam-ples in the immunofluorescence must be confirmed by monospe-cific test systems to obtain a certificate.

Antigen spotspos: SS-A;

neg: nRNP/Sm, Sm

Antigen spotspos: SS-B;

neg: Scl-70, Jo-1

QV 1510-130319 Sample 1Test method: ANA Profile 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

1919

QV 1530-170319 Sample 1Test method: Myositis Profile 3 EUROLINE (EUROIMMUN)

QV 1530-170319 Sample 2Test method: Myositis Profile 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


Order no: QV 1530-0202 (1 set of specimen)QV 1530-0204-1 (2 sets of specimen)


QA reportFurther available figures to complement the QA report (examples)

2020



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





Autoantibodies against phospholipids

2121

positive



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



Evaluation: Certificates 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-specific 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 certified.

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

0

50

100

150

200

6 1

115

2012 17

2111N

um

ber

of p

arti

cip

ants

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)

2222



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



Evaluation: If a screening test is used, only borderline and positive samples need to be retested with a confirmatory test to obtain a certificate.

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

2323



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




Antibodies against hepatitis E virus

QA reportQA report without further figures

2424



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

2525



Evaluated parameter: Parvovirus (IgG, IgM)




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

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

positive

positive


Antibodies against parvovirus B19

2626



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




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

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

2727



Evaluated parameters: Chikungunya virus (IgG, IgM)


Order no:QV 293a-0203 (1 set of specimen) QV 293a-0206-1 (2 sets of specimen)



Antibodies against chikungunya virus

positive:anti-chikungunya virus (IgG, IgM)

IgG

Dilution 1:10

IgM

2828



Evaluated parameters:Dengue virus (IgG, IgM)Dengue virus NS1 antigen


Order no:QV 266a-0203 (1 set of specimen)QV 266a-0206-1 (2 sets of specimen)



Antibodies against dengue virus

positive: anti-dengue virus (IgG)

IgG

Dilution 1:10

IgM

2929



Evaluated parameters: Zika virus (IgG, IgM, IgA, IgAM)





Antibodies against Zika virus

positive: anti-Zika virus (IgG, IgM)

IgG

Dilution 1:10

IgM

3030

Allergology: Total IgE



Evaluated parameters: Total IgE





3131

Allergology: Specific IgE



Evaluated parameters: Specific IgE


Order no: QV 3000-0210 (1 set of specimen)



QA report

Test method: EUROLINE Profile Inhalation

Test method: EUROLINE Profile Food

Test method: EUROLINE Profile 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

3232

Terms and conditions for participation and information on the QA schemes

The Institute for Quality Assurance Lübeck (hereinafter IfQ-Lübeck) organises quality assessment schemes for laboratory external quality control. Participation is only possible under the following conditions.

1. Purpose of the quality assessment serviceThe quality assessment service is designed to evaluate the performance capabilities of participating laboratories, based on performed laboratory tests in comparison to reference values and results from other participating laboratories. It provides an objective aid for assessing and determining the reliability of data obtained and for recognising problems. Based on the results, participating laboratories should introduce corrective measures, if necessary, to improve the quality of their services. Quality assessment schemes are held regularly in order to give the participating laboratories the chance to monitor their performance capabilities continuously. Participation in the quality assessment schemes should establish additional confidence for customers of participating laboratories.

Quality assessment schemes are not aimed at evaluating the products (test systems) used and should not be drawn on to assess the performance of the products.

The use of the quality assessment samples, certificates, participations certificates, reports and other information provided by the IfQ is only permitted within the framework of this intended use.

2. CostsThe participation fees for the quality assessment 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.

3. Quality assessment samplesQuality assessment schemes take place twice a year, each time with two samples. “Real” clinically 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 resultsExpected results for quality assessment samples are determined before delivery of the samples in cooperation with competent external laboratories. 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 laboratory 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 reference laboratories. The qualitative result of the reference laboratories is taken as the expected result.

Stability/preservationThe 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. Occasionally the used preservatives can interfere with certain test methods. To exclude such interference, consult the instructions in the test system used.

Every quality assurance sample undergoes a stability check. In this check, transport and storage 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 (generally 4 weeks).

3333

HomogeneityQuality assurance samples are fluid and are mixed before and during filling to ensure homogeneity. The homogeneity of the samples is determined during process validation of the filling process.

Safety warningsNeither HBsAg, nor antibodies against HCV, HIV-1 or HIV-2 were detected in the quality assessment samples using CE-registered or FDA-approved test systems. Nevertheless, samples should be handled as carefully as infectious material.

4. Registration of participantsAny interested laboratory that routinely carries out the respective laboratory analyses can take part in the quality assessment, including those who are not customers of EUROIMMUN.

Participants are required to register on the internet at www.ifq-portal.de. The quality assessment service 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 portal 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 incorrect, participants are not entitled to a new delivery or refund.

5. Registration for quality assessment schemes, signing up for subscription, and procedure, revocation and terminationRegistration, entering of results and issuing of reports take place online via the quality assessment 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 inscription phase via e-mail. By registering to the quality assessment

schemes, the participant agrees to the terms and conditions 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 registration via subscription, the participants are registered for all future quality assessment schemes offered by the IfQ until further notice. The participants can cancel the participation in the respective 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 conditions of participation change, the participants are expressly informed about the change on the website (“Infobox: Changes in the conditions of participation”). Changed conditions of participation are published at the latest two weeks before the end of the registration period on the website and communicated via e-mail. An isolated revocation is not possible. The revocation always applies to the participation in the quality assessment 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 entitlement to the participant’s results being taken into account in the evaluation of the quality assessment round. The participants commit to handle 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

http://www.ifq-portal.de/

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with the results. Results obtained under routine 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 followed by a confirmatory test, both methods must be entered during registration on the portal, and results for the two methods must be given separately. If the confirmatory test is performed by an external laboratory this should be indicated. The certificate is only valid for tests performed by the participating laboratory; externally performed tests are therefore marked in the certificate.

Falsification and secret communication between participating laboratories contradict the goal of external quality control and are therefore not permitted.

It is recommended that participants double-check that their results are entered correctly in the portal. Participants should also file a printout of their entry with their documen-tation. 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.

6. Evaluation, quality assurance report and issuing of certificatesThe IfQ-Lübeck evaluates the data promptly and places the evaluation online on the quality assessment portal. This includes the results of every participant (only available for the corresponding participant), a statistical total evaluation with anonymous and summarised results of all participating laboratories, and further helpful information

(e.g. images from immunofluorescence tests, blot strips). Participants receive a message when the evaluation is available. Qualitative evaluation is crucial for the granting of a certificate. If the qualitative results of the participant for all samples is in agreement with the expected values, the quality assessment scheme has been passed and a certificate will be issued.

Particularities of individual quality assess-ment schemes are to be found in detail in the respective information in the quality assessment portal. If a quality assessment scheme is not passed, the participant receives a participation confirmation instead of a certificate.

The result evaluation for each participant contains a comparison of the participant’s results with the expected results. For further information, the following statistical figures are also given, based on all participants of the respective 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 measurement 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 parameter to reduce the influence 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 68% of the participants lie.

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In the total evaluation, 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 certificates and participation con-firmations 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. Certificates, confirmations 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 alteration through manipulation of the documents, or by relating them with other documents is not allowed.

7. QueriesComplaints 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 deadline 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.

8. Declaration of confidentiality and data protectionThe IfQ-Lübeck treats all participant data as confidential. 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. The IfQ assures that the data entrusted to them will be handled according to the data protection regulations. The corresponding privacy policy of the IfQ can be found at: www.ifq-portal.de – Contact / site notice / data protection.

9. MiscellaneousFurther information about the quality assess-ment service can be found in the quality assessment portal.

The IfQ-Lübeck reserves the right to exclude a laboratory if it repeatedly does not return results or if a participant has falsified data or has made secret consultations or has tried to. This also applies to attempts to influence 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 completely.

For further issues the general terms and con-ditions of EUROIMMUN AG apply.

Please address any questions about the individual quality assessment schemes or the quality assessment service to the IfQ-Lübeck by e-mail ([email protected]) or telephone (+49 451 29288 233).


mailto:[email protected]

tel:+49 45129288 233

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Autoimmunity

Scheme FormatDates QAS

2019/IDates QAS

2019/II

Autoantibodies against cell nucleiCell nuclei, centromeres, CENP A, CENP B, dsDNA, nucleosomes, ribosomal P-protein, RNP, RNP / Sm, Scl-70, Sm, SS-A, SS-B

1 set of specimen 2 x 400 µl Registrationuntil:

November 30, 2018

Shipment:March 19,

2019

Deadline:April 16,

2019

Registrationuntil:

June 30, 2019

Shipment:September 17,

2019

Deadline:October 15,

2019

Antibodies in autoimmune myopathies 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

2 x 200 µl2 x 400 µl

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


2 x 200 µl2 x 400 µl

Autoantibodies against thyroid glandTG, TPO, TRAb


2 x 300 µl2 x 600 µl

Registrationuntil:

November 30, 2018

Shipment:April 30,

2019

Deadline:May 28,

2019

Registrationuntil:

June 30, 2019

Shipment:October 15,

2019

Deadline:November 12,

2019

Autoantibodies against neuronal antigens Amphiphysin, aquaporin 4, CASPR2, CV2, GAD, Hu, LGI1, Ma/Ta, MOG, NMDA receptor, recoverin, Ri, SOX1, titin, Yo, ZIC4


2 x 200 µl2 x 400 µl

Autoantibodies against granulocytesANCA, MPO, PR3


2 x 200 µl2 x 400 µl

Autoantibodies against structural proteins of the skin BP180, BP230, collagen type VII, desmoglein 1 and 3, desmosomes, epidermal basement membrane


2 x 200 µl2 x 400 µl

Antibodies against CCP1 set of specimen2 sets of specimen

2 x 200 µl2 x 400 µl

Autoantibodies against phospholipidsCardiolipin (IgG, IgM, IgAGM); 2-glycoprotein (IgG, IgM, IgAGM)


2 x 150 µl2 x 300 µl

Antibodies against tissue transglutaminase, endomysium and gliadin(IgA, IgG)


2 x 200 µl2 x 400 µl

Antibodies in autoimmune kidney diseases GBM, PLA2R, THSD7A


2 x 200 µl2 x 400 µl

Autoantibodies in pernicious anaemiaIntrinsic factor, parietal cells


2 x 200 µl2 x 400 µl

Time schedule 2019

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Infectious serology


2019/IDates QAS

2019/II

Antibodies against Borrelia burgdorferi sensu lato (IgG, IgM), serological complete diagnosis


2 x 250 µl2x 500 µl

Registrationuntil:

November 30, 2018

Shipment:March 19,

2019

Deadline:April 16,

2019

Registrationuntil:

June 30, 2019


2019


2019

Antibodies against hepatitis E virus (IgG, IgM, IgAGM)


2 x 200 µl2 x 400 µl

Antibodies against herpes simplex virus HSV-1, HSV-2, HSV-1/2 (IgG, IgM)


2 x 200 µl2x 400 µl

Antibodies against parvovirus B19(IgG, IgM)


2x 200 µl2 x 400 µl

Antibodies against Epstein-Barr virusEBV-CA (IgG, IgM), EBNA-1 (IgG), avidity, serological complete diagnosis


2 x 200 µl2 x 400 µl

Antibodies against Chikungunya virus (IgG, IgM)


2 x 300 µl2 x 600 µl

Antibodies against Dengue virus(IgG, IgM)


2 x 300 µl2 x 600 µl

Antibodies against Zika virus (IgG, IgM, IgA, IgAM)


2 x 300 µl2 x 600 µl


2019/IDates QAS

2019/II

AllergologyTotal IgE


2 x 500 µl2 x 1000 µl

Registrationuntil:

November 30, 2018

Shipment:March 19,

2019

Deadline:April 16,

2019

Registrationuntil:

June 30, 2019


2019


2019

AllergologySpecific IgE

1 set of specimen 2 x 1000 µl

Allergology

Time schedule 2019

Please ask your local distributor for prices.

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Notes

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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-LübeckInstitut für Qualitätssicherung LübeckSeekamp 31, 23560 Lübeck, Germany

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

E-mail: [email protected]

YV_0000_I_UK_B11, 09/2018

Tel: +49 45129288 233

tel:+49 4515855 591

mailto:[email protected]


quality assessment service of the ifq-lübeck · chikungunya virus dengue virus zika virus...

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