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b=9
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 335 page 1
HIV-1 / HIV-2 (335) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20633140 S. 1 RV=1221
Screening and other tests
10. Combined tests for the detection of anti-HIV-1/anti-HIV-2
Manufacturer Name of test kit andcatalog-no of test kit lot-no
state nameof automator "manually"
10. Combined tests for the detectionof anti-HIV-1/anti-HIV-2
Results: reactive (2) negative (2) borderline (2) s / co Index for multiple analysis please statemethod-no.
-
-
-
Sample 335029
Sample 335030
Sample 335031
Sample 335032
10 ELISA - Anti - HIV-1/2 (1)
21 ELISA - Anti - HIV-1/2 + p24 AG (1)
30 MEIA - Anti - HIV-1/2 / IMx (1a)
31 MEIA - Anti - HIV-1/2 + p24 AG / IMx (1a)
32 MEIA - Anti - HIV-1/2 / AxSYM (1a)
33 MEIA - Anti - HIV-1/2 + p24 AG / AxSYM (1a)
40 ELFA - Anti - HIV-1/2 (1d)
41 ELFA - Anti - HIV-1/2 + p24 AG (1d)
50 ChLIA - Anti - HIV-1/2 (1c)
51 ChLIA - Anti - HIV-1/2 + p24 AG (1c)
52 ECLIA - Anti - HIV-1/2 (1e)
53 ECLIA - Anti - HIV-1/2 + p24 AG (1e)
54 CMIA - Anti - HIV-1/2 (1p)
55 CMIA - Anti - HIV-1/2 + p24 AG (1p)
70 Part.aggl.test - Anti-HIV-1/2
80 Rapid test anti-HIV-1/2
81 Rapid test anti-HIV-1/2 +p24 Ag
90 other Anti-HIV-1/2-tests
(1) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA Chemiluminescence immunoassay(1d) ELFA = Enzyme-linked fluorescence assay (1e) ECLIA = Electrochemiluminescence assay(1p) CMIA = Chemiluminescence microparticle immunoassay (2) Mark with (x)P
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INSTAND EQASVirus immunology
March 2012 Lfd. 1group 335 page 2
HIV-1 / HIV-2 (335) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625076 S. 2 RV=1221
Confirmation tests
Manufacturer Name of test kit andcatalog-no of test kit lot-no
state nameof automator "manually"
Results: (please report complete results for all of the 4 samples)
100 Westernblot Anti-HIV-1/2
120 Imm. fluor. test Anti-HIV-1/2
140 Strip-IA Anti-HIV-1/2 (1f)
160 Line-IA Anti-HIV-1/2 (1m)
180 other tests Anti-HIV-1/2
41. Combined tests for the detection of anti-HIV-1
detected proteins in kD
HIV - 1 *
gp p positive(2)
negative(2)
indet.(2)
notdone
for multiple methodsplease state method-no
Sample 335029
Sample 335030
Sample 335031
Sample 335032
* Please state only those proteins giving evidence for the interpretation "positive for HIV-1" according to the manufacturer’s instruction.
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Manufacturer Name of test kit andcatalog-no of test kit lot-no
state nameof automator "manually"
Results: (please report complete results for all of the 4 samples)
100 Westernblot Anti-HIV-1/2
120 Imm. fluor. test Anti-HIV-1/2
140 Strip-IA Anti-HIV-1/2 (1f)
160 Line-IA Anti-HIV-1/2 (1m)
180 other tests Anti-HIV-1/2
42. Combined tests for the detection of anti-HIV-2
detected proteins in kD
HIV - 2 **
gp ppositive
(2)negative
(2)indet.
(2)not
donefor multiple methods
please state method-no
** Please state only those proteins giving evidence for the interpretation "positive for HIV-2" according to the manufacturer’s instruction.
Sample 335029
Sample 335030
Sample 335031
Sample 335032
(1f ) Strip IA = Strip Immunoblot assay (1m) Line IA = Line immunoassay (2) Mark with (x)Ple
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b=3249
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 335 page 3
HIV-1 / HIV-2 (335) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625076 S. 3 RV=1221
Confirmation tests50. Tests for the detection of anti-HIV-1
Manufacturer Name of test kit andcatalog-no of test kit lot-no
state nameof automator "manually"
100 Westernblot Anti-HIV-1
120 Imm. fluor. test Anti-HIV-1
140 Strip-IA Anti-HIV-1 (1f)
160 Line-IA Anti-HIV-1 (1m)
180 other tests Anti-HIV-1
Results: (please report complete results for all of the 4 samples)
detected proteins in kD
HIV - 1
gp p positive(2)
negative(2)
indet.(2)
notdone
for multiple methodsplease state method-no
Sample 335029
Sample 335030
Sample 335031
Sample 335032
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Results: (please report complete results for all of the 4 samples)
60. Tests for the detection of anti-HIV-2
Manufacturer Name of test kit andcatalog-no of test kit lot-no
state nameof automator "manually"
100 Westernblot Anti-HIV-2
120 Imm. fluor. test Anti-HIV-2
140 Strip-IA Anti-HIV-2 (1f)
160 Line-IA Anti-HIV-2 (1m)
180 other tests Anti-HIV-2
detected proteins in kD
HIV - 2
gp p positive(2)
negative(2)
indet.(2)
notdone
for multiple methodsplease state method-no
Sample 335029
Sample 335030
Sample 335031
Sample 335032
(1f ) Strip IA = Strip Immunoblot assay (1m) Line IA = Line immunoassay (2) Mark with (x)
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Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
b=6569
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 337 page 1
HIV-1 p24 antigen (337) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625076 S. 5 RV=1221
10. Testing for HIV-1 p24 Ag (qualitative and quantitative)
Manufacturerof test kit
Name of test kit andcatalog-no of test kit Lot-No.
state nameof automat
or "manually"
10 ELISA - p24 Ag (1)
21 ELISA Anti-HIV1/2 + p24 Ag
11 MEIA - p24 Ag / IMx (1a)
12 MEIA Anti-HIV1/2 + p24 Ag / IMx (1a)
13 MEIA - p24 Ag / AxSYM (1a)
14 MEIA Anti-HIV1/2 + p24 Ag / AxSYM (1a)
30 ELFA - p24 Ag (1d)
31 ELFA Anti-HIV 1/2 + p24 Ag
40 ECLIA - p24 Ag (1e)
41 ECLIA Anti-HIV1/2+p24 Ag (1e)
50 CMIA - p24 Ag (1p)
51 CMIA Anti-HIV1/2+p24 Ag (1p)
52 ChLIA - p24 Ag (1c)
53 ChLIA Anti-HIV1/2+p24 Ag (1c)
99 other p24 Ag - tests
(please list)
Results:
positive (2) negative (2) borderline (2)
pg/ml interpret your results aspositive, negative or borderline.
pg/ml = picogr./ml s / co Index for multiple analysisplease state method-no
Sample 337015
Sample 337016
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(1) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA = Chemiluminescence immunoassay(1d) ELFA = Enzyme-linked fluorescence assay (1e) ECLIA = Electrochemiluminescence(1p) CMIA = Chemiluminescence microparticle immunoassay (2) Mark with (x) Test = test kit reference, Lab = laboratory internal reference, other please list.
Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
b=119
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 343 page 1
Hepatitis A (343) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625148 S. 7 RV=1221
Manufacturerof testkit
Name of test kit andcatalog-no. of test kit Lot-No.
state nameof automat
or "manually"
9 ELISA - Anti - HAV-IgG (1)
10 ELISA - Anti - HAV total (1)
11 MEIA - Anti - HAV-IgG / IMx (1a)
12 MEIA - Anti - HAV total/ IMx (1a)
13 MEIA - Anti - HAV-IgG /AxSYM(1a)
14 MEIA - Anti - HAV-total/AxSYM(1a)
20 ChLIA - Anti - HAV-IgG (1c)
21 ChLIA - Anti - HAV total (1c)
30 ELFA - Anti - HAV-IgG (1d)
31 ELFA - Anti - HAV total (1d)
32 ECLIA - Anti - HAV-IgG (1e)
33 ECLIA - Anti - HAV total (1e)
34 CMIA - Anti - HAV-IgG (1p)
35 CMIA - Anti - HAV total (1p)
98 other Anti - HAV-IgG tests
99 other Anti - HAV total tests
Results:positive (2) negative (2) borderline (2) mIU/ml s / co Index
for multiple analysis please statemethod-no
Sample 343029
Sample 343030
10. Qualitative testing for anti-HAV-IgG or anti-HAV total
(1) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA = Chemiluminescence Immunassay (1d) ELFA = Enzyme-linked fluorescence assay (1e) ECLIA = Electrochemiluminescence(1p) CMIA = Chemiluminescence microparticle immunoassay (2) Mark with (x)
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b=139
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 343 page 2
Hepatitis A (343) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 8 RV=1221
Manufacturerof testkit
Name of test kit andcatalog-no. of test kit Lot-No.
state nameof automat
or "manually"
10 ELISA - Anti - HAV - IgM (1)
11 MEIA - Anti - HAV - IgM / IMx (1a)
12 MEIA - Anti - HAV - IgM / AxSYM (1a)
20 ChLIA - Anti - HAV - IgM (1c)
30 ELFA - Anti - HAV - IgM (1d)
33 ECLIA - Anti - HAV -IgM (1e)
34 CMIA - Anti - HAV -IgM (1p)
99 other Anti - HAV - IgM - tests
Results:
positive (2) negative (2) borderline (2) s / co Index for multiple analysisplease state method-no
Sample 343031
Sample 343032
20. Qualitative testing for anti - HAV - IgM
(1) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA = Chemiluminescence Immunassay (1d) ELFA = Enzyme-linked fluorescence assay (1e) ECLIA = Electrochemiluminescence(1p) CMIA = Chemiluminescence microparticle immunoassay (2) Mark with (x)
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Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
b=159
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 344 page 1
Hepatitis B I (344) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 9 RV=1221
10. Testing for HBsAg (qualitative and quantitative)
Manufacturerof testkit
Name of test kit andcatalog-no. of test kit Lot-No.
state nameof automat
or "manually"
10 ELISA - HBsAg (1)
11 MEIA - HBsAg / IMx (1a)
12 MEIA - HBsAg / AxSYM (1a)
21 CMIA - HBsAg (1p)
30 ChLIA - HBsAg (1c)
31 ECLIA - HBsAg (1e)
33 ELFA - HBsAg (1d)
99 other HBsAg tests
(please list)
Results:
reactive (2) negative (2) borderline (2) IU/ml(intern. Units / ml) s / co Index for multiple analysis
please state method-no
Sample 344085
Sample 344086
Sample 344087
Sample 344088
(1) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA = Chemiluminescence Immunassay (1d) ELFA = Enzyme-linked fluorescence assay(1e) ECLIA = Electrochemiluminescence (1p) CMIA = Chemiluminescence microparticle-immunoassay (2) Mark with (x)P
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b=141
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 344 page 2
Hepatitis B I (344) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 10 RV=1221
Manufacturerof testkit
Name of test kit andcatalog-no. of test kit Lot-No.
state nameof automat
or "manually"
10 ELISA - HBsAg (1)
11 MEIA - HBsAg / IMx (1a)
12 MEIA - HBsAg / AxSYM (1a)
21 CMIA - HBsAg (1p)
30 ChLIA - HBsAg (1c)
31 ECLIA - HBsAg (1e)
33 ELFA - HBsAg (1d)
99 other HBsAg tests
(please list)
positive (2) negative (2) borderline (2) s / co Index not done (2)
Sample 344085
Sample 344086
Sample 344087
Sample 344088
Final results:
15. Confirmation tests for HBsAg
Please note for the final result for a corresponding sample:
A sample "reactive" or "borderline" in your routine test under "10. qualitative testing for HBsAg"should be analyzed in a confirmation test for HBsAg.Please state your final result for a corresponding sample under "15. Confirmation tests for HBsAg".In case you do not report a result of a confirmation test, your result reported under"10. qualitative testing for HBsAg" will be considered as the final result for your certificate.Samples which are HBsAg-negative in the primary screening testshould not be analyzed by confirmation tests. In this case state as your final result "not done"under "15. Confirmation tests for HBsAg".
(1) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA = Chemiluminescence Immunassay (1d) ELFA = Enzyme-linked fluorescence assay(1e) ECLIA = Electrochemiluminescence (1p) CMIA = Chemiluminescence microparticle-immunoassay (2) Mark with (x)P
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INSTAND EQASVirus immunology
March 2012 Lfd. 1group 344 page 3
Hepatitis B I (344) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625148 S. 11 RV=1221
Manufacturerof testkit
Name of test kit andcatalog-no. of test kit Lot-No.
state nameof automat
or "manually"
appliedanti-HBs
standard (4)
10 ELISA - Anti - HBs (1)
11 MEIA - Anti - HBs / IMx (1a)
12 MEIA - Anti - HBs / AxSYM (1a)
21 CMIA - Anti - HBs (1p)
30 ChLIA - Anti - HBs (1c)
31 ECLIA - Anti - HBs (1e)
33 ELFA - Anti - HBs (1d)
99 other Anti - HBs - tests
(please list)
Results: please report quantitative (IU/l) AND qualitative results for all of the 4 samples. Also for negativesamples. Please note: quantitative results with ’>’ for positive samples are not accepted.
IU/l(intern. Unit / l) positive (2) negative (2) for multiple analysis
please state method-no
Sample 344089
Sample 344090
Sample 344091
Sample 344092
20. Testing for anti-HBs (qualitative and quantitative)
(1) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA = Chemiluminescence Immunassay (1d) ELFA = Enzyme-linked fluorescence assay(1e) ECLIA = Electrochemiluminescence (1p) CMIA = Chemiluminescence microparticle-immunoassay (2) Mark with (x)(4) List applied Anti-HBs standards: PEI = Paul-Ehrlich-Institut, WHO = World Health Org., test = test kit reference, lab = laboratory internal reference; other please list. (5) ECLIA = Electrochemiluminescence (6) ELFA = Enzyme-linked fluorescence assay
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INSTAND EQASVirus immunology
March 2012 Lfd. 1group 344 page 4
Hepatitis B I (344) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 12 RV=1221
Manufacturerof testkit
Name of test kit andcatalog-no. of test kit Lot-No.
state nameof automat
or "manually"
10 ELISA - Anti - HBc (1)
11 MEIA - Anti - HBc / IMx (1a)
12 MEIA - Anti - HBc / AxSYM (1a)
21 CMIA - Anti - HBc (1p)
30 ChLIA - Anti - HBc (1c)
31 ECLIA - Anti - HBc (1e)
33 ELFA - Anti - HBc (1d)
99 other Anti - HBc - tests
Results:
positive (2) negative (2) borderline (2) s / co Index for multiple analysisplease state method-no
Sample 344093
Sample 344094
Sample 344095
Sample 344096
30. Qualitative testing for anti-HBc
(1) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA = Chemiluminescence Immunassay (1d) ELFA = Enzyme-linked fluorescence assay(1e) ECLIA = Electrochemiluminescence (1p) CMIA = Chemiluminescence microparticle-immunoassay (2) Mark with (x)
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Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
b=189
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 345 page 1
Hepatitis B II (345) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 13 RV=1221
Manufacturerof testkit
Name of test kit andcatalog-no. of test kit Lot-No.
state nameof automat
or "manually"
10 ELISA - Anti - HBc - IgM (1)
11 MEIA-Anti-HBc-IgM / IMx (1a)
12 MEIA-Anti-HBc-IgM / AxSYM (1a)
30 ECLIA - Anti - HBc - IgM (1e)
31 ChLIA - Anti - HBc - IgM (1c)
33 ELFA - Anti - HBc - IgM (1d)
34 CMIA - Anti - HBc - IgM (1p)
99 other Anti - HBc - IgM - tests
Results:
positive (2) negative (2) borderline (2) s / co Index for multiple analysisplease state method-no
Sample 345043
Sample 345044
20. Qualitative testing for anti-HBc-IgM
(1) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA = Chemiluminescence immunoassay (1d) ELFA = Enzyme-linked fluorescence assay(1e) ECLIA = Electrochemiluminescence assay (1p) CMIA = Chemiluminescence microparticle immunoassay (2) Mark with (x)
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INSTAND EQASVirus immunology
March 2012 Lfd. 1group 345 page 2
Hepatitis B II (345) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 14 RV=1221
Manufacturerof testkit
Name of test kit andcatalog-no. of test kit Lot-No.
state nameof automat
or "manually"
10 ELISA - HBeAg (1)
11 MEIA - HBeAg / IMx (1a)
12 MEIA - HBeAg / AxSYM (1a)
30 ECLIA - HBeAg (1e)
31 ChLIA - HBeAg (1c)
33 ELFA - HBeAg (1d)
34 CMIA - HBeAg (1p)
99 other HBeAg - tests
Results:
positive (2) negative (2) borderline (2) s / co Index for multiple analysisplease state method-no
Sample 345045
Sample 345046
30. Qualitative testing for HBeAg
(1) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA = Chemiluminescence immunoassay (1d) ELFA = Enzyme-linked fluorescence assay(1e) ECLIA = Electrochemiluminescence assay (1p) CMIA = Chemiluminescence microparticle immunoassay (2) Mark with (x)
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b=209
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 345 page 3
Hepatitis B II (345) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 15 RV=1221
Manufacturerof testkit
Name of test kit andcatalog-no. of test kit Lot-No.
state nameof automat
or "manually"
10 ELISA - Anti - HBe (1)
11 MEIA - Anti - HBe / IMx (1a)
12 MEIA - Anti - HBe / AxSYM (1a)
30 ECLIA - Anti - HBe (1e)
31 ChLIA - Anti - HBe (1c)
33 ELFA - Anti - HBe (1d)
34 CMIA - Anti - HBe (1p)
99 other Anti - HBe - tests
Results:
positive (2) negative (2) borderline (2) s / co Index for multiple analysisplease state method-no
Sample 345047
Sample 345048
40. Qualitative testing for anti-HBe
(1) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA = Chemiluminescence immunoassay (1d) ELFA = Enzyme-linked fluorescence assay(1e) ECLIA = Electrochemiluminescence assay (1p) CMIA = Chemiluminescence microparticle immunoassay (2) Mark with (x)
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Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
b=219
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 346 page 1
Hepatitis C (346) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625148 S. 17 RV=1221
Manufacturerof testkit
Name of test kit andcatalog-no. of test kit Lot-No.
please statename of automat
or "manually"
10 ELISA - Anti-HCV (1)
11 ELISA - Anti-HCV + HCV Ag (1)
15 MEIA - Anti-HCV / IMx (1a)
16 MEIA - Anti-HCV + HCV Ag / IMx (1a)
20 MEIA - Anti-HCV / AxSYM (1a)
21 MEIA - Anti-HCV + HCV Ag / AxSYM (1a)
30 ChLIA - Anti-HCV (1c)
31 ChLIA - Anti-HCV + HCV Ag (1c)
50 ECLIA - Anti-HCV (1e)
51 ECLIA - Anti-HCV + HCV Ag (1e)
60 CMIA - Anti-HCV (1p)
61 CMIA - Anti-HCV + HCV Ag (1p)
98 other Anti-HCV tests
99 other Anti-HCV+HCV AG tests
(please list)
Results:
reactive (2) negative (2) borderline(2) (3)
s / co Index for multiple analysisplease state method-no
Sample 346029
Sample 346030
Sample 346031
Sample 346032
10. Screening tests for the detection of anti-HCV and combined detection of anti-HCV and HCV antigen
(1) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA = Chemiluminescence Immunassay(1e) ECLIA = Electrochemiluminescence assay (1f) Strip IA = Strip/Streifen Immunoblot assay(1g) Dot IA = in vitro dot immunoassay (1o) Line IA = Line immunoassay (1p) CMIA = Chemiluminescence microparticle immunoassay (2) Mark with (x) (3) or ’no diagnostic statement possible’
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INSTAND EQASVirus immunology
March 2012 Lfd. 1group 346 page 2
Hepatitis C (346) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 18 RV=1221
Manufacturerof testkit
Name of test kit andcatalog-no. of test kit Lot-No.
please statename of automat
or "manually"
10 ELISA - HCV Ag (1)
11 MEIA - HCV Ag / IMx (1a)
12 MEIA - HCV Ag / AxSYM (1a)
30 ChLIA - HCV Ag (1c)
31 ECLIA - HCV Ag (1e)
33 CMIA - HCV Ag (1p)
99 other HCV Ag test
(please list)
Results:
reactive (2) negative (2) borderline(2) (3)
s / co Index for multiple analysisplease state method-no
Sample 346029
Sample 346030
Sample 346031
Sample 346032
15. Tests for the isolated detection of HCV antigen
(1) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA = Chemiluminescence Immunassay(1e) ECLIA = Electrochemiluminescence assay (1f) Strip IA = Strip/Streifen Immunoblot assay(1g) Dot IA = in vitro dot immunoassay (1o) Line IA = Line immunoassay (1p) CMIA = Chemiluminescence microparticle immunoassay (2) Mark with (x) (3) or ’no diagnostic statement possible’
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b=2319
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 346 page 3
Hepatitis C (346) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 19 RV=1221
manufacturerof testkit
name of test kit andcatalog-no. of test kit Lot-No.
please statename of automat
or "manually"
10 Strip IA-Anti-HCV (1f)
20 Dot IA-Anti-HCV (1g)
21 Line IA-Anti-HCV (1o)
30 Western Blot
99 other Anti-HCV-Best.tests
(please list)
Results: (please report complete results for all of the 4 samples)
positive (2) negative (2) indeterm. (2) (3)
notdone
detected proteins(if determined)
for multiple analysisplease state method-no
Sample 346029
Sample 346030
Sample 346031
Sample 346032
20. Complementary tests for the detection of anti-HCV
(1) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA = Chemiluminescence Immunassay(1e) ECLIA = Electrochemiluminescence assay (1f) Strip IA = Strip/Streifen Immunoblot assay(1g) Dot IA = in vitro dot immunoassay (1o) Line IA = Line immunoassay (1p) CMIA = Chemiluminescence microparticle immunoassay (2) Mark with (x) (3) or ’no diagnostic statement possible’
Ple
ase
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Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
b=21000
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 350 page 1
Dengue viruses (350) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 21 RV=1221
Manufacturerof testkit
Name of test kit andcatalog-no. of test kit Lot-No.
please statename of automat
or "manually"
10 ELISA - Anti-Dengue-IgG (1)
20 IFT - Anti-Dengue-IgG (1h)
30 Blot - Anti-Dengue-IgG
40 Rapid test - Anti-Dengue-IgG *
99 other - Anti-Dengue-IgG test
* Please state ONLY THE RESULTS FOR ANTI-DENGUE-IgG in case you apply a test for simultaneous detection of anti-dengue-IgG and anti-dengue-IgM.
Results:positive
(2)negative
(2)border-
line(2)
Titer U/ml s / co index for multiple analysisplease state method-no
Sample 350013
Sample 350014
Sample 350015
Sample 350016
10. Testing for anti-Dengue-IgG
(1 ) ELISA = EIA = Enzyme immunoassay (1h) IFT = Immunfluorescencetest (2) Mark with (x)
Ple
ase
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pro
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b=21020
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 350 page 2
Dengue viruses (350) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 22 RV=1221
Manufacturerof testkit
Name of test kit andcatalog-no. of test kit Lot-No.
Rheumatoid fact.absorption( yes / no )
please statename of automat
or "manually"
10 ELISA - Anti-Dengue-IgM (1)
20 IFT - Anti-Dengue-IgM (1h)
30 Blot - Anti-Dengue-IgM
40 Rapid test - Anti-Dengue-IgM **
99 other - Anti-Dengue-IgM test
** Please state ONLY THE RESULTS FOR ANTI-DENGUE-IgM in case you apply a test for simultaneous detection of anti-dengue-IgG and anti-dengue-IgM.
Results:positive
(2)negative
(2)border-
line(2)
Titer U/ml s / co index for multiple analysisplease state method-no
Sample 350013
Sample 350014
Sample 350015
Sample 350016
20. Testing for anti-Dengue-IgM
(1 ) ELISA = EIA = Enzyme immunoassay (1h) IFT = Immunfluorescencetest (2) Mark with (x)
Ple
ase
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f yo
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pro
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ts.
b=21040
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 350 page 3
Dengue viruses (350) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625148 S. 23 RV=1221
Manufacturerof testkit
Name of test kit andcatalog-no. of test kit Lot-No.
please statename of automat
or "manually"
10 ELISA - Dengue-NS1 Ag
40 Rapid test - Dengue-NS1 Ag
99 other Dengue-NS1 Ag test
Results:positive
(2)negative
(2)border-
line(2)
Titer U/ml s / co index for multiple analysisplease state method-no
Sample 350013
Sample 350014
Sample 350015
Sample 350016
30. Testing for Dengue-NS1 antigen
(1 ) ELISA = EIA = Enzyme immunoassay (1h) IFT = Immunfluorescencetest (2) Mark with (x)
Ple
ase
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pro
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b=21060
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 350 page 4
Dengue viruses (350) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 24 RV=1221
acute infection
NS1-Ag pos.anti-Dengue-IgG neg.anti-Dengue-IgM neg.
or
NS1-Ag posanti-Dengue-IgG neg.anti-Dengue-IgM pos.
or
NS1-Ag pos.anti-Dengue-IgG pos.anti-Dengue-IgM pos.
recent infection
NS1-Ag neg.anti-Dengue-IgG pos.anti-Dengue-IgM pos.
past infection
NS1-Ag neg.anti-Dengue-IgG pos.anti-Dengue-IgM neg.
negative statusof infection
NS1-Ag neg.anti-Dengue-IgG neg.anti-Dengue-IgM neg.
remarks
Sample 350013
Sample 350014
Sample 350015
Sample 350016
199. Summary of the results of the confirmation tests
Ple
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Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
b=319
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 351 page 1
Cytomegalovirus (351) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 25 RV=1221
(Cytomegalovirus specific IgG or total antibodies = IgG+IgM)
Manufacturerof testkit
Name of test kitcatalog-no.
of test kitLot-No.
state nameof automat
or "manually"
10 ELISA - Anti-CMV-IgG (1)
11 ELISA - Anti-CMV total (1)
12 MEIA - Anti-CMV-IgG IMx (1a)
13 MEIA - Anti-CMV-IgG AxSYM (1a)
30 IFT - Anti-CMV-IgG (1h)
31 IFT - Anti-CMV total (1h)
32 CMIA - Anti-CMV-IgG (1p)
33 ELFA - Anti-CMV-IgG (1d)
34 ChLIA - Anti-CMV-IgG (1c)
35 ECLIA - Anti-CMV-IgG (1e)
40 Complement fixation test
50 Western Blot
51 Line IA - Anti-CMV-IgG (1o)
98 other tests for Anti-CMV-IgG
99 other Anti-CMV-total tests
Results: posi-tive(2)
nega-tive(2)
border-line(2)
If you report titers or International Units per ml pleaseinterpret as "positive", "negative" or "borderline".
Titer U/ml s / co index for multiple analysisplease state method-no
Sample 351015
Sample 351016
10. Testing for anti-CMV-IgG or anti-CMV total
(1 ) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA = Chemiluminescence Immunassay (1d) ELFA = Enzyme-linked fluorescence assay (1e) ECLIA = Electrochemiluminescence(1h) IFT = Immunfluorescencetest (1o) Line IA = Line immunoassay (1p) CMIA = Chemiluminescence microparticle-Immunassay(2 ) Mark with (x)
Ple
ase
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pro
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ts.
b=30019
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 351 page 2
Cytomegalovirus (351) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 26 RV=1221
(Cytomegalovirus specific IgG antibodies)
Manufacturerof testkit
Name of test kitand catalog-no. of test kit Lot-No.
state nameof automat
or "manually"
please check resp. insert, correctmethod, e.g. ELISA, MEIA, IFT,etc (see previous page)
. .
Results:high(2)
low(2)
inter-med.(2)
noavidity
(2)
notdone(2)
Per-cent others
report the detected proteinsWITHOUT reagent when
applying western / immunoblot
report the detected proteinsWITH reagent when
applying western / immunoblot
Sample 351015
Sample 351016
11. Testing for avidity of anti-CMV-IgG
(2) Mark with (x)
Ple
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b=339
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 351 page 3
Cytomegalovirus (351) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 27 RV=1221
( Cytomegalovirus specific IgM antibodies )
Manufacturerof testkit
Name of test kitcatalog-no.
of test kitLot-No.
Rheumatoid fact.absorption( yes / no )
state nameof automat
or "manually"
10 ELISA - Anti-CMV-IgM (1)
11 MEIA - Anti-CMV-IgM IMx (1a)
12 MEIA - Anti-CMV-IgM AxSYM (1a)
30 IFT - Anti-CMV-IgM (1h)
32 CMIA - Anti-CMV-IgM (1p)
33 ELFA - Anti-CMV-IgM (1d)
34 ChLIA - Anti-CMV-IgM (1c)
35 ECLIA - Anti-CMV-IgM (1e)
50 Western Blot
51 Line IA - Anti-CMV-IgM (1o)
99 other tests for Anti-CMV-IgM
Results: posi-tive(2)
nega-tive(2)
border-line(2)
If you report titers or International Units per ml pleaseinterpret as "positive", "negative" or "borderline".
Titer U/ml s / co index for multiple analysisplease state method-no
Sample 351015
Sample 351016
20. Testing for anti-CMV-IgM
(1 ) ELISA = EIA = Enzyme immunoassay (1a) MEIA = Microparticle EIA (1c) ChLIA = Chemiluminescence Immunassay (1d) ELFA = Enzyme-linked fluorescence assay (1e) ECLIA = Electrochemiluminescence(1h) IFT = Immunfluorescencetest (1o) Line IA = Line immunoassay (1p) CMIA = Chemiluminescence microparticle-Immunassay(2 ) Mark with (x)
Ple
ase
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op
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f yo
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pro
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l sh
ee
ts.
Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
b=20000
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 355 page 1
Hantaviruses (355) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625148 S. 29 RV=1221
----- Please consider the anamnestic information (see manual) ----10. ELISA for detection of anti-hantavirus-IgG
Detection with Manufacturer of test kit Trade name Lot-No.
10 ELISA anti-Dobrava-IgG
20 ELISA anti-Hantaan-IgG
30 ELISA anti-Puumala-IgG
50 ELISA anti-Seoul-IgG
60 ELISA anti-Sin Nombre-IgG
80 ELISA anti-Hanta-IgG (without diff. of serotype)
98 other specificity please insert
Results: If you report titer / units please interpret as "positive", "negative" or "borderline"
positive negative borderline titer U/ml s / co index for multiple analysisplease state method-no
Sample 355013
Sample 355014
Sample 355015
Sample 355016
Ple
ase
ke
ep
a c
op
y o
f yo
ur
pro
toco
l sh
ee
ts.
20. ELISA for the detection of anti-hantavirus-IgM
Detection with Manufacturer of test kit Trade name Lot-No.
10 ELISA anti-Dobrava-IgM
20 ELISA anti-Hantaan-IgM
30 ELISA anti-Puumala-IgM
50 ELISA anti-Seoul-IgM
60 ELISA anti-Sin Nombre-IgM
80 ELISA anti-Hanta-IgM (without diff. of serotype)
98 other specificity please insert
Results: If you report titer / units please interpret as "positive", "negative" or "borderline"
positive negative borderline titer U/ml s / co index for multiple analysisplease state method-no
Sample 355013
Sample 355014
Sample 355015
Sample 355016
Ple
ase
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ep
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f yo
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pro
toco
l sh
ee
ts.
b=20400
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 355 page 2
Hantaviruses (355) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 30 RV=1221
----- Please consider the anamnestic information (see manual) ----30. IFT for the detection of anti-hantavirus-IgG
Detection with Manufacturer of test kit Trade name Lot-No.
10 IFT anti-Dobrava-IgG
20 IFT anti-Hantaan-IgG
30 IFT anti-Puumala-IgG
40 IFT anti-Saaremaa-IgG
50 IFT anti-Seoul-IgG
60 IFT anti-Sin Nombre-IgG
80 IFT anti-Hanta-IgG (without diff. of serotype)
98 other specificity please insert
Results: If you report titer / units please interpret as "positive", "negative" or "borderline"
positive negative borderline titer U/ml s / co index for multiple analysisplease state method-no
Sample 355013
Sample 355014
Sample 355015
Sample 355016
Ple
ase
ke
ep
a c
op
y o
f yo
ur
pro
toco
l sh
ee
ts.
40. IFT for the detection of anti-hantavirus-IgM
Detection with Manufacturer of test kit Trade name Lot-No.
10 IFT anti-Dobrava-IgM
20 IFT anti-Hantaan-IgM
30 IFT anti-Puumala-IgM
40 IFT anti-Saaremaa-IgM
50 IFT anti-Seoul-IgM
60 IFT anti-Sin Nombre-IgM
80 IFT anti-Hanta-IgM (without diff. of serotype)
98 other specificity please insert
Results: If you report titer / units please interpret as "positive", "negative" or "borderline"
positive negative borderline titer U/ml s / co index for multiple analysisplease state method-no
Sample 355013
Sample 355014
Sample 355015
Sample 355016
Ple
ase
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a c
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f yo
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pro
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l sh
ee
ts.
b=20450
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 355 page 3
Hantaviruses (355) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 31 RV=1221
----- Please consider the anamnestic information (see manual) ----
45. IFT for the detection of anti-hantavirus-IgG/IgM (without differentiation of IgG and IgM)
Detection with Manufacturer of test kit Trade name Lot-No.
10 IFT anti-Dobrava-IgG/IgM
20 IFT anti-Hantaan-IgG/IgM
30 IFT anti-Puumala-IgG/IgM
40 IFT anti-Saaremaa-IgG/IgM
50 IFT anti-Seoul-IgG/IgM
60 IFT anti-Sin Nombre-IgG/IgM
80 IFT anti-Hanta-IgG/IgM (without diff. of serotype)
98 other specificity please insert
Results: If you report titer / units please interpret as "positive", "negative" or "borderline"
positive negative borderline titer U/ml s / co index for multiple analysisplease state method-no
Sample 355013
Sample 355014
Sample 355015
Sample 355016
Ple
ase
ke
ep
a c
op
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f yo
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pro
toco
l sh
ee
ts.
b=20600
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 355 page 4
Hantaviruses (355) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 32 RV=1221
----- Please consider the anamnestic information (see manual) ----50. Rapid test for the detection of anti-hantavirus-IgG
Detection with Manufacturer of test kit Trade name Lot-No.
10 Rapid test anti-Dobrava-IgG
20 Rapid test anti-Hantaan-IgG
30 Rapid test anti-Puumala-IgG
40 Rapid test anti-Saaremaa-IgG
50 Rapid test anti-Seoul-IgG
60 Rapid test anti-Sin Nombre-IgG
80 Rapid test anti-Hanta-IgG (without diff. of serotype)
98 other specificity please insert
Results: If you report titer / units please interpret as "positive", "negative" or "borderline"
positive negative borderline titer U/ml s / co index for multiple analysisplease state method-no
Sample 355013
Sample 355014
Sample 355015
Sample 355016
Ple
ase
ke
ep
a c
op
y o
f yo
ur
pro
toco
l sh
ee
ts.
60. Rapid test for the detection of anti-hantavirus-IgM
Detection with Manufacturer of test kit Trade name Lot-No.
10 Rapid test anti-Dobrava-IgM
20 Rapid test anti-Hantaan-IgM
30 Rapid test anti-Puumala-IgM
40 Rapid test anti-Saaremaa-IgM
50 Rapid test anti-Seoul-IgM
60 Rapid test anti-Sin Nombre-IgM
80 Rapid test anti-Hanta-IgM (without diff. of serotype)
98 other specificity please insert
Results: If you report titer / units please interpret as "positive", "negative" or "borderline"
positive negative borderline titer U/ml s / co index for multiple analysisplease state method-no
Sample 355013
Sample 355014
Sample 355015
Sample 355016
Ple
ase
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ep
a c
op
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f yo
ur
pro
toco
l sh
ee
ts.
b=20800
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 355 page 5
Hantaviruses (355) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625148 S. 33 RV=1221
----- Please consider the anamnestic information (see manual) ----70. Immunoblot for the detection of anti-hantavirus-IgG
Detection with Manufacturer of test kit Trade name Lot-No.
10 Immunoblot
Results:Detected antibodies against the corresponding hantavirus specific antigens (PLEASE REPORT THE BAND INTENSITY)
Puumala +Hantaan(Pu+Ha)
Puumala-Nucleocapsid-protein (PuN)
Hantaan-Nucleocapsid-protein (HaN)
Dobrava-Nucleocapsid-protein (DobN)
Seoul-Nucleocapsid-protein (SeoN)
other proteins
Sample 355013
Sample 355014
Sample 355015
Sample 355016
Ple
ase
ke
ep
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op
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f yo
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pro
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l sh
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ts.
80. Immunoblot for the detection of anti-hantavirus-IgM
Detection with Manufacturer of test kit Trade name Lot-No.
10 Immunoblot
Results:Detected antibodies against the corresponding hantavirus specific antigens (PLEASE REPORT THE BAND INTENSITY)
Puumala +Hantaan(Pu+Ha)
Puumala-Nucleocapsid-protein (PuN)
Hantaan-Nucleocapsid-protein (HaN)
Dobrava-Nucleocapsid-protein (DobN)
Seoul-Nucleocapsid-protein (SeoN)
other proteins
Sample 355013
Sample 355014
Sample 355015
Sample 355016
Ple
ase
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f yo
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l sh
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ts.
b=20950
INSTAND EQASVirus immunology
March 2012 Lfd. 1group 355 page 6
Hantaviruses (355) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 34 RV=1221
----- Please consider the anamnestic information (see manual) ----
Finalevaluation
acute past negativeCONSIDER THE ANAMNESTIC INFORMATION!REPORTING OF MORE THAN ONE SEROTYPE
WILL NOT BE ACCEPTED!
Sample 355013
Sample 355014
Sample 355015
Sample 355016
98. Status of hantavirus infection (without differentiation of serotype) STATEMENT REQUIRED FOR EVALUATION
99. Statement of serotype (when applying tests for differentiation of serotypes)
Ple
ase
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Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
b=6000
INSTAND EQASVirus genome detection
March 2012 Lfd. 1group 360 page 1
PCR-/ NAT - HIV-1 (360) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 35 RV=1221
10. Quantitative detection of HIV-1 (RNA)
manufacturergenome detection test
test name andcatalog no
genome detection test
Lot-nogenome detection test ultrasensitive
yes / no
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No: Sample preparation
Cycler
Primer
Detection method
Results:
Genome equivalents (copies/ml) orbelow detection level / negative
International units (IU/ml) orbelow detection level / negative
Ct- / Cp-value ** RemarksSample *
Sample 360029
Sample 360030
Sample 360031
Sample 360032
* Reconstitute each lyophilized plasma in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free)and allow reconstitution at room temp. for 20 min. Mix frequently.** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Attention !Quantitative values with > or >= will not be considered and evaluated as missing result.Quantitative values with < or <= should be interpreted: Please indicate, if(i) you interpret a given sample as "negative" or if the measured value(ii) is below detection level of the corresponding test, however, represents a low virus concentration.In this case please report this low value if possible.
Ple
ase
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ep
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f yo
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pro
toco
l sh
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ts.
b=6200
INSTAND EQASVirus genome detection
March 2012 Lfd. 1group 360 page 2
PCR-/ NAT - HIV-1 (360) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 36 RV=1221
20. Qualitative detection of HIV-1 (RNA)
manufacturergenome detection test
test name andcatalog no
genome detection test
Lot-nogenome detection test ultrasensitive
yes / no
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No: Sample preparation
Cycler
Primer
Detection method
Results:
positivebelow detection level /
negativeindeter-minate
Ct- / Cp-value ** RemarksSample *
Sample 360029
Sample 360030
Sample 360031
Sample 360032
* Reconstitute each lyophilized plasma in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free)and allow reconstitution at room temp. for 20 min. Mix frequently.** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Ple
ase
ke
ep
a c
op
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f yo
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pro
toco
l sh
ee
ts.
Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
b=6400
INSTAND EQASVirus genome detection
March 2012 Lfd. 1group 361 page 1
PCR-/ NAT - HBV (361) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 37 RV=1221
10. Quantitative detection of HBVmaufacturer of test
genome detection testname of testcatalog-no
genome detection test
Lot-nogenome detection test ultrasensitive
yes / no
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
30 Hybridization
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No: Sample preparation
Cycler
Primer
Detection method
Results:
Genome equivalents (copies/ml) orbelow detection level / negative
International units (IU/ml) orbelow detection level / negative
Ct-/Cp-value ** RemarksSample *
Sample 361029
Sample 361030
Sample 361031
Sample 361032
* Reconstitute each lyophilized plasma in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free)and allow reconstitution at room temp. for 20 min. Mix frequently.** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Attention !Quantitative values with > or >= will not be considered and evaluated as missing result.Quantitative values with < or <= should be interpreted: Please indicate, if(i) you interpret a given sample as "negative" or if the measured value(ii) is below detection level of the corresponding test, however, represents a low virus concentration.In this case please report this low value if possible.P
lea
se k
ee
p a
co
py
of
you
r p
roto
col
she
ets
.
b=6600
INSTAND EQASVirus genome detection
March 2012 Lfd. 1group 361 page 2
PCR-/ NAT - HBV (361) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625148 S. 38 RV=1221
20. Qualitative detection of HBV
maufacturer of testgenome detection test
name of testcatalog-no
genome detection test
Lot-nogenome detection test ultrasensitive
yes / no
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
30 Hybridization
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No: Sample preparation
Cycler
Primer
Detection method
Results:positive below detection level /
negativeindeter-minate
Ct-/Cp-value ** RemarksSample *
Sample 361029
Sample 361030
Sample 361031
Sample 361032
* Reconstitute each lyophilized plasma in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free)and allow reconstitution at room temp. for 20 min. Mix frequently.** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
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Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
b=7000
INSTAND EQASVirus genome detection
March 2012 Lfd. 1group 362 page 1
PCR-/ NAT - HCV (362) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 39 RV=1221
10. Quantitative detection of HCVmanufacturer of test
genome detection testname of test and
catalog-nogenome detection test
Lot-nogenome detection test ultrasensitive
yes / no
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No: Sample preparation
Cycler
Primer
Detection method
Results:
Genome equivalents (copies/ml) orbelow detection level / negative
International units (IU/ml) orbelow detection level / negative
Ct-/Cp-value ** RemarksSample *
Sample 362029
Sample 362030
Sample 362031
Sample 362032
* Reconstitute each lyophilized plasma in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free) and allow reconstitution at room temp. for 20 min. Mix frequently.** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Attention !Quantitative values with > or >= will not be considered and evaluated as missing result.Quantitative values with < or <= should be interpreted: Please indicate, if(i) you interpret a given sample as "negative" or if the measured value(ii) is below detection level of the corresponding test, however, represents a low virus concentration.In this case please report this low value if possible.P
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b=7100
INSTAND EQASVirus genome detection
March 2012 Lfd. 1group 362 page 2
PCR-/ NAT - HCV (362) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 40 RV=1221
20. Qualitative detection of HCV
manufacturer of testgenome detection test
name of test andcatalog-no
genome detection test
Lot-nogenome detection test ultrasensitive
yes / no
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No: Sample preparation
Cycler
Primer
Detection method
Results:
positivebelow detection level /
negative indeter-minate
Ct-/Cp-value ** RemarksSample *
Sample 362029
Sample 362030
Sample 362031
Sample 362032
* Reconstitute each lyophilized plasma in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free) and allow reconstitution at room temp. for 20 min. Mix frequently.** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
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Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
b=8510
INSTAND EQASVirus genome detection
March 2012 Lfd. 1group 365 page 1
PCR-/ NAT - CMV (365) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 41 RV=1221
manufacturer of testgenome detection test
name of test andcatalog-no
genome detection test
lot-nogenome detection test
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
30 Hybridization
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
Manufacturer: Lot-No: Sample preparation
Cycler
Primer
Detection method
Results:Genome equivalents (copies/ml) or
below detection level / negativeInternational units (IU/ml) or
below detection level / negativeCt-/Cp-value ** RemarksSample *
Sample 365029
Sample 365030
Sample 365031
Sample 365032
* Reconstitute each lyophilized cell lysate in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free) and allow reconstitution at room temp. for 20 min. Mix frequently.** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
10. Quantitative detection of CMV ( Cytomegalovirus )
Attention !Quantitative values with > or >= will not be considered and evaluated as missing result.Quantitative values with < or <= should be interpreted: Please indicate, if(i) you interpret a given sample as "negative" or if the measured value(ii) is below detection level of the corresponding test, however, represents a low virus concentration.In this case please report this low value if possible.P
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of
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b=8600
INSTAND EQASVirus genome detection
March 2012 Lfd. 1group 365 page 2
PCR-/ NAT - CMV (365) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 42 RV=1221
20. Qualitative detection of CMV ( Cytomegalovirus )
manufacturer of testgenome detection test
name of test andcatalog-no
genome detection test
lot-nogenome detection test
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
30 Hybridization
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
Manufacturer: Lot-No: Sample preparation
Cycler
Primer
Detection method
Results:
positive below detection level /negative
indeter-minate
Ct-/Cp-value ** RemarksSample *
Sample 365029
Sample 365030
Sample 365031
Sample 365032
* Reconstitute each lyophilized cell lysate in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free) and allow reconstitution at room temp. for 20 min. Mix frequently.** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Ple
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Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
b=10350
INSTAND EQASVirus genome detection
March 2012 Lfd. 1group 367 page 1
PCR-/ NAT - Parvovirus B19 (367) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625148 S. 43 RV=1221
10. Quantitative detection of Parvovirus B19 (DNA)test manufacturer
genome detection testtest name and
catalog-no.genome detection test
lot-nogenome detection test
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No:Sample preparation
Cycler
Primer
Detection method
Results:Genome equivalents (copies/ml) or
below detection level / negativeInternational units (IU/ml) or
below detection level / negativeCt-/Cp-value ** RemarksSample *
Sample 367029
Sample 367030
Sample 367031
Sample 367032
* Reconstitute each lyophilized plasma in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free) and allow reconstitution at room temp. for 20 min. Mix frequently.
** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Attention !Quantitative values with > or >= will not be considered and evaluated as missing result.Quantitative values with < or <= should be interpreted: Please indicate, if(i) you interpret a given sample as "negative" or if the measured value(ii) is below detection level of the corresponding test, however, represents a low virus concentration.In this case please report this low value if possible.
Ple
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b=10390
INSTAND EQASVirus genome detection
March 2012 Lfd. 1group 367 page 2
PCR-/ NAT - Parvovirus B19 (367) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 44 RV=1221
20. Qualitative detection of Parvovirus B19 (DNA)
test manufacturergenome detection test
test name andcatalog-no.
genome detection test
lot-nogenome detection test
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No:Sample preparation
Cycler
Primer
Detection method
Results:
positive below detection level / negative
indeter-minate
Ct-/Cp-value ** RemarksSample *
Sample 367029
Sample 367030
Sample 367031
Sample 367032
* Reconstitute each lyophilized plasma in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free) and allow reconstitution at room temp. for 20 min. Mix frequently.** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Ple
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pro
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Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
b=9200
INSTAND EQASVirus detection, Genome/AG
March 2012 Lfd. 1group 370 page 1
PCR-/NAT and AG influenza A/B (370) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 45 RV=1221
Genome detection of influenza A and B viruses5. Quantitative genome detection of influenza A virus
Manufacturergenome detection test
Test name and catalog nogenome detection test
Lot-nogenome detection test
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No: Sample preparation
Cycler
Primer
Detection method
copies/ml or belowdetection level / negative Ct- / Cp-value ** Remarks
Results:
Sample *
Sample 370019
Sample 370020
Sample 370021
Sample 370022
Sample 370023
Sample 370024
* Reconstitute each lyophilized cell lysates or lyophilized allantoic fluid in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free, PCR-grade) and allow reconstitution at room temp. for 20 min. Mix frequently. Please see instructions.
** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Attention !Quantitative values with > or >= will not be considered and evaluated as missing result.Quantitative values with < or <= should be interpreted: Please indicate, if(i) you interpret a given sample as "negative" or if the measured value(ii) is below detection level of the corresponding test, however, represents a low virus concentration.In this case please report this low value if possible.
Please note! Report on this protocol page only results of screening-PCRs for the general detection of influenza A viruses.Please consider the subsequent protocols for results of tests differentiating between influenza A subtypes and influenzs B virus, resp.
Ple
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b=9150
INSTAND EQASVirus detection, Genome/AG
March 2012 Lfd. 1group 370 page 2
PCR-/NAT and AG influenza A/B (370) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 46 RV=1221
Genome detection of influenza A and B viruses10. Qualitative genome detection of influenza A virus
Manufacturergenome detection test
Test name and catalog nogenome detection test
Lot-nogenome detection test
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No: Sample preparation
Cycler
Primer
Detection method
Results:
positivebelow detectionlevel / negative indeterminate Ct- / Cp-value ** Remarks Sample *
Sample 370019
Sample 370020
Sample 370021
Sample 370022
Sample 370023
Sample 370024
* lyophilisierte Zellkulturmaterialien in !! 1.0 ml !! Aqua bidest. (steril, pyrogenfrei) aufnehmen. 20 min bei Raumtemperatur stehen lassen und mehrfach gut mixen. Weiteres s. Informationen zur Testdurchfuehrung.
** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Please note! Report on this protocol page only results of screening-PCRs for the general detection of influenza A viruses.Please consider the subsequent protocols for results of tests differentiating between influenza A subtypes and influenzs B virus, resp.
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b=9450
INSTAND EQASVirus detection, Genome/AG
March 2012 Lfd. 1group 370 page 3
PCR-/NAT and AG influenza A/B (370) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 47 RV=1221
Genome detection of influenza A and B viruses11. Subtyping of influenza A viruses
Manufacturergenome detection test
Test name and catalog nogenome detection test
Lot-nogenome detection test
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No.: Sample preparation
Cycler
Primer
Detection method
Results:
Influenza A virus subtypebelow detectionlevel / negative not done
Ct- / Cp-value **
Remarks Sample *
Sample 370019
Sample 370020
Sample 370021
Sample 370022
Sample 370023
Sample 370024
* Reconstitute each lyophilized cell lysates or lyophilized allantoic fluid in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free, PCR-grade) and allow reconstitution at room temp. for 20 min. Mix frequently. Please see instructions.
** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Please report on this protocol page the results when you analyzed each sample on subtypes of influenza A virus.Please state: - the detected influenza A subtype as ’Hx’ or ’HxNx’, ’below level of detection/negative’ or ’not done’.
- for the H1N1 subtype if you determined the influenza A(H1N1) pdm09 virus. - the applied subtype specific primer pairs and / or probes.
Please consider: - for the exclusive detection of avian influenza A(H5N1) virus with specific primers / probes: the results should be reported under category (12).
- for the exclusive detection of influenza A(H1N1) pdm09 virus with specific primers / probes: the results should be reported under category (13).
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b=9650
INSTAND EQASVirus detection, Genome/AG
March 2012 Lfd. 1group 370 page 4
PCR-/NAT and AG influenza A/B (370) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625148 S. 48 RV=1221
Genome detection of influenza A and B viruses12. Qualitative detection of avian influenza A(H5N1) virus with H5N1 or H5 specific primers / probes
Manufacturergenome detection test
Test name and catalog nogenome detection test
Lot-nogenome detection test
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No.: Sample preparation
Cycler
Primer
Detection method
Results:specification of H5 or H5N1of avian influenza A virus
below detectionlevel / negative not done
Ct- / Cp-value **
Remarks Sample *
Sample 370019
Sample 370020
Sample 370021
Sample 370022
Sample 370023
Sample 370024
* Reconstitute each lyophilized cell lysates or lyophilized allantoic fluid in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free, PCR-grade) and allow reconstitution at room temp. for 20 min. Mix frequently. Please see instructions.
** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Please state : - on this protocol page only results when you solely applied a test with primers / probes for the exclusive detection of avian influenza A(H5N1) virus - your result for avian influenza A virus ’H5’ or ’H5N1’, ’below level of detection/negative’ or ’not done’. - the applied subtype specific primer pairs and / or probes.
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b=9700
INSTAND EQASVirus detection, Genome/AG
March 2012 Lfd. 1group 370 page 5
PCR-/NAT and AG influenza A/B (370) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 49 RV=1221
Genome detection of influenza A and B viruses13. Qualitative detection of influenza A(H1N1) pdm09 virus with H1N1 or H1 specific primers / probes
Manufacturergenome detection test
Test name and catalog nogenome detection test
Lot-nogenome detection test
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No.: Sample preparation
Cycler
Primer
Detection method
Results:specification of H1 or H1N1
of influenza A virusbelow detectionlevel / negative not done
Ct- / Cp-value **
Remarks Sample *
Sample 370019
Sample 370020
Sample 370021
Sample 370022
Sample 370023
Sample 370024
* Reconstitute each lyophilized cell lysates or lyophilized allantoic fluid in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free, PCR-grade) and allow reconstitution at room temp. for 20 min. Mix frequently. Please see instructions.
** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Please state : - on this protocol page only results when you solely applied a test with primers / probes for the exclusive detection of influenza A(H1N1) pdm09 virus. - your result for influenza A(H1N1) pdm09 virus as ’H1 pdm09 virus’ or ’H1N1 pdm09 virus’ ,’below level of detection/negative’ or ’not done’.
- the applied subtype specific primer pairs and / or probes.
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b=9300
INSTAND EQASVirus detection, Genome/AG
March 2012 Lfd. 1group 370 page 6
PCR-/NAT and AG influenza A/B (370) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 50 RV=1221
Genome detection of influenza A and B viruses15. Quantitative genome detection of influenza B virus
Manufacturergenome detection test
Test name and catalog nogenome detection test
Lot-nogenome detection test
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No: Sample preparation
Cycler
Primer
Detection method
copies/ml or belowdetection level / negative Ct- / Cp-value ** Remarks
Results:
Sample *
Sample 370019
Sample 370020
Sample 370021
Sample 370022
Sample 370023
Sample 370024
* Reconstitute each lyophilized cell lysates or lyophilized allantoic fluid in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free, PCR-grade) and allow reconstitution at room temp. for 20 min. Mix frequently. Please see instructions.
** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Please report on this protocol page only results of PCRs for the detection of influenza B viruses.
Attention !Quantitative values with > or >= will not be considered and evaluated as missing result.Quantitative values with < or <= should be interpreted: Please indicate, if(i) you interpret a given sample as "negative" or if the measured value(ii) is below detection level of the corresponding test, however, represents a low virus concentration.In this case please report this low value if possible.
Ple
ase
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b=9250
INSTAND EQASVirus detection, Genome/AG
March 2012 Lfd. 1group 370 page 7
PCR-/NAT and AG influenza A/B (370) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 51 RV=1221
Genome detection of influenza A and B viruses20. Qualtitative genome detection of influenza B virus
Manufacturergenome detection test
Test name and catalog nogenome detection test
Lot-nogenome detection test
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No: Sample preparation
Cycler
Primer
Detection method
Results:
positivebelow detectionlevel / negative indeterminate Ct- / Cp-value ** Remarks Sample *
Sample 370019
Sample 370020
Sample 370021
Sample 370022
Sample 370023
Sample 370024
* Reconstitute each lyophilized cell lysates or lyophilized allantoic fluid in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free, PCR-grade) and allow reconstitution at room temp. for 20 min. Mix frequently. Please see instructions.
** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Please report on this protocol page only results of PCRs for the detection of influenza B viruses.
Ple
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b=9350
INSTAND EQASVirus detection, Genome/AG
March 2012 Lfd. 1group 370 page 8
PCR-/NAT and AG influenza A/B (370) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 52 RV=1221
Genome detection of influenza A and B viruses25. Qualitative genome detection of influenza viruses
without differentiation of influenza A and B viruses
Manufacturergenome detection test
Test name and catalog nogenome detection test
Lot-nogenome detection test
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No: Sample preparation
Cycler
Primer
Detection method
Results:
positive below detection level /negative
indeter-minate Ct- / Cp-value ** Remarks Sample *
Sample 370019
Sample 370020
Sample 370021
Sample 370022
Sample 370023
Sample 370024
* Reconstitute each lyophilized cell lysates or lyophilized allantoic fluid in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free, PCR-grade) and allow reconstitution at room temp. for 20 min. Mix frequently. Please see instructions.
** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Please report on this protocol page only results obtained by PCR for the general detection of influenza viruseswithout differentiation of influenza A and B viruses.The results should be reported as ’positive’, ’below level of detection/negative’ or ’indeterminate’.
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b=9400
INSTAND EQASVirus detection, Genome/AG
March 2012 Lfd. 1group 370 page 9
PCR-/NAT and AG influenza A/B (370) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625148 S. 53 RV=1221
Antigen detection of influenza A and B viruses
30. Antigen detection of influenza A virus
Manufacturerantigen detection test
Test name and catalog-no.antigen detection test
Lot-no.antigen detection test
10 ELISA
25 HIT
50 Rapid tests
99 other tests
if applicable:erythrocytes
HI = hemagglutination test
Results:
positive negative border-line Remarks Sample *
Sample 370019
Sample 370020
Sample 370021
Sample 370022
Sample 370023
Sample 370024
* Reconstitute each lyophilized cell lysates or lyophilized allantoic fluid in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free, PCR-grade) and allow reconstitution at room temp. for 20 min. Mix frequently. Please see instructions.
Please note: The samples are not suitable for virus propagation or antigen detection by immunofluorescence assays (IFA).The results should be reported as ’positive’, ’negative’ or ’borderline’.
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b=9500
INSTAND EQASVirus detection, Genome/AG
March 2012 Lfd. 1group 370 page 10
PCR-/NAT and AG influenza A/B (370) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 54 RV=1221
40. Antigen detection of influenza B virus
Manufacturerantigen detection test
Test name and catalog-no.antigen detection test
Lot-no.antigen detection test
10 ELISA
25 HIT
50 Rapid tests
99 other tests
if applicable:erythrocytes
HI = hemagglutination test
Results:
positive negative border-line Remarks Sample *
Sample 370019
Sample 370020
Sample 370021
Sample 370022
Sample 370023
Sample 370024
* Reconstitute each lyophilized cell lysates or lyophilized allantoic fluid in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free, PCR-grade) and allow reconstitution at room temp. for 20 min. Mix frequently. Please see instructions.
Antigen detection of influenza A and B viruses
Please note: The samples are not suitable for virus propagation or antigen detection by immunofluorescence assays (IFA).The results should be reported as ’positive’, ’negative’ or ’borderline’.
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Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
b=16000
INSTAND EQASVirus genome detection
March 2012 Lfd. 1group 377 page 1
PCR-/ NAT - HAV (377) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 55 RV=1221
10. Quantitative detection of HAV ( Hepatitis A virus )test manufacturer
genome detection testtest name and
catalog-no.genome detection test
lot-no.genome detection test
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No: Sample preparation
Cycler
Primer
Detection method
Results:Genome equivalents (copies/ml) or
below detection level / negativeInternational units (IU/ml) or
below detection level / negativeCt-/Cp-value ** RemarksSample *
Sample 377029
Sample 377030
Sample 377031
Sample 377032
* Reconstitute each lyophilized plasma in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free) and allow reconstitution at room temp. for 20 min. Mix frequently.
** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Attention !Quantitative values with > or >= will not be considered and evaluated as missing result.Quantitative values with < or <= should be interpreted: Please indicate, if(i) you interpret a given sample as "negative" or if the measured value(ii) is below detection level of the corresponding test, however, represents a low virus concentration.In this case please report this low value if possible.
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b=16100
INSTAND EQASVirus genome detection
March 2012 Lfd. 1group 377 page 2
PCR-/ NAT - HAV (377) Important state your participant no:
Cvir / Lprot 20.3.2012 8:33h DG_E.112(Tue Mar 20 08:40:22 2012 ) 20625124 S. 56 RV=1221
20. Qualitative detection of HAV ( Hepatitis A virus )
test manufacturergenome detection test
test name andcatalog-no.
genome detection test
lot-no.genome detection test
11 PCR
12 nested PCR
13 Taq Man
15 bDNA
20 NASBA
40 Light Cycler
50 LCR
60 TMA
70 Multiplex PCR
75 Multiplex Taq Man
98 other PCR
99 other tests
Manufacturer: Lot-No: Sample preparation
Cycler
Primer
Detection method
Results:
positivebelow detection level
/ negative indeterm. Ct-/Cp-value ** RemarksSample *
Sample 377029
Sample 377030
Sample 377031
Sample 377032
* Reconstitute each lyophilized plasma in *** 1.0 ml *** aqua bidest. (sterile, pyrogen-free) and allow reconstitution at room temp. for 20 min. Mix frequently.** Please report the Ct-value (cycle threshold) or Cp-value (crossing point) depending on your thermocycler in case you performed a Real-Time-PCR.
Ple
ase
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a c
op
y o
f yo
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pro
toco
l sh
ee
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Participating laboratory / Date / Signature / Stamp Deadline : 10.4.2012
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