External Quality Assurance Research Articles

Analysis of immunogenetics interlaboratory comparisons' success rates. External quality assurance system of the Spanish Society for Immunology GECLID-SEI.

For many years, transplantation outcomes were uncertain and not hopeful, until histocompatibility testing spread. Common criteria for histocompatibility assays and communications' improvement allowed an efficient organ sharing system. The possibility of organ exchanges is closely linked to the importance of interlaboratory comparisons for histocompatibility and immunogenetics methods. The external proficiency testing (EPT) systems are the most powerful quality assurance tools. They help achieve harmonization of analyses, set a standard of performance, and a common interpretation. The external quality assurance program for diagnostic immunology laboratories (Garantía Externa de Calidad para Laboratorios de Inmunología Diagnóstica, GECLID) program nowadays runs 13 external quality assurance (EQA) histocompatibility and immunogenetics schemes, with the first of them from 2011 to date: serological and molecular: low- and high-resolution human leukocyte antigen (HLA), human platelet antigen (HPA), and killer inhibitory receptor (KIR) typing(HLA-B*27, HLA-B*57:01, and coeliac disease-related HLA), cell-dependent cytotoxicity (CDC) and flow cytometry (FC) crossmatches, anti-HLA and anti-HPA antibodies, and chimerism. A total of 85 laboratories participated in this subprogram in the last 12years reporting over 1.69M results: 1.46M for anti-HLA and anti-HPA antibodies, 203.810 molecular typing data (HLA, HPA, and KIR genes), 2.372 for chimerism analyses, and 39.352 for crossmatches. Based on the European Federation for Immunogenetics (EFI) standards for EPT providers, the mean success rates ranged from 99.2% for molecular typing schemes and antibodies and 94.8% for chimerism, was 96.7% regarding crossmatches, and was 98.9% in serological typing. In 2022, 61.3% of the participating laboratories successfully passed every HLA EQA scheme, although 87.9% annual reports were satisfactory. Most penalties were due to nomenclature errors or misreporting of the risk associated to HLA and disease. This EQA confirms the reliability of HLA and immunogenetics assays in routine care. There is little heterogeneity of results of different assays used by participating laboratories, even when in-house assays are used. Reliability of test results is reasonably granted.

Quality assurance dysfunctions

This article presents findings from a longitudinal case study of academic audit as enacted at a typical New Zealand university between 1994 and 2019. Academic audit is a higher education quality assurance methodology applied to New Zealand universities. The longitudinal study yielded findings that could not have been detected in a single, five-year audit cycle, in particular, that very similar recommendations were given more than once. Three sets of recurrent recommendations were studied in detail: closing the student feedback loop; monitoring PhD students’ progress and ‘quality assurance infrastructure and leadership’. The issues emerging from these three topics are ‘audit dysfunctions’, some of which are attributable to the institution and some of which belong to the external quality assurance agency. The audit dysfunctions are intended as a heuristic for improving the rigour and effectiveness of higher education quality assurance.

Using analytical performance specifications in a medical laboratory.

Analytical performance specifications (APS) are used for the quantitative assessment of assay analytical performance, with the aim of providing information appropriate for clinical care of patients. One of the major locations where APS are used is in the routine clinical laboratory. These may be used to assess and monitor assays in a range of settings including method selection, method verification or validation, external quality assurance, internal quality control and assessment of measurement uncertainty. The aspects of assays that may be assessed include imprecision, bias, selectivity, sample type, analyte stability and interferences. This paper reviews the practical use of APS in a routine clinical laboratory, using the laboratory I supervise as an example.

Comparison of the sigma metrics using the total error allowable algorithm with variation of bias source

Sigma Metrics, as a quality indicator, have been widely applied in clinical laboratories to assess the performance of analytical methods. Described in the document Clinical and Laboratory Standards Institute (CLSI) EP15- A3, the use of target values can be sourced from certified reference standards, survey materials from the Proficiency Testing (PT)/External Quality Assessment (EQA), materials used in inter-laboratory quality control programs and internal quality control materials with predetermined targets. This research aims to determine whether there is a difference in the sigma metrics between the bias derived from the manufacturer's target value and those from the peer group source in the External Quality Assurance Services (EQAS) program. The research methodology employed is descriptive comparative analysis, utilizing the results of material inspection data for 15 internal quality control parameters of Clinical Chemistry over a span of 2 years at the Pramita Laboratory in Bandung. The calculation of the sigma metrics commences with computing the coefficient of variation (CV), and the appropriate Total Error aalowable (Tea) sources for each parameter are determined beforehand using the TEa algorithm. The research findings indicate a difference between the sigma metrics derived from the manufacturer's target value and those from the EQAS-peer group target value, accounting for 33% or 10 parameters out of the total parameters with 2 levels of inspection are calculated on the sigma scale. However, in 67% or 20 parameters out of the total parameters, no such difference is observed. Bias associated with the target value from the manufacturer and the EQAS peer group shows no significant difference, suggesting that the laboratory can utilize pre-existing target values confidently.

Prevalence of gestational diabetes mellitus in Germany: Temporal trend and differences by regional socioeconomic deprivation.

Gestational diabetes mellitus (GDM) increases the risk for adverse pregnancy outcomes. In 2012, a general screening for GDM was introduced in Germany. The analysis is based on data from the external inpatient quality assurance for obstetrics from the years 2013 to 2021. Women with pregestational diabetes were excluded. GDM was defined either by documentation in the maternity record or by ICD diagnosis O24.4 during hospitalisation. We reported the prevalence stratified by year, maternal age and regional socioeconomic deprivation. The age-standardized prevalence of GDM continuously rose from 4.7 % in 2013 to 8.5 % in 2021. The increase was observed in all age groups. In 2021, this corresponded to 63,563 women with GDM. The prevalence was higher in highly deprived regions than in low deprived regions. A steady increase in GDM prevalence and evidence of health inequalities emphasise the need for primary prevention strategies for GDM.

Longitudinal analysis of 20Years of external quality assurance schemes for PCR/NAAT-based bacterial genome detection in diagnostic testing.

Quality control (QC), quality assurance, and standardization are crucial for modern diagnostic testing in the field of medical microbiology. The need for efficient QC to ensure accurate laboratory results, treatment, and infection prevention has led to significant efforts in standardizing assay reagents and workflows. External quality assessment (EQA) schemes, like those offered by INSTAND, play a vital role in evaluating in-house and commercial routine diagnostic assays, regarded as mandatory by national and global guidelines. The recent impact of polymerase chain reaction/nucleic acid amplification technology (PCR/NAAT) assays in medical microbiology requires that high-performing assays be distinguished from inadequately performing ones, especially those made by inexperienced suppliers. The study assesses the evolving diagnostic performance trends over 2decades for the detection of EHEC/STEC, Borrelia (B.) burgdorferi, and MRSA/cMRSA. It explores the historical context of assay utilization, participant engagement, and rates of correct results in EQA schemes. The research seeks to identify patterns in assay preferences, participant proficiency, and the challenges encountered in detecting emerging variants or clinical strains. The study highlights the decline in in-house PCR assay usage, the emergence of new diagnostic challenges, and educational aspects within EQA schemes. Specific examples, such as the inclusion, in certain EQA surveys, of EHEC strains carrying stx-2f or B. miyamotoi, highlight the role of EQAs in increasing awareness and diagnostic capabilities. Advancements in MRSA detection, especially through the adoption of commercial assays, demonstrate the impact that technology evolution has had on diagnostic performance. Achieving excellence in diagnostic molecular microbiology involves a multifaceted approach, including well-evaluated assays, careful instrumentation selection, and structured training programs. EQA schemes contribute significantly to this pursuit by providing insights into the evolving diagnostic landscape and identifying areas for improvement in the diagnostic workflow as well as in PCR/NAAT assay design.

External quality assurance program for diagnostic complement laboratories: evaluation of the results of the past seven years.

The complement external quality assurance (EQA) program was first organized in 2010 by a group of researchers working in diagnostic complement laboratories. Starting in 2016, INSTAND e.V., a German, non-profit interdisciplinary scientific medical society dedicated to providing expert EQA programs for medical laboratories, started organizing the EQAs for complement diagnostic laboratories together with the same group of experienced scientists and doctors who also work as EQA experts. The aim of the current work is to provide descriptive analysis of the past seven years' complement EQA results and evaluate timeline changes in proficiency testing. Each year, in March and October, blinded samples (normal, pathological) were sent to the participating diagnostic laboratories, where complement parameters were evaluated exactly as in daily routine samples. Since no reference method/target values exist for these parameters, and participants used different units for measurement, the reported results were compared to the stable mean (Algorithm A) of the participants using the same method/measurement units. A reported result was qualified as "passed" if it fell into the 30-50% evaluation/target range around the mean of reported results (depending on the given parameter). While the number of participating laboratories has increased in the past years (from around 120 to 347), the number of complement laboratories providing multiple determinations remained mostly unchanged (around 30 worldwide). C3, C4, C1-inhibitor antigen and activity determinations provided the best proficiency results, with >90% passing quotas in the past years, independent of the applied method. Determination of the functional activity of the three activation pathways was good in general, but results showed large variance, especially with the pathological samples. Complement factor C1q and regulators FH and FI are determined by only a few laboratories, with variable outcomes (in general in the 85-90% pass range). Activation products sC5b-9 and Bb were determined in 30 and 10 laboratories, respectively, with typical passing quotas in the 70-90% range, without a clear tendency over the past years. With these accumulated data from the past seven years, it is now possible to assess sample-, method-, and evaluation related aspects tofurtherimprove proficiency testing and protocolize diagnostic complement determinations.

Role of Strategic Planning in Quality Enhancement of Higher Education Institutions: Case Study of Bamyan University

Afghanistan is a conflict-impacted country with a higher education sector that is undergoing rapid growth in the last two decades. The Ministry of Higher Education established the Quality Assurance & Accreditation Commission in 2009; and established the Quality Assurance & Accreditation Directorate (QAAD) in 2011. This body is to administer and oversee the accreditation process in all public and private HEIs of Afghanistan with a strategic outlook. By providing a comprehensive QA Framework and aiming to meet international standards; QAAD is functioning for Internal and External Quality Assurance of HEIs. This Framework emphasizes the development of a Strategic Plan for Higher Education Institutions in its first main criteria. Since QAAD and its relevant processes of Quality Assurance are newly implemented phenomena for the Higher Education Institutions; the processes of Developing Strategic Plans seem to be ineffective, challenging, and not used as a fundamental tool for quality enhancement. Furthermore, there are considerable challenges facing the implementation level of developed plans. Considering the important role of strategic planning in quality assurance; this study aims to evaluate the effectiveness and impacts of strategic planning on the processes of quality enhancement of Bamyan University as one of the National Higher Education Institutions. Nine major aspects of quality issues focusing on three main levels of strategic planning at the institution, Faculty, and Department are among the core subjects of this study. This study is carried out from the implementers’ point of view and includes the responses of all academic and non-academic members of Departments, Faculties, and Leadership of Bamyan University. Furthermore, this provides lessons learned and recommendations for institutions, policy makers, and other Higher Education Institutions. This study is conducted from February to August 2021 in Bamyan University of Afghanistan. A questionnaire was adopted and developed as the instrument of this study and nine major aspects of the qualification issues were included in the instrument. SPSS tool was employed to descriptively analyze the findings of the study. This study has shown that the exercise and experiences of strategic planning have not meaningfully and satisfactorily contributed to the enhancement of the quality of education of this University. The mean value of all aspects is somehow below average or average level. From the respondents’ point of view; the impact of strategic planning on quality assurance activities is greater than other aspects and this impact is lower in the sustainability of financial resources.

Evaluation of cryoprotein investigation using a digital external quality assurance scheme.

Background: Robust preanalytical and analytical processes are critical for the detection of cryoproteins. There is significant variation in practice in the detection, analysis and reporting. Results: A survey in 2018 of 137 laboratories participating in the UK National External Quality Assessment Service (UK NEQAS) (6) quality control program showed significant variation in the laboratory processes which highlighted the need for standardisation of the detection, analysis and reporting of cryoglobulins.Conclusion: The first available EQA scheme aiming to harmonise practice for cryoprotein testing has been developed by UK NEQAS and laboratories should participate in an appropriate EQA scheme to fulfil requirements for ISO accreditation.

Sharing reference intervals and monitoring patients across laboratories- findings from a likely commutable external quality assurance program.

Laboratory results are increasingly interpreted against common reference intervals (CRIs), published clinical decision limits, or previous results for the same patient performed at different laboratories. However, there are no established systems to determine whether current analytical performance justifies these interpretations. We analysed data from a likely commutable external quality assurance program (EQA) to assess these interpretations. The use of CRIs was assessed by evaluating instrument group medians against minimum specifications for bias. The use of clinical decision limits was assessed using specifications from professional bodies, and the monitoring of patients by testing at different laboratories was assessed by comparing all-laboratory imprecision to within-subject biological variation. Five of the 18 analytes with Australasian CRIs did not meet specification for all instrument groups. Among these, calcium and magnesium failed for one instrument group out of seven, while bicarbonate, chloride, and lipase failed for two instrument groups. Of the 18 analytes reviewed currently without CRIs in Australasia, 10 candidates were identified. Among analytes with clinical decision limits, i.e.lipids, glucose, and vitamin D, only triglycerides met both bias and imprecision specifications, while vitamin D met the imprecision specification. Monitoring patients by testing at different laboratories was supported for 15 of the 46 (33 %) analyte-method principles groups that met minimum imprecision specifications. Analysis of data from commutable EQA programs can provide a mechanism for monitoring whether analyticalperformance justifies the interpretations made incontemporary laboratory practice. EQA providers shouldestablish systems for routinely providing this information to the laboratory community.

Lessons learned from an external quality assurance program in applying CLSI interpretive criteria for reporting piperacillin/tazobactam susceptibility

We evaluated the performance of automated susceptibility testing for piperacillin/tazobactam (PTZ) MICs against the reference microbroth dilution method. The Minimum Inhibitory Concentration of PTZ against a clinical isolate of Klebsiella pneumoniae was determined by reference broth micro-dilution method in 10 replicates which yielded a modal MIC of 16 mg/L (susceptible dose-dependent). Out of 434 laboratories who obtained MIC of 16 mg/L correctly, only 301 interpreted the result as susceptible dose dependent as per 2022 revised CLSI criteria. Educating the clinical laboratories in validating AST methods as per latest CLSI guidelines is of utmost important.

Perceived Changes to Quality Assurance after AUN-QA Programme Assessment: Voices of Quality Assurance Practitioners, Academic Staff, and Students

Quality assurance in Vietnamese higher education has been turning to a new page since it was made in recent years. Foreign accreditation is accepted in Vietnam, and, among foreign accrediting agencies, AUN-QA is more popular. This study examines the extent to which quality assessment by the AUN-QA could lead to changes in Vietnamese universities. This study adopted a basic qualitative approach to explore various stakeholders’ perceived changes with AUN-QA assessment with convenience and purposeful sampling techniques. Qualitative data were collected through interviews with various stakeholders such as students, academic staff, and quality assurance practitioners, followed by thematic analysis. The findings suggest that the AUN-QA quality assessment appeared to be the driver of positive changes, varying from accepting external quality assurance to learning the principles of constructive alignment in curriculum design, teaching and learning approaches, and student assessment. When the principle was learnt, superficial and minor changes were reported. The impacts were also evident in forming a culture of evidence (to demonstrate compliance with the external assessment). There were a few instances whereby changes were perceived as “perfunctory” because institutions used copying strategies for external assessment. Less evidence in the findings with not much discussion related to regular improvements and the dependence on individual academic staff for quality can be seen as directions for actions to be taken not only for the participating universities but also for other universities in Vietnam. The findings suggest that external assessment if applied appropriately to trigger stakeholders’ perceptions, could contribute to quality enhancement.

External proficiency testing for histocompatibility and immunogenetics in today and future.

The Histocompatibility and Immunogenetics laboratories provide disease association and pharmacogenetic analyses as well as the tests required for transplantation immunology and transfusion medicine. They perform Human Leukocyte Antigen (HLA) genotyping in patients/recipients and potential donor candidates for solid organ and stem cell transplants using various molecular methods, and determine mismatches. In addition, they also perform HLA antibody tests to detect anti-HLA antibodies in patients and flow cross-matches to evaluate donor-recipient compatibility. Evidence-based clinical guidelines have emphasized the importance of laboratory tests in clinical practices for a long time. Understanding the principles of Quality Control and External Quality Assurance is a fundamental requirement for the effective management of Tissue Typing laboratories. When these processes are effectively implemented, errors in routine assays for transplantation are reduced and quality is improved. In this review, the importance of Quality Assurance, Quality control and proficiency testing in Histocompatibility and Immunogenetic testing, the necessity of external proficiency testing (EPT) for accreditation, and existing and potential EPT programmes will be reviewed and evaluated in the light of the literature.

Predicting flow cytometry crossmatch results from single-antigen bead testing.

The aim of this study was to devise an algorithm that would predict flow cytometry crossmatch (FCXM) results using single-antigen bead (SAB) mean fluorescent intensity (MFI) levels using samples received through the National External Quality Assurance Scheme (NEQAS) 2B external proficiency testing scheme between 2019 and 2023. A total of 159 serum samples were retrospectively screened using LABScreen Single Antigen Class I and II (SAB), and 40 peripheral blood samples were human leucocyte antigen (HLA) typed with LABType SSO. Donor-specific antibodies were identified for each cell-serum combination tested, and cumulative MFI values were calculated for each test before correlating the screening result with the consensus crossmatch results for this scheme. HLA Class I MFIs were combined to predict the T cell crossmatch. For the B cell crossmatch prediction, two options were considered: (i) HLA Class II MFI values alone and (ii) HLA Class I+Class II MFIs. Receiver operating characteristic analysis was carried out to identify the combined MFI threshold that predicted NEQAS consensus results with the greatest sensitivity and specificity. HLA Class I combined MFI >5000 predicted T cell crossmatch results with 96% sensitivity, 100% specificity, 100% positive predictive value (PPV) and 92% negative predictive value (NPV). For B cell results, HLA Class I+Class II combined MFIs >11,000 gave the best model, showing 97% sensitivity, 82% specificity, 96% PPV and 85% NPV. However, for samples with only HLA Class II sensitization, combined MFIs >13,000 improved the B cell crossmatch predictions: 92% sensitivity, 95% specificity, 96% PPV and 91% NPV. Using this model, combined MFI can be used to predict the immunological risk posed by donor-specific antibodies when it is not possible to carry out an FCXM.

A Retrospective Study to Evaluate the Quality Assurance of Thyroid Profile In A Tertiary Care Clinical Biochemistry Laboratory

Background: The Six Sigma methodology has become a standard in quality assessment and management, widely adopted in various industries since the mid-1980s. This methodology is applicable wherever the outcome of a process needs measurement. One area where Sigma metrics find utility is in laboratory services, particularly in evaluating the quality assurance of biochemical parameters. Aims: This study aimed to measure and analyze the sigma metrics of thyroid hormones T3, T4, and TSH within the framework of NABL accreditation (National Accreditation Board for Testing and Calibration Laboratories). Materials & Methods: The study was designed as a retrospective observational study, utilizing quality control data from the Clinical Biochemistry section spanning from January 2021 to December 2021 retrieved from laboratory records. The data considered included Bio-Rad Lyphochek Immunoassay Internal Quality Control (IQC) Control and Bio-Rad External Quality Assurance Scheme (EQAS) Immunoassay monthly program data. Calculations for Coefficient of variation (CV %), Bias %, and Total Error allowable (TEa) were made to derive the sigma metric. The formula used for sigma calculation was Sigma Σ(σ) = (TEa% - Bias%) / CV%, while the Quality Goal Index (QGI) ratio was determined using the formula QGI = Bias / 1.5CV. Results: The results categorized the assay performance based on sigma levels: >6 denoted world-class performance, 5-6 indicated excellence, 4-5 represented good performance, 3-4 was deemed acceptable, and 2-3 signified poor performance. All analytes demonstrated sigma levels below 6 (2.61-5.85) varying from poor to excellent and the QGI was below 0.8, indicating a need to enhance the precision of assays. Conclusion: The Six Sigma metric analysis serves as a benchmark tool that can aid laboratories in enhancing assay performance, formulating protocols for Internal Quality Control (IQC), and evaluating existing laboratory procedures. Keywords Six sigma, Quality Goal Index, Internal Quality Control

To rule-in, or not to falsely rule-out, that is the question: evaluation of hs-cTnT EQA performance in light of the ESC-2020 guideline.

To accurately evaluate non-ST-elevated acute cardiac syndrome (NSTE-ACS), the quality of high-sensitive cardiac troponin (hs-cTn) assays is of vital importance. The 2020 revision of the NSTE-ACS guideline includes clinical decision-limits (CDL's) to both rule-in and rule-out NSTE-ACS for most commercially available platforms, providing both 0/1 h and 0/2 h delta limits. Our study evaluated whether laboratories are able to meet the analytical performance specifications for imprecision (APS) for hs-cTnT. Results from external quality assurance (EQA) in commutable samples were used to evaluate the current and historic performance of analyzers. The performance of analyzers that either passed or failed to comply with 0/1 h-APS were used on a real-world dataset of first hs-cTnT-values to simulate 10.000 samples of t=0, t=1 and t=2 h values with multiple delta's for all relevant CDL's. We compared the simulated values to the input values to obtain the percentage of aberrant results simulated. The majority of analyzers complies with APS for rule-in in 2022 (0/1 h: 90.4 % and 0/2 h: 100 %), compliance for the 0/1 h rule-out is still far from optimal (0/1 h: 30.7 %, 0/2 h: 75.4 %), with improving compliance over the past years (rule-in p=<0.0001, rule-out p=0.011, χ2). Whilst 0/1 h-APS-passing analyzers have a minute risk to falsely rule-out patients whom should be ruled-in (0.0001 %), failing performance increases this risk to 2.1 % upon using 0/1 h CDL's. Here, adopting 0/2 h CDL's is favorable (0.01 %). Laboratories that fail to meet hs-cTnT 0/1 h-APS should improve their performance to the required and achievable level. Until performance is reached clinics should adopt the 0/2 h CDL's.

Cell block practices in European cytopathology laboratories.

There are numerous methods and procedures described for the preparation of cell blocks (CBs) from cytological samples. The objective of this study was to determine current practices and issues with CBs in European laboratories. A link to an online survey, with 11 questions about CB practices, was distributed to cytology laboratories via participants of United Kingdom National External Quality Assurance Service for Cellular Pathology Techniques and national representatives in the European Federation of Cytology Societies. A total of 402 laboratories responded completely (337/402, 84%) or partially (65/402, 16%) to the survey by February 4, 2022. The most common CB practice is embedding cell pellets using plasma and thrombin (23.3%), agar (17.1%), Shandon/Epredia Cytoblock (11.4%), HistoGel (7.9%), and Cellient (3.5%). Other methods such as CytoFoam, albumin, gelatin, Cytomatrix, and collodion bags are rarely used (1.0%, 0.7%, 0.7%, 0.3%, and 0.2%, respectively). CBs are also prepared from naturally occurring clots or tissue fragments (29.5%) and cells scraped from unstained or prestained smears (4.4%). The most frequent issues with the CBs in a daily cytology practice are low cellularity (248/402, 62%) and dispersed cells (89/402, 22%), regardless of the CBs preparation method or how the samples for embedding were selected. There is a great variability in CB practices in European laboratories with low cellular CBs as the main issue. Additional studies are mandatory to evaluate and improve performance and cellular yield of CBs.

Improvement of laboratory testing services by implementation of quality assurance scheme

Introduction: The National AIDS Control Organization (NACO), Government of India and the Uttar Pradesh State AIDS Control Society (UPSACS) established the State Referral Laboratory (SRL) in the Department of Microbiology, Motilal Nehru Medical College, Prayagraj for HIV testing and monitoring of linked HIV Counselling and Testing Services (HCTS) in Uttar Pradesh.Methods: This is a retrospective study conducted from 2008 to 2021. In this evaluation period 10144 serum samples (9580 HIV negative, 555 HIV positive and 9 discordant) were received for retesting at SRL. The Quality Control serum samples received from testing sites consisted of 5% negative and 20% positive from all tested samples collected in the first seven days in the External Quality Assurance Scheme (EQAS) quarter month i.e. January, April, July and October. All samples were tested using rapid diagnostic kits procured by NACO/UPSACS with NACO testing strategy. All linked centres with SRL received 4 coded serum samples for proficiency testing (PT) which were tested similarly.Results: Of 10144 serum samples, 99.92% reported correct results and 0.08% reported discrepancy due to various issues. Similarly in the proficiency testing programme, of 4072 samples tested between 2010 to 2021 by testing sites, 4061 (99.07%) reported concordant results and the remaining14 (0.34%) samples reported indeterminate results. Of the 4072 samples, 14 shows discordant results by three different rapid tests based on different principles. Hands on training were provided for technicians who reported indeterminate results in PT or retesting.Conclusion: The tremendous increase in quality testing at peripheral centrally linked centres increase the reliability of HIV diagnosis at ground level. The study also concluded that continuous monitoring and mentoring of technicians of the diagnostic laboratories under EQAS improves their quality for HIV diagnosis.

A phased strengthening of laboratory capacity in the Eastern Mediterranean Region during the COVID-19 pandemic.

The Eastern Mediterranean Region (EMR) faces ongoing challenges in its public health system due to limited resources, logistical issues, and political disruptions. The COVID-19 pandemic accelerated the need for stronger laboratory capacities to handle the increased demand for testing. In a phased response, EMR countries utilized the National Influenza Centers to rapidly establish and scale molecular testing for SARS-CoV-2, the causative agent of COVID-19. The expansion of capacity included strong collaborations between public health bodies and private and academic sectors to decentralize and expand testing to the subnational level. To ensure that the quality of testing was not impacted by rapid expansion, national and subnational laboratories were enrolled in external quality assurance programs for the duration of the response. Implementation of genomic surveillance was prioritized for variant tracking, leading to the establishment of regional sequencing reference laboratories and the distribution of MinION sequencing platforms to complex emergency countries who previously had limited experience with pathogen sequencing. Challenges included a lack of technical expertise, including in implementing novel diagnostic assays and sequencing, a lack of bioinformatics expertise in the region, and significant logistical and procurement challenges. The collaborative approach, coordinated through the WHO Eastern Mediterranean Regional Office, enabled all 22 countries to achieve SARS-CoV-2 diagnostic capabilities, highlighting the pivotal role of laboratories in global health security.

Wide metabolite coverage LC-MS/MS assay for the diagnosis of inherited metabolic disorders in urine

ObjectiveThe laboratory diagnosis of inherited metabolic disorders (IMD) has undergone significant development in recent decades, mainly due to the use of mass spectrometry, which allows rapid multicomponent analysis of a wide range of metabolites. Combined with advanced software tools, the diagnosis becomes more efficient as a benefit for both physicians and patients. MethodsA hydrophilic interaction liquid chromatography coupled with tandem mass spectrometry assay for determination of urinary purines, pyrimidines, N-acylglycines, N-acetylated amino acids, sugars, sugar alcohols and other diagnostically important biomarkers was developed and validated. Evaluation of the results consisting of utilisation of robust scaling and advanced visualization tools is simple and even suitable for urgent requirements. ResultsThe developed method, covering 65 biomarkers, provides a comprehensive diagnostic platform for 51 IMD. For most analytes, linearity with R2 > 0.99, intra and inter-day accuracy between 80 and 120 % and precision lower than 20 % were achieved. Diagnostic workflow was evaluated on 47 patients and External Quality Assurance samples involving a total of 24 different IMD. Over seven years, more than 2300 urine samples from patients suspected for IMD have been routinely analysed. ConclusionsThis method offers the advantage of a broad coverage of intermediate metabolites of interest and therefore may be a potential alternative and simplification for clinical laboratories that use multiple methods for screening these markers.