Quality assessment service of the Institute for Quality Assurance Lübeck - EUROIMMUN ...
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Institut für
IfQ-Lübeck Qualitätssicherung
Lübeck
Quality assessment
service of the
Institute for
Quality Assurance
Lübeck
IfQ-Lübeck · Institut für Qualitätssicherung Lübeck · Seekamp 31 · 23560 Lübeck (Germany) · Tel +49 451 29288 233 · Fax +49 451 5855 591 · E-mail ifq@euroimmun.de
Table of contents
Institute for Quality Assurance Lübeck (IfQ-Lübeck).........................................................5
Quality assessment parameters............................................................................................6
Characteristics of the IfQ-Lübeck quality assessment ......................................................6
Participation process..............................................................................................................7
Example of an evaluation report...........................................................................................8
Quality assessment schemes for autoimmunity..............................................................10
Autoantibodies against thyroid gland.........................................................................10
Autoantibodies against neuronal antigens.................................................................11
Autoantibodies against granulocytes..........................................................................12
Antibodies in autoimmune kidney diseases...............................................................13
Antibodies in autoimmune liver diseases...................................................................14
Autoantibodies in pernicious anaemia........................................................................15
Autoantibodies against structural proteins of the skin.............................................16
Antibodies against CCP.................................................................................................17
Autoantibodies against cell nuclei...............................................................................18
Antibodies in autoimmune myopathies......................................................................19
Autoantibodies against phospholipids........................................................................20
Antibodies against tissue transglutaminase (tTG), endomysium and gliadin........21
Quality assessment schemes for infectious serology......................................................22
Antibodies against Borrelia burgdorferi sensu lato...................................................22
Antibodies against hepatitis E virus............................................................................23
Antibodies against herpes simplex virus....................................................................24
Antibodies against parvovirus B19..............................................................................25
Antibodies against Epstein-Barr virus.........................................................................26
Antibodies against chikungunya virus........................................................................27
Antibodies against dengue virus.................................................................................28
Antibodies against Zika virus.......................................................................................29
Quality assessment schemes for allergology....................................................................30
Total IgE..........................................................................................................................30
Specific IgE.....................................................................................................................31
Terms and conditions for participation and information on the QA schemes..............32
Price list and timetable.........................................................................................................36
Autoimmunity schemes................................................................................................36
Allergology schemes.....................................................................................................37
Infectious serology schemes........................................................................................37
3
Institute for Quality Assurance
Lübeck (IfQ-Lübeck)
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The Institute for Quality Assurance Lübeck ised samples. The reference values are
was founded as an affiliated institution of determined by independent external ref-
EUROIMMUN Medizinische Labordiagnos- erence laboratories, which use reagents
tika AG (hereinafter called EUROIMMUN from different manufacturers for analysis
AG) in 2005. It belongs 100 % to EURO- and share their test results. Our quality
IMMUN AG, Lübeck (umbrella organisa- assessment schemes are not restricted
tion). The Institute for Quality Assurance to specific test systems. Based on the re-
Lübeck is responsible for the organisa- sults, participating laboratories should
tion, management and evaluation of quali- introduce corrective measures, if neces-
ty assessment schemes and the provision sary, to improve the quality of their ser-
of professional support to participants. In vices. The Institute for Quality Assurance
December 2008, the Institute for Quality Lübeck supports participants with com-
Assurance Lübeck received accreditation. petent scientific advice. Quality assess-
The quality assessment service is de- ment schemes are held regularly in order
signed to evaluate the capabilities of to give the participating laboratories the
participating laboratories, based on per- chance to monitor their performance ca-
formed analyses in comparison to refer- pabilities continuously.
ence values and results from other par-
ticipating laboratories. It aims to provide Further information can be found at
an objective aid for assessing and deter- www.ifq-portal.de
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-
IfQ-Lübeck staff. From the left: Sybille Kubald, Jessica Nehlsen, Juliane Eggert,
Erik Fortenbacher, Dr. Monika Probst, Anne Kahl, Michaela Pfeiffer, Mareen Zimmermann-Ahmari
4 5
Quality assessment parameters Participation process
Autoimmunity Infectious serology
General registration at
Thyroid gland Borrelia www.ifq-portal.de
Neuronal antigens Hepatitis E virus
ANCA Herpes simplex virus
Kidney Parvovirus B19
Liver Epstein-Barr virus
Structural proteins of the skin Chikungunya virus
CCP Dengue virus
Cell nuclei Zika virus Registration for the
individual schemes
Autoimmune myopathies Allergology
Phospholipids
Total IgE
Coeliac disease
Specific IgE
Pernicious anaemia
Timetable
on pages 36
and 37!
Registration possible until: Shipment of samples
as indicated
30 June 30 November
for schemes during the second half-year for schemes during the first half-year
Characteristics of the IfQ-Lübeck quality assessment
Online registration, entry of results and evaluation
No restriction to specific test systems
Data entry
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
Evaluation available on
Numbers of participants I/2019 the internet
600
Number of participants (I/2019)
Participants other countries (light)
Participants Germany (dark)
500
400
Autoimmunity Infectious serology Allergology
300
200
Certificates sent by
100
postal mail
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QA rep ort
Example of an evaluation report Individual evaluation
Participant: Represented by:
Test system used in your lab (class IgG):
All users of this test system
EUROIMMUN Anti-PR3-hn-hr ELISA
Intended Interval of 68 % Correct
Parameter Your result Median [U/ml] n
result of results [%]
Dear Ms./Mr. ...,
Sample 1 anti-PR3 positive positive 428.0 U/ml 282.9 200.0 - 546.0 75 98.7
we thank you for your participation in the interlaboratory test. A total of 440 labo- Sample 2 anti-PR3 negative negative 2.0 U/ml 2.0 1,7 - 4,2 75 98.7
ratories participated. The rate of correct results was 98 %. 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
Characterisation of samples
Target value Target value Target value Target value
Clinical expression
(cANCA) (anti-PR3) (pANCA) (anti-MPO)
Rate of correct results of the different test systems
Sample 1 Wegener‘s granulomatosis pos pos neg neg
2. Anti-PR3 Correct results
Sample 2 Healthy blood donor neg neg neg neg Number of Sample 1 Sample 2 Sample 3
Test
Sample 3 Wegener‘s granulomatosis pos pos neg neg Test system Manufacturer partici- target: target: target:
method
pants anti-PR3 pos anti-PR3 neg anti-PR3 pos
Aeskulisa PR3 sensitive Aesku.Diagnostics ELISA 5 100 % 100 % 100 %
Anti-PR3-ELISA Biorad ELISA 2 100 % 100 % 100 %
Rate of correct results per test method (IgG) Anti-PR3-ELISA Diesse ELISA 2 100 % 100 % 100 %
Anti-PR3-ELISA Eurodiagnostica ELISA 4 100 % 100 % 100 %
Test methods Frequency of use Correct single results Anti-PR3-hn-hr ELISA EUROIMMUN ELISA 104 99 % 98 % 98 %
IIFT 404 98 % ANCA-Profile ELISA EUROIMMUN ELISA 25 96 % 96 % 92 %
Quanta Lite PR3 Inova Diagnostics ELISA 8 100 % 88 % 88 %
ELISA (PR3 and MPO) 261 99 %
Lineblot (PR3 and MPO) 123 98 %
Anti-proteinase 3 Other Other 1 100 % 100 % 100 %
Westernblot (PR3 and MPO) 2 100 % Antibodies against
MPO and PR3 Other Other 2 100 % 100 % 100 %
Other (PR3 and MPO) 78 100 %
All anti-PR3 test systems 371 99 % 97 % 98 %
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 Results of reference laboratories
assessment portal. The next interlaboratory test for the investigation of “Autoan- Anti-PR3 Units Cut-off Sample
tibodies against granulocytes” will take place in October 2017. We hope you will External ref.
Test system (manufacturer) 1 2 3
participate again! laboratory
Laboratory 1 Anti-PR3-hn-hr ELISA (EUROIMMUN) U/ml 20 769
Autoantibodies against thyroid gland Autoantibodies against neuronal antigens
Shipment: April and October Shipment: April and October
Number of samples: 2 Number of samples: 2
Amphiphysin, aquaporin 4, CASPR2, CV2, GAD, Hu, LGI1, Ma/Ta,
Evaluated parameters: TG, TPO, TRAb Evaluated parameters:
MOG, NMDA receptor, recoverin, Ri, SOX1, titin, Yo, ZIC4
Sample volume: 300 µl Order no: 200 µl
QV 1010-0203 (1 set of specimen) QV 1111-0202 (1 set of specimen)
Order no: Quality assessment no:
QV 1010-0206-1 (2 sets of specimen) QV 1111-0204-1 (2 sets of specimen)
Evaluation: The test systems are evaluated individually. A certificate is only Evaluation: The test systems are evaluated individually. A certificate is only
awarded upon correct analysis of both samples. awarded upon correct analysis of both samples.
Further available figures to complement the QA report (examples)
QA rep ort
Further available figures to complement the QA report (examples)
QA rep ort 50 50
within target range
Number of participants
40 40 outside target range
32 32 no target range
30 30
20 20
11 11
10 10 8 8
5 5
3 3
1 1 1 1 1 1
0 0
neg. bdl. pos. 1:10 1:32 1:100 1:320 1:1,000
Qualitative Titer
positive: anti-TPO, anti-TG positive: anti-NMDAR
Test substrate: Test substrate: Cerebellum Hippocampus Transfected Control-
Thyroid gland (monkey) Thyroglobulin BIOCHIP (monkey) (rat) cells transfected cells
Dilution 1:10
Dilution 1:10 QV 1111-151013 Sample 2
positive: anti-Hu
Test method: PNS Profile 12 Ag EUROLINE (EUROIMMUN)
10 11
Autoantibodies against granulocytes Antibodies in autoimmune kidney diseases
Shipment: April and October Shipment: April and October
Number of samples: 2 Number of samples: 2
Evaluated parameters: ANCA, MPO, PR3 Evaluated parameters: GBM, PLA2R, THSD7A
Sample volume: 200 µl Sample volume: 200 µl
QV 1200-0202 (1 set of specimen) QV 1250-0202 (1 set of specimen)
Order no: Order no:
QV 1200-0204-1 (2 sets of specimen) QV 1250-0204-1 (2 sets of specimen)
Evaluation: If immunofluorescence is used, only borderline and positive sam- Evaluation: The test systems are evaluated individually. A certificate is only
ples in the immunofluorescence must be confirmed by monospe- awarded upon correct analysis of both samples.
cific test systems to obtain a certificate.
Further available figures to complement the QA report (examples) Further available figures to complement the QA report (examples)
QA rep ort QA rep ort
350 350 within target range
327 327 inside target range 200 200
Number of participants
Number of participants
300 300
outside target range
outside target range
250 250 150 150
no target range
200 200
p pANCA
c cANCA 100 100
150 150
100 100 55 55
79 79 50 50
66 66
50 50 41 41
33 33 18 18
16 16
27 27 9 9 11 11
7 3 7
0 30 01 01 10 21 0 0 2 0
2 2 2 12 1
0 0 0 0
c p p c pc cpp c cp p c c p p c c p p c cp p c p c p
neg . pos . 10 32 10
100 32
320 100
1.000 320
3.200 1,000 3,200 neg. pos. 1:10 1:32 1:100 1:320 1:1,000 1:3,200
Qualitative Quantitative Qualitative Titer
dominant pattern (titer) -1
positive: cANCA positive: anti-GBM
Test substrate: Test substrate: Test substrate: Test substrate: Antigen spots PLA2R-trans- THSD7A-trans-
Ethanol-fixed HEp-2/ethanol-fixed Formalin-fixed Kidney
granulocytes granulocytes granulocytes
PR3 BIOCHIP GBM fected cells fected cells
Dilution 1:10 Dilution 1:10
QV 1200-160419 Sample 1 positive: anti-PR3 QV 1250-161011 Sample 1 positive: anti-GBM
Test method: ANCA Profile EUROLINE (EUROIMMUN) Test method: ANCA/-GBM Profile EUROLINE (EUROIMMUN)
12 13
Antibodies in autoimmune liver diseases Autoantibodies in pernicious anaemia
Shipment: March and September Shipment: April and October
Numbers of samples: 2 Number of samples: 2
AMA, ASMA, F-actin, gp210, LC-1, LKM-1, M2, nuclear dots,
Evaluated parameters: Evaluated parameters: Intrinsic factor, parietal cells (PCA)
nuclear membrane, SLA/LP, Sp100
Sample volume: 200 µl Sample volume: 200 µl
QV 1300-0202 (1 set of specimen) QV 1360-0202 (1 set of specimen)
Order no: Ordner no:
QV 1300-0204-1 (2 sets of specimen) QV 1360-0204-1 (2 sets of specimen)
Evaluation: The test systems are evaluated individually. A certificate is only Evaluation: The test systems are evaluated individually. A certificate is only
awarded upon correct analysis of both samples. awarded upon correct analysis of both samples.
Further available figures to complement the QA report (examples) Further available figures to complement the QA report (examples)
QA rep ort QA rep ort
100
100 100 within target range 50 50 within target range
100
100 100 8787 87
outside target range outside target range
Number of participants
Number of participants
40 40
8080 80 no target range
no target range
30 30 29 29
6060 60
4141 41 20 20
4040 40
2828 28
2020 20 10 10
10 10
2020 20
6 6 6 5 5
3 3 3 4 4 4 2 2 1 3 3
1 1 1 2 2 2 1 1 1 1 1 1 1 1
0 0 0 0 0
pos neg AMA ASMA cellular nuclear 100 320 1,000 3,200 10,000 neg. bdl. pos. 1:10 1:32 1:100 1:320 1:1,000
membrane dots
Qualitative Pattern Quantitative Qualitative Titer
dominant pattern (titer) -1
positive: AMA positive: anti-PCA, anti-intrinsic factor
Antigen spots Test substrate: Test substrate:
HEp-2 cells Liver Kidney pos: Anti-M2 Stomach (monkey) Intrinsic factor BIOCHIP
Dilution 1:100
QV 1300-140325 Sample 1
positive: anti-gp210, anti-M2-3E, anti-M2
Test method: Liver Profile EUROLINE (EUROIMMUN)
Dilution 1:10
14 15
Autoantibodies against structural proteins of the skin Antibodies against CCP
Shipment: April and October Shipment: April and October
Numbers of samples: 2 Number of samples: 2
BP180, BP230, collagen type VII, desmoglein 1, desmoglein 3,
Evaluated parameters: Evaluated parameter: CCP
desmosomes, epidermal basement membrane
Sample volume: 200 µl Sample volume: 200 µl
QV 1501-0202 (1 set of specimen) QV 1505-0202 (1 set of specimen)
Order no: Qrder no:
QV 1501-0204-1 (2 sets of specimen) QV 1505-0204-1 (2 sets of specimen)
Evaluation: The test systems are evaluated individually. A certificate is only Evaluation: The test systems are evaluated individually. A certificate is only
awarded upon correct analysis of both samples. awarded upon correct analysis of both samples. Only test systems
that detect antibodies against CCP will be accepted.
Further available figures to complement the QA report (examples)
QA rep ort
inside target range
QA report without further figures
50 50 47 47
QA rep ort
outside target range
40 40
D desmosomes
Number of particpants
EBM epidermal basement membrane
30 30
20 20
15 15
10 10 11 11
10 10
4 4
1 1 1 1 1 1 2 2
0 0 0 0 0 00 0
0 0
D D EBM
EBM D EBM
D EBMD EBM
D EBMD EBM
D EBMD EBM
D EBM D EBM
D EBM
neg. pos. 10 10 32 32 100100 320320 1.000
1,000
Qualitative Quantitative
dominant pattern (titer) -1
positive: anti-desmosomes, anti-Dsg 1, anti-Dsg 3
Oesophagus Anti-Dsg 1 Anti-Dsg 3
Dilution 1:10 Dilution 1:100 Dilution 1:10 Dilution 1:10
16 17
Autoantibodies against cell nuclei Antibodies in autoimmune myopathies
Shipment: March and September Shipment: March and September
Number of samples: 2 Number of samples: 2
Cell nuclei, centromeres, CENP A, CENP B, dsDNA, nucleosomes, cN-1A, EJ, Jo-1, Ku, Mi-2, Mi-2α, Mi-2, OJ, PL-7, PL-12, PM-Scl,
Evaluated parameters: Evaluated parameters:
ribosomal P-protein, RNP, RNP / Sm, Scl-70, Sm, SS-A, SS-B SRP
Sample volume: 400 µl Sample volume: 200 µl
Order no: QV 1510-0204 (1 set of specimen) QV 1530-0202 (1 set of specimen)
Order no:
QV 1530-0204-1 (2 sets of specimen)
Evaluation: If immunofluorescence is used, only borderline and positive sam-
ples in the immunofluorescence must be confirmed by monospe- Evaluation: The test systems are evaluated individually. A certificate is only
cific test systems to obtain a certificate. awarded upon correct analysis of both samples.
Further available figures to complement the QA report (examples) Further available figures to complement the QA report (examples)
QA rep ort 508 508 QA rep ort
500 500 500
463 within target range
Number of participants
400 400 400 outside target range
no target range
300 300 300
210 210
200 200 200
140 140
100 100 100 100
49 49
34 23 34
1 7 13 6
1 7
0 0 0
pos neg 100
granular 320nucleolar
1.000 3.200
homo- 10.000
cytoplasm nuclear 100 320 1,000 3,200 10,000
genous granular dots
Qualitative granul nucleolar homogen
Pattern
Zytoplasma granul nuclear dot
Quantitative
dominant pattern (titer) -1
positive: ANA (pattern: granular / nucleolar) QV 1530-170319 Sample 1 positive: anti-Jo-1, anti-Ro-52
Test method: Myositis Profile 3 EUROLINE (EUROIMMUN)
Antigen spots Antigen spots
HEp-2 cells Liver pos: SS-A; pos: SS-B;
neg: nRNP/Sm, Sm neg: Scl-70, Jo-1
QV 1530-170319 Sample 2 positive: anti-Ku
Test method: Myositis Profile 3 EUROLINE (EUROIMMUN)
Dilution 1:100
QV 1510-130319 Sample 1
positive: anti-SS-B, anti-SS-A, anti-Ro-52
Test method: ANA Profile 5 EUROLINE (EUROIMMUN)
18 19Antibodies against tissue transglutaminase (tTG),
Autoantibodies against phospholipids
endomysium and gliadin
Shipment: April and October Shipment: April and October
Number of samples: 2 Number of samples: 2
Evaluated parameters: Cardiolipin (IgG, IgM, IgAGM); 2-glycoprotein (IgG, IgM, IgAGM) Evaluated parameters: Tissue transglutaminase (tTG), endomysium, gliadin (IgA, IgG)
Sample volume: 150 µl Sample volume: 200 µl
QV 1632-0201 (1 set of specimen) QV 1913-0202 (1 set of specimen)
Order no: Order no:
QV 1632-0203-1 (2 sets of specimen) QV 1913-0204-1 (2 sets of specimen)
Evaluation: The test systems are evaluated individually. A certificate is only Evaluation: Certificates will only be awarded to participants who use a test
awarded upon correct analysis of both samples. 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
QA report without further figures EMA (IgG), or an IgG test system based on deamidated gliadin.
QA rep ort Test systems using native gliadin will not be certified.
Further available figures to complement the QA report (examples)
QA rep ort
200 200
within target range
Number of participants
150 150 outside target range
115 115 no target range
100 100
50 50
20 20
6 6 12 1217 11 17 11
1 1 2 1 2 1
0 0
neg bdl. pos 1:10 1:32 1:100 1:320 1:1,000 1:3,200
Qualitative Titer
positive: anti-endomysium (IgA), anti-gliadin (IgA, IgG)
Test substrate: Test substrate: Test substrate: Test substrate:
Liver Intestine Oesophagus Gliadin (deamidated)
IgA
positive positive
IgG
negative positive
Dilution 1:10
20 21Antibodies against Borrelia burgdorferi sensu lato Antibodies against hepatitis E virus
Shipment: March and September Shipment: March and September
Number of samples: 2 Number of samples: 2
Evaluated parameters: Borrelia (IgG, IgM), serological complete diagnosis Evaluated parameter: Hepatitis E virus (IgG, IgM, IgAGM)
Sample volume: 250 µl Sample volume: 200 µl
QV 2132-0202 (1 set of specimen) QV 2525-0202 (1 set of specimen)
Order no: Order no:
QV 2132-0205-1 (2 sets of specimen) QV 2525-0204-1 (2 sets of specimen)
Evaluation: If a screening test is used, only borderline and positive samples Evaluation: The test systems are evaluated individually. A certificate is only
need to be retested with a confirmatory test to obtain a certificate. awarded upon correct analysis of both samples.
Further available figures to complement the QA report (examples) QA report without further figures
QA rep ort QA rep ort
QV 2132-130319 Sample 2 Test method: EUROLINE-WB (IgG) negative
QV 2132-130319 Sample 2 Test method: EUROLINE-WB (IgM) positive
QV 2132-130319 Sample 2 Test method: EUROLINE-RN-AT (IgG) negative
QV 2132-130319 Sample 2 Test method: EUROLINE-RN-AT (IgM) positive
22 23Antibodies against herpes simplex virus Antibodies against parvovirus B19
Shipment: March and September Shipment: March and September
Number of samples: 2 Number of samples: 2
Evaluated parameters: HSV-1, HSV-2, HSV-1 / 2 (IgG, IgM) Evaluated parameter: Parvovirus (IgG, IgM)
Sample volume: 200 µl Sample volume: 200 µl
QV 2531-0202 (1 set of specimen) QV 2580-0202 (1 set of specimen)
Order no: Order no:
QV 2531-0204-1 (2 sets of specimen) QV 2580-0204-1 (2 sets of specimen)
Evaluation: The test systems are evaluated individually. A certificate is only Evaluation: The test systems are evaluated individually. A certificate is only
awarded upon correct analysis of both samples. awarded upon correct analysis of both samples.
Further available figures to complement the QA report (examples) Further available figures to complement the QA report (examples)
QA rep ort QA rep ort
QV 2531-130319 Sample 2 Test method: EUROLINE-WB (IgG) positive: anti-HSV-1 QV 2580-130319 Sample 2 Test method: EUROLINE (IgG) positive
QV 2531-130319 Sample 2 Test method: EUROLINE-WB (IgM) negative
QV 2580-130319 Sample 2 Test method: EUROLINE (IgM) positive
24 25Antibodies against Epstein-Barr virus Antibodies against chikungunya virus
Shipment: March and September Shipment: March
Number of samples: 2 Number of samples: 2
EBV-CA (IgG, IgM), EBNA-1(IgG), avidity, serological complete Evaluated parameters: Chikungunya virus (IgG, IgM)
Evaluated parameters:
diagnosis
Sample volume: 200 µl Sample volume: 300 µl
QV 2790-0202 (1 set of specimen) QV 293a-0203 (1 set of specimen)
Order no: Order no:
QV 2790-0204-1 (2 sets of specimen) QV 293a-0206-1 (2 sets of specimen)
Evaluation: The test systems are evaluated individually. A certificate is only Evaluation: The test systems are evaluated individually. A certificate is only
awarded upon correct analysis of both samples. awarded upon correct analysis of both samples.
Further available figures to complement the QA report (examples)
QA rep ort
QA rep ort Further available figures to complement the QA report (examples)
positive: anti-EBV-CA (IgG), anti-EBNA (IgG); high avidity
EBV-CA (IgG) EBV-CA (IgG) EBV-CA (IgM) EBNA (IgG)
treated with urea
positive:anti-chikungunya virus (IgG, IgM)
IgG IgM
Dilution 1:10
QV 2580-130319 Sample 2
positive: anti-EBV-CA, anti-EBNA-1
Test method: EUROLINE EBV Profile 2 (IgG)
Dilution 1:10
QV 2580-130319 Sample 2
positive: anti-EBV-EA, anti-EBV-CA
Test method: EUROLINE EBV Profile 2 (IgM)
26 27Antibodies against dengue virus Antibodies against Zika virus
Shipment: March Shipment: March
Number of samples: 2 Number of samples: 2
Dengue virus (IgG, IgM)
Evaluated parameters: Evaluated parameters: Zika virus (IgG, IgM, IgA, IgAM)
Dengue virus NS1 antigen
Sample volume: 300 µl Sample volume: 300 µl
QV 266a-0203 (1 set of specimen) QV 2668-0203 (1 set of specimen)
Order no: Order no:
QV 266a-0206-1 (2 sets of specimen) QV 2668-0206-1 (2 sets of specimen)
Evaluation: The test systems are evaluated individually. A certificate is only Evaluation: The test systems are evaluated individually. A certificate is only
awarded upon correct analysis of both samples. awarded upon correct analysis of both samples.
QA rep ort Further available figures to complement the QA report (examples) QA rep ort Further available figures to complement the QA report (examples)
positive: anti-dengue virus (IgG) positive: anti-Zika virus (IgG, IgM)
IgG IgM IgG IgM
Dilution 1:10 Dilution 1:10
28 29Allergology: Total IgE Allergology: Specific IgE
Shipment: March and September Shipment: March and September
Number of samples: 2 Number of samples: 2
Evaluated parameters: Total IgE Evaluated parameters: Specific IgE
Sample volume: 500 µl Sample volume: 1000 µl
QV 3840-0205 (1 set of specimen) Order no: QV 3000-0210 (1 set of specimen)
Order no:
QV 3840-0210-1 (2 sets of specimen)
Evaluation: The test systems are evaluated individually. A certificate is only
Evaluation: The test systems are evaluated individually. A certificate is only awarded upon correct analysis of both samples.
awarded upon correct analysis of both samples.
QA rep ort
Further available figures to complement the QA report (examples)
QA report without further figures Quality Assessment Report QV 3000-150922, II/2015
"Allergology": Evaluation of your results
QA rep ort
Participants: Represented by:
Test systems employed at your lab (class IgE): Sample 3 (Number of participants)
EUROIMMUN 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30
Allercoat 6 system (EAST class [0-6]) 0
ELISA
EAST class(0-6)
1
Intended result 2
Parameter (EAST class [0-6]) Your Result 3 **
4
Sample 2 w1 (common ragweed) 0-1 0 kU/l:Terms and conditions for participation 3. Quality assessment samples Homogeneity schemes, the participant agrees to the terms
and information on the QA schemes Quality assessment schemes take place twice Quality assurance samples are fluid and and conditions of the IfQ in its relevant
a year, each time with two samples. “Real” are mixed before and during filling to valid version, to be found in the quality
clinically characterised samples are used ensure homogeneity. The homogeneity of assessment portal. Registration for the
The Institute for Quality Assurance Lübeck
preferably. These are obtained in collaboration the samples is determined during process quality assessment schemes can also be
(hereinafter IfQ-Lübeck) organises quality
with doctors or sample donors. The origin validation of the filling process. made via subscription. With registration via
assessment schemes for laboratory external
of each sample is known. The samples can subscription, the participants are registered
quality control. Participation is only possible
be serum or plasma. Methods used by the Safety warnings for all future quality assessment schemes
under the following conditions.
participants must therefore be validated for Neither HBsAg, nor antibodies against HCV, offered by the IfQ until further notice. The
both serum and plasma. HIV-1 or HIV-2 were detected in the quality participants can cancel the participation in the
1. Purpose of the quality assessment service
assessment samples using CE-registered or respective quality assessment scheme until
The quality assessment service is designed
Determination of expected results FDA-approved test systems. Nevertheless, the end of the registration period or cancel
to evaluate the performance capabilities
Expected results for quality assessment samples should be handled as carefully as the subscription by this date. Revocation
of participating laboratories, based on
samples are determined before delivery of infectious material. and cancellation can be done via e-mail.
performed laboratory tests in comparison
the samples in cooperation with competent The conditions of participation apply in their
to reference values and results from other
external laboratories. A list of the reference 4. Registration of participants relevant valid version. If the conditions of
participating laboratories. It provides an
laboratories is available on the quality Any interested laboratory that routinely participation change, the participants are
objective aid for assessing and determining
assessment portal. For each quality carries out the respective laboratory analyses expressly informed about the change on the
the reliability of data obtained and for
assessment scheme at least one reference can take part in the quality assessment, website (“Infobox: Changes in the conditions
recognising problems. Based on the results,
laboratory is commissioned which is including those who are not customers of of participation”). Changed conditions of
participating laboratories should introduce
accredited for performance of the respective EUROIMMUN. participation are published at the latest two
corrective measures, if necessary, to
analysis according to the corresponding weeks before the end of the registration
improve the quality of their services. Quality
laboratory norm (e.g. DIN EN ISO 15189, Participants are required to register on the period on the website and communicated
assessment schemes are held regularly in
DIN EN ISO/IEC 17025, DIN EN ISO 15195). internet at www.ifq-portal.de. The quality via e-mail. An isolated revocation is not
order to give the participating laboratories
The samples are measured and assessed by assessment service portal allows participants possible. The revocation always applies to
the chance to monitor their performance
the appropriate reference laboratories. The to register for the different quality assessment the participation in the quality assessment
capabilities continuously. Participation in the
qualitative result of the reference laboratories schemes and later enter their results online. scheme.
quality assessment schemes should establish
is taken as the expected result. The e-mail address provided by the participant
additional confidence for customers of
is used to provide effective communication Despite careful planning it may happen that
participating laboratories.
Stability/preservation between the IfQ-Lübeck and the participants. the sample contingent is used up before
The quality assessment scheme samples are Participants have to ensure availability via the end of the registration phase. There is
Quality assessment schemes are not aimed
preserved, usually with sodium azide (< 1%). this e-mail address. Participants are required no entitlement to the number of samples
at evaluating the products (test systems)
In individual cases, also other preservatives to notify the IfQ-Lübeck via the portal of any being extended. Early registration ensures
used and should not be drawn on to assess
may be used. Avoid contact with the skin. changes in their personal details (e.g. e-mail participation.
the performance of the products.
Occasionally the used preservatives can or delivery address) and to keep their details
interfere with certain test methods. To exclude up to date. If the provided address is incorrect, After the end of the registration period, the
The use of the quality assessment samples,
such interference, consult the instructions in participants are not entitled to a new delivery quality assessment samples are sent by the
certificates, participations certificates, reports
the test system used. or refund. IfQ-Lübeck at the date announced in the
and other information provided by the IfQ is
portal. If samples are lost or damaged and
only permitted within the framework of this
Every quality assurance sample undergoes 5. Registration for quality assessment the IfQ-Lübeck is informed straightaway,
intended use.
a stability check. In this check, transport schemes, signing up for subscription, and replacements will be sent if possible.
and storage of the samples are simulated in procedure, revocation and termination However, participants are not entitled to
2. Costs
stress tests. The stability check establishes Registration, entering of results and replacements. If a new delivery results in
The participation fees for the quality
that the sample is stable at the given storage issuing of reports take place online via lateness or delayed service, there is no
assessment schemes are to be taken from
temperature for the duration of the quality the quality assessment portal. There, the entitlement to the participant’s results being
the relevant valid price list (for Switzerland,
assessment round (generally 4 weeks). dates for every quality assessment scheme taken into account in the evaluation of the
please refer to the responsible EUROIMMUN
are announced. Participants can apply to quality assessment round. The participants
subsidiary for information on the costs).
the quality assessment schemes during commit to handle and store the quality
Participants bear the costs for their reagents,
the registration period. The registered assessment samples in the same way as
time expenditure, etc.
participants are informed on the start and routine samples and measure them in their
end dates of the inscription phase via e-mail. own laboratory. Participants must state their
By registering to the quality assessment method(s) used (routine method) together
32 33with the results. Results obtained under (e.g. images from immunofluorescence tests, In the total evaluation, the following 9. Miscellaneous
routine conditions must be entered online blot strips). Participants receive a message information is given for each test that was Further information about the quality assess-
in the portal by the respective deadline. No when the evaluation is available. used by participants in the quality assessment ment service can be found in the quality
additional determinations or further methods Qualitative evaluation is crucial for the scheme. assessment portal.
that are not used for routine samples may granting of a certificate. If the qualitative
be used to obtain results. It is not permitted results of the participant for all samples is • Number of participants The IfQ-Lübeck reserves the right to exclude
to enter test results which are consolidated in agreement with the expected values, the • Number of correct results (pass rate) a laboratory if it repeatedly does not return
from different methods. quality assessment scheme has been passed results or if a participant has falsified data or
and a certificate will be issued. The certificates and participation con- has made secret consultations or has tried
If a test procedure consists of a screening firmations of the IfQ-Lübeck are sent to to. This also applies to attempts to influence
test followed by a confirmatory test, both Particularities of individual quality assess- the participants via mail to the address employees of the IfQ-Lübeck.
methods must be entered during registration ment schemes are to be found in detail in provided. The complete quality assessment
on the portal, and results for the two methods the respective information in the quality scheme reports are provided in the quality The IfQ reserves the right to introduce
must be given separately. If the confirmatory assessment portal. If a quality assessment assessment portal. Certificates, confirmations participant fees and to change individual
test is performed by an external laboratory scheme is not passed, the participant of participation and reports may be used quality assessment schemes with regard to
this should be indicated. The certificate is only receives a participation confirmation instead within the framework of the intended used of their scope or to discontinue them completely.
valid for tests performed by the participating of a certificate. the quality assessment schemes as described
laboratory; externally performed tests are above. Misuse or tampering, or alteration For further issues the general terms and con-
therefore marked in the certificate. The result evaluation for each participant through manipulation of the documents, or
contains a comparison of the participant’s by relating them with other documents is not ditions of EUROIMMUN AG apply.
Falsification and secret communication results with the expected results. For further allowed.
between participating laboratories contradict information, the following statistical figures Please address any questions about the
the goal of external quality control and are are also given, based on all participants of 7. Queries individual quality assessment schemes or the
therefore not permitted. the respective scheme using the same test Complaints about the quality assessment quality assessment service to the IfQ-Lübeck
system. carried out by the IfQ-Lübeck should be sent
by e-mail (ifq@euroimmun.de) or telephone
It is recommended that participants double- in written form to the institute within 4 weeks
check that their results are entered correctly • Median of results* of receiving the quality assessment report. (+49 451 29288 233).
in the portal. Participants should also file a • 68 % result range* After this deadline complaints can no longer
printout of their entry with their documen- • Number of participants be considered.
tation. Errors in data entry can be corrected • Number of correct results (pass
up until the deadline for entering the results. rate) If it should happen that a quality assessment
After the deadline no changes may be made *
if at least 6 participants gave a scheme becomes invalid through a mistake
to the entered results. In cases of necessity, quantitative result by the IfQ-Lübeck, an additional scheme will
for example faulty internet connection, results be offered free of charge (with the same
can be submitted to the IfQ-Lübeck in writing The median is the middle value of all conditions for participation). Further claims
(e. g. e-mail, fax). These will be entered into measurement values when sorted by size, so on the IfQ-Lübeck are excluded.
the portal by the quality assurance team, as that half of the values lie under the median
long as the deadline is met. If results are not and half over. If the number of measurement 8. Declaration of confidentiality and data
entered or transmitted within the time limit, values is even, the arithmetic mean of the protection
no evaluation can be made. In this case, the two middle values is taken as the median. The IfQ-Lübeck treats all participant data as
costs are not refunded. confidential. Merely the data required for
The median rather than the arithmetic mean invoicing are passed on to the responsible
6. Evaluation, quality assurance report and is used as a statistical parameter to reduce departments. In the quality assessment
issuing of certificates the influence of extreme values. Outlier tests portal, the anonymised results of each quality
The IfQ-Lübeck evaluates the data promptly are not performed. assessment scheme are made accessible to
and places the evaluation online on the the participants. The IfQ assures that the data
quality assessment portal. This includes the The 68 % result range gives the distribution entrusted to them will be handled according
results of every participant (only available range of quantitative results, within which to the data protection regulations. The
for the corresponding participant), a the measurement values of 68% of the corresponding privacy policy of the IfQ can
statistical total evaluation with anonymous participants lie. be found at: www.ifq-portal.de – Contact / site
and summarised results of all participating notice / data protection.
laboratories, and further helpful information
34 35Time schedule 2020 Time schedule 2020
Autoimmunity Infectious serology
Dates QAS Dates QAS Dates QAS Dates QAS
Scheme Format Scheme Format
2020/I 2020/II 2020/I 2020/II
Autoantibodies against cell nuclei Antibodies against Borrelia burgdorferi
1 set of specimen 2 x 250 µl
Cell nuclei, centromeres, CENP A, CENP B, sensu lato
1 set of specimen 2 x 400 µl 2 sets of specimen 2x 500 µl
dsDNA, nucleosomes, ribosomal P-protein, RNP, Registration Registration (IgG, IgM), serological complete diagnosis
RNP / Sm, Scl-70, Sm, SS-A, SS-B until: until: Registration Registration
November 30, June 30, Antibodies against hepatitis E virus 1 set of specimen 2 x 200 µl until: until:
2019 2020 (IgG, IgM, IgAGM) 2 sets of specimen 2 x 400 µl November 30, June 30,
Antibodies in autoimmune 2019 2020
myopathies 1 set of specimen 2 x 200 µl Shipment: Shipment:
cN-1A, EJ, Jo-1, Ku, Mi-2, Mi-2α, Mi-2, OJ, PL-7, 2 sets of specimen 2 x 400 µl March 17, September 15, Antibodies against herpes simplex virus
1 set of specimen 2 x 200 µl Shipment: Shipment:
PL-12, PM-Scl, SRP 2020 2020 HSV-1, HSV-2, HSV-1/2
2 sets of specimen 2x 400 µl March 17, September 15,
(IgG, IgM)
2020 2020
Deadline: Deadline:
Antibodies in autoimmune liver diseases April 14, October 13, Antibodies against parvovirus B19 1 set of specimen 2x 200 µl Deadline: Deadline:
1 set of specimen 2 x 200 µl 2020 2020
AMA, ASMA, F-actin, gp210, LC-1, LKM-1, M2, (IgG, IgM) 2 sets of specimen 2 x 400 µl April 14, October 13,
2 sets of specimen 2 x 400 µl
nuclear dots, nuclear membrane, SLA/LP, Sp100 2020 2020
Antibodies against Epstein-Barr virus
1 set of specimen 2 x 200 µl
EBV-CA (IgG, IgM), EBNA-1 (IgG),
2 sets of specimen 2 x 400 µl
avidity, serological complete diagnosis
Autoantibodies against thyroid gland 1 set of specimen 2 x 300 µl
TG, TPO, TRAb 2 sets of specimen 2 x 600 µl Registration
Antibodies against chikungunya virus 1 set of specimen 2 x 300 µl until:
(IgG, IgM) 2 sets of specimen 2 x 600 µl November 30,
Autoantibodies against neuronal 2019
antigens Antibodies against dengue virus
1 set of specimen 2 x 200 µl 1 set of specimen 2 x 300 µl Shipment:
Amphiphysin, aquaporin 4, CASPR2, CV2, GAD, (IgG, IgM) No shipping
2 sets of specimen 2 x 400 µl 2 sets of specimen 2 x 600 µl March 17,
Hu, LGI1, Ma/Ta, MOG, NMDA receptor, Dengue virus NS1 antigen
recoverin, Ri, SOX1, titin, Yo, ZIC4 2020
Antibodies against Zika virus 1 set of specimen 2 x 300 µl Deadline:
(IgG, IgM, IgA, IgAM) 2 sets of specimen 2 x 600 µl April 14,
Autoantibodies against granulocytes 1 set of specimen 2 x 200 µl
2020
ANCA, MPO, PR3 2 sets of specimen 2 x 400 µl
Registration Registration
Autoantibodies against structural proteins of
until: until:
the skin
1 set of specimen 2 x 200 µl November 30, June 30, Allergology
BP180, BP230, collagen type VII, desmoglein
2 sets of specimen 2 x 400 µl 2019 2020
1 and 3, desmosomes, epidermal basement
membrane
Shipment: Shipment: Dates QAS Dates QAS
Scheme Format
April 21, October 13, 2020/I 2020/II
2020 2020
1 set of specimen 2 x 200 µl
Antibodies against CCP Registration Registration
2 sets of specimen 2 x 400 µl Deadline: Deadline: Allergology 1 set of specimen 2 x 500 µl until: until:
May 19, November 10, Total IgE 2 sets of specimen 2 x 1000 µl November 30, June 30,
2020 2020 2019 2020
Autoantibodies against phospholipids
1 set of specimen 2 x 150 µl Shipment: Shipment:
Cardiolipin (IgG, IgM, IgAGM);
2 sets of specimen 2 x 300 µl March 17, September 15,
2-glycoprotein (IgG, IgM, IgAGM) Allergology 2020 2020
1 set of specimen 2 x 1000 µl
Specific IgE
Antibodies against tissue transglutaminase, Deadline: Deadline:
1 set of specimen 2 x 200 µl April 14, October 13,
endomysium and gliadin
2 sets of specimen 2 x 400 µl 2020 2020
(IgA, IgG)
Antibodies in autoimmune kidney diseases 1 set of specimen 2 x 200 µl Please ask your local distributor for prices.
GBM, PLA2R, THSD7A 2 sets of specimen 2 x 400 µl
Autoantibodies in pernicious anaemia 1 set of specimen 2 x 200 µl
Intrinsic factor, parietal cells 2 sets of specimen 2 x 400 µl
36 37Notes Notes 38 39
Institut für
IfQ-Lübeck Qualitätssicherung
Lübeck
IfQ-Lübeck
Institut für Qualitätssicherung Lübeck
Seekamp 31, 23560 Lübeck, Germany
Tel: +49 451 29288 233
Fax: +49 451 5855 591
E-mail: ifq@euroimmun.de
www.ifq-portal.de
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