instand eqas hiv-1 / hiv-2 (335) important …...a sample "reactive" or...

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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b=3209





Confirmation tests



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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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


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





Confirmation tests50. Tests for the detection of anti-HIV-1



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



HIV - 1

gp p positive(2)

negative(2)

indet.(2)

notdone


Sample 335029

Sample 335030

Sample 335031

Sample 335032

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60. Tests for the detection of anti-HIV-2



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


HIV - 2

gp p positive(2)

negative(2)

indet.(2)

notdone


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



HIV-1 p24 antigen (337) Important state your participant no:


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.


b=119



Hepatitis A (343) Important state your participant no:


Manufacturerof testkit

Name of test kit andcatalog-no. of test kit Lot-No.


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



Hepatitis A (343) Important state your participant no:





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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b=159



Hepatitis B I (344) Important state your participant no:


10. Testing for HBsAg (qualitative and quantitative)




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


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








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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b=169








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


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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b=179








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:


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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b=189



Hepatitis B II (345) Important state your participant no:





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:


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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b=199








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:


Sample 345045

Sample 345046

30. Qualitative testing for HBeAg


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b=209








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:


Sample 345047

Sample 345048

40. Qualitative testing for anti-HBe


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b=219



Hepatitis C (346) Important state your participant 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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b=2368








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


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b=2319





manufacturerof testkit

name of test kit andcatalog-no. of test kit Lot-No.


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)


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


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b=21000



Dengue viruses (350) Important state your participant no:





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)

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b=21020







Rheumatoid fact.absorption( yes / no )


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)


Sample 350013

Sample 350014

Sample 350015

Sample 350016

20. Testing for anti-Dengue-IgM


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b=21040








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)


Sample 350013

Sample 350014

Sample 350015

Sample 350016

30. Testing for Dengue-NS1 antigen


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b=21060





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

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b=319



Cytomegalovirus (351) Important state your participant no:


(Cytomegalovirus specific IgG or total antibodies = IgG+IgM)


Name of test kitcatalog-no.

of test kitLot-No.


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".


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)

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b=30019





(Cytomegalovirus specific IgG antibodies)


Name of test kitand catalog-no. of test kit Lot-No.


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)

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b=339





( Cytomegalovirus specific IgM antibodies )


Name of test kitcatalog-no.

of test kitLot-No.

Rheumatoid fact.absorption( yes / no )


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".


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)

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b=20000



Hantaviruses (355) Important state your participant no:


----- 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

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20. ELISA for the detection of anti-hantavirus-IgM


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)




Sample 355013

Sample 355014

Sample 355015

Sample 355016

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b=20400





----- Please consider the anamnestic information (see manual) ----30. IFT for the detection of anti-hantavirus-IgG


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)




Sample 355013

Sample 355014

Sample 355015

Sample 355016

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40. IFT for the detection of anti-hantavirus-IgM


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)




Sample 355013

Sample 355014

Sample 355015

Sample 355016

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b=20450





----- Please consider the anamnestic information (see manual) ----

45. IFT for the detection of anti-hantavirus-IgG/IgM (without differentiation of IgG and IgM)


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)




Sample 355013

Sample 355014

Sample 355015

Sample 355016

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b=20600





----- Please consider the anamnestic information (see manual) ----50. Rapid test for the detection of anti-hantavirus-IgG


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)




Sample 355013

Sample 355014

Sample 355015

Sample 355016

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60. Rapid test for the detection of anti-hantavirus-IgM


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)




Sample 355013

Sample 355014

Sample 355015

Sample 355016

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b=20800





----- Please consider the anamnestic information (see manual) ----70. Immunoblot for the detection of anti-hantavirus-IgG


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

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80. Immunoblot for the detection of anti-hantavirus-IgM


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

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b=20950





----- 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)

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b=6000

INSTAND EQASVirus genome detection


PCR-/ NAT - HIV-1 (360) Important state your participant no:


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.

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b=6200



PCR-/ NAT - HIV-1 (360) Important state your participant no:


20. Qualitative detection of HIV-1 (RNA)

manufacturergenome detection test

test name andcatalog no



yes / no

11 PCR

12 nested PCR

13 Taq Man

15 bDNA

20 NASBA

40 Light Cycler

50 LCR

60 TMA

70 Multiplex PCR


98 other PCR

99 other tests


Cycler

Primer

Detection method

Results:

positivebelow detection level /

negativeindeter-minate

Ct- / Cp-value ** RemarksSample *

Sample 360029

Sample 360030

Sample 360031

Sample 360032


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b=6400



PCR-/ NAT - HBV (361) Important state your participant no:


10. Quantitative detection of HBVmaufacturer of test

genome detection testname of testcatalog-no



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


98 other PCR

99 other tests


Cycler

Primer

Detection method

Results:



Ct-/Cp-value ** RemarksSample *

Sample 361029

Sample 361030

Sample 361031

Sample 361032


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=6600



PCR-/ NAT - HBV (361) Important state your participant no:


20. Qualitative detection of HBV

maufacturer of testgenome detection test

name of testcatalog-no



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


98 other PCR

99 other tests


Cycler

Primer

Detection method

Results:positive below detection level /

negativeindeter-minate


Sample 361029

Sample 361030

Sample 361031

Sample 361032


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b=7000



PCR-/ NAT - HCV (362) Important state your participant no:


10. Quantitative detection of HCVmanufacturer of test

genome detection testname of test and

catalog-nogenome detection test


yes / no

11 PCR

12 nested PCR

13 Taq Man

15 bDNA

20 NASBA

40 Light Cycler

50 LCR

60 TMA

70 Multiplex PCR


98 other PCR

99 other tests


Cycler

Primer

Detection method

Results:




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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b=7100



PCR-/ NAT - HCV (362) Important state your participant no:


20. Qualitative detection of HCV

manufacturer of testgenome detection test

name of test andcatalog-no



yes / no

11 PCR

12 nested PCR

13 Taq Man

15 bDNA

20 NASBA

40 Light Cycler

50 LCR

60 TMA

70 Multiplex PCR


98 other PCR

99 other tests


Cycler

Primer

Detection method

Results:

positivebelow detection level /

negative indeter-minate


Sample 362029

Sample 362030

Sample 362031

Sample 362032


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b=8510



PCR-/ NAT - CMV (365) Important state your participant no:





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


98 other PCR


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 )


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b=8600



PCR-/ NAT - CMV (365) Important state your participant no:


20. Qualitative detection of CMV ( Cytomegalovirus )





11 PCR

12 nested PCR

13 Taq Man

15 bDNA

20 NASBA

30 Hybridization

40 Light Cycler

50 LCR

60 TMA

70 Multiplex PCR


98 other PCR


Cycler

Primer

Detection method

Results:

positive below detection level /negative

indeter-minate


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.

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b=10350



PCR-/ NAT - Parvovirus B19 (367) Important state your participant no:


10. Quantitative detection of Parvovirus B19 (DNA)test manufacturer

genome detection testtest name and

catalog-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


98 other PCR

99 other tests

Manufacturer: Lot-No:Sample preparation

Cycler

Primer

Detection method




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.


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b=10390



PCR-/ NAT - Parvovirus B19 (367) Important state your participant no:


20. Qualitative detection of Parvovirus B19 (DNA)

test manufacturergenome detection test

test name andcatalog-no.



11 PCR

12 nested PCR

13 Taq Man

15 bDNA

20 NASBA

40 Light Cycler

50 LCR

60 TMA

70 Multiplex PCR


98 other PCR

99 other tests

Manufacturer: Lot-No:Sample preparation

Cycler

Primer

Detection method

Results:

positive below detection level / negative

indeter-minate


Sample 367029

Sample 367030

Sample 367031

Sample 367032


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b=9200

INSTAND EQASVirus detection, Genome/AG


PCR-/NAT and AG influenza A/B (370) Important state your participant no:


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


98 other PCR

99 other tests


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 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=9150





Genome detection of influenza A and B viruses10. Qualitative genome detection of influenza A virus




11 PCR

12 nested PCR

13 Taq Man

15 bDNA

20 NASBA

40 Light Cycler

50 LCR

60 TMA

70 Multiplex PCR


98 other PCR

99 other tests


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 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





Genome detection of influenza A and B viruses11. Subtyping of influenza A viruses




11 PCR

12 nested PCR

13 Taq Man

15 bDNA

20 NASBA

40 Light Cycler

50 LCR

60 TMA

70 Multiplex PCR


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



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





Genome detection of influenza A and B viruses12. Qualitative detection of avian influenza A(H5N1) virus with H5N1 or H5 specific primers / probes




11 PCR

12 nested PCR

13 Taq Man

15 bDNA

20 NASBA

40 Light Cycler

50 LCR

60 TMA

70 Multiplex PCR


98 other PCR

99 other tests


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



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





Genome detection of influenza A and B viruses13. Qualitative detection of influenza A(H1N1) pdm09 virus with H1N1 or H1 specific primers / probes




11 PCR

12 nested PCR

13 Taq Man

15 bDNA

20 NASBA

40 Light Cycler

50 LCR

60 TMA

70 Multiplex PCR


98 other PCR

99 other tests


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



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





Genome detection of influenza A and B viruses15. Quantitative genome detection of influenza B virus




11 PCR

12 nested PCR

13 Taq Man

15 bDNA

20 NASBA

40 Light Cycler

50 LCR

60 TMA

70 Multiplex PCR


98 other PCR

99 other tests


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



Please report on this protocol page only results of PCRs for the detection of influenza B viruses.


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b=9250





Genome detection of influenza A and B viruses20. Qualtitative genome detection of influenza B virus




11 PCR

12 nested PCR

13 Taq Man

15 bDNA

20 NASBA

40 Light Cycler

50 LCR

60 TMA

70 Multiplex PCR


98 other PCR

99 other tests


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



Please report on this protocol page only results of PCRs for the detection of influenza B viruses.

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b=9350





Genome detection of influenza A and B viruses25. Qualitative genome detection of influenza viruses

without differentiation of influenza A and B viruses




11 PCR

12 nested PCR

13 Taq Man

15 bDNA

20 NASBA

40 Light Cycler

50 LCR

60 TMA

70 Multiplex PCR


98 other PCR

99 other tests


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



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





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


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





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


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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b=16000



PCR-/ NAT - HAV (377) Important state your participant no:


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


98 other PCR

99 other tests


Cycler

Primer

Detection method




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.



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b=16100



PCR-/ NAT - HAV (377) Important state your participant no:


20. Qualitative detection of HAV ( Hepatitis A virus )

test manufacturergenome detection test

test name andcatalog-no.


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


98 other PCR

99 other tests


Cycler

Primer

Detection method

Results:

positivebelow detection level

/ negative indeterm. Ct-/Cp-value ** RemarksSample *

Sample 377029

Sample 377030

Sample 377031

Sample 377032


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E

instand eqas hiv-1 / hiv-2 (335) important …...a sample "reactive" or...

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