A new matrix for scoring the functionality of national laboratory networks in Africa: introducing the LABNET scorecard

Ondoa, Pascale; Datema, Tjeerd; Keita-Sow, Mah-Sere; Ndihokubwayo, Jean-Bosco; Isadore, Jocelyn; Oskam, Linda; Nkengasong, John N.; Lewis, Kim

doi:10.4102/ajlm.v5i3.498

Cited by 9 publications

(9 citation statements)

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“…Clinicians depend on accurate and rapid results for appropriate patient diagnosis and treatment. 8 Rapid implementation of the Xpert MTB/RIF assay occurred in many resource-limited settings to quickly increase capacity for tuberculosis diagnosis and treatment initiation; unfortunately, QA activities have not kept pace with the expansion of Xpert MTB/RIF testing. When we initiated development of the dried tube specimen (DTS) for the Xpert MTB/RIF external quality assessment (EQA) procedure in 2012, only 386 of 907 (43%) global Xpert MTB/RIF testing sites participated in EQA, and only 77 of 318 (24%) African testing sites, participated in EQA.…”

Section: Introductionmentioning

confidence: 99%

Development of dried tube specimens for Xpert MTB/RIF proficiency testing

et al. 2020

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Background: Proficiency testing (PT) is part of a comprehensive quality assurance programme, which is critical to ensuring patients receive accurate and reliable diagnostic testing. Implementation of the Cepheid Xpert® MTB/RIF assay to aid in the diagnosis of tuberculosis has expanded rapidly in recent years; however, PT material for Xpert MTB/RIF is not readily available in many resource-limited settings.Objective: To develop an accurate and precise PT material based on the dried tube specimen (DTS) method, using supplies and reagents available in most tuberculosis culture laboratories.Methods: Dried tube specimens were produced at the United States Centers for Disease Control and Prevention from 2013 to 2015 by inactivating liquid cultures of well-characterised mycobacterial strains. Ten percent of DTS produced were tested with Xpert MTB/RIF and evaluated for accuracy and precision.Results: Validation testing across eight rounds of PT demonstrated that DTS are highly accurate, achieving an average of 96.8% concordance with the Xpert MTB/RIF results from the original mycobacterial strains. Dried tube specimen testing was also precise, with cycle threshold standard deviations below two cycles when inherent test cartridge variability was low.Conclusion: Dried tube specimens can be produced using equipment already present in tuberculosis culture laboratories, making Xpert MTB/RIF PT scale-up more feasible in resource-limited settings. Use of DTS may fill the gap in tuberculosis laboratory access to external quality assessment, which is an essential component of a comprehensive continuous quality improvement programme.

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Section: Introductionmentioning

confidence: 99%

Development of dried tube specimens for Xpert MTB/RIF proficiency testing

et al. 2020

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“…Some of the reported causes of unsuccessful tests, such as power failures and stockouts of testing kits, are recurring challenges in RLS. 17 …”

Section: Discussionmentioning

confidence: 99%

A global proficiency testing programme for Xpert® MTB/RIF using dried tube specimens, 2013–2015

Klein¹,

DeGruy²,

Rey³

et al. 2020

Afr. J. Lab. Med.

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Background: Proficiency testing (PT) is an important quality assurance measure toward ensuring accurate and reliable diagnostic test results from clinical and public health laboratories. Despite the rapid expansion of the Xpert® MTB/RIF assay for the detection of tuberculosis in resource-limited settings (RLS), low-cost PT materials for Xpert MTB/RIF external quality assessment (EQA) are not widely available.Objective: We sought to determine whether a dried tube specimen (DTS)-based PT programme would be a feasible option to support Xpert MTB/RIF EQA in RLS.Methods: Between 2013 and 2015, the United States Centers for Disease Control and Prevention developed and conducted a voluntary EQA programme using DTS-based PT material. Eight rounds of PT, each comprising five DTS samples, were provided to enrolled testing sites. After each round, participant results were compared to expected results, scored as satisfactory or unsatisfactory, and sites were provided with performance reports.Results: Programme enrolment increased from 102 testing sites in seven countries to 441 testing sites in 14 countries over the course of three years. In each PT round, approximately 90% of participating sites demonstrated satisfactory performance. In seven of the 14 enrolled countries, the proportion of sites with a satisfactory score increased between the first round of participation and the most recent round of participation.Conclusion: This programme demonstrated that it is possible to implement an Xpert MTB/RIF PT programme for RLS using DTS, that substantial demand for Xpert MTB/RIF PT material exists in RLS, and that country performance can improve in a DTS-based PT programme.

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“…This would ensure that no policy is formulated without a strategic plan or vice versa and that national laboratory policies are adequately aligned with other related health policies and integrate all key elements necessary for implementation. In addition, a (self-applied) national laboratory system assessment using available standardised tools, for example, the World Health Organization Laboratory Assessment Tool (LAT)-system assessment, 21 Laboratory Network (LABNET) scorecard, 22 and a strengths, weaknesses, opportunities, threats (SWOT) analysis of laboratory cross-cutting areas by a large inter-sectoral group of laboratory stakeholders conducted prior to the policy formulation, could facilitate the adequate prioritisation of strategic areas for improvements. Such a strictly standardised approach is ongoing for the development of national laboratory policies in Eastern Europe and central Asia, under the ‘Better Lab for Better Health Initiative’ 23 of the World Health Organization’s Regional Office for Europe, with promising results.…”

Section: Discussionmentioning

confidence: 99%

National laboratory policies and plans in sub-Saharan African countries: gaps and opportunities

et al. 2017

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IntroductionLaboratory services are key to the quality of healthcare but have remained a historicallyneglected component of health systems in low-and middle-income countries. The need for quality medical laboratory services to form an integrated part of the health system has been widely acknowledged by key national and international players during the past decade, resulting in the mobilisation of substantial funding earmarked for laboratory improvement in resource-limited settings. 1,2 Alongside these efforts, the development of a national laboratory policy and strategic plan (NLSP) relevant to each country's needs, and aligned with its health policy(ies) and plan(s), has also been advocated. 3,4,5 A national laboratory policy defines the vision and the mission of a country's laboratory system, whereas a strategic plan provides the corresponding roadmap guiding the process of the practical implementation of the necessary laboratory system improvement. The coherence of NLSPs with other national health guidance documents, such as national health policies, plans for development of human resources for the health sector, or disease-specific policies or plans, increases the likelihood that laboratory development strategies will be implemented.Despite the recent prioritisation of laboratory services in global and national health agendas, various aspects of the laboratory system fail to meet standards in several countries of sub-Saharan Africa. Clinical diagnostic capacity often remains insufficient for the control of HIV, malaria, tuberculosis and other infectious diseases and for responding to the rise in incidence of noncommunicable diseases. 6,7,8 In addition, the lack of laboratory-based surveillance precludes the Background:The 2008 Maputo Declaration calls for the development of dedicated national laboratory policies and strategic plans supporting the enhancement of laboratory services in response to the long-lasting relegation of medical laboratory systems in sub-Saharan Africa.Objectives: This study describes the extent to which laboratories are addressed in the national health policies and plans created directly following the 2008 momentum for laboratory strengthening.Method: National health policies and plans from 39 sub-Saharan African countries, valid throughout and beyond 31 December 2010 were collected in March 2012 and analysed during 2013. Results:Laboratories were addressed by all countries. Human resources were the most addressed topic (38/39) and finances and budget were the least addressed (< 5/39). Countries lagging behind in national laboratory strategic planning at the end of 2013 (17/39) were more likely to be francophone countries located in West-Central Africa (13/17) and have historically low HIV prevalence. The most common gaps anticipated to compromise the implementation of the policies and plans were the disconnect between policies and plans, under-developed finance sections and monitoring and evaluating frameworks, absence of points of reference to define gaps and shortages, and inappropr...

show abstract

A new matrix for scoring the functionality of national laboratory networks in Africa: introducing the LABNET scorecard

Cited by 9 publications

References 20 publications

Development of dried tube specimens for Xpert MTB/RIF proficiency testing

Development of dried tube specimens for Xpert MTB/RIF proficiency testing

A global proficiency testing programme for Xpert® MTB/RIF using dried tube specimens, 2013–2015

National laboratory policies and plans in sub-Saharan African countries: gaps and opportunities

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