TESSy - The European
Surveillance System
Gonococcal Antimicrobial Surveillance
Reporting Protocol 2019
Euro-GASP
Surveillance data for 2018 and 2019
March 2019
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Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Contents
Introduction ............................................................................................................... 6
How to use this document ..................................................................................................... 6
Finding further information .................................................................................................... 7
Copyright ............................................................................................................................. 7
Framework for European Gonococcal Antimicrobial Surveillance Programme: isolates
collected in 2018 and 2019 ......................................................................................... 8
Isolate collection................................................................................................................... 8
Submitted isolates ........................................................................................................... 8
Selection criteria .............................................................................................................. 8
Submission of isolates for centralised testing ..................................................................... 8
Schedule of isolate collection 2018/2019 ........................................................................... 8
Data collection ..................................................................................................................... 9
Epidemiological information .............................................................................................. 9
Centralised testing ........................................................................................................... 9
Susceptibility testing ............................................................................................................. 9
Centralised testing ........................................................................................................... 9
Decentralised testing ..................................................................................................... 10
National protocol ................................................................................................................ 11
Gonococcal susceptibility data analysis ........................................................................... 11
Reporting to TESSy ................................................................................................. 13
Checking the data collection schedule ................................................................................. 13
Preparing data ................................................................................................................... 13
Checking metadata ............................................................................................................ 13
Checking your data source profile ....................................................................................... 14
Submitting your data ........................................................................................................... 14
Finalising your submission .................................................................................................. 14
Changes in current GONOAMR metadata .................................................................. 16
Annex 1 GONOAMR metadata .................................................................................. 17
GONOAMR metadata set ................................................................................................... 17
GONOAMR metadata change history .................................................................................. 26
GONOAMR metadata change history ............................................................................. 26
Annex 2 GONOAMR-specific material ........................................................................ 28
Procedure for saving gonococcal isolates ............................................................................ 28
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Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Annex 3 Protocol for Euro-GASP implementation at the national level .......................... 30
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Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
List of tables
Table 1: Description of the variables to be collected for the European Gonococcal Antimicrobial
Surveillance Programme. .............................................................................................................17
Table 2: Validation rules ...............................................................................................................21
Table 3: Euro-GASP data source variables ....................................................................................25
Table 4: Summary of implemented general changes (applicable to several record types)..................26
Table 5: Concentrations (mg/L) of antimicrobials used for the agar dilution breakpoint technique ......28
Table 6. WHO Control Strains for use in Euro-GASP – MICs and susceptibility categories (SCs)
obtained from Euro-GASP data .....................................................................................................29
Table 7. MIC breakpoints for specific antimicrobials .......................................................................29
Table 8. Euro-GASP information form ...........................................................................................30
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Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Introduction
The emergence of antimicrobial resistance (AMR) in Neisseria gonorrhoeae (NG) is a serious threat to
the treatment and control of gonorrhoea. Numerous formerly effective therapeutic agents can no
longer be used due to the emergence of resistance and subsequent rapid global spread. The
development and spread of resistance to third generation cephalosporins in recent decades has
further limited treatment options. The current European guideline recommends dual treatment with
ceftriaxone and azithromycin to try to delay the development and/or spread of resistance against the
last options for treatment.
One of the specific objectives for surveillance of sexually transmitted infections in Europe is “to detect
and monitor the resistance patterns in gonococci, preferably by epidemiological characteristics, in
Europe to contribute to the treatment guidelines of gonorrhoea and to ensure appropriate treatment
by promoting the coordination of laboratory network on gonococci resistance testing, including quality
assurance and training.” In order to fulfil this objective, the European Gonococcal Antimicrobial
Surveillance Programme (Euro-GASP) was launched in August 2009, and is currently outsourced to an
international team lead by Public Health England and Örebro University Hospital (Sweden).
The current objectives and scope of Euro-GASP are:
Support the ECDC in monitoring the susceptibility of N. gonorrhoeae isolates in the European
Union/European Economic Area (EU/EEA) and EU enlargement countries by conducting
surveillance for antimicrobial resistance in gonococci;
Support EU/EEA Member States and EU enlargement countries in developing high quality
antimicrobial susceptibility testing and molecular typing including whole genome sequencing
(WGS);
Support EU/EEA Member States in improving the quality of epidemiological data reported
through Euro-GASP;
Through an external quality assessment (EQA) scheme, assess the accuracy of quantitative N.
gonorrhoeae antimicrobial susceptibility testing reported by participating laboratories and the
comparability of results between laboratories in order to identify any training needed for
targeted capacity building;
Perform WGS of N. gonorrhoeae strains in order to inform about the geographic and temporal
distribution patterns of public health relevant strains of N. gonorrhoeae in the EU/EEA region,
including associations between genotype, antimicrobial resistance and patient characteristics;
Provide training on STI laboratory diagnostics, N. gonorrhoeae susceptibility testing and
molecular typing including WGS.
Sentinel surveillance has followed a hybrid centralized-decentralized model, with some countries
performing susceptibility testing in their own laboratories, while others lacking capacity have sent
isolates to hub laboratories.
This protocol presents the instructions for collecting gonococcal strains and reporting of AMR data in
the European surveillance system (TESSy).
The Reporting Protocol is supplemented by the
Technical Annex, which contains updated generic
information for each data collection.
Likewise, the Surveillance Protocol will contain some of the generic information previously contained
in the Reporting Protocols.
How to use this document
This Reporting Protocol provides information for laboratories participating in Euro-GASP and reporting
countries’ data managers in three main sections:
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Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Information on the
European Gonococcal Antimicrobial Surveillance Programme.
Reporting to TESSy – contains guidelines on how to prepare data for submission to TESSy,
deadlines, subject-specific information (e.g. new changes to metadata), and links to further
information.
Annex 1 – contains:
o A history of metadata changes for the subject(s) covered by this Reporting Protocol.
o The metadata set for the subject(s) covered by this Reporting Protocol.
Annex 2 – contains subject-specific material relevant for distribution with the Reporting
Protocol, including:
o Contact information
o Testing protocols
Annex 3 – contains information related to the protocol for implementation of Euro-GASP at a
national level
Finding further information
Paragraphs denoted by the information icon tell where you can find further information.
Updated links to all the schedules, documentation and training materials mentioned in this Reporting
Protocol are included in the
Technical Annex, including:
Metadata sets and history.
Tutorials for data transformation using respectively Excel and Access.
TESSy user documentation.
CSV and XML transport protocols.
Copyright
© European Centre for Disease Prevention and Control, 2019. Reproduction is authorised, provided
the source is acknowledged.
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Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Framework for European Gonococcal
Antimicrobial Surveillance Programme: isolates
collected in 2018 and 2019
Isolate collection
Submitted isolates
Each country should aim to collect 110 gonococcal isolates each year, with the overall aim to retrieve
and test 100 isolates (200 isolates in some countries, see below). Countries participating in centralised
testing should collect a minimum number of 10 isolates per year for a shipment to be organised. If
less than 10 isolates are available then multiple years can be combined and the results added to ECDC
surveillance atlas for those years, even if the reports for those years have been published.
For countries performing decentralised testing where 100 isolates likely represent less than 10% of
the total number of cases of gonorrhoea (Belgium, Denmark, France, Germany, Hungary, Ireland, the
Netherlands, Spain, Sweden and the United Kingdom), up to 200 isolates should be collected in order
to provide a more representative sample. If more than 200 isolates are reported in TESSy, the first
two hundred isolates by date of diagnosis may be selected for analysis if a justification to include the
additional isolates is not available.
Selection criteria
Isolates should be selected from consecutive patients and from patients representing different patient
groups and geographical regions within the country to reflect the distribution of gonorrhoea cases in
that country, if known. Consecutive isolate selection may not be possible if particular patient
groups/regions are selected or if isolates with corresponding epidemiological data are selected in
place of isolates with no data. Care should be taken to avoid selection bias.
Multiple isolates from a single patient should be considered as a single episode of infection if the
isolates were recovered within a period of ≤4 weeks, and only one isolate should be submitted,
according to the hierarchy below. Where more than one isolate is collected from a patient, then a
hierarchy of desired isolates for collection would be:
Males - 1. Pharyngeal 2. Rectal 3. Urethral 4. Other
Females – 1. Pharyngeal 2. Cervical 3. Other anogenital (High vaginal swab (HVS)/rectal/urethral) 4.
Other
Given the current view that cephalosporin resistance emerged through interaction between
commensal Neisseria species and N. gonorrhoeae in the pharynx and the fact that cephalosporins and
most other antimicrobials have a lower efficacy in the pharynx, pharyngeal samples (where available)
should be selected first as cephalosporin resistance is most likely to develop at this site.
Submission of isolates for centralised testing
Each participating laboratory will be provided with cryopreservative beads to store gonococcal isolates
(see Annex 1) until collection by courier once annually.
Schedule of isolate collection 2018/2019
The collection dates are between September and November. Countries with low collection numbers
should use isolates from throughout the year. In addition, isolates outside of the September-
November collection period may be submitted if this enables a more representative isolate set from
patients to be submitted (i.e. isolates representing different patient groups and geographical regions
within the country to reflect the distribution of gonorrhoea cases in that country).
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Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Data collection
It is the aim of this surveillance system to link N. gonorrhoeae susceptibility data with basic
epidemiological data to get an overview of risk groups and to target prevention measures. All data
from the AMR susceptibility testing should be submitted to TESSy. The set of variables and validation
rules are described in the section
GONOAMR metadata set. This section also includes the variables
which are part of the “Datasource”. Instructions on data reporting can be found in the section
Reporting to TESSy.
Epidemiological information
A set of variables is collected as part of the enhanced STI surveillance and submitted by the national
STI surveillance contact points in each country. It is suggested that the same source of
epidemiological information is used for the GONOAMR surveillance database where it is possible to
link the epidemiological information with the microbiological information in case-based formats.
The method of obtaining epidemiological data could be implemented as follows:
1. The STI microbiology contact points who are submitting or testing isolates for AMR
surveillance, will contact the national contact points for STI surveillance, who will already
have collated this information, and request the information. This will require a patient
identifier – at national level - to link the information. However, the patient identifier should
not be sent to TESSy, it should be used for internal purposes only.
2. If the information submitted by the national contact points for STI surveillance cannot be
linked with gonococcal isolates and associated antimicrobial susceptibility data (e.g. if the
data for STI surveillance are aggregate, or there is no shared patient identifier between the
epidemiological and microbiological data), the national contact points for STI microbiology
would enter the available epidemiological data that were possible for the laboratory to
retrieve (either data submitted with the isolate or data requested from place of sample
collection).
In both instances the epidemiological and microbiology data will be submitted by the national STI
contact point (either microbiologist or epidemiologist or data managers) in TESSy.
Please note that the submission of AMR results should not be delayed by missing epidemiological
data; AMR results should be uploaded as soon as they become available and the data can be replaced
by complete data at a later stage.
Centralised testing
Where centralised testing is being carried out, the hub will send results back to member states’
laboratories. Epidemiological and AMR data should then be entered in TESSy by member states. This
could be done by the microbiology or epidemiological focal point as discussed above. As a quality
control process, the hub will be able to check with the TESSy helpdesk on whether all cases tested
have been reported through TESSy so further follow-up can be organised with individual
laboratory/epidemiological contacts.
Susceptibility testing
Centralised testing
For countries participating through centralised testing, all isolates sent to the hub will be tested for
susceptibility to the following panel of therapeutically relevant antimicrobials. Further details on the
testing methodology can be foun
d in Annex 2.
Ciprofloxacin (agar dilution breakpoint technique or MIC gradient strip testing)
Azithromycin (MIC gradient strip testing)
Cefixime (MIC gradient strip testing)
Ceftriaxone (MIC gradient strip testing)
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β-lactamase test (nitrocefin test) for detection of high-level penicillin resistance
In addition, gentamicin and spectinomycin should be tested for isolates
collected in 2019 if possible
as 2019 is a “snapshot” year1.
Laboratories participating through centralised testing will be supported to move to decentralised
testing through training, including country visits and twinning activities where necessary.
Decentralised testing
Laboratories from individual countries meeting the criteria described below will perform their own
susceptibility testing and enter their results directly into TESSy. Even though antimicrobial
susceptibility testing methods may vary, it is important that the breakpoints are harmonised and
breakpoints used in Euro-GASP are adhered to
(Annex 2). Selection criteria for decentralised testing
To ensure the data quality is maintained for decentralised testing, the criteria for selecting individual
laboratories to use their own methods to test the agreed core antimicrobial panel would include:
Laboratories should perform consistently well in the EQA (no more than 5% of MIC results
should differ by more than two doubling dilutions of the modal MICs). EQA results not
fulfilling these criteria can result in exclusion of national data for one or several years.
Laboratories should have a good comparability (at least 90% concordance between resistance
category and no more than 5% of MIC results should differ by more than two doubling
dilutions) between the laboratories own national or regional susceptibility testing data and
susceptibility data generated by centralised susceptibility testing.
If laboratories participating in decentralised testing wish to include data from gonococcal isolates that
have undergone antimicrobial susceptibility testing in other laboratories, the decentralised laboratory
needs to ensure that all submitting laboratories additionally pass the decentralised criteria stated
above. Details of these additional laboratories should be provided to the hub.
If laboratories significantly change their susceptibility testing methods i.e. changing from agar dilution
to MIC gradient strip testing, then the Euro-GASP hub should be notified. Local validation data can be
submitted to Euro-GASP for review, however this is not mandatory and decentralised laboratories are
expected to use appropriate control strains (see Annex 2) so any potential issues are identified and to
ensure consistency in the longitudinal data.
Procedure for decentralised testing
Laboratories identified as suitable candidates for participating in decentralised testing are required to:
Submit MIC data and corresponding resistance category assigned, that has been generated
using MIC gradient strip testing, the agar dilution method or the agar dilution breakpoint
method.
Use appropriate gonococcal control strains (see
Annex 2) (previously supplied by ECDC via
the EQAs, also available at NCTC) and internal quality control (IQC) data should ideally be
submitted annually to the Euro-GASP hub for quality assurance purposes. The MICs of the
control strains should be within the modal MIC ranges and the Euro-GASP hub can help in
troubleshooting if deviations from these MIC ranges are noted.
1 Gentamicin and spectinomycin are no longer routinely tested annually as neither spectinomycin nor
gentamicin is routinely used for treatment of gonorrhoea. Spectinomycin is also difficult to acquire.
However, a snapshot of the current antibiotic susceptibility situation is performed every third year
using an extended panel of antibiotics, including spectinomycin and gentamicin. This is not
mandatory. The last “snapshot” year was 2016 and 2019 is therefore a “snapshot” year.
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Test a core group of antimicrobials, ideally as close as possible to the core panel tested by the
centralised approach, but as an absolute minimum to include ceftriaxone, cefixime and
azithromycin:
o Ceftriaxone
o Cefixime
o Azithromycin
o Ciprofloxacin
o ß-lactamase/penicillinase activity
Submit susceptibility data to TESSy in a timely fashion.
In the short-term it is anticipated that data should be submitted from one laboratory per country. If
multiple testing sites exist within a country then there should be local organisation of data collection
and data should be submitted by the (main) national STI laboratory contact.
Confirmation of resistant isolates
The susceptibility testing and N. gonorrhoeae species identification should be repeated for all isolates
that are resistant to ceftriaxone (MICs>0.125 mg/L), on isolates that show elevated resistance to
cefixime (MICs>0.25 mg/L), and all isolates showing high-level resistance to azithromycin (MICs≥256
mg/L). Those isolates are also recommended to be sent to the Reference Laboratory Hub
(London/Örebro) for further verification and whole genome sequencing (including determination of
NG-MAST ST, MLST ST, NG-STAR ST and genetic resistance determinants). If necessary, a Material
Transfer Agreement (MTA) can be signed by the ECDC/Reference Laboratory Hub and the owner of
the isolates.
National protocol
Each country reporting susceptibility data should provide the following additional information on how
surveillance for N. gonorrhoeae is implemented at national level. This information is critical in
interpreting data and in ensuring accurate linking of laboratory and epidemiological data. The National
Protocol template, including data to be provided, is available in
Annex 3.
Gonococcal susceptibility data analysis
Collated data will be analysed for a brief Euro-GASP report will be analysed for emerging trends in
AMR. All susceptibility category data will be available on-line here:
https://atlas.ecdc.europa.eu/public/index.aspx. The following analyses are currently performed and a
selection included in the surveillance report. Additional analyses might be included in the report based
on emerging trends:
1. Summary of isolates tested and percentage of epidemiological data completeness for
each country (table).
2. Patient characteristics reported for Euro-GASP gonococcal isolates (table).
3. Patient age distribution by gender and sexual orientation (table).
4. Overall incidence of resistance for each included antimicrobial for each testing year (line
graph).
5. Resistance to cefixime, azithromycin and ciprofloxacin, beta-lactamase production, by
country with trends over time (table).
6. Map of proportion of isolates with cefixime resistance by country.
7. MIC distribution by year for cefixime (bar graph).
8. Percentage of isolates with cefixime resistance by gender and sexual orientation (line
graph).
9. MIC distribution by year for ceftriaxone (bar graph).
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10. Map of proportion of isolates with azithromycin ECOFF > 1 mg/L by country.
11. MIC distribution by year for azithromycin (bar graph).
12. Percentage of isolates with azithromycin ECOFF > 1 mg/L by gender and sexual
orientation (line graph).
13. Ciprofloxacin resistance by gender and sexual orientation (described in text).
14. Summary of diagnostic tests used (supplementary table).
15. Percentage of known treatments used (supplementary table).
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Reporting to TESSy
This section provides both an overview of the TESSy reporting process and tips on where you can find
useful information.
The overall process is:
1.
Familiarise yourself with the data collection deadlines.
2.
Prepare (export and transform) your data.
3.
Check that your data complies with the metadata.
4.
Check that your data source profile is up-to-date.
5.
Submit your file(s) to TESSy.
6.
Finalise and approve your submission.
Checking the data col ection schedule
An updated link to the current data collections schedule is provided in the
Technical Annex.
The deadline for reporting isolates collected in 2018 is 31 May 2019. The aim is to produce a report
on 2018 data before the end of 2019. Please note that if epidemiological data is not available by the
collection deadline, this can still be uploaded to TESSy at a later stage. It is important that schedules
are respected to achieve the updated timeframes. Countries not reporting in time will be excluded
from the 2018 report.
Any emerging AMR issues which need to be disseminated rapidly can also be reported via EPIS STI
(Epidemic Intelligence Service for STI).
Preparing data
After you have exported the data from your national database, you need to ensure that the data are
in a format that TESSy can accept. This applies both to the type of file submitted to TESSy (only CSV
and XML files can be submitted) and to the format of the data in certain fields.
Tutorials covering how you can transform your data to the correct TESSy format using Excel or
Access are available on the TESSy documents website. Information on the file formats is available in
the CSV Transport Protocol and XML Transport Protocol.
Checking metadata
The TESSy metadata define the fields and data formats that are valid as input to TESSy for a given
subject.
As requirements to the data to be shared among TESSy users change, the data changes needed to
support the new requirements are identified and agreed upon between the National Surveillance
Contact Points, the Network Coordination Groups and ECDC’s Disease Experts, and then implemented
as changes to the TESSy metadata.
In order to ensure that your data can be saved correctly in TESSy, you therefore need to check that
your data are correctly formatted according to the most recent metadata set.
Changes to the metadata for the subject of this Reporting Protocol are described in:
Changes to current metadata – changes since the last Reporting Protocol.
Annex 1 Metadata change history – all preceding changes.
It is especially important to focus on:
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Field formats
Many fields require that data are formatted in a specific way. For example, dates must be in the
YYYY-MM-DD format; dates in the DD/MM/YYYY format will be rejected.
Coded values
Some fields only permit the use of specific values (coded values). For example,
M,
F,
UNK, or
Other are the
coded values for Gender and any other value in a Gender field will be rejected.
The metadata file contains all the definitions and rules you need to comply with to format your data
correctly for every subject (usually a disease). The file can be downloaded as an Excel file from the
TESSy documents website.
By filtering the fields in the file by subject, you can see the fields required for your subject and the
rules applying to these fields.
The
Technical Annex provides an overview of how you work with the metadata file, and the
TESSy user documentation provides in-depth details on metadata.
Checking your data source profile
Before submitting your file(s), please review the profile for your data source(s) in TESSy (go to
Data
Sources), and update the information, if necessary.
Complete and up-to-date data source information for each subject is important for improving
interpretation of data - each surveillance system has different features that need to be taken into
account when comparing data at an international level.
If your data source information is out-of-date and you do not have access rights to update it, please
request your National Focal Point for Surveillance or National Coordinator to do so.
In-depth information on the data source variables is available in the TESSy user documentation.
Submitting your data
Data is submitted through the TESSy web interface (go to
Upload).
The
Technical Annex provides an overview of how you submit files to TESSy, and the TESSy user
documentation provides in-depth descriptions of all the upload methods.
Finalising your submission
The compliance of your data with the validation rules in the metadata is checked automatically during
the data upload process.
The result of your upload – i.e. rejected or validated – is displayed immediately after the conclusion
of the check in the
Validation details webpage. Please review the result carefully:
If your file has been rejected, there will be a message explaining each instance of non-
compliance with the metadata that you need to correct.
If your file has been validated, there might be warnings and remarks relating to possible data
quality issues or to potential overwriting of existing records that you should consider.
When your file has been validated and you are satisfied that all corrections have been made, please
ensure prompt approval – unapproved uploads can block for the approval of other uploads.
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The TESSy user documentation provides information on reviewing validation results and adjusting
reporting periods to avoid overwriting existing records.
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Changes in current GONOAMR metadata
The 2018 changes are summarised in Annex 1:
Table 4: Summary of implemented general changes
(applicable to several record types)
The previous metadata changes are described in
Annex 1.
Information on changes to the metadata for other subjects is available on the TESSy
documentation website.
In 2019 additional validation rules have been introduced and applied to RecordType 8:
The variables AZMSIR, CROSIR, CIPSIR, CFMSIR and SPTSIR have been made mandatory,
however UNK is allowed. Reporting of the SIR variables is essential to allow for appropriate
analysis and display of the data in the surveillance atlas
For the variables CROSIR, CIPSIR, CFMSIR and SPTSIR and respective ResultSign variables, a
warning is given if SIR is "I" and ResultSign is not "=". For variables AZMSIR, CROSIR, CIPSIR,
CFMSIR and SPTSIR if SIR is "R" and ResultSign is "<" and if SIR is "S" and ResultSign is ">".
This has been introduced as some errors with the ResultSign variables have been noticed.
For variable AZMSIR the ECOFF at 1 mg/L should be used for “R”, <=1 mg/L should be “S”.
Please note that the ECOFF is not to be used for recording resistance and susceptibility, but for
distinguishing between isolates with acquired resistance mechanisms (MIC > 1 mg/L).
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Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Annex 1 GONOAMR metadata
This section describes:
The GONOAMR metadata set
Previous changes to the GONOAMR metadata
GONOAMR metadata set
Table 1: Description of the variables to be collected for the European Gonococcal Antimicrobial
Surveillance Programme.
Note: Changes from previous versions are highlighted.
Variable
Variable description
Coding
Validation rules
RecordId
Unique identifier for each record
Text
Mandatory
within and across the national
surveillance system – Member
State selected and generated. A
unique identifier must be used for
all years; repeat use of a specific
identifier will replace the contents
of the original entry. We suggest to
include the isolate year in the
RecordId to avoid overwriting data.
RecordType
RecordType corresponding to the
GONOAMR
Mandatory
Subject
RecordTypeVersion
Version of the RecordType used.
8
This should be reported as 8. If
you use different RecordType
versions the data may be rejected.
Status
Default if left out: NEW/UPDATE. If Status of reporting
set to DELETE, the record with the
NEW/UPDATE or DELETE
given RecordId will be deleted from (inactivate).
the TESSy database (or better
stated, invalidated). If set to
NEW/UPDATE or left empty, the
record is newly entered into the
database.
Subject
Subject corresponding to the
GONOAMR
Mandatory
RecordType
ReportingCountry
The country reporting the record.
ISO coded value list
Mandatory
DataSource
The data source for AMR NG
Coded value list; codes
Mandatory
(laboratory) that the record
maintained by each
originates from.
Member State in the Data
Source editing interface in
TESSy
DateUsedForStatistics
Date the specimen was taken from
Preferred format: yyyy-
Mandatory
the patient, alternatively use date
mm-dd
received in laboratory
Gender
Gender of the infected person
F = Female
Mandatory
M = Male
O = Other
UNK = UNK
Age
Age in years of patient as reported
0-120, UNK
Mandatory
in the national system
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Variable
Variable description
Coding
Validation rules
PlaceOfResidence
Place of residence of patient, NUTS NUTS code 0-3. Available
level 0-3 (region)
from the TESSy
metadataset (sheet “coded
value lists”; coded value
list “NUTS”)
ClinicalServiceType
Type of clinical service where
ANC - ANC
patient was first seen
COMB - Combined service
DV - Dermatology-
venereology clinic
ED - Hospital Emergency
Dept
FPC - Family Planning
Clinic
GP - General Practitioner
GYN - Gynaecology clinic
ID - Infectious disease
clinic
OPC - Other primary care
STI - Dedicated STI clinic
URO - Urology
YTH - Youth clinics
O - Other
UNK – Unknown
ClinicLocation
Clinic location
Free text address using the
format: Street, Number,
Postcode, City. As a
minimum please report
City.
ClinicCoordinates
Clinic coordinates
Latitude and Longitude of
the STI clinic where the
case was tested. Latitude
and Longitude in this
order. Format: NN.NN,
NN.NN
CountryOfBirthGONOAMR
Country of birth of patient
ISO coded value list
(Country), UNK
ProbableCountryOfInfectio
Probable country(ies) of infection,
ISO coded value list, UNK
n
country(ies) visited during the
incubation period of the reported
disease.
Repeatable field.
Transmission
Mode of transmission
HETERO = Heterosexual
Error if Transmission
contact
= MSM and Gender
MSM = MSM/homo or
= F
bisexual male
Error if Transmission
MTCT = Mother-to-child
= MSM, Gender is
transmission
not Male or Other
O = Other
UNK = Unknown
SiteOfInfection
Site of Infection
AR = Ano-Rectal
GEN = Genital
PH = Pharyngeal
O = Other
UNK = Unknown
PrevGono
Existing evidence about previous
Y = Yes
gonorrhoea
N = No
UNK =Unknown
© ECDC March 2019 All rights reserved.
Page 18 of 31
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Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Variable
Variable description
Coding
Validation rules
HIVStatus
HIV Status of patient at time of
POS = Positive
diagnosis
POSKNOWN = Known HIV
positive
POSNEW = New HIV
diagnosis
NEG = Negative
UNK = Unknown
ConcurrentSTI
Concurrent STI
CHLAM = Chlamydia
HEPB = Hepatitis B
HEPC = Hepatitis C
HERP = Genital herpes
LGV = LGV
SYPH = Syphilis
WARTS = Genital warts
MYCO = Mycoplasma
genitalium
NO = No concurrent STI
UNK = Unknown
ResultPor2
porB allele number generated from Number
number should be
a 490 nucleotide porB sequence
>=1 and an integer
submitted to the NG-MAST website
(http://www.ng-mast.net)
ResultTbp
B2
tbpB allele number generated from Number
number should be
a 390 nucleotide tbpB sequence
>=1 and an integer
submitted to the NG-MAST website
(http://www.ng-mast.net)
ResultSeqTyp
e2
NG-MAST sequence type. A
Number
number should be
combination of the porB and tbpB
>=1 and an integer
allele numbers, obtained by
submission to the NG-MAST
website (http://www.ng-mast.net)
Genogro
up2
NG-MAST genogroup as defined in
‘G’ and number e.g. G1407
molecular typing surveys
DiagnosticTest
Diagnostic test used
CULT = culture (including
methods used to identify
Note: this is a repeatable field and
N. gonorrhoeae from
multiple columns with this variable
culture, such as MALDI-
name can be included.
TOF, API and Phadebact)
MICRO = microscopy
N/A = Not applicable
NUCLACID = detection of
nucleic acid
O = Other
UNK = Unknown
2 To upload only for years when whole genome sequencing studies are implemented
© ECDC March 2019 All rights reserved.
Page 19 of 31
Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Variable
Variable description
Coding
Validation rules
TreatmentUsed
Treatment used
AZM = Azithromycin
CFM = Cefixime
Note: this is a repeatable field and
CIP = Ciprofloxacin
multiple columns with this variable
CRO = Ceftriaxone
name can be included.
CROAZM = Ceftriaxone
and Azithromycin
GEN = Gentamicin
O = Other
SPT = Spectinomycin
CFMAZM = Cefixime and
Azithromycin
DOX = Doxycycline
PEN = Penicillin
CRO_250mg_AZM_1g =
Ceftriaxone 250mg and
Azithromycin 1g
CRO_250mg_AZM_2g =
Ceftriaxone 250mg and
Azithromycin 2g
CRO_500mg_AZM_1g =
Ceftriaxone 500mg and
Azithromycin 1g
CRO_500mg_AZM_2g=
Ceftriaxone 500mg and
Azithromycin 2g
CRO_1g_AZM_1g =
Ceftriaxone 1g and
Azithromycin 1g
CRO_1g_AZM_2g =
Ceftriaxone 1g and
Azithromycin 2g
CRO_250mg = Ceftriaxone
250mg
CRO_500mg = Ceftriaxone
500mg
CRO_1g = Ceftriaxone 1g
AZM_1g = Azithromycin 1g
AZM_2g = Azithromycin 2g
CFM_400mg_AZM_1g =
Cefixime 400mg and
Azithromycin 1g
CFM_400mg_AZM_2g =
Cefixime 400mg and
Azithromycin 2g
CFM_400mg = Cefixime
400mg
UNK = Unknown
PenicillinaseActivityGONO
Penicillinase activity
POS = Positive
NEG = Negative
UNK = Unknown
AZMResultSign
Sign
< Less than
CFMResultSign
Sign
<= Less than or equal
= Equal
CIPResultSign
Sign
> Greater than
CROResultSign
Sign
GENResultSign
Sign
SPTResultSign
Sign
AZMResultValue
Value
Number
Error if TestMethod
= Etest/MIC and
CFMResultValue
Value
ResultValue is not
CIPResultValue
Value
© ECDC March 2019 All rights reserved.
Page 20 of 31
Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Variable
Variable description
Coding
Validation rules
CROResultValue
Value
reported
GENResultValue
Value
SPTResultValue
Value
AZMSIR
Final interpretation result
S = Susceptible
Mandatory, UNK
I = Intermediate
allowed.
CFMSIR
Final interpretation result
susceptibility
Error if ResultValue
CIPSIR
Final interpretation result
R = Resistant
is reported and SIR
CROSIR
Final interpretation result
UNK = Unknown
is not reported or is
GENSIR
Final interpretation result
reported as “UNK”
SPTSIR
Final interpretation result
AZMTestMethod
Test method
ETEST = MIC gradient
strip test
CFMTestMethod
Test method
MIC = MIC
CIPTestMethod
Test method
BKP = Breakpoint
CROTestMethod
Test method
GENTestMethod
Test method
SPTTestMethod
Test method
Table 2: Validation rules
Variables in rule
Severity Validation rule
Validation message
Gender,
Error
If Gender is not 'M' or ‘Other’ and
If MSM transmission is reported, gender
Transmission
Transmission is 'MSM'
should be ‘M’ or ‘Other’
Gender,
Error
If Gender is 'F' and Transmission is
Females cannot have Transmission =
Transmission
'MSM'
MSM.
CIPResultValue,
Error
If CIPResultValue > 0.03 and
If CIPResultValue > 0.03 and
CIPSIR
CIPResultValue <= 0.06 and CIPSIR is CIPResultValue <= 0.06, CIPSIR must
not 'I'
be I.
CIPResultValue,
Error
If CIPResultValue > 0.06 and CIPSIR is If CIPResultValue > 0.06, CIPSIR must
CIPSIR
not 'R'
be R.
CIPResultValue,
Error
If CIPResultValue <= 0.03 and CIPSIR If CIPResultValue <= 0.03, CIPSIR must
CIPSIR
is not 'S'
be S.
SPTResultValue,
Error
If SPTResultValue > 64 and SPTSIR is If SPTResultValue > 64, SPTSIR must
SPTSIR
not 'R'
be R.
SPTResultValue,
Error
If SPTResultValue <= 64 and SPTSIR is If SPTResultValue <= 64, SPTSIR must
SPTSIR
not 'S'
be S.
AZMResultValue,
Error
If AZMResultValue > 1 and AZMSIR is If AZMResultValue > 1, AZMSIR must
AZMSIR
not 'R'
be R (ECOFF).
AZMResultValue,
Error
If AZMResultValue<= 1.0 and AZMSIR If AZMResultValue <= 1.0, AZMSIR
AZMSIR
is not 'S'
must be S.
CFMResultValue,
Error
If CFMResultValue>0.125 and CFMSIR If CFMResultValue > 0.125, CFMSIR
CFMSIR
is not 'R'
must be R.
CFMResultValue,
Error
If CFMResultValue<=0.125 and CFMSIR If CFMResultValue <= 0.125, CFMSIR
CFMSIR
is not 'S'
must be S.
CROResultValue,
Error
If CROResultValue>0.125 and CROSIR If CROResultValue > 0.125, CROSIR
CROSIR
is not 'R'
must be R.
CROResultValue,
Error
If CROResultValue<=0.125 and CROSIR IF CROResultValue <= 0.125, CROSIR
CROSIR
is not 'S'
must be S.
GENSIR
Error
If GENSIR is not 'UNK'
There are no resistance breakpoints
defined for gentamicin: GENSIR must
be UNK.
GENResultSign,
Error
If GENResultSign is reported and
If GENResultSign is reported, then
GENResultValue
GENResultValue is not reported
GENResultValue should be reported.
CIPResultSign,
Error
If CIPResultSign is reported and
If CIPResultSign is reported, then
CIPResultValue
CIPResultValue is not reported
CIPResultValue should be reported.
SPTResultSign,
Error
If SPTResultSign is reported and
If SPTResultSign is reported, then
SPTResultValue
SPTResultValue is not reported
SPTResultValue should be reported.
© ECDC March 2019 All rights reserved.
Page 21 of 31
Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Variables in rule
Severity Validation rule
Validation message
AZMResultSign,
Error
If AZMResultSign is reported and
If AZMResultSign is reported, then
AZMResultValue
AZMResultValue is not reported
AZMResultValue should be reported.
CFMResultSign,
Error
If CFMResultSign is reported and
If CFMResultSign is reported, then
CFMResultValue
CFMResultValue is not reported
CFMResultValue should be reported.
CROResultSign,
Error
If CROResultSign is reported and
If CROResultSign is reported, then
CROResultValue
CROResultValue is not reported
CROResultValue should be reported.
GENResultSign,
Error
If GENResultValue is reported and
If GENResultValue is reported, then
GENResultValue
GENResultSign is not reported
GENResultSign should be reported.
CIPResultSign,
Error
If CIPResultValue is reported and
If CIPResultValue is reported, then
CIPResultValue
CIPResultSign is not reported
CIPResultSign should be reported.
SPTResultSign,
Error
If SPTResultValue is reported and
If SPTResultValue is reported, then
SPTResultValue
SPTResultSign is not reported
SPTResultSign should be reported.
AZMResultSign,
Error
If AZMResultValue is reported and
If AZMResultValue is reported, then
AZMResultValue
AZMResultSign is not reported
AZMResultSign should be reported.
CFMResultSign,
Error
If CFMResultValue is reported and
If CFMResultValue is reported, then
CFMResultValue
CFMResultSign is not reported
CFMResultSign should be reported.
CROResultSign,
Error
If CROResultValue is reported and
If CROResultValue is reported, then
CROResultValue
CROResultSign is not reported
CROResultSign should be reported.
GENResultValue,
Error
If GENResultValue is not reported and If GENSIR is unknown(UNK), then
GENSIR
GENSIR is 'UNK'
GENResultValue must be known.
CIPResultValue,
Error
If CIPResultValue is not reported and
If CIPSIR is unknown(UNK), then
CIPSIR
CIPSIR is 'UNK'
CIPResultValue must be known.
SPTResultValue,
Error
If SPTResultValue is not reported and If SPTSIR is unknown(UNK), then
SPTSIR
SPTSIR is 'UNK'
SPTResultValue must be known.
AZMResultValue,
Error
If AZMResultValue is not reported and If AZMSIR is unknown(UNK), then
AZMSIR
AZMSIR is 'UNK'
AZMResultValue must be known.
CFMResultValue,
Error
If CFMResultValue is not reported and If CFMSIR is unknown(UNK), then
CFMSIR
CFMSIR is 'UNK'
CFMResultValue must be known.
CROResultValue,
Error
If CROResultValue is not reported and If CROSIR is unknown(UNK), then
CROSIR
CROSIR is 'UNK'
CROResultValue must be known.
CFMResultValue
Warning If CFMResultValue is > 0.25
Please note that the cefixime MIC
reported is > 0.25: according to the
Euro-GASP reporting protocol, the MIC
should be repeated and identification
confirmed.
CROResultValue
Warning If CROResultValue is > 0.125
Please note that the ceftriaxone MIC
reported is > 0.125: according to the
Euro-GASP reporting protocol, the MIC
should be repeated and identification
confirmed.
AZMResultSign,
Error
if AZMResultSign='<' and AZMSIR='R' If the AZMResultSign is “<” or “<=”
AZMSIR
then AZMSIR should not be reported as
“R”
CFMResultSign,
Error
if CFMResultSign='<' and CFMSIR='R' If the CFMResultSign is “<” or “<=”
CFMSIR
then CFMSIR should not be reported as
“R”
CIPResultSign,
Error
if CIPResultSign='<' and CIPSIR='R'
If the CIPResultSign is “<” or “<=” then
CIPSIR
CIPSIR should not be reported as “R”
CROResultSign,
Error
if CROResultSign='<' and CROSIR='R' If the CROResultSign is “<” or “<=”
CROSIR
then CROSIR should not be reported as
“R”
SPTResultSign,
Error
if SPTResultSign='<' and SPTSIR='R' If the SPTResultSign is “<” or “<=”
SPTSIR
then SPTSIR should not be reported as
“R”
CFMResultSign,
Error
if CFMResultSign='<=' and CFMSIR='R' If the CFMResultSign is “<” or “<=”
CFMSIR
then CFMSIR should not be reported as
“R”
CIPResultSign,
Error
if CIPResultSign='<=' and CIPSIR='R' If the CIPResultSign is “<” or “<=” then
CIPSIR
CIPSIR should not be reported as “R”
© ECDC March 2019 All rights reserved.
Page 22 of 31
Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Variables in rule
Severity Validation rule
Validation message
CROResultSign,
Error
if CROResultSign='<=' and CROSIR='R' If the CROResultSign is “<” or “<=”
CROSIR
then CROSIR should not be reported as
“R”
SPTResultSign,
Error
if SPTResultSign='<=' and SPTSIR='R' If the SPTResultSign is “<” or “<=”
SPTSIR
then SPTSIR should not be reported as
“R”
AZMResultSign,
Error
if AZMResultSign='<=' and AZMSIR='R' If the AZMResultSign is “<” or “<=”
AZMSIR
then AZMSIR should not be reported as
“R”
AZMResultSign,
Error
if AZMResultSign='>' and AZMSIR='S' If theAZMResultSign is “>” or “>=” then
AZMSIR
AZMSIR should not be reported as “S”
CFMResultSign,
Error
if CFMResultSign='>' and CFMSIR='S' If the CFMResultSign is “>” or “>=”
CFMSIR
then CFMSIR should not be reported as
“S”
CIPResultSign,
Error
if CIPResultSign='>' and CIPSIR='S'
If the CIPResultSign is “>” or “>=” then
CIPSIR
CIPSIR should not be reported as “S”
CROResultSign,
Error
if CROResultSign='>' and CROSIR='S' If the CROResultSign is “>” or “>=”
CROSIR
then CROSIR should not be reported as
“S”
SPTResultSign,
Error
if SPTResultSign='>' and SPTSIR='S' If the SPTResultSign is “>” or “>=”
SPTSIR
then SPTSIR should not be reported as
“S”
AZMResultSign,
Error
if AZMResultSign='>=' and AZMSIR='S' If the AZMResultSign is “>” or “>=”
AZMSIR
then AZMSIR should not be reported as
“S”
CFMResultSign,
Error
if CFMResultSign='>=' and CFMSIR='S' If the CFMResultSign is “>” or “>=”
CFMSIR
then CFMSIR should not be reported as
“S”
CIPResultSign,
Error
if CIPResultSign='>=' and CIPSIR='S' If the CIPResultSign is “>” or “>=” then
CIPSIR
CIPSIR should not be reported as “S”
CROResultSign,
Error
if CROResultSign='>=' and CROSIR='S' If the CROResultSign is “>” or “>=”
CROSIR
then CROSIR should not be reported as
“S”
SPTResultSign,
Error
if SPTResultSign='>=' and SPTSIR='S' If the SPTResultSign is “>” or “>=”
SPTSIR
then SPTSIR should not be reported as
“S”
AZMResultSign,
Warning if AZMResultSign '>=' and
Please note that in case the highest
AZMTestMethod
AZMTestMethod = MIC
tested concentration shows growth, you
should report AZMResultValue =[the
highest tested concentration] and
AZMResultSign=">".
CFMResultSign,
Warning if CFMResultSign '>=' and
Please note that in case the highest
CFMTestMethod
CFMTestMethod = MIC
tested concentration shows growth, you
should report CFMResultValue =[the
highest tested concentration] and
CFMResultSign=">".
CIPResultSign,
Warning if CIPResultSign '>=' and
Please note that in case the highest
CIPTestMethod
CIPTestMethod = MIC
tested concentration shows growth, you
should report CIPResultValue =[the
highest tested concentration] and
CIPResultSign=">".
CROResultSign,
Warning if CROResultSign '>=' and
Please note that in case the highest
CROTestMethod
CROTestMethod = MIC
tested concentration shows growth, you
should report CROResultValue =[the
highest tested concentration] and
CROResultSign=">"..
GENResultSign,
Warning if GENResultSign '>=' and
Please note that in case the highest
GENTestMethod
GENTestMethod = MIC
tested concentration shows growth, you
should report GENResultValue =[the
highest tested concentration] and
GENResultSign=">".
© ECDC March 2019 All rights reserved.
Page 23 of 31
Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Variables in rule
Severity Validation rule
Validation message
SPTResultSign,
Warning if SPTResultSign '>=' and
Please note that in case the highest
SPTTestMethod
SPTTestMethod = MIC
tested concentration shows growth, you
should report SPTResultValue =[the
highest tested concentration] and
SPTResultSign=">".
AZMResultSign,
Warning if AZMResultSign '>=' and
Please note that in case the highest
AZMTestMethod
AZMTestMethod =ETEST
tested concentration shows growth, you
should report AZMResultValue =[the
highest tested concentration] and
AZMResultSign=">"..
CFMResultSign,
Warning if CFMResultSign '>=' and
Please note that in case the highest
CFMTestMethod
CFMTestMethod = ETEST
tested concentration shows growth, you
should report CFMResultValue =[the
highest tested concentration] and
CFMResultSign=">".
CIPResultSign,
Warning if CIPResultSign '>=' and
Please note that in case the highest
CIPTestMethod
CIPTestMethod = ETEST
tested concentration shows growth, you
should report CIPResultValue =[the
highest tested concentration] and
CIPResultSign=">".
CROResultSign,
Warning if CROResultSign '>=' and
Please note that in case the highest
CROTestMethod
CROTestMethod = ETEST
tested concentration shows growth, you
should report CROResultValue =[the
highest tested concentration] and
CROResultSign=">".
GENResultSign,
Warning if GENResultSign '>=' and
Please note that in case the highest
GENTestMethod
GENTestMethod = ETEST
tested concentration shows growth, you
should report GENResultValue =[the
highest tested concentration] and
GENResultSign=">"..
SPTResultSign,
Warning if SPTResultSign '>=' and
Please note that in case the highest
SPTTestMethod
SPTTestMethod =ETEST
tested concentration shows growth, you
should report SPTResultValue =[the
highest tested concentration] and
SPTResultSign=">".
AZMResultValue,
Error
If AZMTestMethod = Etest/MIC then If a method which produces an MIC is
AZMTestMethod
AZMResultValue must be reported used then the resulting MIC should be
reported
CFMResultValue,
Error
If CFMTestMethod = Etest/MIC then If a method which produces an MIC is
CFMTestMethod
CFMResultValue must be reported used then the resulting MIC should be
reported
CIPResultValue,
Error
If CIPTestMethod = Etest/MIC then If a method which produces an MIC is
CIPTestMethod
CIPResultValue must be reported used then the resulting MIC should be
reported
CROResultValue,
Error
If CROTestMethod = Etest/MIC then If a method which produces an MIC is
CROTestMethod
CROResultValue must be reported used then the resulting MIC should be
reported
GENResultValue,
Error
If GENTestMethod = Etest/MIC then If a method which produces an MIC is
GENTestMethod
ResultValue must be reported
used then the resulting MIC should be
reported
SPTResultValue,
Error
If SPTTestMethod = Etest/MIC then If a method which produces an MIC is
SPTTestMethod
ResultValue must be reported
used then the resulting MIC should be
reported
CIPSIR,
Error
If CIPResultValue is reported and If an MIC is reported then the
CIPResultValue
CIPSIR is not reported or is
interpretation according to EUCAST
reported as “UNK”
guidelines should be reported
AZMSIR,
Error
If AZMResultValue is reported and If an MIC is reported then the
AZMResultValue
AZMSIR is not reported or is
interpretation according to EUCAST
reported as “UNK”
guidelines should be reported
© ECDC March 2019 All rights reserved.
Page 24 of 31
Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Variables in rule
Severity Validation rule
Validation message
SPTSIR,
Error
If SPTResultValue is reported and If an MIC is reported then the
SPTResultValue
SPTSIR is not reported or is
interpretation according to EUCAST
reported as “UNK”
guidelines should be reported
CFMSIR,
Error
If CFMResultValue is reported and If an MIC is reported then the
CFMResultValue
CFMSIR is not reported or is
interpretation according to EUCAST
reported as “UNK”
guidelines should be reported
CROSIR,
Error
If CROResultValue is reported and If an MIC is reported then the
CROResultValue
CROSIR is not reported or is
interpretation according to EUCAST
reported as “UNK”
guidelines should be reported
CROSIR; CIPSIR;
Warning if SIR is “I” and ResultSign is not “=”
If the SIR value is “I” then the
CFMSIR; SPTSIR and
ResultSign should usually be reported
respective
as “=”
*ResultSign variables
AZMSIR; CROSIR;
Warning if SIR is “R” and ResultSign is “<”
If the SIR value is “R” then the
CIPSIR; CFMSIR;
ResultSign should usually not be “<”
SPTSIR and
respective
*ResultSign variables
AZMSIR; CROSIR;
Warning if SIR is “S” and ResultSign is “>”
If the SIR value is “S” then the
CIPSIR; CFMSIR;
ResultSign should usually not be “>”
SPTSIR and
respective
*ResultSign variables
AZMSIR
Error
if SIR is “I”
No clinical breakpoints for azithromycin
available, ECOFF > 1 mg/L
Table 3: Euro-GASP data source variables
Variable
Variable description
Coding
Validation rule
Subject mnemonic
Mnemonic of country data source
Coded value list
Subject name
Name of country data source
Coded value list
Comment
Short description of the surveillance
Text
system for the disease. Important
details for the analysis.
Coverage
Coverage of the surveillance system
NAT = National
Mandatory
REG = Regional
LOC = Local
UNK = Unknown
Comprehensive
Comprehensive: Reporting is based on
Comp =
Mandatory
cases occurring within the whole
Comprehensive
population of the geographical area
O = Other
where the surveillance system is set up
Sent = Sentinel
(national, regional, etc.). Sentinel:
UNK = Unknown
Reporting is based on a selected group
of physicians/hospitals/laboratories/or
other institutions’ notifications and/or
cases occurring within a selected group
of population defined by age group,
gender, exposure or other selection
criteria. Other: Reporting is based on a
part of the population or group of
physicians (or other institutions) which
is not specified, for example reporting
of some laboratories with no selection
criteria.
StartSurvSys
Start year for data collection in the
YYYY
surveillance system.
© ECDC March 2019 All rights reserved.
Page 25 of 31
Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Variable
Variable description
Coding
Validation rule
InternalQualityContro
WHO-recommended strains used for
WHOCS = WHO
l
quality control procedures.
control strains
OTH = Other control
strains used
NT = Not tested
UNK = Unknown
GONOAMR metadata change history
Metadata changes prior to 2014 can be found on the TESSy documents website.
GONOAMR metadata change history
Table 4: Summary of implemented general changes (applicable to several record types)
Year
Subject
Description
2019
GONOAMR
The variables AZMSIR, CROSIR, CIPSIR, CFMSIR and SPTSIR have been made mandatory, however
UNK is allowed. Reporting of the SIR variables is essential to allow for appropriate analysis and
display of the data in the surveillance atlas
For the variables CROSIR, CIPSIR, CFMSIR and SPTSIR and respective ResultSign variables, a warning
is given if SIR is "I" and ResultSign is not "=". For variables AZMSIR, CROSIR, CIPSIR, CFMSIR and
SPTSIR, if SIR is "R" and ResultSign is "<" and if SIR is "S" and ResultSign is ">". This has been
introduced as some errors with the ResultSign variables have been noticed.
For variable AZMSIR the ECOFF at 1 mg/L should be used for “R”, <=1 mg/L should be “S”. Please
note that the ECOFF is not to be used for recording resistance and susceptibility, but for
distinguishing between isolates with acquired resistance mechanisms (MIC > 1 mg/L)
2018
GONOAMR
New optional variables have been added (ClinicLocation, ClinicCoordinates) to collect alternative
information on the clinic location in order to better understand the source of isolates included in
Euro-GASP.
Update coded value lists for SiteOfInfectionSTI: removed NA (Not applicable)
Add validation rules for:
Transmission and Gender
TestMethod and ResultValue
Change coded value list for CountryOfBirth from Country_Incl_HistCountries to Country - previously
included historical countries make analysis more difficult when historical countries have broken up
(eg USSR).
Update coded value lists for TreatmentUsed - addition of doses for the main antimicrobials used for
treatment
Add validation rules for SIR and ResultValue variables to reduce the likelihood of errors where
countries report MIC values but not the interpretation of the result.
2017
GONOAMR
Ciprofloxacin breakpoints have been implemented to conform with EUCAST breakpoints (S≤0.03
mg/L, I=0.047-0.06 mg/L, R>0.06 mg/L) and a subsequent update of the validation rules for
variables ‘CIPResultValue’ and ‘CIPSIR’;
Three additional treatment options were added to the variable ‘TreatmentUsed’; CFMAZM =
Cefixime and Azithromycin, DOX = Doxycycline, PEN = Penicillin
A new variable ‘Genogroup’ was added to record the NG-MAST genogroups from the molecular
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Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Year
Subject
Description
typing surveys.
These changes have been implemented through a new record type version GONOAMR.v7 and were
previously agreed by the Euro-GASP network at the co-ordination meeting in Bratislava, March
2016.
Validation rules have been added to improve the quality of reported data and reduce errors. These
2016
GONOAMR
include validation rules comparing ResultSign and SIR to reject combinations which are not logical
and validation rules for ResultSign and ResultValue which do not allow the use of ResultSign '>='
2015
GONOAMR
Following discussions at the Euro-GASP co-ordination meeting in December 2013 and the STI
Network Meeting in 2014, the structure of the metadata has been changed to a single level one.
This means that only one file needs to be uploaded now. This file includes all the epidemiological
and microbiological variables.
In addition, the following changes have been made:
New variables to collect data on diagnostic tests used and treatment used (both
repeatable fields)
Removing Ureaplasma from the list of possible co-infections (not considered an STI in
many patients)
Specifying “Mycoplasma genitalium” as a possible co-infection (previously defined as
“mycoplasma”)
Reporting of penicillinase activity is now through the PenicillinaseActivityGONO field,
coded as “Pos”, “Neg” or “Unk”.
Updating of validation rules in the context of the new structure.
These changes have been implemented through a new record type version GONOAMR.v5. All
previous metadata versions have been deactivated. This means that only this format can be used
for reporting.
2014
All
Update NUTS codes according to the NUTS Codes 2010 classification from EUROSTAT
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Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Annex 2 GONOAMR-specific material
Contact information:
o ECDC expert:
Gianfranco Spiteri
Email:
xxxxxxxxxx.xxxxxxx@xxxx.xxxxxxx.xx
Phone: +46 (0)8 5860 1445
o Project manager:
Michelle Cole
Email:
xxxxxxxx.xxxx@xxx.xxx.xx
Phone: +44 (0)208 3276465
Procedure for saving gonococcal isolates
1. Label a cryovial with a study number using a permanent marker, or the labels provided.
2. Using a loop, gather as much growth as possible from a pure fresh culture and re-suspend in
the microbank fluid.
3. Close the cryovial tightly and invert 5 times to mix up the organism with the fluid.
4. Using a fine-tip pastette remove as much liquid as possible, and close the cryovial tightly.
5. Place in the freezer (preferable -70oC, range -50°C to -80°C) in a designated box.
6. Record the data for that strain and study number.
Centralised testing protocol
1. Isolates are shipped frozen to Public Health England, London, UK or Örebro University Hospital, Örebro,
Sweden
2. The isolates are stored at −70°C or in liquid nitrogen.
3. Isolates are transferred to non-selective agar (such as GCVIT with 1% Vitox (Oxoid)) and incubated for
18 to 24 hours at 36°C in humid 5% CO2-enriched atmosphere.
4. The purity and the identity of the isolates are confirmed by Gram stain, oxidase and PCR or Maldi-TOF. A
further sub-culture from a single colony (to avoid mixed infections) is grown.
5. If there is a high level of contamination, cultures are repeatedly transferred to selective agar.
6. Susceptibility testing is performed using the agar dilution breakpoint technique Etest for ciprofloxacin,
azithromycin, spectinomycin and gentamicin (spectinomycin and gentamicin tested in snapshot years
only; 2016 and 2019). Suspensions of cultures aged 18 to 24 hours are prepared equivalent to
McFarland standard 0.5 (approximately 104 colony forming units (cfu)/µL) in sterile saline. Using a
multipoint inoculator, suspensions are inoculated onto GC agar plates with 1% Vitox, containing a panel
of antimicrobials at the following breakpoint concentrations:
Table 5: Concentrations (mg/L) of antimicrobials used for the agar dilution breakpoint technique
Antimicrobial
Intermediate
Resistant
Ciprofloxacin
0.03
0.06
Spectinomycinⱡ
64
Gentamicinⱡ (no breakpoint
1, 2, 4, 8, 16
determined yet)
ⱡTesting in snapshot years; 2016 and 2019
7. The ceftriaxone and cefixime MICs are determined using Etests according to the
manufacturer’s instructions.
8. All isolates are tested for penicillinase production using the chromogenic reagent Nitrocefin.
9. The following control strains are tested on the poured agar dilution plates and each batch of
Etests (Table 6):
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Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
WHO G
WHO K
WHO M
WHO P
WHO O (for use when spectinomycin is being tested)
Table 6. WHO Control Strains for use in Euro-GASP – MICs and susceptibility categories (SCs)
obtained from Euro-GASP data
Azithromycin
Cefixime
Ceftriaxone
Ciprofloxacin Gentamicin Spectinomycin
Strain
β-
lactamase
MIC
SC
MIC
SC
MIC
SC
MIC
SC
MIC
SC
MIC
WHO G
NEG
0.25
S
≤0.016
S
0.008
R
0.125
UK
4
S
16
WHO K
NEG
0.25
R
0.25
S
0.064
R
>32
UK
4
S
16
WHO M
POS
0.5
S
≤0.016
S
0.008
R
2
UK
4
S
16
WHO O
POS
0.25
S
0.016
S
0.016
S
0.008
UK
4
R
>1024
WHO P
NEG
4
S
≤0.016
S
0.004
S
0.004
UK
4
S
16
Notes: MIC data col ated from the centralised/decentralised testing centres and the Euro-GASP EQAs to establish modal MICs
and SCs. Decentralised laboratories should also establish their own local modal MIC data. Control strain MICs should be no
more than one doubling dilution different to the MICs in the Table 6. The modal MICs in Table 6 may be updated when further
data has been col ected. Decentralised testing laboratories are ultimately responsible for their own QC data however QC data
should be sent to the ECDC microbiologists regularly to ensure the data is within the expected limits.
10. Bacterial growth is recorded for the agar dilution plates and the MIC is recorded from the
Etest plates. The category of resistance is determined using the following breakpoints:
Table 7. MIC breakpoints for specific antimicrobials
MIC breakpoint (mg/L)
Antimicrobial
R >
I
S ≤
Azithromycin
1*
1*
Cefixime
0.12*
0.12
Ceftriaxone
0.12*
0.12
Ciprofloxacin
0.06
0.06
0.03
Spectinomycin
64
64
Gentamicin
No breakpoints determined yet
Note: European Committee on Antimicrobial Susceptibility Testing breakpoints are used (www.eucast.org/clinical_breakpoints).
*ECOFF used to detect isolates with antimicrobial resistance determinants, which are recorded as “R” in Euro-GASP
**0.125 mg/L if Etest or other MIC gradient strip test is used
11. Isolates that are contaminated in the original vial or are slow to grow are re-saved.
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Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
Annex 3 Protocol for Euro-GASP implementation
at the national level
Each country referring gonococcal isolates or susceptibility data should provide the following
additional information to implement Euro-GASP at national level. This information is critical in
interpreting data and in ensuring accurate linking of laboratory and epidemiological data. Data to be
provided includes:
•
Sampling strategy – providing information on the geographical coverage of isolates
submitted (complete, national, regional, local).
•
Information on regions of the country covered (or place of residence)
•
Describe the Data source and sampling frame: where the isolates come from (STI clinics,
DV clinics, GPs, hospitals etc.); how are they sampled (consecutive patients; sampling)
•
How is the AMR data linked to the epidemiological data (available with isolate submitted
to the laboratory, data is requested from the isolate source, such as the STI clinic/GP
surgery, data is requested from the epidemiologist)
•
MIC range of testing method for each antimicrobial;
•
Control strains tested for each media/reagent batch or for each antimicrobial tested;
•
Institute/Laboratory/Person submitting the AMR and epidemiological AMR data in TESSy;
•
Information on how the AMR data and epidemiological data is linked.
Please complete and return it to:
Email: xxxxxxxxx@xxxx.xxxxxx.xx in co
py to xxxxxxxx.xxxx@xxx.xxx.xx
Table 8. Euro-GASP information form
1. Identifying information
Name:
Laboratory/Institute name:
Date form completed:
2. Sampling strategy – Please provide information on the geographical coverage of isolates submitted (complete,
national, regional, local)
3. Please provide information on regions of the country covered (or place of residence)
4. Please describe the source of the isolates (STI clinics, DV clinics, GPs, hospitals etc.)
5. How are the isolates sampled (consecutive, selective)?
6. How were the epidemiological data obtained (available with isolate submitted to the laboratory; data were
requested from the isolate source, such as the STI clinic/GP surgery; data were requested from the
epidemiologist)?
7. How are the AMR data and epidemiological data linked?
8. Institute/laboratory/person submitting the GC AMR data to TESSy.
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Gonococcal Antimicrobial Surveillance Reporting Protocol 2019
9. Institute/laboratory/person submitting the epidemiological data to TESSy.
10. For laboratories performing decentralised testing, please provide the following antimicrobial information:
Methodology
Agar base (GC,
MIC range (min – max)
chocolate, DST etc.)
(MIC gradient strip
testing and
manufacturer/Agar
dilution/breakpoint)
Ceftriaxone
Cefixime
Azithromycin
Ciprofloxacin
Spectinomycin
Gentamicin
Beta-lactamase
11. Please list the control strains tested for each media/reagent batch or for each antimicrobial tested.
© ECDC March 2019 All rights reserved.
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