Implementation of GeneXpert MTB/Rif proficiency testing program: A Case of the Uganda national tuberculosis reference laboratory/supranational reference laboratory

Kabugo, Joel; Namutebi, Joanita; Mujuni, Dennis; Nsawotebba, Andrew; Kasule, George William; Musisi, Kenneth; Kigozi, Edgar; Nyombi, Abdunoor; Lutaaya, Pius; Kangave, Fredrick; Joloba, Moses

doi:10.1371/journal.pone.0251691

Cited by 6 publications

(5 citation statements)

References 19 publications

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“…Laboratories should participate in EQA activities to monitor the accuracy of the testing process ( International Organization for Standardization, 2013 ; Sciacovelli et al., 2018 ; Kabugo et al., 2021 ). The personnel performing nucleic acid POCT examinations should use the same testing system to assess samples for EQA, and there should be regulations prohibiting comparing EQA results with other laboratories.…”

Section: Quality Assurance Measuresmentioning

confidence: 99%

Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus

Wang

Zhu

et al. 2021

Front. Cell. Infect. Microbiol.

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COVID-19 continues to circulate globally in 2021, while under the precise policy implementation of China’s public health system, the epidemic was quickly controlled, and society and the economy have recovered. During the pandemic response, nucleic acid detection of SARS-CoV-2 has played an indispensable role in the first line of defence. In the cases of emergency operations or patients presenting at fever clinics, nucleic acid detection is required to be performed and reported quickly. Therefore, nucleic acid point-of-care testing (POCT) technology for SARS-CoV-2 identification has emerged, and has been widely carried out at all levels of medical institutions. SARS-CoV-2 POCT has served as a complementary test to conventional polymerase chain reaction (PCR) batch tests, thus forming an experimental diagnosis platform that not only guarantees medical safety but also improves quality services. However, in view of the complexity of molecular diagnosis and the biosafety requirements involved, pathogen nucleic acid POCT is different from traditional blood-based physical and chemical index detection. No guidelines currently exist for POCT quality management, and there have been inconsistencies documented in practical operation. Therefore, Shanghai Society of Molecular Diagnostics, Shanghai Society of Laboratory Medicine, Clinical Microbiology Division of Shanghai Society of Microbiology and Shanghai Center for Clinical Laboratory have cooperated with experts in laboratory medicine to generate the present expert consensus. Based on the current spectrum of major infectious diseases in China, the whole-process operation management of pathogen POCT, including its application scenarios, biosafety management, personnel qualification, performance verification, quality control, and result reporting, are described here. This expert consensus will aid in promoting the rational application and robust development of this technology in public health defence and hospital infection management.

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Section: Quality Assurance Measuresmentioning

confidence: 99%

Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus

Wang

Zhu

et al. 2021

Front. Cell. Infect. Microbiol.

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“…One of the pioneering devices is the GeneXpert platform with the MTB/RIF assay (Cepheid Inc. Sunnyvale CA, USA), which detects M. tuberculosis as well as the mutations that confer resistance to first-line therapies [12,13]. These platforms, distributed to a network of nearly 150 laboratories, are now utilized for routine tuberculosis (TB) across Uganda [14]. However, multiple studies have shown that device implementation alone did not reduce TB-associated mortality, the proportion of people who had initiated treatment, nor the time to treatment for people with a positive test result, even though detection rates were increased [15,16].…”

Section: Introductionmentioning

confidence: 99%

It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda

Boyce

Ndizeye

Ngelese

et al. 2023

PLOS Glob Public Health

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Barriers continue to limit access to viral load (VL) monitoring across sub-Saharan Africa adversely impacting control of the HIV epidemic. The objective of this study was to determine whether the systems and processes required to realize the potential of rapid molecular technology are available at a prototypical lower-level (i.e., level III) health center in rural Uganda. In this open-label pilot study, participants underwent parallel VL testing at both the central laboratory (i.e., standard of care) and on-site using the GeneXpert HIV-1 assay. The primary outcome was the number of VL tests completed each clinic day. Secondary outcomes included the number of days from sample collection to receipt of result at clinic and the number of days from sample collection to patient receipt of the result. From August 2020 to July 2021, we enrolled a total of 242 participants. The median number of daily tests performed on the Xpert platform was 4, (IQR = 2–7). Time from sample collection to result was 51 days (IQR = 45–62) for samples sent to the central laboratory and 0 days (IQR = 0–0.25) for the Xpert assay conducted at the health center. However, few participants elected to receive results by one of the expedited options, which contributed to similar time-to-patient between testing approaches (89 versus 84 days, p = 0.07). Implementation of a rapid, near point-of-care VL assay at a lower-level health center in rural Uganda appears feasible, but interventions to promote rapid clinical response and influence patient preferences about result receipt require further study. Trial registration: ClinicalTrials.gov Identifier: NCT04517825, Registered 18 August 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT04517825.

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“…In many lower-middle-income countries (LMIC), PT programs have been hard to set up due to costs and limitations in technical capacity. In Uganda, the national tuberculosis reference laboratory (NTRL) which is also a WHO Supra-National Reference Laboratory (Uganda-SRL) initiated the preparation of Ultra panels using a liquid matrix which was associated with the need for special storage and transportation conditions, poor stability and high rates of cross-contamination during preparation stages [8,9]. Moreover, effective PT should be conducted biannually requiring preparing of fresh panels for each round which is costly and labor-intensive [8].…”

Section: Introductionmentioning

confidence: 99%

“…To overcome the rigorous and expensive biannual preparations processes while maintaining semiannual PT rounds, the Uganda-SRL adopted the use of DTS, a method that had been used by the United States centers for disease control and prevention (CDC) and in other disease PT schemes such as HIV viral load testing [8,10,11]. We designed this study to demonstrate the stability of DTS panels and compatibility with testing protocol when stored under different environmental conditions for one year.…”

Section: Introductionmentioning

confidence: 99%

Advancing proficiency testing for ultra in resource-limited settings using dried tube specimen: A study by SRL-Uganda

Kabugo

Namutebi²,

Adam³

et al. 2023

PLoS ONE

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Background Proficiency testing (PT) has been hard to set up due to cost limitations and technical capacity. Conventional Xpert MTB/RIF PT programs use liquid and culture spots which require stringent storage and transportation conditions with cross-contamination chances prevalent. These setbacks prompted the use of dried tube specimens (DTS) for Ultra assay PT. For continuity of PT provision, stability of DTS and compatibility with testing protocols when kept for a long period needs to be established. Methods DTS were prepared from known isolates inactivated using a hot air oven at 85°C. 100μl of bacterial suspensions were aliquoted and dried inside a Biosafety cabinet. Panel validation was done to establish the baseline Deoxyribonucleic acid (DNA) concentration in terms of cycle threshold (Ct) value. DTS aliquots were shipped to participants to test and report within six weeks. The remaining DTS were kept at 2–8°C and room temperature for one year with testing at six months. Twenty (20) DTS samples per set remaining at one year were heated at 55°C for two weeks before testing. The means of the different samples were compared to validation data using paired t-tests. Boxplots were designed to visualize the differences in the medians of the DTS. Results Overall mean Ct value increased by 4.4 from the validation to testing after one year at the different storage conditions. Samples heated at 55°C showed a 6.4 Ct difference from validation data. Testing done at six months on 2–8°C stored items showed no statistical difference. At all the remaining testing times and conditions, P-values were less than 0.008 although the absolute mean Ct when compared showed slight increments and accommodated differences for the detection of MTB and rifampicin resistance. Median values for samples stored at 2–8°C were lower compared to those at room temperature. Conclusion DTS stored at 2–8°C remain more stable for one year compared to higher temperatures and can be consistently used as PT materials in more than one PT round for biannual PT providers.

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Implementation of GeneXpert MTB/Rif proficiency testing program: A Case of the Uganda national tuberculosis reference laboratory/supranational reference laboratory

Cited by 6 publications

References 19 publications

Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus

Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus

It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda

Advancing proficiency testing for ultra in resource-limited settings using dried tube specimen: A study by SRL-Uganda

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