legionella serology - rcpaqapdataentry.rcpaqap.com.au/serology/admin/document... · test both sera...

© 2013 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B3-2013-leg Report Issued Wednesday, 3 July 2013 Page of 19

RCPA Quality Phone +61 2 9045 6000

NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043:2010 Site Number: 15003

Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Level 2, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au

Survey B3:2013: 3A, 3B, 3C & 3D

Final Generic Report Bacterial Program

Legionella Serology Report prepared and collated by: RCPAQAP Serology Comments provided by: David Leslie

on behalf of RCPAQAP Serology Microbiology Department, Victorian Infectious Diseases Reference Laboratory (VIDRL), VIC, Australia

Report prepared by

RCPAQAP Serology Suite 201, 8 Herbert Street St Leonards NSW 2065 AUSTRALIA Phone +61 2 9045 6070 Facsimile +61 2 9356 2003 Email [email protected] Web http://www.rcpaqap.com.au/serology

Contact

Susan Badman Group Manager Infectious Diseases & Immunology | Manager - Serology

The completed report has been authorised for issue by

Professor William Rawlinson AM Deputy Program Chair ‐ Serology

Copyright

This material is copyright and may not be used in any form for advertising, sales promotion or publicity. The material may not be reproduced in whole or in part for any purpose whatsoever (including presentations at meetings and conferences), without the prior written permission of the RCPA Quality Assurance Programs Pty Limited. Permission must be sought in writing from the Program but will not be unreasonably refused.

Confidentiality

RCPA Quality Assurance Programs Pty Limited keeps all participant details confidential. No information related to any of the participants will be divulged to a third party, unless required by legislation, without the express written consent of the participant. General information may be discussed at meetings or presented as papers to journals.

mailto:[email protected]

http://www.rcpaqap.com.au/serology





Kit Performance

It is up to all users to form their own opinion or conclusions on each kit's performance based on the accumulation of data and information that is supplied by this survey, and other information available to the participant. A variety of samples are used in this Program (straight, undiluted serum; diluted serum and pooled serum) and this can sometimes impact on results and performance of some kits. With serum specimens, occasional artefactual problems are encountered with some kits due to changes in the matrix caused by rethrombinisation of plasma or dilution. Clinical Notes The “Clinical Notes” were created so as to highlight particular issues relating to interpretation of serological results. They do not necessarily reflect the clinical history of the patient from whom the sample was obtained.

3A A 66 year old with lower lobe pneumonia for one week who stopped smoking 5 years ago. 3B A 30 year old with an upper respiratory infection for nearly two weeks. 3C 72 year old male smoker recently admitted to hospital with upper lobe pneumonia. 3D A 60 year old with a chronic cough for investigation.

Request

Test both sera for evidence of Legionella infection and test in the same manner as patient specimens. Please test the urine for Legionella antigen and test in the same manner as patient specimens.

Specimen Details

Specimens are of human origin and tested negative for hepatitis B surface antigen, hepatitis C antibody and HIV. (Ref. 2013 SQA Program Plan section B3:2013)

3A is a serum sample diluted 1:2 with another serum sample that tested positive for Legionella pneumophila serology. Source: Southern Cross Pathology, VIC and SEALS, Prince of Wales Hospital, NSW.

3B is a serum sample that tested negative for Legionella serology.

Source: SEALS, Prince of Wales Hospital, NSW. 3C is a urine sample diluted 1:10 with another urine sample that tested positive to Legionella Urinary Antigen. Source: ICPMR, Westmead Hospital, NSW and RCPAQAP Serology Specimen Bank. 3D is a urine sample that tested negative to Legionella Urinary Antigen. Source: RCPAQAP Serology Specimen Bank. Pre-issue testing: ICPMR, Westmead Hospital, NSW.

Analysis of Results

For information on “Analysis of Results” please refer to your RCPAQAP Serology Participation Handbook for the current year. The Participant Performance Table is an indicator for participants to review their results and evaluate their own performance as ‘Satisfactory’ or ‘Unsatisfactory’.





Serum Results

Legionella IFA Total Antibody 15/33 (45%) participants returned results for Legionella IFA Total Antibody. Results for Specimen 3A

Part Manufacturer Cut-off

LP1-3A

LP2-3A

LP3-3A

LP4-3A

LP5-3A

LP6-3A

LL1-3A

LP1-6-3A

L species b-j-3A

41302 Biocell Diagnostics,Inc. 128 256 N

21229 In-house 128 128 < 128 < 128 < 128 < 128 < 128 < 128 128

51077 In house N/A <64

61253 In-house. 64 <64 <64

21624 MARDX 128 128 <128

51063 MarDx 64 128

59006 MarDx Diagnostics 64 64

89061 Meridian 256 < 256 < 256 < 256 < 256 < 256 < 256

89173 MERIDIAN 128 128

89319 MERIDIAN 64 64 <64 <64 64 64 64

41133 m-Tech 64 <64 <64 <64

51077 4M Tech N/A <64 <128

21500 Scimedx 512 <128 <128

89041 Zeus 16 512 512 512 512

80010 Zeus Scientific 128 256

89318 ZEUS SCIENTIFIC 16 64

Results for Specimen 3B


LP1-3B

LP2-3B

LP3-3B

LP4-3B

LP5-3B

LP6-3B

LL1- 3B

LP1-6-3B

L species b-j-3B

41302 Biocell Diagnostics,Inc. 128 N N

21229 In-house 128 < 128 < 128

51077 In house N/A 64

61253 In-house. 64 <64 <64

21624 MARDX 128 <128 <128

51063 MarDx 64 <64

59006 MarDx Diagnostics 64 <64

89061 Meridian 256 ND ND ND ND ND ND

89173 MERIDIAN 128 <128

89319 MERIDIAN 64

41133 m-Tech 64 <64 <64 <64

51077 4M Tech N/A <64 <128

21500 Scimedx 512 <128 <128





Results for Specimen 3B (continued)

Part Manufacturer Cut- off

LP1-3B

LP2-3B

LP3-3B

LP4-3B

LP5-3B

LP6-3B

LL1- 3B

LP1-6-3B

L species b-j-3B

89041 Zeus 16 <16 <16 <16 <16

80010 Zeus Scientific 128 <128

89318 ZEUS SCIENTIFIC 16 NEG

Inconsistencies in this Survey

Legionella Serum IFA Total Antibody

Participant Comment

Test Group 51077 Cut-off value not provided.





Legionella IgG IFA 12/33 (36%) participants returned results for Legionella IgG using IFA. Results for Specimen 3A


LP1-3A

LP2-3A

LP3-3A

LP4-3A

LP5-3A

LP6-3A

LP7-3A

LP8-3A

LP9-3A

LP10-3A

LP11-3A

LP12-3A

LP13-3A

LP14-3A

LP1-4-3A

LP1-6-3A

LP7-14-3A

L species b-j-3A

89152 Euroimmun 100 Neg Neg Pos Neg Neg Neg Neg Pos Neg Pos Neg Neg Neg Neg

89012 MarDx 256 512

89110 MarDx (Trinity Biotech) 256 64

91119 MARDX OMNI

256 256 <128

91317 MARDX 256 64 64 <64

91487 Mardx 128 512 256 128

39022 Vircell 128 128 512 128

41183 Vircell 64 64 128 64

89258 Vircell 0.004 0.002

89260 VIRCELL, SL 128 128

89072 zeus

pos pos pos pos

89127 Zeus 64 <64



LP1-3B

LP2-3B

LP3-3B

LP4-3B

LP5-3B

LP6-3B

LP7-3B

LP8-3B

LP9-3B

LP10-3B

LP11-3B

LP12-3B

LP13-3B

LP14-3B

LP1-4-3B

LP1-6-3B

LP7-14-3B

L species b-j-3B

89152 Euroimmun 100 Neg Neg Neg Neg Neg Neg Neg Neg Neg Neg Neg Neg Neg Neg

89012 MarDx 256 256

89110 MarDx (Trinity Biotech) 256 <64

91119 MARDX OMNI

<128 <128 <128

91317 MARDX 256 <64 <64 <64





Results for Specimen 3B (continued)


LP1-3B

LP2-3B

LP3-3B

LP4-3B

LP5-3B

LP6-3B

LP7-3B

LP8-3B

LP9-3B

LP10-3B

LP11-3B

LP12-3B

LP13-3B

LP14-3B

LP1-4-3B

LP1-6-3B

LP7-14-3B

L species b-j-3B

91487 Mardx 128 <128 <128 <128

39022 Vircell 128 <128 <128 <128

41183 Vircell 64 <64 <64 <64

89258 Vircell 0.004 0.016

89260 VIRCELL, SL 128 <32

89072 zeus

neg neg neg neg

89127 Zeus 64 <64


Legionella Serum IFA IgG Participant Comment

Test Group 89072 Cut-off value not provided.

89258 Reported cut-off and result values appear inconsistent to other participants within the user group.

91119 Cut-off value not provided.





Legionella IgM IFA 6/33 (18%) participants returned results for Legionella IgM using IFA. Results for Specimen 3A


LP1- 3A

LP2- 3A

LP3- 3A

LP4- 3A

LP5- 3A

LP6- 3A

LP7- 3A

LP8- 3A

LP9- 3A

LP10-3A

LP11-3A

LP12-3A

LP13-3A

LP14-3A

LP1-6-3A

L species b-j-3A


21624 MARDX 64 <64 <64

89012 Vircell 96 <96

89021 vircell microbiologist 96 neg

89258 Vircell 0.01 <0.01

89260 VIRCELL, SL 96 96



LP1-3B

LP2- 3B

LP3-3B

LP4-3B

LP5- 3B

LP6-3B

LP7-3B

LP8-3B

LP9- 3B

LP10-3B

LP11-3B

LP12- 3B

LP13-3B

LP14-3B

LP1-6-3B

L species b-j-3B


21624 MARDX 64 <64 <64

89012 Vircell 96 <96

89021 vircell microbiologist 96 neg

89258 Vircell 0.01 <0.01

89260 VIRCELL, SL 96 <12


Legionella Serum IFA IgM Participant Comment

Test Group 89258 Reported cut-off and result values appear inconsistent to other participants within the user group.

© 2013 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File B3-2013-leg Report issued Wednesday, 3 July 2013 Page of 19




IFA Pool Results 6/33 (18%) participants returned results for Legionella pools using IFA.

Part Cut-off Pool

Result 3A Causative Agent 3A

Titre 3A

Result 3B

Causative Agent 3B

Titre 3B

21412 512 A 128 L.pneumophila 1-8 128 <128 N/A N/A

512 B <128 <128

31126 256 A 256 N/A 256 <256 N/A <256

256 B <256 <256

59006 64 A <64 L.longbeachae <64 <64 L.longbeachae <64

89260 128 A 128 LEGIONELLA PNEUMOPHILA SEROGROUP 7-14 256 <32 NEGATIVE <32

128 B 256 <32

128 C 32 <32

128 D 64 <32

89318 16 A 64 L pneumophilia sg 1-6 64 <16 N/A <16

92005 256 A 64 none identified <256 <64 none identified <256

256 B <64 <64

256 C 64 <64

256 D 128 <64

256 E 128 <64

IFA Pool Components

Part Pool Manufacturer Group

21412 A EUROIMMUNE L pneumophila sg1,L.pneumophila sg2,L pneumophila sg3,L pneumophila sg4,L pneumophila sg5,L pneumophila sg6,L pneumophila sg7,L pneumophila sg8

B EUROIMMUNE L longbeachae sg1 (Adelaide)

31126 A In-house L pneumophila sg1 (Philadelphia),L.pneumophila sg2,L pneumophila sg3,L pneumophila sg4 (LA),L pneumophila sg5

B In-house L longbeachae sg1 (Adelaide),L longbeachae sg2,L micadei

59006 A Euroimmun L longbeachae sg1 (Adelaide)

89260 A VIRCELL, SL L pneumophila sg1,L.pneumophila sg2,L pneumophila sg3,L pneumophila sg4,L pneumophila sg5,L pneumophila sg6

B VIRCELL, SL L pneumophila sg7,L pneumophila sg8,L pneumophila sg9,L pneumophila sg10,L pneumophila sg11,L pneumophila sg12,L pneumophila sg13,L pneumophila sg14

C VIRCELL, SL L bozemanii sg1,L bozemanii sg2,L longbeachae sg1 (Adelaide),L longbeachae sg2,L gormannii,L micadei,L jordanis,L dumoffi

D VIRCELL, SL L longbeachae sg1 (Adelaide),L longbeachae sg2,L micadei

89318 A ZEUS SCIENTIFIC

L pneumophila sg1,L pneumophila sg1 (Philadelphia),L pneumophila sg1 (Knoxville),L.pneumophila sg2,L pneumophila sg3,L pneumophila sg4,L pneumophila sg4 (LA),L pneumophila sg4 (Portland),L pneumophila sg5,L pneumophila sg6

92005 A in-house L pneumophila sg1,L.pneumophila sg2,L pneumophila sg3,L pneumophila sg4

B in-house L pneumophila sg5,L pneumophila sg6,L pneumophila sg7,L pneumophila sg8,L pneumophila sg9

C in-house L pneumophila sg10,L pneumophila sg11,L pneumophila sg12,L pneumophila sg13,L pneumophila sg14,L pneumophila sg15

D in-house L anisa,L bozemanii sg1,L bozemanii sg2,L dumoffi,L feelei sg1,L feelei sg2,L gormannii

E in-house L jordanis,L longbeachae sg1 (Adelaide),L longbeachae sg2,L micadei,L oakridgensis





Serum Legionella EIA Total Antibodies 2/33 (6%) participants returned results for Legionella total antibodies using EIA.

Part Antigen Serogroup Conjugate Units Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

89260 LIPOPOLYSACC

HARIDE

LEGIONELLA PNEUMOPHILA

SEROGROUPS 1-6 ANTI IG(G,M,A) HRP S/CO 1.1 0.96 equ 0.07 neg

89319

ATCC 33152, 33154, 33155, 33156,33216 LP1,2,3,4,5,6

HRP conjugate : goat ant humain IgG/IgM S/CO 1.1 1.62 pos 0.17 neg

Serum Legionella EIA IgG 3/33 (9%) participants returned results for Legionella IgG using EIA.


Value 3A

Result 3A

Value 3B

Result 3B

80030 VIRION SERION LP1 - LP7 ALP Labelled Anti-

Human IgG U/mL 50 260 pos 10 neg

89061 Lp1 to Lp6 Lp1 to Lp6 Trinity Biotech S/CO 0.7 1.3 pos 0.2 neg

89260 LIPOPOLYSACCH

ARIDE

LEGIONELLA PNEUMOPHILA SEROGROUP 1 ANTI-IGG HRP S/CO 1.1 1.48 pos 0.04 neg

Serum Legionella pneumophilia EIA IgM 3/33 (9%) participants returned results for Legionella pneumophila IgM using EIA.


Value 3A

Result 3A

Value 3B

Result 3B

21375 L PNEUMOPHILA SEROGROUP 1 IGM S/CO 1 0.32 neg 0.03 neg

80030 VIRION SERION LP1 - LP7 ALP Labelled Anti-

Human IgM U/mL 120 63 neg 44 neg

89260 LIPOPOLYSACCHA

RIDE

LEGIONELLA PNEUMOPHILA SEROGROUP 1 ANTI-IGM HRP S/CO 1.1 0.67 neg 0.05 neg

Serum Legionella longbeachae EIA IgM 1/33 (3%) participants returned results for Legionella longbeachae IgM using EIA.


Value 3A

Result 3A

Value 3B

Result 3B

21375 L LONGBEACHAE IGM S/CO 1 0.19 neg 0.08 neg


Legionella Longbeachae EIA IgM Participant Comment

Test Group 21357 Serogroup information not provided.





Interpretative Comments for Legionella Serum Specimens Combination responses have been split into their appropriate option – for example, if a participant chose 1 & 5, they are counted once in each of those options. % is based on the total number of participants who provided comments and not the total number of comments. Therefore, the total % adds to more than 100%. Extra Comments

89152 3A:Please add comment "Submit a respiratory sample for PCR test."





Legionella Urinary Antigen 57 participants returned results for urinary antigen.

Survey Results B3:2013 Legionella Urinary Antigen

Legionella Urinary Antigen Detection EIA - Specimen 3C pos: 8 = 100.00% Total Results =8 Consensus: pos

Legionella Urinary Antigen Detection EIA - Specimen 3D neg: 8 = 100.00% Total Results =8 Consensus: neg

Legionella Urinary Antigen Detection ICT - Specimen 3C pos: 50 = 100.00% Total Results =50 Consensus: pos

Legionella Urinary Antigen Detection ICT - Specimen 3D neg: 50 = 100.00% Total Results =50 Consensus: neg


Legionella Urinary EIA Participant Comment

Specimens 3C & 3D 31252 Cut-off and result values inconsistent with manufacturer’s instructions.

Specimen 3C 89149 Result value not provided.

Test Group 31126 Units appear inconsistent with manufacturer’s instructions.

31252 Units not provided.

Legionella Urinary ICT Participant Comment

Test Group 1034 Edit - Re-assigned kit according to lot number provided.

28262 Edit - Re-assigned kit according to lot number provided.

49027 Other users of the same lot number have a different expiry date.

89129 Serogroup information has not been provided.

Legionella Urinary Interpretative Comments

Participant Comment

Specimens 3C & 3D 21356 Only interpretative comments reported; no results provided for Specimens 3C and 3D.





Interpretative Comments for Legionella Urine Specimens Combination responses have been split into their appropriate option – for example, if a participant chose 1 & 5, they are counted once in each of those options. % is based on the total number of participants who provided comments and not the total number of comments. Therefore, the total % adds to more than 100%.

Comments provided by: David Leslie, Microbiology Department, Victorian Infectious Diseases Reference Laboratory (VIDRL), VIC, Australia, on behalf of the RCPAQAP Serology

Thirty-three participants returned legionella serology results for Specimens 3A and 3B.

Review of Results by Methodology

IF Assays Due to the very wide range of methods in use, including testing individual species / serogroups and pooled strains, combined results (regardless of species reported) are shown in the table below. As can be seen, there was no consensus for Specimen 3A, though the high number of low positive results (reported value the same as the cut-off) indicate low level legionella antibodies were present. Specimen 3B was consensus negative. Most positive or low positive results were obtained against L pneumophila serogroup 1 or Lp sg1 containing pools.

Specimen Positive Low Positive Negative

IFA total (15 participants/16 sets of results*)

3A 5 5 6

3B 0 1 14

IFA IgG (11participants#)

3A 7 1 3

3B 0 1 10

IFA total pool (participants)

3A 2 1 3

3B 0 0 6 *1 participant did not submit results for Specimen 3B # One participant (89258) excluded as results were not reported as reciprocal titres





Five participants returned negative and one participant positive result for Specimen 3A using IgM assays. All six participants using IgM assay reported negative result for Specimen 3B. EIA Assays Four participants used either IgG or total Ab EIAs, and all returned a positive result for Specimen 3A. All reported Specimen 3B as negative.

Specimen Positive Equivocal Negative

EIA, total & IgG (4 participants/5 sets of results)

3A 4 1 0

3B 0 0 4

Participant 21375 appears to screen with an Lp and Ll IgM EIA assays only. Interpretation Although a consensus result was not achieved for Specimen 3A, most participants comments were appropriate to the result obtained. As noted in previous surveys, seroconversion may be delayed following legionella infection, and Comment 10 is probably more appropriate than Comments 6 to 9 suggesting shorter follow-up periods. Legionella urinary antigen Fifty-six (56) participants returned analysable results with 48 using ICT alone, six using EIA alone, and two using both ICT and EIA. All participants correctly reported Specimen 3C as positive, and Specimen 3D as negative. Values reported for the EIAs indicate that Specimen 3C was clearly positive. The comments made were appropriate to the results obtained. Overall Comments This survey highlights some of the problems with currently available methods for performing legionella serology – virtually no two participants use exactly the same methods and cut-offs are highly variable, even between participants using the same IF slides. Specimen 3A did contain low levels of legionella antibodies, but beyond the limits of detection for many laboratories. Participants are again reminded that seroconversion may be delayed or non-existent following Legionnaires’ disease or Pontiac fever, and requesting a second bleed at less the 6 to 8 weeks may miss cases. On the other hand, legionella urinary antigen detection by EIA or ICT appears a much more robust test with 100% correct response rate, although as Specimen 3C gave positive EIA and ICT results in the absence of concentration, it was not possible to demonstrate the higher sensitivity of EIA compared to ICT on this survey.





Legionella Serum Summary for Survey B3:2013:3A & 3B

Part

Specimen 3A

Specimen 3B

IgG IgM L.I IgM L.p Tot Ab Interp IgG IgM L.I IgM L.p Tot Ab Interp

21229 4,10 1,10

21375 neg neg 1,7,12,13 neg neg 1,7,12,13

21412 5,10 1,10

21500 1,10 1,10

21624 3,5,10 1,5,10

31126 3,5,10 1,5

39022 4,10 1

41133 1,10 1,10

41183 4,10 1,10

41302 4,10 1,5,10

51063 7 1,10

51077 1,8 1,8

59006 5,10 5,10

61253 1,9 1,9

80010 4,6 5,8

80030 pos neg 7,8 neg neg 5

89012 5,10 1

89021 1 1

89041 2 1

89061 pos 5,8,9,13 neg 5,8,9,13

89110 1,5,10 1,5,10

89127 1,5,10,13 1,5,10,13

89152 5,10,13 1

89173 5,12,13 1,10

89260 pos neg equ 2,8 neg neg neg 1

89318 5,8 1

89319 pos 1,8 neg 1

91119 5,12 5

91317 1,5 1,5

91487 4,7 1,5

92005 1,5,12,13 1,5,8





Legionella Urine Antigen Summary for Survey B3:2013:3C & 3D

Part

Specimen 3C

Specimen 3D

EIA ICT Interp EIA ICT Interp

1034 pos 1,4 neg 2,4

21189 pos 1 neg 2,3

21207 pos 1,4 neg 2

21229 pos 1,4 neg 2,3,4

21347 pos 1 neg 2,3

21356 1 2

21394 pos 1 neg 2

21412 pos 1,4 neg 2,4

21452 pos 1,4 neg 2,3

21489 pos 1,4 neg 2,4

21500 pos 1,4 neg 2,3

28262 pos 1 neg 2,3,4

29081 pos 1 neg 5

31008 pos 1,4 neg 2

31126 pos pos neg neg

31221 pos 1 neg 2

31252 pos neg

31293 pos 1 neg 2

31342 pos 1,4 neg 2

31378 pos 1,4 neg 2

31702 pos 1,4 neg 2,3

39050 pos neg

39055 pos neg

41018 pos 1,4 neg 2,3,4

41062 pos 1,4 neg 2,3

41073 pos neg

41080 pos 1 neg 2

41133 pos 1 neg 2

41179 pos 1,4 neg 2,3

41183 pos 1 neg 2

42225 pos neg

42362 pos neg

49000 pos 1 neg 2

49027 pos neg

51063 pos 1,4 neg 2,3

51077 pos 1,4 neg 2,4

61033 pos neg

61253 pos 1 neg 2,3

71246 pos neg

71358 pos 1,4 neg 2,3

71683 pos 1,4 neg 2,4

80500 pos 1,4 neg 2,3

82216 pos pos 1,4 neg neg 2,3

83618 pos 1,4 neg 2,4

89035 pos 1,4 neg 2,3,4

89036 pos 1 neg 2

89061 pos neg

89114 pos 1 neg 2





Legionella Urine Antigen Summary for Survey B3:2013:3C & 3D

Part

Specimen 3C

Specimen 3D

EIA ICT Interp EIA ICT Interp

89128 pos neg

89129 pos 1 neg 2

89130 pos neg

89149 pos neg

89151 pos 5 neg 5

89152 pos 1 neg 2

89325 pos 1 neg 2

91119 pos 1,4 neg 2,4

91267 pos 1,4 neg 2





Legionella Urinary Antigen Detection ICT Results for Survey B3:2013:3C & 3D

Part Manufacturer Kit Name Method Lot No. Expiry Date

Result 3C

Result 3D Species/Serotypes

1034 - Binax Now - 58199 Jul-14 pos neg Legionella pneumophilia Serogroup1

21189 Binax NOW Legionella urinary Ag ICT 61840 Feb-15 pos neg Legionella pneumophillia serogroup 1 antigen

21207 Binax NOW Legionella urinary Ag ICT 58782 Aug-14 pos neg 1

21229 Binax NOW Legionella urinary Ag ICT 61106 Sep-14 pos neg Legionella pneumophila serogroup 1

21347 Binax NOW Legionella urinary Ag ICT 56962 Jul-14 pos neg Legionella pneumophila serogroup 1

21394 Binax NOW Legionella urinary Ag ICT 58199 Jul-14 pos neg L.pneumophila 1

21412 Binax NOW Legionella urinary Ag ICT 61106 Sep-14 pos neg Serotype 1

21452 Binax NOW Legionella urinary Ag ICT 57618 May-14 pos neg Legionella pneumophila serogroup 1

21489 Binax NOW Legionella urinary Ag ICT 61580 Nov-14 pos neg Legionella pneumophila serogroup 1 antigen

21500 Binax NOW Legionella urinary Ag ICT 58199 Jul-14 pos neg LP1

28262 - - - 58199 Jul-14 pos neg Legionella pneumophila serogroup 1

29081 Binax NOW Legionella urinary Ag ICT 61106 Sep-14 pos neg L. pneumophila serogroup 1

31008 Binax NOW Legionella urinary Ag ICT 056594A Aug-14 pos neg L. pneumophilia serogroup 1

31126 Binax NOW Legionella urinary Ag ICT 56596 Apr-14 pos neg Legionells pneumophila serogroup 1

31293 Binax NOW Legionella urinary Ag ICT 58782 Aug-14 pos neg pneumophila serogroup 1

31378 Binax NOW Legionella urinary Ag ICT 61106 Sep-14 pos neg serogroup 1

31702 Binax NOW Legionella urinary Ag ICT 56596 Apr-14 pos neg L. pneumophilia serogroup 1

39050 Binax NOW Legionella urinary Ag ICT 54795 Dec-13 pos neg L. pneumophila serogroup 1 antigen

39055 Binax NOW Legionella urinary Ag ICT 58199 Jul-14 pos neg pneumophila

41018 Binax NOW Legionella urinary Ag ICT 61106 Sep-14 pos neg L.pneumophila serogroup1

41062 Binax NOW Legionella urinary Ag ICT 61106 Sep-14 pos neg L.pneumophilia serogroup 1

41073 Binax NOW Legionella urinary Ag ICT 58199 Jul-14 pos neg Legionella pneumophila serogroup 1

41080 Binax NOW Legionella urinary Ag ICT 60981 Aug-14 pos neg L. pneumophila Serogroup 1

41133 Binax NOW Legionella urinary Ag ICT 58199 Jul-14 pos neg serogroup 1

41179 Binax NOW Legionella urinary Ag ICT 61106 Sep-14 pos neg Legionella pneumophila serogp1

41183 Binax NOW Legionella urinary Ag ICT 61106 Sep-14 pos neg L. pnemophila serogroup 1

42225 Binax NOW Legionella urinary Ag ICT 58199 Jul-14 pos neg pneumophila serogroup 1

42362 Binax NOW Legionella urinary Ag ICT 56962 Jul-14 pos neg L.pneumophila serogroup 1





Legionella Urinary Antigen Detection ICT Results for Survey B3:2013:3C & 3D

Part Manufacturer Kit Name Method Lot No. Expiry Date

Result 3C



49027 Binax NOW Legionella urinary Ag ICT 58199 Sep-14 pos neg LP1

51063 Binax NOW Legionella urinary Ag ICT 56596 Apr-14 pos neg L. pneumophila Serogroup 1

51077 Binax NOW Legionella urinary Ag ICT 61106 Sep-14 pos neg LP1

61033 Binax NOW Legionella urinary Ag ICT 56596 Apr-14 pos neg Legionella pneumophila serogroup 1

61253 Binax NOW Legionella urinary Ag ICT 58782 Aug-14 pos neg L.pneumoniae group1

71246 Binax NOW Legionella urinary Ag ICT 58082 Jun-14 pos neg Legionella pneumophila serogroup 1

71358 Binax NOW Legionella urinary Ag ICT 61106 Sep-14 pos neg L. pneumophila Serogroup 1

71683 Binax NOW Legionella urinary Ag ICT 61106 Sep-14 pos neg Legionella pneumophila serotype 1

80500 Binax NOW Legionella urinary Ag ICT 56217 Jan-14 pos neg Legionella pneumophila serogroup 1


83618 Binax NOW Legionella urinary Ag ICT 56579 Feb-14 pos neg Serogroup 1

89035 Binax NOW Legionella urinary Ag ICT 506579 Feb-14 pos neg 1

89036 Binax NOW Legionella urinary Ag ICT E01265 Jun-14 pos neg 1

89114 Binax NOW Legionella urinary Ag ICT 61106 Sep-14 pos neg serotype 1

89129 Binax NOW Legionella urinary Ag ICT E01265 Jun-14 pos neg NA

89151 Binax NOW Legionella urinary Ag ICT 58082 Jun-14 pos neg Legionella pneumophila serogroup 1 antigen

89152 Binax NOW Legionella urinary Ag ICT 56588 Apr-14 pos neg Legionella pneumophila serogroup 1

89325 Binax NOW Legionella urinary Ag ICT E01265 Jun-14 pos neg L.pneunophila serogroup 1



31342 Oxoid Xpect Legionella ICT 311311 May-14 pos neg pneumophila/SG1 and 6





Legionella Urinary Antigen Detection EIA Results for Survey B3:2013:3C & 3D

Part Manufacturer Kit Name Method Automation Lot No. Expiry Date Units

Cut Off

Value 3C

Result 3C

Value 3D


31126 Binax Legionella urinary Ag EIA - 57596 Nov-13 S/CO 3 37.9 pos 1.1 neg Legionella pneumophila serogroup 1

31221 Binax Legionella urinary Ag EIA - 59273 Mar-14 S/N 3 30.1 pos 1.698 neg L.pneumophilia Serotype 1

31252 Binax Legionella urinary Ag EIA - 59272 Mar-14 N/A 0.15 1.73 pos 0.04 neg L. pneumophilia serogroup 1 Antigen

82216 Binax Legionella urinary Ag EIA - 61590 May-14 S/N 3 36.828 pos 1.528 neg Legionella pneumophila serogroup 1

89061 Binax Legionella urinary Ag EIA - 44255 Dec-13 N/A NA NA pos NA neg Lp1

89130 Binax Legionella urinary Ag EIA - 58199 Jul-14 N/A N/A N/A pos N/A neg 1

89149 IVD Research Legionella EIA - LN986 Jul-13 OD 0.15 N/A pos N/A neg Legionella Urinary Antigen Detection EIA

89128 Trinity Biotech Bartels Legionella

Urinary Antigen ELISA Eti-Max 30 Feb-14 OD 0.232 1.957 pos 0.066 neg 1 antigen

legionella serology - rcpaqapdataentry.rcpaqap.com.au/serology/admin/document... · test both sera...

Documents