Background: Standardising procedures is the best way to harmonise and strengthen the quality of laboratory-based antimicrobial resistance surveillance. Since 2018, Burkina Faso has developed and disseminated the national manual of procedures for performing antibiotic susceptibility tests in sentinel laboratories within its national antimicrobial resistance surveillance network.
Objective: Our study aimed to assess these sentinel laboratories' compliance with good practices for antibiotics susceptibility tests.
Methods: Four teams evaluated the antimicrobial resistance sentinel sites laboratories throughout Burkina Faso from 19 to 28 September 2022. Eighteen out of 19 sentinel laboratories were evaluated. A four-member technical committee designed and validated the evaluation tool composed of three Microsoft Excel sheets. The evaluation emphasised quality controls for culture media, antibiotic discs and compliance with antimicrobial susceptibility testing procedures by the laboratories. Excel software was used for data recording and graphs and table design. The free R software version 4.2.0 was used for descriptive statistics. An overall score below 80% was considered noncompliance.
Results: Most (83.33%) of the sentinel laboratories conducted at least one quality control activity for culture media, and 66.67% conducted at least one quality control activity for antibiotic discs. Over three-quarters (76.47%) of the laboratories were more than 80% compliant with the modified Kirby Bauer antimicrobial susceptibility testing method.
Conclusion: The evaluation revealed the noncompliance of sentinel laboratories with the national procedure manual, particularly in the quality control component.
What this study adds: This study has provided baseline data on the sentinel laboratories' compliance with the national antimicrobial susceptibility testing procedures manual, particularly in areas performing quality control checks or meeting quality indicators for culture media and antibiotic discs.
Background: Critical value notification (CVN) entails notifying doctors or other laboratory users of aberrant laboratory results that threaten the patient's life and of any values for which reporting delays could negatively impact the patient's health. Critical value notification practices in clinical laboratories in Nigeria and sub-Saharan Africa are largely unknown.
Objective: We conducted a nationwide survey to obtain baseline information on CVN practice by Nigeria's laboratories.
Methods: This cross-sectional study was conducted among purposively selected secondary- and tertiary-tier, public and private clinical laboratories across northern and southern Nigeria between October 2015 and December 2015. Consenting senior laboratory staff completed and returned a structured questionnaire, that gathered data on respondents' demographics, designations, and institutional characteristics and practices regarding CVN.
Results: One hundred and thirty-four laboratories responded to the questionnaires. Only 69 (51.5 %) laboratories practised CVN; only 23 (33.3%) had existing written policies guiding the practice. Most (43; 62.3%) laboratories use similar critical values (CVs) for adult and paediatric populations. Most laboratories (27; 39.1%) obtained their CVs by combining published literature and local opinions from stakeholders. Physical dispatch (42; 60.9%) followed by telephone calls (38; 55.1%) were the most common means of notification. Private laboratories, compared with public hospital laboratories, were likelier to have separate paediatric CV lists (p = 0.019) and practise telephone notifications (p < 0.001).
Conclusion: Critical value notification practices vary and are often suboptimal in many clinical laboratories in Nigeria, which is exacerbated by the absence of guiding policies and national recommendations for post-analytical procedures.
What this study adds: This study provides baseline information on CVN practice by Nigeria's laboratories. The study explores the causes of practice variations that can serve as a foundation for enhancing critical reporting and post-analytical services, particularly in clinical laboratories in sub-Saharan Africa.
Background: Haemoglobinopathies, including sickle cell disease and β-thalassaemia, are monogenic disorders with a relatively higher prevalence among malaria-endemic areas in Africa. Despite this prevalence, most African countries lack the necessary resources for diagnosing and managing these debilitating conditions.
Aim: This study provides a critical review of newborn screening for detecting haemoglobinopathies in Africa, highlighting challenges and proposing strategies for improved diagnosis and management.
Methods: A literature search on haemoglobinopathies in Africa was conducted in PubMed, Google Scholar and ScienceDirect, using specific keywords and Boolean operators, including articles published from January 1981 to December 2022.
Results: The data show that sickle cell disease is prevalent among populations in Central and West Africa; however, β-thalassaemia is prevalent among people in the northern parts of Africa. Newborn screening pilot initiatives for haemoglobinopathies were being implemented in Angola, Nigeria, Ghana, the Democratic Republic of Congo and the Republic of Benin. The cost of testing, lack of sufficient and accessible medical records, and inadequacy in healthcare infrastructure pose significant challenges in bridging the gaps in newborn screening. Furthermore, the stigmatisation and lack of awareness of haemoglobinopathies and access to newborn screening programmes pose additional challenges.
Conclusion: This review highlights the challenges associated with haemoglobinopathy testing, effective strategies for mitigating these challenges, and future perspectives for expanding efforts toward detecting and managing these disorders across Africa. Providing affordable diagnostic tools, mobile clinics, government subsidies, education campaigns, and the implementation of electronic medical records systems could help bridge the gaps in newborn screening in Africa.
What this study adds: The study presents a comprehensive view of newborn screening of haemoglobinopathies in Africa, provides a detailed outline of the challenges faced by newborn screening for haemoglobinopathies in Africa, and offers strategies for better diagnosis and care.
Background: Countries across the globe report an increase in expenditure associated with medical laboratory testing. In 2020, the United States Department of Health and Human Services reported that laboratory test expenditures increased by $459 million US dollars (USD) from $7.1 billion USD in 2018. In South Africa, laboratory testing expenditure in the public sector increased from $415 million USD in 2014 to $723 million USD in 2021.
Objective: This study aimed to evaluate the impact of an innovative software, electronic gatekeeping (EGK), on medical laboratory test expenditures at Nelson Mandela Academic Hospital, in the Eastern Cape, South Africa.
Methods: In this cross-sectional study, an interrupted time series analysis technique was used to evaluate trends in expenditure during a 48-month study period. To measure the impact of EGK on laboratory expenditure, we analysed laboratory expenditure over two study periods: a period of 24 months occurring before EGK implementation (01 June 2013 to 31 May 2015) and a period of 24 months occurring during EGK implementation (01 June 2015 to 30 May 2017).
Results: There was a significant reduction (211 928 fewer tests) in the number of tests performed during the intervention (434 790) compared to before the intervention (646 718). Laboratory test expenditure was $1 663 756.72 USD before the intervention period and $1 105 036.88 USD during the intervention period, demonstrating a cost savings of $558 719.84 USD.
Conclusion: Electronic gatekeeping is a cost-effective intervention for managing medical laboratory expenditures. We recommend that the health sector scale up this intervention nationally.
What this study adds: Using an interrupted time series interval, the authors determined that EGK is a cost-effective intervention for managing medical laboratory expenditures at a tertiary hospital. This study's findings can promote and contribute to improved laboratory systems and test investigations.
Background: Serum protein electrophoresis (SPE), urine protein electrophoresis and immunofixation electrophoresis were traditionally utilised for the diagnosis of monoclonal gammopathies. The quantitative serum-free light chain (SFLC) assay is reportedly more sensitive and has been introduced to recent clinical guidelines.
Objective: This study aimed to investigate SFLC test utilisation and describe SPE findings in patients with abnormal SFLC ratios.
Methods: A retrospective audit of SFLC analyses was conducted in Cape Town, South Africa, from May 2018 to April 2020. Agreement between abnormal SFLC ratios and SPE results was determined in a sub-group of patients screened for monoclonal gammopathies. Serum-free light chains were analysed using Freelite® Kappa and Lambda assays.
Results: Of the 1425 patients included in the audit, 741 (52%) had abnormal SFLC ratios; 636 (45%) had increased and 105 (7%) had decreased SFLC ratios. In a sub-group analysis of 117 new patients with an abnormal SFLC ratio, 57 had a monoclonal protein (M-protein) on SPE (49%), and 60 (51%) did not. Four out of 60 patients without M-protein had a plasma cell dyscrasia, while renal impairment or inflammatory response accounted for the rest. Of the 57 patients with a M-protein and abnormal SFLC ratio, 41 (72%) had a plasma cell dyscrasia, seven (12%) had lymphomas and nine patients (16%) were unclassifiable.
Conclusion: Serum-free light chains should be requested when there is a high index of clinical suspicion. Neither SFLC nor SPE should be performed in isolation when screening patients for monoclonal gammopathy, to ensure that no patient is missed.
What this study adds: The study adds to the evidence on SFLC test utilisation. Serum protein electrophoresis alone may miss cases of light chain myeloma, while SFLC performed in isolation may produce false positive results in the setting of inflammatory disorders or renal impairment, leading to unnecessary further investigation.