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RCPAQAP SerologyGeneric ReportP4:2015 Bordetella pertussis Serology

CopyrightThis material is copyright and may not be used in any form for advertising, sales promotion or publicity. The material maynot 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 inwriting from the Program but will not be unreasonably refused.

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

RCPA Quality Phone +61 2 9045 6000Assurance Programs Fax +61 2 9356 2003

ABN 32 003 520 072Suite 201, 8 Herbert StreetSt Leonards NSW 2065 www.rcpaqap.com.au

© 2015 RCPA Quality Assurance Programs Pty Ltd. All rights reservedReport Issued Friday, 30 October 2015Page of 14

Method PerformanceIt is up to all users to form their own opinion or conclusions on each method’s performance based on the accumulationof data and information that is supplied by this survey, and other information available to the participant. A variety ofsamples are used in this Program (undiluted, diluted and pooled serum or plasma) and this can sometimes impact onresults and performance of some kits. With serum specimens, occasional artefactual problems are encountered withsome kits due to changes in the matrix caused by rethrombinisation of plasma or dilution.

Clinical NotesThe “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.

4E 27 years old, recent vaccination, check immune status.

4F 6 years old, paroxysmal cough then vomits for last three days. Whooping cough at school.

RequestPlease test both specimens for the presence of Bordetella pertussis antibodies and treat in the same manner as patientspecimens.

Specimen DetailsSpecimens are of human origin and tested negative for hepatitis B surface antigen, hepatitis C antibody and HIV.(Ref. 2015 RCPAQAP Serology Program Plan section P4:2015)

4E is a pooled serum sample that tested positive to Bordetella pertussis Toxin & FHA IgG and IgA, Bordetellapertussis IgG and IgA.[This is the same specimen as P2:2015:2F].Source: QML Pathology, QLD.

4F is a serum sample that tested negative to Bordetella pertussis Toxin & FHA IgG and IgA, Bordetella pertussis IgGand IgA.[This is the same specimen as P2:2015:2E].Source: SEALS, Prince of Wales Hospital, NSW.

Pre-issue testing: Laverty Pathology, North Ryde, NSW and Douglass Hanly Moir, North Ryde, NSW.

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

Robust StatisticsAnalysis of Results using Robust Statistics is performed on user groups of five (5) or more participants using the sameunits and is now available on your personalised Assessment Report.In order to calculate the statistics as accurately as possible, results that are presented as < or > are entered into thecalculations as the next whole number. For example, <10 is entered into the calculation as 9 and >500 is entered as501.To view robust statistics of user groups other than your own, login to the RCPAQAP Serology websitehttp://www.rcpaqap.com.au/serology and go to ‘Graphs of Results’.


Results38 participants returned results for Bordetella pertussis.

Survey Results P4:2015 Bordetella pertussis

Bordetella pertussis IgG - Specimen 4Eneg: 2 = 28.57%pos: 5 = 71.43%Total Results =7Consensus: No

Bordetella pertussis IgG - Specimen 4Fneg: 6 = 85.71%pos: 1 = 14.29%Total Results =7Consensus: No

Bordetella pertussis IgM - Specimen 4Eneg: 1 = 100.00%Total Results =1Consensus: Insufficient data (less than 5 results)

Bordetella pertussis IgM - Specimen 4Fneg: 1 = 100.00%Total Results =1Consensus: Insufficient data (less than 5 results)

Bordetella pertussis IgA - Specimen 4Enot tested: Excludedpos: 7 = 100.00%Total Results =7Consensus: pos

Bordetella pertussis IgA - Specimen 4Fneg: 9 = 90.00%pos: 1 = 10.00%Total Results =10Consensus: neg

Bordetella pertussis Toxin & FHA IgG - Specimen 4Epos: 3 = 100.00%Total Results =3Consensus: Insufficient data (less than 5 results)

Bordetella pertussis Toxin & FHA IgG - Specimen 4Fneg: 3 = 100.00%Total Results =3Consensus: Insufficient data (less than 5 results)

Bordetella pertussis Toxin & FHA IgM - Specimen 4Epos: 1 = 100.00%Total Results =1Consensus: Insufficient data (less than 5 results)

Bordetella pertussis Toxin & FHA IgM - Specimen 4Fneg: 1 = 100.00%Total Results =1Consensus: Insufficient data (less than 5 results)

Bordetella pertussis Toxin & FHA IgA - Specimen 4Enot tested: Excludedpos: 3 = 100.00%Total Results =3Consensus: Insufficient data (less than 5 results)

Bordetella pertussis Toxin & FHA IgA - Specimen 4Fneg: 4 = 100.00%Total Results =4Consensus: Insufficient data (less than 5 results)

Bordetella pertussis Toxin IgG - Specimen 4Eequ: 7 = 31.82%neg: 12 = 54.55%not tested: Excludedpos: 3 = 13.64%Total Results =22Consensus: No

Bordetella pertussis Toxin IgG - Specimen 4Fequ: 1 = 4.35%neg: 21 = 91.30%pos: 1 = 4.35%Total Results =23Consensus: neg

Bordetella pertussis Toxin IgA - Specimen 4Eneg: 2 = 18.18%not tested: Excludedpos: 9 = 81.82%Total Results =11Consensus: pos

Bordetella pertussis Toxin IgA - Specimen 4Fneg: 10 = 76.92%not tested: Excludedpos: 3 = 23.08%Total Results =13Consensus: No


Inconsistencies in this Survey

Bordetella pertussis IgG Participant Comment

Specimen 4E 89123 Result assigned is inconsistent with the cut-off and result value provided.

Test Group 89072 Units appear inconsistent with cut-off and result values reported.

89123 Units appear inconsistent with manufacturer’s instructions.

89123 The cut-off is inconsistent with SQAP definition & kit insert for a value above whichis positive.

Bordetella pertussis IgA Participant Comment

Specimen 4F 89123 Result inconsistent with the consensus.

Test Group 31293 Units appear inconsistent with manufacturer’s instructions.


Bordetella pertussis IgG(Toxin & FHA) Participant Comment

Specimen 4F 89197 Result value inconsistent with the methodology used.

Test Group 91487 The cut-off is inconsistent with SQAP definition & kit insert for a value above whichis positive.

Bordetella pertussisIgM (Toxin & FHA) Participant Comment

Test Group 89197 Cut-off in incorrect format. Please see instructions on results sheet.

Bordetella pertussis IgA(Toxin & FHA) Participant Comment

Test Group 89197 Cut-off in incorrect format. Please see instructions on results sheet.

Bordetella pertussisToxin IgG Participant Comment

Specimen 4F 89197 Result inconsistent with the consensus. An error appears to have occurred whentranscribing the result.

89319 Result inconsistent with the consensus.

Test Group 21267 Other users of the same lot number have a different expiry date.

41183 Other users of the same lot number have a different expiry date.


89149 Edit - Entered results in incorrect data entry screen; moved by SQAP to correctsection.






Inconsistencies in this Survey (continued)

Bordetella pertussisToxin IgG Participant Comment

Test Group 89318 Edit - Entered results in incorrect data entry screen; moved by SQAP to correctsection.


Bordetella pertussisToxin IgA Participant Comment

Specimen 4E 21092 Result inconsistent with the consensus.

21375 Result inconsistent with the consensus.

Test Group 21267 Other users of the same lot number have a different expiry date.

41183 Other users of the same lot number have a different expiry date.



Interpretative CommentsCombination responses have been split into their appropriate option – for example, if a participant chose 3 & 5, theyare counted once in each of those options. % is based on the total number of participants and not the total number ofcomments. Therefore, the total % adds to more than 100%.

Extra Comments

21229 4E: This serological test is not recommended for the determination of immunity to Pertussis.21401 Specimen 4E tested for QA purposes only.91317 Immune status requests for B.pertussis are not tested in our laboratory.


Comparison of Replicate Specimens 2F and 4E, and 2E and 4FReview of the replicate Specimens 2F and 4E and 2E and 4F yielded consistent results from the majority of participants.Any discrepant results reported are tabulated below.

Participants who have changed methodology between surveys have been excluded.

Specimen 2F Specimen 4E

Part IgG IgA IgM IgG (Toxin& FHA)

IgA (Toxin& FHA)

IgM (Toxin& FHA) Toxin IgG Toxin IgA IgG IgA IgM IgG (Toxin

& FHA)IgA (Toxin

& FHA)IgM (Toxin

& FHA) Toxin IgG Toxin IgA

21401 neg equ

21624 pos pos neg pos pos pos

31221 pos pos equ pos

41302 equ equ neg pos

51077 neg equ

61253 pos neg

89153 equ neg neg pos

89197 pos pos equ neg pos pos pos pos equ pos

89318 equ neg equ

Specimen 2E Specimen 4F

Part IgG IgA IgM IgG (Toxin &FHA)

IgA (Toxin &FHA)

IgM (Toxin& FHA) Toxin IgG Toxin IgA IgG IgA IgM IgG (Toxin &

FHA)IgA (Toxin &

FHA)IgM (Toxin

& FHA) Toxin IgG Toxin IgA

89197 neg neg pos neg neg neg neg neg pos neg

89319 neg equ


Pertussis Antibodies and Testing ChoicesWhile traditionally IgA has been viewed as a standard marker for acute pertussis infection, the literature for some timehas indicated that measurement of pertussis toxin (PT) IgG is probably our current most sensitive and specific markerfor acute infection (1). Whole cell measurements, both IgG and IgA, can be affected by non-specific cross-reactionswith other Bordetella species, and also Haemophilus influenzae and Mycoplasma pneumoniae, making interpretation ofa positive result in the context of a respiratory illness difficult. IgA responses in children may be limited (2).Unlike most other acute infections, IgM plays a very limited role in pertussis diagnostics. This is because most clinicaldisease represents re-infection following prior exposure from either vaccination or infection. Hence any IgM responsegenerated is very transient and rarely captured on a clinical test.The antigen target used in pertussis assays has a significant bearing on the interpretation of results. Assays using wholecell lysates can only interpret positive IgG results as past exposure. Assays using whole cell or combination antigens (egFHA & toxin combinations) will not be able to report in international units.

Of particular importance for this RCPAQAP Serology survey, there are currently no well-established serologicalcorrelates of pertussis immune status. Indeed, it remains uncertain which immune responses to pertussis are in fact themost relevant with respect to protective effect, with possible candidates including antibodies to PT, PRN (pertactin)and FIM (fimbrial proteins)(3). While either positive whole cell or low level (10-50 IU/mL) PT IgG antibodies can indicatethe presence of past exposure to pertussis (4), it remains unknown what (if any) antibody level is protective. Similarly,it also remains unknown whether patients who test negative to, or who have low level (<10 IU/mL) PT IgG antibodies,are indeed susceptible to re-infection. Many research papers use PT IgG levels as a surrogate marker for vaccineresponse or pertussis exposure, but a definitive clinical correlation with protective immunity has NOT been established.As mentioned in the initial section, positive whole cell IgG may be either an indicator of past exposure (which is not tobe extrapolated as immunity) or simply a non-specific cross-reaction. Significant re-education of occupational healthand safety coordinators of many university and hospital campuses across Australia is required in order to reduce theamount of testing requests for pertussis immune status generated through primary practice.

Overall across the testing group there is a continued shift away from IgM and whole cell IgG testing towards morespecific antigen-based testing and hence the ability to report quantitative results using international units.

The table below highlights the changes in laboratory testing amongst the RCPAQAP participants from Survey 2 2014 tothe current survey:

Pertussis Serological Antigen utilisedNumber of Participants

P2:2014 P4:2015B. pertussis IgG 8 7B. pertussis IgA 12 10B. pertussis IgM 3 1B. pertussis Toxin & FHA IgG 5 3B. pertussis Toxin & FHA IgA 6 4B. pertussis Toxin & FHA IgM 3 1B. pertussis Toxin IgG 14 23B. pertussis Toxin IgA 11 14

ResultsAs the serum samples utilised in the current survey are the same as those from Survey 2 2015, and there is goodreproducibility demonstrated (see table on page 6 of this report for discrepancies).

As stated in the previous report (P2:2015), the most variability in testing results was seen in the PT assays, presumablydue to the survey specimen containing borderline levels of PT (pre-issue testing was performed on toxin + FHA assaysand whole cell assays). This assumption is supported by the data in the comparison table on page 6, which confirms


that the PT IgG and IgA levels are fluctuating around the cut-off for positivity in most assays. Hence any inconsistenciesfor participants using this testing between current and previous results are unlikely to be of major significance.

Specimen 4EThe majority of participants indicated correctly via Comments 5 “B. pertussis IgA and IgG are not suitable for immunestatus investigation” and Comment 6 “Uncertain serological significance; detected antibodies may be due to arecent infection or vaccination” that immune testing is not validated. Four participants elected not to test Specimen4E given the immune status request. This is often the best approach for these requests, if workload of the laboratorypermits it. For Participants 21439, 21624 and 41133 comments for Specimen 4E are inappropriate (Comment 4Serological evidence of recent infection). Please review. The finding of a positive pertussis serological result (eventoxin IgG) in this context is not indicative of recent infection. Comments for Specimen 4E from Participants 21624 and51077 are also inappropriate (Comment 7 If symptoms have been present for less than 3-4 weeks the collection ofNPA, deep nasal swab, throat swab or sputum for PCR testing is recommended). Although it is frequent laboratorypractice to request a follow-up sample, in this particular clinical context it is not appropriate (Participants 21375,21624, 51077, 89061, 89114 and 89318), as a follow-up sample is not going to provide further diagnostic information.

Specimen 4FRegardless of testing used, results for Specimen 4F were consistently negative for all antigens tested. (The positivetoxin IgG result from Participant 89197 appears to be a transcription error - please review.) The only exception was theEuroimmun Bordetella toxin IgA which had positive results for all users, all of a similar magnitude to when thespecimen was last tested in the previous survey as Specimen 2E. It is difficult to ascertain the significance of thisobservation. Comments correctly indicated in the majority of cases that results indicated no evidence of recentinfection. Participants 89061 interpreted a positive whole cell B pertussis IgG result as evidence of recent infection(Comment 4). This is not correct. Positive whole cell pertussis IgG results indicate possible past exposure, but are toonon-specific to diagnose recent infection. Most participants also correctly suggested either (Comment 7) PCR testingand/or follow-up serology samples (Comment 8).

References1) EUpert-Labnet surveillance network. Guidance and protocol for the serological diagnosis of human infection

with Bordetella pertussis. Version 1.0, October 2012.http://ecdc.europa.eu/en/publications/_layouts/forms/Publication_DispForm.aspx?ID=704&List=4f55ad51-4aed-4d32-b960-af70113dbb90 accesed 28/10/2015

2) May ML, et al. Prospective Evaluation of an Australian Pertussis Toxin IgG and IgA Enzyme Immunoassay. ClinVaccine Immunol 2012; 19(2):190.

3) Tondella ML, et al. Interntaional Bordetella pertussis assay standardization and harmonization meeting report.Centres for Disease Control and Prevention, Atlant, Georgia, United States, 19-20 July 2007. Vaccine 2009; 27:803-814.

4) Campbell P, et al. Increased Population Prevelance of Low Pertussis Toxin Antibody Levels in Young ChildrenPreceding a Record Pertussis Epidemic in Australia. PLoS ONE 7(4): e35874. doi: 10.1371/journal.pone.0035874

Comments prepared for and on behalf of RCPAQAP by Dr Meryta May, Paediatric Infectious Diseases Specialist andClinical Microbiologist, Sullivan Nicolaides Pathology, QLD, Australia.


Bordetella pertussis Results Summary for Survey P4:2015:4E & 4F

Part


IgG IgA IgM IgG(Toxin & FHA)

IgA(Toxin & FHA)

IgM(Toxin & FHA)

ToxinIgG

ToxinIgA Interp IgG IgA IgM IgG

(Toxin & FHA)IgA

(Toxin & FHA)IgM

(Toxin & FHA)Toxin

IgGToxin

IgA Interp

21092 neg neg 3,5 neg neg 3,7,821229 not tested 10 neg 3,821267 not tested not tested 5 neg neg 3,721292 neg not tested 5 neg neg 3,721375 pos neg 6,8 neg neg 1,321401 equ 5 neg 3,721439 pos 4 neg 3,821624 pos pos pos 4,7,8 neg neg neg 1,7,821763 pos pos 6 neg neg 3,731221 equ pos 5 neg not tested 331252 pos not tested 5 neg neg 1,3,7,831293 pos 5,6 neg 3,731342 neg pos 5,6 neg neg 3,7,831369 neg pos 5 neg neg 7,841018 not tested 5 neg 3,7,841125 pos pos 5,6 neg neg 3,7,841133 pos 4,5 neg 3,7,841183 neg not tested 5 neg neg 1,3,7,841302 neg pos 5,6 neg neg 3,5,7,851077 equ 6,7,8 neg 1,3,7,859006 equ 5,6 neg 3,761247 pos 5 neg 3,861253 neg 3,5 neg 3,861455 not tested 5 neg 3,789061 neg 3,8 pos 489072 pos neg89114 neg pos 1,3,8 neg pos 3,889123 pos pos 2 neg pos 489149 neg pos neg neg89152 equ pos 5,6 neg pos 6,7,889153 neg pos neg pos


Bordetella pertussis Results Summary for Survey P4:2015:4E & 4F

Part


IgG IgA IgM IgG(Toxin & FHA)

IgA(Toxin & FHA)

IgM(Toxin & FHA)

ToxinIgG

ToxinIgA Interp IgG IgA IgM IgG

(Toxin & FHA)IgA

(Toxin & FHA)IgM

(Toxin & FHA)Toxin

IgGToxin

IgA Interp

89197 pos pos pos equ pos neg neg neg pos neg89318 neg equ 6,8 neg neg 1,389319 pos 5,6 equ 7,891089 neg 3,5 neg 3,7,891119 neg 3 neg 391317 neg 10 neg 1,3,891487 pos pos 6 neg neg 3,7,8

Bordetella pertussis IgG Results for Survey P4:2015:4E & 4F

Part Manufacturer Kit Name Method Automation Lot No. ExpiryDate Units Cut

OffValue

4EResult

4EValue

4FResult

4F89061 BioAdvance Eurolines Bordetella pertussis IgG WB - D150623AC Dec 16 S/CO 10 5 neg 26 pos

91119 Euroimmun Anti-Bordetella IgG ELISA Triturus E141013AE Dec 15 U/mL 100 30.1 neg <5 neg

41125 NovaTec Immundiagnostica NovaLisa Bordetella pertussis IgG ELISA Evolis BOPG-114 May 16 NTU 11 14.75 pos 2.35 neg

21624 Ridascreen Bordetella IgG EIA - 12384 Aug 16 U/mL 30 121 pos 1 neg

89123 Sekisui Virotech B.pertussis IgG/IgA ELISA Eti-Max 3000 E150625AW Jun 16 U/mL 100 35.2 pos <5 neg

21763 Siemens Healthcare Diagnostics Novagnost Bordetella pertussis IgG EIA BEP2000 BOPG-114 Feb 16 U 11.5 16.6 pos 2.04 neg

89072 Virion Serion Bordetella pertussis IgG ELISA - SBE.CY Sep 15 OD 30 188.30 pos 16.94 neg

89072 The test was performed on 24 Sept 2015 which is before the expiry of the kit.


Bordetella pertussis IgM Results for Survey P4:2015:4E & 4F


OffValue

4EResult

4EValue

4FResult

4F89318 Euroimmun Anti-Bordetella IgM ELISA Eti-Max E150409BO Apr 16 S/CO 1.1 0.69 neg 0.38 neg

Bordetella pertussis IgA Results for Survey P4:2015:4E & 4F


OffValue

4EResult

4EValue

4FResult

4F21439 NovaTec Immundiagnostica NovaLisa Bordetella pertussis IgA ELISA SQII BOPA-115 Aug 16 NTU 11 17.51 pos 3.75 neg41125 NovaTec Immundiagnostica NovaLisa Bordetella pertussis IgA ELISA Evolis BOPA-115 Aug 16 NTU 11 19.27 pos 2.67 neg61455 NovaTec Immundiagnostica NovaLisa Bordetella pertussis IgA ELISA Triturus BOPA - 115 Aug 16 S/CO 1.1 not tested 0.29 neg

21624 Ridascreen Bordetella IgA EIA - 14105 Jan 17 U/mL 30 127 pos 9 neg

89123 Sekisui Virotech B.pertussis IgG/IgA ELISA Eti-Max 3000 E150618AS Jun 16 U/mL 12 33.9 pos 18.7 pos

31293 Siemens Healthcare Diagnostics Novagnost Bordetella pertussis IgA EIA BEP 2000 112 Dec 15 NTU 10 17.70 pos 3.50 neg21229 Siemens Healthcare Diagnostics Novagnost Bordetella pertussis IgA EIA - BOPA-115 May 16 S/CO 1.15 not tested 0.25 neg21763 Siemens Healthcare Diagnostics Novagnost Bordetella pertussis IgA EIA BEP 2000 BOPA-112 Dec 15 U 11.5 29.5 pos 3.58 neg41018 Siemens Healthcare Diagnostics Novagnost Bordetella pertussis IgA EIA - BOPA -112 Dec 15 OD 0.294 not tested 0.136 neg41133 Siemens Healthcare Diagnostics Novagnost Bordetella pertussis IgA EIA - BOPA-112 Dec 15 S/CO 1.15 2.76 pos 0.36 neg

21229 4E not tested as this serological test is not recommended for the determination of immunity to Pertussis.

Bordetella pertussis Toxin & FHA IgG Results for Survey P4:2015:4E & 4F


OffValue

4EResult

4EValue

4FResult

4F31252 Savyon Diagnostics SeroPertussis IgG ELISA Triturus 231-51237600 Jun 16 BU/mL 10 63.2 pos 0 neg89197 Savyon Diagnostics SeroPertussis IgG ELISA - 231-S1237600 Jun 16 BU/mL 10 64 pos -15 neg91487 Savyon Diagnostics SeroPertussis IgG ELISA Triturus 231-S0537900 Nov 15 BU/mL 20 60 pos <10 neg


Bordetella pertussis Toxin & FHA IgM Results for Survey P4:2015:4E & 4F

Part Manufacturer Kit Name Method Lot No. ExpiryDate Units Cut

OffValue

4EResult

4EValue

4FResult

4F89197 Savyon Diagnostics SeroPertussis IgA/IgM ELISA 230-S0534400 Dec 15 S/CO 1-1.1 1.170 pos 0.99 neg

Bordetella pertussis Toxin & FHA IgA Results for Survey P4:2015:4E & 4F


OffValue

4EResult

4EValue

4FResult

4F31252 Savyon Diagnostics SeroPertussis IgA/IgM ELISA Triturus 233-51130300 May 16 S/CO 1.1 not tested 0.11 neg61247 Savyon Diagnostics SeroPertussis IgA/IgM ELISA Triturus 233-S1130300 May 16 S/CO 1.1 1.79 pos 0.09 neg89197 Savyon Diagnostics SeroPertussis IgA/IgM ELISA - 230-T0173100 Dec 15 S/CO 1-1.1 3.258 pos 0.152 neg91487 Savyon Diagnostics SeroPertussis IgA/IgM ELISA Triturus 233-S1130300 May 16 S/CO 1.1 2.18 pos 0.08 neg

Bordetella pertussis Toxin IgG Results for Survey P4:2015:4E & 4F


OffValue

4EResult

4EValue

4FResult

4F21092 Diasorin Liaison B pertussis toxin IgG CLIA Liaison XL 237001 Jul 16 IU/mL 100 32.6 neg 10 neg21267 DiaSorin Liaison Bordetella pertussis Toxin IgG CLIA Liaison XL 237001 Oct 15 IU/mL 100 not tested <10.0 neg21292 Diasorin Liaison Bordetella pertussis Toxin IgG CLIA Liaison XL 237001 Jul 16 IU/mL 100 32.3 neg <10.0 neg41183 Diasorin Liaison Bordetella pertussis Toxin IgG ChLIA Liaison XL 237001X Jul 17 IU/mL 100 34.6 neg <10.0 neg

21401 Euroimmun Bordetella IgG toxin ELISA Evolis E150416AL Apr 16 IU/mL 100 42 equ <5 neg51077 Euroimmun Bordetella IgG toxin ELISA - E150416AL Apr 16 IU/mL 40 40 equ 5 neg61253 Euroimmun Bordetella IgG toxin ELISA BEP 2000 E150416AL Apr 16 IU/mL 100 33.30 neg 9.60 neg89152 Euroimmun Bordetella IgG toxin ELISA - E150416AL Apr 16 IU/mL 100 44.46 equ <5 neg91089 Euroimmun Bordetella IgG toxin ELISA Quantalyser 160 E150416AL Apr 16 IU/mL 100 26.35 neg 2.68 neg91317 Euroimmun Bordetella IgG toxin ELISA DS2 E150416AL Apr 16 IU/mL 100 39 neg <5 neg89318 Euroimmun Anti-Bordetella IgG ELISA Triturus E150416AL Apr 16 IU/mL 40 47.76 equ <5 neg31221 Euroimmun Bordetella IgG toxin ELISA Euroimmun Analyser E150625AW Jun 16 IU/mL 100 40.5 equ <5 neg89114 Euroimmun Bordetella IgG toxin ELISA Eti-Max 3000 E150625AW Jun 16 IU/mL 100 28.5 neg <5 neg59006 Euroimmun Bordetella IgG toxin ELISA - EI50416AL Apr 16 IU/mL 100 55 equ <5 neg89153 Euroimmun Bordetella IgG toxin ELISA Eti-Max 3000 E150416AL Apr 16 U/mL 100 33 neg <5.0 neg


Bordetella pertussis Toxin IgG Results for Survey P4:2015:4E & 4F


OffValue

4EResult

4EValue

4FResult

4F41302 In house B. pertussis Toxin IgG EIA - 15201 Jul 16 IU/mL 100 56 neg <20 neg89319 In house B.pertussis toxin IgG EIA - NA NA U/mL 10 64 pos 15 equ

21375 MEDAC B PERTUSSIS TOXIN IgG EIA NO PTG-05 Dec 15 IU/mL 40 40 pos <10 neg

21624 Ridascreen IgG Toxin Elisa - 13294 Mar 16 U/mL 30 37 pos 5 neg

31342 Savyon Diagnostics SeroPertussis Toxin IgG ELISA DS2 1231-S0649800 Dec 15 IU/mL 100 21.4 neg 1.7 neg31369 Savyon Diagnostics SeroPertussis Toxin IgG ELISA BEP 2000 T0307200 Oct 16 IU/mL 100 38.7 neg <30 neg89149 savyon diagnostic pertusis toxin eia triturus 1231-TO306700 May 16 U/mL 100 27.5 neg 5.32 neg89197 Savyon Diagnostics SeroPertussis Toxin IgG ELISA - 1231-T0173200 Jul 16 BU/mL 40 47 equ 5 pos

61253 Automated system is BEP 2000. Could BEP 2000 be added to the drop down menu for kit ID.89318 Euroimmun reports in IU/mL

Bordetella pertussis Toxin IgA Results for Survey P4:2015:4E & 4F


OffValue

4EResult

4EValue

4FResult

4F21092 Diasorin Liaison B pertussis toxin IgA CLIA Liaison XL 235001 Jul 16 IU/mL 12 10.3 neg 6 neg21267 Dia Sorin Liaison Bordetella pertussis Toxin IgA CLIA Liaison XL 235001 Oct 15 IU/mL 12 not tested <6.0 neg21292 Diasorin Liaison Bordetella pertussis Toxin IgA CLIA Liaison XL 235001 Jul 16 IU/mL 12 not tested <6.0 neg41183 Diasorin Liaison Bordetella pertussis Toxin IgA ChLIA Liaison XL 235001X Jul 17 IU/mL 12 not tested <6.0 neg

31221 Euroimmun Bordetella toxin IgA ELISA Euroimmun Analyser E150521BF May 16 IU/mL 12 33.9 pos not tested89114 Euroimmun Bordetella IgA toxin ELISA Eti-Max 3000 E150610AM Jun 16 IU/mL 12 32.4 pos 14.7 pos89152 Euroimmun Bordetella IgA toxin ELISA - E150618AS Jun 16 IU/mL 12 30.59 pos 18.97 pos89153 Euroimmun Bordetella IgA toxin ELISA Eti-Max 3000 E150610AM Jun 16 IU/mL 12 33.0 pos 15.0 pos

41302 In house B. pertussis Toxin IgA EIA - 15161 Jun 16 IU/mL 20 25 pos <5 neg

21375 MEDAC B PERTUSSIS TOXIN IgA EIA NO PTA - 05 Dec 15 IU/mL 12 <10 neg <10 neg


Bordetella pertussis Toxin IgA Results for Survey P4:2015:4E & 4F


OffValue

4EResult

4EValue

4FResult

4F31342 Savyon Diagnostics SeroPertussis Toxin IgA/IgM ELISA DS2 1233-T0173100 Jul 16 IU/mL 12 18.0 pos 2.0 neg31369 Savyon Diagnostics SeroPertussis Toxin IgA/IgM ELISA BEP 2000 T0172400 May 16 IU/mL 12 19 pos <10 neg89149 savyon diagnostics pertusis toxin eia triturus 1233TO307200 Oct 16 U/mL 12 23 pos 3.4 neg89197 Savyon Diagnostics SeroPertussis Toxin IgA/IgM ELISA - 1233-R0754300 Jul 16 U/mL 12 24 pos 2 neg

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