Invasive Aspergillosis is initially an infection of the lower respiratory tract and can cause systemic dissemination, without antifungal intervention. Aspergillus fumigatus species complex is the most prevalent fungal pathogen responsible for fatal invasive aspergillosis and immune-compromised individuals (solid organ transplant, hematologic malignancies and neutropenic patients) are most susceptible. The use of galactomannan antigen detection as a criterion in the diagnosis of invasive aspergillosis is recommended by the European Organisation for Research and Treatment of Cancer (EORTC) and the Mycology Study Group (MSG)(2008).
UK NEQAS began investigation of an EQA scheme for galactomannan antigen detection in 2015 with the early research work being carried by our placement student Anthony Christopher. The study addressed usage of the test by participating laboratories and the homogeneity and stability of samples prepared from serum spiked with galactomannan antigen. The antigen was prepared from a filtered suspension of an NCPF strain Aspergillus fumigatus complex.
Presently the Platelia Aspergillus ELISA kit (BioRad) is the only licenced detection kit on the market for the diagnosis of invasive aspergillosis. The variabilities in storage of specimens, stability of the antigen and interpretation of the results with the ELISA, warranted the need for an external quality assessment (EQA) scheme to assess the performance of laboratories providing a service in the detection of GM.
In 2016 three pilot distributions were dispatched to laboratories providing the diagnostic test. The results were collated and analysed and justified the need for an established EQA to be available.
The first distribution was dispatched in June 2017 to 52 registered participants, in September 2017 to 58 participants and in January 2018 to 70 registered participants.
Simulated specimens (serum and Broncho alveolar lavage (BAL)) spiked with levels of GM were dispatched to participants worldwide, to assess the absence or presence of the antigen with the ELISA kit. Results were collated and analysed.
Results from two recent distributions in June and September showed a strong correlation between poor participant performance and testing of specimens designed close to the positive cut off reading of the Platelia Aspergillus ELISA (BioRad) (table 1).
Table 1: Galactomannan index values and interpretation of index.
|Galactomannan antigen index values
/(absence )/+ (presence of antigen)
Participants demonstrated excellent concordance (96%) with intended results, with specimens 3859, 4026, 4027 and 4267, (serum samples containing either high levels of GM or no GM).
Specimens designed to determine a galactomannan index value close to the positive cut off value of the ELISA, for serum (0.5) and BAL (1), proved challenging, table 1.
Manufacturer’s instructions recommend that if a GM index value below the positive cut off and the symptoms of the patient are suggestive of IA, the test should be repeated. It is probable some participants did not perform repeat testing to eliminate false negatives.
Participation in this EQA scheme will help the continued monitoring of performance in laboratories providing a service in the detection of galactomannan antigen in clinical specimens.
To register for this scheme, please email email@example.com
A one day course for Mycology teaching in Central London.
Participation in the UK NEQAS Mycology Teaching Workshop can help increase both familiarity with a range of fungi and promote self-confidence in the accuracy of personal performance and laboratory reports.
This unique teaching programme is intended to complement the educational aspects of the UK NEQAS for Microbiology Mycology Scheme.
Delegates will have the opportunity to examine cultures and characterise phenotypically and microscopically.
The day will encompass clinically significant fungal pathogens including:
Venue: University of Westminster, London
Date: September 2018 (TBC)
For further details please email at firstname.lastname@example.org, also details will be provided in the new year as part of re-registration process for 2018-19.
The scheme remains in pilot status following migration to the new software platform in January 2017. The primary function of the scheme is to support continuing professional development (CPD). We continue to cover a wide range of topics (as seen in the table) with around 200 out of 387 registered participants responding to each distribution. We consider linking distributions to national (and international) clinical management guidance to be very important. Therefore distribution 4244 tested the ability of participants to locate and follow the relevant UK CJD guidance in order to plan the management of an endoscope following a procedure in a patient with probable sporadic Creutzfeldt-Jakob disease. This is not information that many of our participants will know without reviewing the guidance, which is also the situation when dealing with such queries as they arise clinically. Many of our distributions therefore test the ability to interpret information with reference to guidelines, rather than test knowledge that participants hold in their heads. Despite this being a potentially difficult topic, only five participants declared the distribution to be ‘out of scope’ for their practice and consensus was achieved for all four questions in the distribution.
We are also prepared to offer topical distributions. A potentially ‘brave’ distribution, which, fortunately, very few participants will have experienced, was a distribution (4247) aimed to highlight awareness of infection management issues following recent terror-related incidents. Participants achieved a consensus for two out of three questions and of course the principles of this illustrative case can be applied to other (non terror-related) clinical scenarios. A further important aspect of the scheme is to link interpretation of results and deciding on further testing to good practice guidance, including UK Standards for Microbiology Investigations. An example of this was seen with distribution 4249 which reviewed the diagnosis of Cytomegalovirus (CMV) infection. Interestingly, although most scheme participants are currently microbiologists (rather than virologists), only 12 declared this distribution to be ‘out of scope’ and this perhaps reflects the broad range of clinical topics that is encountered in the daily life of clinical microbiologists (with perhaps also an enthusiasm to engage in challenging CPD)!
Table. Topics covered by the Interpretive Comments scheme during 2017
|Isolated anti-HBc positivity
|CJD and endoscopy
|Recurrent HSV (Mollaret’s) meningitis
|Immunisation in bomb blast victims
|CMV following splenectomy
|Legionella in water
The format for questions and answers continues to be multiple choice, with 2 to 4 MCQs for each topic. This format allows individual scores to be provided to participants, however there is currently no formal performance monitoring by the Scheme Organiser while the scheme is in pilot status. For a question to be scored 80% participants must agree with the scheme panel’s intended answer (and there must be no good evidence provided by participants that the intended answer is incorrect). Most questions in the scheme have been suitable for scoring and concordance of results for the period April to September can be seen in the figure. The new format also allows records of participation to be provided to individuals, as evidence that can be used to support appraisal and revalidation (for UK medical specialists).
At present there is ongoing debate around interpretive EQA (iEQA) schemes and performance monitoring. The Royal College of Pathologists published a guideline on principles and guidance for iEQA schemes in October 2017  and UK NEQAS is intending to produce guidance in 2018. Within the Royal College document, there is a strong statement which addresses potential concerns held by microbiologists about the place of iEQA schemes in personal performance assessment. The guidance states that ‘…interpretive EQA schemes are not normally designed to have the rigour of a professional examination and therefore the results should NOT be regarded as a form of proficiency testing that provides a measure of a pathologist’s competence.’ Thus iEQA schemes are not able to detect substandard clinical performance, but they can provide evidence that there may be a problem requiring further review.
The Royal College also provides clarity and rationale around another common query from participants about whether responses should be from laboratories or from groups of individuals: ‘the purpose of the scheme is to assess personal ability to make an interpretation, therefore discussion with a colleague prior to result submission is not permitted, even in circumstances where consultation with a colleague would be good practice in a routine workload.’ However, opt-outs are allowed. The design of the Microbiology Interpretive Comments scheme does provide a mechanism for individual participants to opt out of responding to cases in areas that are outside their normal repertoire of work, but any such opt-out should be justified by the participant during their appraisal meeting and opt outs will be recorded on records of participation in the scheme that we aim to provide to participants in the future. At the present time, the scheme continues to be extended as a pilot pending agreement of mechanisms for formal performance monitoring. It also remains free to participants until April 2018, although participants have already agreed in principle to pay a subscription charge.
In view of the ongoing changes to the scheme and also the recent Royal College consultation around iEQA, we feel that it is important to monitor participants’ views on the scheme closely. We also continue to seek from participants both ideas for improvements to the scheme and cases to form the basis of future distributions. In December 2017 scheme participants will therefore be surveyed and we encourage you to respond to this and help us to shape the future of the Interpretive Comments scheme.
 Furness P. Principles and guidance for interpretive external quality assessment schemes in laboratory medicine. Royal College of Pathologists, October 2017.
From April 2018 participants will no longer be required to identify the organisms distributed in the Antimicrobial susceptibility scheme as the full organism identity will be provided in the clinical details.
The antibiotic panel for Haemophilus in both the Antimicrobial susceptibility and Community medicine schemes will be updated as of January 2018. Participants can now report susceptibility results for doxycycline, ciprofloxacin, levofloxacin, nalidixic acid, penicillin and trimethoprim-sulfamethoxazole.
UK NEQAS Parasitology was inspected by UKAS from 4 to 6 September, 2017. UKAS inspected all the current schemes offered by Parasitology i.e. Faecal Parasitology, Blood Parasitology, Toxoplasma Serology, Parasite Serology and Malaria Rapid. In addition, UKAS inspected the team for new premises (as the lab has moved to the Halo building), use of new analyte for Malaria Rapid (freeze dried blood) and one new scheme (Malaria Molecular that was launched in January 2016). The team successfully cleared all assessments and UKAS accreditation is maintained subject to addressing the findings. Similarly the new extensions to scope and the new scheme have also been given approval subject to addressing the findings.
The session also included presentations by Sten Westgard (son of Westgard Rules) on ‘How Viral Load Assay Performance Translates into Clinical Outcome’ and also Ben Courtney (UKAS) on test assurance and the importance of IQC and EQA method validation & verification underpinning the quality of testing. The session was well attended with positive feedback.
Professor Peter L Chiodini attended the Excellence in Healthcare (June 2017) conference in Glasgow. He presented a poster on behalf of UK NEQAS Parasitology “The first malaria Molecular EQA scheme launched UK NEQAS Parasitology”. The poster was short listed for best poster award at the meeting.
Agatha Saez attended the EQALM (October 2017) meeting in Dublin. She presented a poster titled “Launch of the new Malaria Molecular EQA scheme”. Her poster gave details of the rationale of the scheme, the data generated during the pilot stages and also the first data from the live stages of the scheme.
Jaya Shrivastava attended the ECTMIH (October 2017) held in Antwerp. She headed and organised a session on “Raising standards and quality of Parasite diagnostics in non-endemic clinical settings using molecular and lateral flow technologies.” The session had international speakers from Europe and USA. The panel was comprised of expert Parasitologists with added unique know-how in the field of molecular and rapid diagnostic assays and running the relevant EQA schemes. Jaya presented a talk on the UK NEQAS Malaria molecular scheme with a special highlight on samples that the participants struggled with.
Jaya Shrivastava attended the ASTMH (November 2017) held in Baltimore, USA. She chaired the session on “Malaria: Enhancing and optimizing Quality of care”. She also presented a talk on “Development of the WHO international EQA scheme for Malaria Nucleic Acid Amplification techniques.” The talk highlighted the launch of the WHO Malaria Molecular scheme and presented rationale of the scheme plus the data from the first round of distribution and the associated challenges.
For three days (February 2017), UK NEQAS was hosted by our distributor Genetrics in Dubai, where we had the opportunity to understand the relationship between our participants and our distributor.
The next day we visited some participants in the beautiful city of Oman to answer their queries on the services provided and promote prospective EQA programmes. Finally we travelled to Kuwait that evening to conduct three workshops on UK NEQAS for Microbiology Scheme Best Practices, Good laboratory Practice and Total Quality Management the following afternoon. The audience comprised of various levels of experienced scientific staff and clinicians and the presentations were received within an interactive forum. We travelled back that same evening, tired but with a positive feedback from all we had visited.
UK NEQAS Microbiology (Shila Seaton) attended the annual international meeting in Vienna. As many as 12,494 specialists from 127 countries attended with more than 3,000 abstracts presented at the congress in oral sessions, as posters or e-Posters. We were successful to present two posters. One was on the collaborative exercise with ECDC (European Centre for Disease Prevention and Control) illustrating results from the 2016 antimicrobial susceptibility testing external quality assessment (EQA) exercise organised for EARS-Net Participants.
The other poster was on the development of a UK NEQAS EQA scheme: Galactomannan antigen detection in clinical specimens to aid diagnosis of Invasive Aspergillosis disease. The EARS-Net poster was selected as an e-poster and provided the option for delegates to view the poster throughout the duration of the conference. The EQA on galactomannan detection study was presented as a paper poster and this provided an excellent opportunity to meet with delegates and potential participants. The main objective was to present our work but also have the occasion to attend the multitude of presentations on topics of interest.
November has been a busy month with visits to our distributors to meet our participants in Kuwait, Italy and Israel. In Kuwait we gave a workshop to our participants followed by a Q&A session, whilst in Israel we presented at The Workshop on QC Programs in Clinical Microbiology, held in Tel Aviv. The workshops were well- attended and this was a marvellous opportunity for us to meet face-to-face with both our participants and distributors, as well as answer their queries directly rather than via email or telephone.
Mahmood Sadigh (IT Manager) and Vipul Sharma (Operations Manager) took the opportunity to visit Thermo Fisher Scientific our Italian distributor based in Rodano, Milan. We were able to discuss ideas and improvement’s to our re-registration processes, customer queries, password problems, general website questions and Marketing opportunities. Ideas on how to gain more interest from new Italy laboratories for UK NEQAS and enhance communications with participants in relation to overall processes. The face to face meeting allowed us to further build on an existing strong relationship encouraging more interaction and benefits for both Thermo Fisher Scientific and NEQAS.
UKNEQAS were invited by Thermo Fisher Scientific to be part of a team of representatives at a stand at the Italian Congress of Clinical Microbiology in Rimini on the 12-13 November 2017.
Thermo Fisher Scientific is the sole distributor of UK NEQAS schemes and supplies our EQA to over 300 participating laboratories across Italy. Two members of the UK NEQAS team (Shila Seaton and Manpreet Sahni) were able to meet with several of the Thermo Fisher team as well as speak to participants first hand regarding their participation and any queries.
The presence of UK NEQAS was very well received by a Congress of over 500 delegates. We were able to deal with queries regarding the website, technical queries, performance analysis and returning of results, as well as meet many of our participants and gain invaluable feedback. Many participants embraced the presence of the UK NEQAS team, and the response from the Italian distributors was a very positive one and we hope this relationship of UK NEQAS and laboratory quality assessment long continues.
UK NEQAS would like to thank the Italian Thermo Fisher Scientific team for inviting us to be part of the congress and being able to witness the first snowfall in Italy in November, something that has not been seen in many years.
A similar meeting on POCT will be held in 2018. Watch this space!
The UK NEQAS consortium meeting was held on 9 and 10 November 2017 in Birmingham. The meeting was very well attended from all centres over the two days. Session topics covered on the first day included the use of digital imaging in EQA schemes and interpretive EQA schemes. Day two topics included developing EQA to meet participant needs with feedback from centres on new schemes and workshops. This continued with quality management in EQA and a presentation on the 100,000 Genome Project. The meeting ended with presentations on feedback and news from all the UK NEQAS working groups.
This year’s meeting theme was ‘Special Populations Matter to us!’. As 1 December 2017 was World Aids Day the plenary presentation was Reflections on HIV. Other topics included Unwanted Holiday Souvenirs, Immuno-compromised patients, Chickenpox, Cystic Fibrosis, Diabetes and ISO15189. There was also a free paper on Aciclovir toxicity as well as updates from UK NEQAS Microbiology team members. The meeting was held at the Holiday Inn, Coram St, and was attended by 150 delegates which included delegates from the UK, Malta, Republic of Ireland, Isle of Man, Portugal, Kuwait and Norway. There was also a trade show of 10 different manufacturers who each had an opportunity to do a small presentation to the delegates. Next year’s meeting will be held in Central London on Friday 30 November 2018. Further details will be available next year.
We are looking forward to seeing you at our next meeting in Central London on
30 November 2018 the theme is to be announced.
Yonas Legesse – Healthcare Scientist
Kimberley Pandian – Healthcare Scientist Support Worker
David Lloyd – Healthcare Scientist Support Worker
Pavandeep Chahal – Placement student
Mr Ushmanthe Arachchige
Mrs Rinu Bandopadhyay
Mrs Nazma Kadri
Mrs Vay Mistry
Mr Vipul Sharma