African Journal of Laboratory Medicine最新文献

{"title":"Nasal carriage rate and multiple antimicrobial resistance indices of <i>Staphylococcus aureus</i> among healthcare students at the Ahmadu Bello University, Nigeria.","authors":"Sumayya Abdullahi, Idris N Abdullahi, Hafeez A Adekola, Nicholas Baamlong, Amos Dangana, Yahaya Usman, Abdurrahman E Ahmad, Sumaiya Salisu, Mukhtar M Abdulaziz","doi":"10.4102/ajlm.v14i1.2667","DOIUrl":"10.4102/ajlm.v14i1.2667","url":null,"abstract":"<p><strong>Background: </strong>Healthcare students could harbour multidrug-resistant (MDR) and methicillin-resistant <i>Staphylococcus aureus</i> (MRSA). There is a need to understand the extent and factors associated with nasal carriage of these strains.</p><p><strong>Objective: </strong>This study determined the frequency and risk of nasal <i>S. aureus,</i> and multiple antimicrobial resistance indices among students at Ahmadu Bello University, Zaria, Nigeria.</p><p><strong>Methods: </strong>This comparative cross-sectional study collected nasal samples from 02 January 2024 to 31 July 2024 from healthcare students at Ahmadu Bello University, Nigeria, which were processed for <i>S. aureus</i> identification. Antimicrobial resistance phenotype was determined by the disk diffusion method. Structured questionnaires were used to collect participants' sociodemographic and risk factor data.</p><p><strong>Results: </strong>A total of 251 students participated, including 126 (50.2%) men and 125 (49.8%) women (aged 17-44 years). The nasal carriage of <i>S. aureus</i> was 31.5% (79/251) and MRSA was 23.5% (59/251). Clinical-phase students had a higher frequency of nasal MRSA (25%) than preclinical-phase students (22.1%). <i>Staphylococcus aureus</i> resistance against non-beta-lactams was highest for tetracycline (49.4%) and ciprofloxacin (29.1%), with 39.2% (31/79) showing MDR. Medical and pharmacy students had statistically significant higher nasal carriage of MDR-<i>S. aureus</i> (<i>p</i> < 0.05). Students residing in households of 5-8 individuals had the highest nasal MDR-<i>S. aureus</i> carriage (<i>p</i> = 0.0044). <i>Staphylococcus aureus</i> isolates with multiple antimicrobial resistance indices of 0.2 (29.1%) and 0.3 (24%) were the most predominant.</p><p><strong>Conclusion: </strong>High levels of nasal MRSA and MDR-<i>S. aureus</i> were obtained from this study. The predominance of strains with high antimicrobial resistance indicates sources with high antibiotic use.</p><p><strong>What this study adds: </strong>To our knowledge, this is the first epidemiological study on the multiple antimicrobial resistance indices of nasal <i>S. aureus</i> in healthcare students in Africa. Moreover, this is the first report to categorises subgroup variation of nasal MDR-<i>S. aureus</i> carriage by the six major groups of healthcare students.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"14 1","pages":"2667"},"PeriodicalIF":1.0,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12223919/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144561465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Thromboelastography in COVID-19 patients: An observational study in the South African context.","authors":"Bavinash Pillay, Sarah A van Blydenstein, Shahed Omar","doi":"10.4102/ajlm.v14i1.2681","DOIUrl":"10.4102/ajlm.v14i1.2681","url":null,"abstract":"<p><strong>Background: </strong>Coronavirus disease 2019 (COVID-19) increases the risk of venous thromboembolism, requiring monitoring of low molecular weight heparin (LMWH) via a time-consuming, costly and often unavailable test - anti-factor Xa (anti-Xa). An affordable, rapid point-of-care alternative, the thromboelastogram, is available, but performance comparisons to anti-Xa are lacking.</p><p><strong>Objective: </strong>This study evaluated the relationship between anti-Xa and thromboelastogram in patients with COVID-19 receiving LMWH.</p><p><strong>Methods: </strong>This was a retrospective study of patients with COVID-19 receiving LMWH at Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa, between November 2020 and January 2021. Blood samples tested with thromboelastogram and anti-Xa were drawn at three timepoints (one prior to and two after administration of LMWH). Thromboelastogram parameters comprised reaction time (R-time; onset of testing to the start of clot formation), kinetics time (K-time; start of clot formation until the clot reached 20 mm), and thromboelastogram coagulation index (overall coagulation status of whole blood).</p><p><strong>Results: </strong>Forty-two patients with COVID-19 (15 male and 27 female) met the study criteria. There was a statistically significant, low to moderate correlation (Spearman's correlation coefficient [<i>r</i> _s 0.43, <i>p</i> = 0.014]) between anti-Xa and thromboelastogram coagulation index. A statistically significant moderate correlation (<i>r</i> _s 0.52, <i>p</i> = 0.002) between anti-Xa and R-time, and a statistically significant low correlation (<i>r</i> _s 0.35, <i>p</i> = 0.049) between anti-Xa and K-time, were found. All correlations were 48 h post admission.</p><p><strong>Conclusion: </strong>Thromboelastogram coagulation index, R-times and K-times had a statistically significant association with anti-Xa levels in patients with COVID-19. Further research is required regarding their clinical utility.</p><p><strong>What this study adds: </strong>Thromboelastograms may represent a more cost-effective and accessible option to the conventional anti-Xa test in patients receiving LMWH. However, future research with larger sample sizes, varying disease profiles, and severity of illness is required.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"14 1","pages":"2681"},"PeriodicalIF":1.0,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12223966/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144561466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of pre-storage leukoreduction on erythrocyte concentrates and performance of newer generation leuko-filters at a tertiary care oncology hospital in Western India.","authors":"Deep Madkaiker, Shashank Ojha, Arunkumar N, Kalpesh Chawan","doi":"10.4102/ajlm.v14i1.2723","DOIUrl":"10.4102/ajlm.v14i1.2723","url":null,"abstract":"<p><strong>Background: </strong>Leukoreduction is a post-processing technique that reduces residual leukocytes in cellular blood components. Previous studies have evaluated these parameters mainly among older generation leuko-filters.</p><p><strong>Objective: </strong>This study evaluated the immediate effects of pre-storage leukoreduction on red cell indices and the performance efficacy of two newer generation leuko-filters.</p><p><strong>Methods: </strong>This retrospective analysis collected quality control data before and after leukoreduction for erythrocyte concentrates (ECs) from laboratory registers from the Blood Transfusion Laboratory at the Advanced Centre for Treatment, Research and Education in Cancer in Mumbai, India, for the period January 2015 to December 2019. Data related to red cell indices and performance characteristics for Fresenius and Macopharma filters were included.</p><p><strong>Results: </strong>A total of 500 records was included in the study. All EC units demonstrated a 99.99% leukocyte log reduction, with both filters showing equal efficacy. Post-leukoreduction haemoglobin concentrations were lower than the pre-leukoreduction for all units (<i>p</i> < 0.001). Of those prepared from 350 mL units, 11.6% (28/240) had haemoglobin levels under 40 g/bag as compared to 1.1% (3/260) among those prepared from 450 mL units. All indices exhibited statistically significant changes after leukoreduction (<i>p</i> < 0.001) except for mean corpuscular haemoglobin (<i>p</i> = 0.215). The Fresenius filter required less time for leukoreduction compared to the Macopharma filter (<i>p</i> < 0.001).</p><p><strong>Conclusion: </strong>Red cell indices show several changes following leukoreduction. Further studies are needed to assess the microscopic and functional impact of leukoreduction. Leuko-filters vary in their performance characteristics, which may influence vendor selection.</p><p><strong>What this study adds: </strong>This study found changes among several red cell indices after leukoreduction of ECs, which have not been extensively studied in previous literature. Further, we found that the newer generation leuko-filters differ in specific performance characteristics, which may influence vendor selection.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"14 1","pages":"2723"},"PeriodicalIF":1.0,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12223950/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144561464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mpox: An emerging or re-emerging infection with a potential colossal burden on healthcare globally.","authors":"Chikwelu L Obi, Nqobile M Mkolo, Liziwe L Mugivhisa, Modupe O Ogunrombi, Mukhethwa M Mphephu, Clarissa M Naidoo","doi":"10.4102/ajlm.v14i1.2644","DOIUrl":"10.4102/ajlm.v14i1.2644","url":null,"abstract":"<p><p>The World Health Organization identified mpox (formerly known as monkeypox), as a resurgent zoonotic epidemic caused by the mpox virus. It is an emerging and re-emerging pathogen with a range of hosts and geographical distribution worldwide. Peer-reviewed scientific articles from 1958 to 29 August 2024 related to global mpox research were extracted from Web of Science^TM Core Collection and Google Scholar Databases to gauge the extent of the infection. Mpox is marked by a recent resurgence of infections across continents, with Africa being the hardest-hit region. The mpox re-emergence has shown a new mechanism of transmission, with several causes such as a rise in the number of unvaccinated individuals, behaviour risk factors, waning immunity, genetic evolution, and environmental circumstances. Preventive and control measures of mpox include vaccination and patient isolation, while treatment involves antivirals and antibiotics for secondary bacterial infections. Laboratory diagnosis entailing polymerase chain reaction can be effective for routine purposes, but results of serological tests must be interpreted with caution, because of cross-reacting determinants among orthopoxviruses. The structure and classification of the mpox virus, clinical manifestations, pathophysiology, epidemiology, historical antecedent, therapeutics, vaccines, and laboratory diagnosis of the disease are explicated, showcasing mpox as an emerging or re-emerging infection with a potential colossal burden on healthcare, and its classification as an international public health emergency by the World Health Organization.</p><p><strong>What this study adds: </strong>This review provides the global situation of mpox as an emerging or re-emerging infection, warranting its designation as an international public health emergency.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"14 1","pages":"2644"},"PeriodicalIF":1.0,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12135148/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144227141","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of sample age and storage temperature on the flow cytometric diagnosis of chronic lymphocytic leukaemia in South Africa.","authors":"Shaun M Grobler, Anne-Cecilia van Marle","doi":"10.4102/ajlm.v14i1.2688","DOIUrl":"10.4102/ajlm.v14i1.2688","url":null,"abstract":"<p><strong>Background: </strong>Chronic lymphocytic leukaemia (CLL) is a haematological neoplasm with characteristic flow cytometric immunophenotyping. Pre-analytical variables impact the quality and reproducibility of flow cytometric data, which could alter the diagnosis from CLL to atypical CLL (aCLL).</p><p><strong>Objective: </strong>This study investigated the effects of pre-analytical variables, specifically sample age and storage temperature, on the stability of key antigens used in the diagnosis of CLL.</p><p><strong>Methods: </strong>Serial flow cytometric analyses were performed from January 2022 to March 2023 on blood samples of 10 CLL patients from the Universitas Academic Hospital Haematology Clinic in Bloemfontein, South Africa. Samples were stored at room and refrigerator temperatures and analysed at baseline, 24 h, 48 h, 72 h and 96 h. We recorded the percentage and intensity of antigen expression of CLL makers, including CD5, CD20, CD23, CD79b, CD200 and sIgM, and assessed whether these affected the adapted and modified Matutes scores.</p><p><strong>Results: </strong>Statistically significant changes were observed in CD5 (<i>p</i> = 0.028), CD23 (<i>p</i> = 0.003) and CD200 (<i>p</i> = 0.005) expression, with better stability at refrigerator temperature. Two samples showed changes in both Matutes scores by 24 h, irrespective of storage temperature. By 48 h, scores changed to aCLL in six room-temperature and four refrigerated samples. A majority shift in diagnosis to aCLL (modified Matutes: <i>n</i> = 8/10; adapted Matutes: <i>n</i> = 7/10) was observed at 96 h for refrigerated samples.</p><p><strong>Conclusion: </strong>These findings indicate that pre-analytical variables influence antigen stability in CLL samples, with better preservation at refrigerator temperature, recommending analysis within 48 h of collection.</p><p><strong>What this study adds: </strong>This study highlights the impact of pre-analytical variables on the flow cytometric diagnosis of CLL. Extended room temperature storage alters antigen expression, shifting Matutes scores and potentially affecting the final diagnosis. The findings emphasise optimised sample handling, for improved diagnostic accuracy in laboratory medicine.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"14 1","pages":"2688"},"PeriodicalIF":1.0,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12135094/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144227139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Narrative review: Continuous professional development training programmes in Africa and their limitations.","authors":"Nqobile Ndlovu, Rajiv T Erasmus, Annalise E Zemlin","doi":"10.4102/ajlm.v14i1.2602","DOIUrl":"10.4102/ajlm.v14i1.2602","url":null,"abstract":"<p><p>Continuous professional development (CPD) represents a cornerstone in the advancement of professional skills and knowledge across various sectors. It is globally recognised as a transformative process that unlocks potential, increases capacity, and fosters personal growth. This narrative review article aimed to understand how the CPD training programmes for laboratory professionals are implemented and sustained in Africa. A narrative review was conducted where a comprehensive search was conducted across PubMed, Embase, and web searches for white and/or grey literature, facilitated by a custom Python script. A combination of keywords, truncations, and subject headings targeted four key themes: Continuing professional development (and related terms), laboratory professionals, African countries, and aspects of implementation and scoring. The search was restricted to articles in English published from 2009 to 2024. While the actual training needs and gaps for CPD programmes are widely known, the actual implementation of CPD has remained a challenge. In the past, CPD training programmes have been implemented to address the lack of skills and the insufficient and skewed distribution of these health workers. This approach is not sustainable and has led to some challenges with coordination, quality assurance, and regulation. Each country has its unique context and training needs; therefore, CPD needs to be more coordinated and tailored so that professionals are given the right training for their needs.</p><p><strong>What this study adds: </strong>Addressing training gaps for laboratory professionals in Africa will require a well-structured, coordinated and tailored approach that will deliver a continent-wide CPD programme.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"14 1","pages":"2602"},"PeriodicalIF":1.0,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12135160/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144227142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"United States foreign aid freeze: An urgent call to action for support for African national laboratory programmes.","authors":"Farouk A Umaru","doi":"10.4102/ajlm.v14i1.2794","DOIUrl":"10.4102/ajlm.v14i1.2794","url":null,"abstract":"","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"14 1","pages":"2794"},"PeriodicalIF":1.0,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12135109/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144227143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ending nuclear weapons, before they end us.","authors":"Kamran Abbasi, Parveen Ali, Virginia Barbour, Marion Birch, Inga Blum, Peter Doherty, Andy Haines, Ira Helfand, Richard Horton, Kati Juva, Jose F Lapena, Robert Mash, Olga Mironova, Arun Mitra, Carlos Monteiro, Elena N Naumova, David Onazi, Tilman Ruff, Peush Sahni, James Tumwine, Carlos Umaña, Paul Yonga, Chris Zielinski","doi":"10.4102/ajlm.v14i1.2847","DOIUrl":"10.4102/ajlm.v14i1.2847","url":null,"abstract":"","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"14 1","pages":"2847"},"PeriodicalIF":1.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12135199/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144227140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation of the laboratory strategic framework to strengthen health laboratory services in Eastern Mediterranean Region, 2016-2023.","authors":"Fausta S Mosha, Rana Hajjeh, Rachel Ochola, Amany Ghoniem, Yvan J-F Hutin","doi":"10.4102/ajlm.v14i1.2611","DOIUrl":"10.4102/ajlm.v14i1.2611","url":null,"abstract":"<p><strong>Background: </strong>Laboratories and diagnostics services are critical to universal health coverage and public health response. We assessed the extent of the implementation and functionality of the 2016-2023 Eastern Mediterranean Region (EMR) laboratory strategic framework.</p><p><strong>Intervention: </strong>Documents and reports from World Health Organization country offices were examined between September 2022 and November 2022, supplemented by stakeholder-provided documents, to enhance data collection and reporting across the framework's five goals. An intervention using a performance evaluation scorecard assessed the progress of EMR Member States (MSs) towards strengthening health laboratory services, with findings validated during the December 2022 regional public health laboratory directors' meeting in Egypt.</p><p><strong>Lessons learnt: </strong>We analysed results from 21 of 22 MSs. Three (14%) MSs, all high income, had the capacity to implement all indicators, while only one of five low-income (20%) MSs could not demonstrate any capacity across all five goals evaluated. Irrespective of income category, the least implemented domains were: (1) availability of either or both fully implemented laboratory policy, and (2) a fully implemented integrated national laboratory strategic plan, both of which were implemented in only 50% of MSs.</p><p><strong>Recommendations: </strong>Addressing the identified gaps requires concerted efforts, collaboration, and sustained investment to ensure the delivery of high-quality laboratory services and advance public health outcomes across the EMR. Implementation of laboratory strategies should be coordinated through the specific laboratory department or unit at the Ministry of Health level, above the central public health laboratories and with the support of a national laboratory technical working group.</p><p><strong>What this study adds: </strong>This study revealed substantial gaps in implementing laboratory policies and strategic plans in the EMR, with full implementation achieved by only 50% of MSs. It underscores the necessity for coordinated efforts and sustained investment to enhance laboratory services and promote effective laboratory practices in EMR.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"14 1","pages":"2611"},"PeriodicalIF":1.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12067354/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144037816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mitigating the risk of tube shortages: A blood collection tube validation study conducted in South Africa.","authors":"Marizna Korf, Jody Rusch, Aye Aye Khine, Nalene Strauss, Lourens Jacobsz, Annalise E Zemlin, Helena Vreede","doi":"10.4102/ajlm.v14i1.2628","DOIUrl":"https://doi.org/10.4102/ajlm.v14i1.2628","url":null,"abstract":"<p><strong>Background: </strong>The National Health Laboratory Service was using Becton Dickinson (BD) blood drawing tubes and, in 2021, the supplier notified customers of supply challenges, indicating a risk of global shortages.</p><p><strong>Objective: </strong>This study aimed to validate candidate blood collection tubes from four brands (VACUCARE, VACUETTE^®, VACUTEST^®, and V-TUBE^™) compared to BD Vacutainer^® tubes in three National Health Laboratory Service laboratories in Cape Town, South Africa.</p><p><strong>Methods: </strong>Blood was collected from 300 healthy volunteers between October 2021 and November 2021. The technical validation assessed 11 quality indicators, with a sigma metric greater than 4 deemed acceptable. Usability feedback was gathered from phlebotomists. The clinical validation estimated differences in results across 52 clinical chemistry tests, using desirable bias specified by the European Federation of Clinical Chemistry and Laboratory Medicine Biological Variation Database, or Ricos, as acceptance criteria. Analysis was performed on Roche cobas^® 6000 and DiaSorin Liaison^® XL analysers.</p><p><strong>Results: </strong>All VACUCARE tubes exhibited sigma metrics above 4, indicating excellent performance. VACUETTE^® and V-TUBE^™ were not uncapped by all Roche pre-analytical systems. VACUTEST^® caps had rigid rubber, making it more challenging to puncture and detach the tube, which resulted in needle displacement. Both VACUCARE and V-TUBE^™ were reported as user-friendly. All candidate tube analytes showed acceptable clinical performance.</p><p><strong>Conclusion: </strong>VACUCARE, VACUETTE^®, VACUTEST^® and V-TUBE^™ are viable alternatives to BD Vacutainer^®. However, based on the results obtained from the technical validation, VACUCARE was identified as the most suitable interim replacement for BD Vacutainer^® during the shortage.</p><p><strong>What this study adds: </strong>This study addresses a gap in the literature on tube validation and provides valuable insights for clinical laboratories considering a replacement. It also presents an alternative approach to technical validation by utilising sigma metrics.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"14 1","pages":"2628"},"PeriodicalIF":1.0,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12067025/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144049955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}