Market penetration of Xpert MTB/RIF in high tuberculosis burden countries: A trend analysis from 2014 - 2016

Cazabon, Danielle; Pande, Tripti; Kik, Sandra V.; Gemert, Wayne van; Sohn, Hojoon; Denkinger, Claudia M.; Qin, Zhi Zhen; Waning, Brenda; Pai, Madhukar

doi:10.12688/gatesopenres.12842.2

Cited by 35 publications

(22 citation statements)

References 10 publications

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“…Multidisease testing on GeneXpert across HIV VL, EID, and TB has been shown feasible in Zimbabwe. 33 Indeed, a large fleet of GeneXpert devices already exists in many resource-limited settings mostly for TB testing, 34 , 35 which could be leveraged for targeted VL testing to benefit more patients living with HIV on ART, without requiring large capital investments in new devices.…”

Section: Discussionmentioning

confidence: 99%

Near Point-of-Care HIV Viral Load: Targeted Testing at Large Facilities

Ganesh

Heller

Chione

et al. 2020

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Introduction: Point-of-care (POC) technologies in resource-limited settings can circumvent challenges of centralized laboratory testing, improving clinical management. However, higher device costs and uncertain indications for use have inhibited scaling up POC modalities. To address this gap, we investigated the feasibility and cost of targeted near-POC viral load (VL) testing in 2 large HIV clinics in Lilongwe, Malawi. Methods: VL testing using GeneXpert was targeted for patients suspected of treatment failure or returning to care after a previously elevated VL (>1000 copies/mL). Descriptive analysis of retrospective clinical and cost data is presented. Results: Two thousand eight hundred thirteen near-POC VL tests were conducted. One thousand five hundred eleven (54%) tests were for patients for whom results and reason for the test were documented: 57% (794/1389) of tests were to confirm a previously high VL, and 33% (462/1389) were due to clinical indications. Sixty-one percent (926/1511) of patients had a high VL, of whom 78% (719/926) had a recorded clinical action: 77% (557/719) switched to second line antiretroviral therapy, and 15% (194/719) were referred for intensive adherence counseling. Eighty-two percent (567/687) of patients received a clinical action on the same day as testing. The “all-in” cost was $33.71 for a valid POC VL test, compared with an international benchmark for a centralized VL test of $28.62. Conclusion: Targeted, near-POC VL testing was feasible and consistently enabled prompt clinical action. The difference between the “all-in” cost of near-POC VL and centralized testing of $5.09 could be further reduced in an optimized national program by combining targeted near-POC testing and centralized testing.

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Section: Discussionmentioning

confidence: 99%

Near Point-of-Care HIV Viral Load: Targeted Testing at Large Facilities

Ganesh

Heller

Chione

et al. 2020

JAIDS Journal of Acquired Immune Deficiency Syndromes

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“…Nucleic acid amplification testing (NAAT) is recommended by the World Health Organization (WHO) as an initial test for pulmonary TB. In particular, WHO has endorsed Xpert MTB/RIF (Cepheid, Sunnyvale, CA USA), and 34.4 million Xpert MTB/RIF (Xpert) cartridges have been procured globally [ 1 ]. However, Xpert sensitivity has been sub-optimal for smear-negative pulmonary TB [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

The transition to Xpert MTB/RIF ultra: diagnostic accuracy for pulmonary tuberculosis in Kampala, Uganda

et al. 2021

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Background The World Health Organization (WHO) has endorsed the next-generation Xpert MTB/RIF Ultra (Ultra) cartridge, and Uganda is currently transitioning from the older generation Xpert MTB/RIF (Xpert) cartridge to Ultra as the initial diagnostic test for pulmonary tuberculosis (TB). We assessed the diagnostic accuracy of Ultra for pulmonary TB among adults in Kampala, Uganda. Methods We sampled adults referred for Xpert testing at two hospitals and a health center over a 12-month period. We enrolled adults with positive Xpert and a random 1:1 sample with negative Xpert results. Expectorated sputum was collected for Ultra, and for solid and liquid culture testing for Xpert-negative patients. We measured sensitivity and specificity of Ultra overall and by HIV status, prior history of TB, and hospitalization, in reference to Xpert and culture results. We also assessed how classification of results in the new “trace” category affects Ultra accuracy. Results Among 698 participants included, 211 (30%) were HIV-positive and 336 (48%) had TB. The sensitivity of Ultra was 90.5% (95% CI 86.8–93.4) and specificity was 98.1% (95% CI 96.1–99.2). There were no significant differences in sensitivity and specificity by HIV status, prior history of TB or hospitalization. Xpert and Ultra results were concordant in 670 (96%) participants, with Ultra having a small reduction in specificity (difference 1.9, 95% CI 0.2 to 3.6, p=0.01). When “trace” results were considered positive for all patients, sensitivity increased by 2.1% (95% CI 0.3 to 3.9, p=0.01) without a significant reduction in specificity (− 0.8, 95% CI − 0.3 to 2.0, p=0.08). Conclusions After 1 year of implementation, Ultra had similar performance to Xpert. Considering “trace” results to be positive in all patients increased case detection without significant loss of specificity. Longitudinal studies are needed to compare the benefit of greater diagnoses to the cost of overtreatment.

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“…The framework could also be used in low-income and middle-income countries, where many people live in rural and remote areas with limited or no access to laboratory testing. In many low-income and middle-income countries, GeneXpert platforms are already located within provincial and regional hospitals for tuberculosis management 32 but are often not used at full capacity, providing an opportunity to leverage existing infrastructure in response to the COVID-19 pandemic. Outside of hospitals, the framework could be used at large rural health facilities, hub-and-spoke models, or mobile outreach models to rapidly deploy to locations of epidemiological concern.…”

Section: Resultsmentioning

confidence: 99%

A decentralised point-of-care testing model to address inequities in the COVID-19 response

Hengel

Causer

Matthews

et al. 2021

The Lancet Infectious Diseases

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The COVID-19 pandemic is growing rapidly, with over 37 million cases and more than 1 million deaths reported by mid-October, 2020, with true numbers likely to be much higher in the many countries with low testing rates. Many communities are highly vulnerable to the devastating effects of COVID-19 because of overcrowding in domestic settings, high burden of comorbidities, and scarce access to health care. Access to testing is crucial to globally recommended control strategies, but many communities do not have adequate access to timely laboratory services. Geographic dispersion of small populations across islands and other rural and remote settings presents a key barrier to testing access. In this Personal View, we describe a model for the implementation of decentralised COVID-19 point-of-care testing in remote locations by use of the GeneXpert platform, which has been successfully scaled up in remote Aboriginal and Torres Strait Islander communities across Australia. Implementation of the decentralised point-of-care testing model should be considered for communities in need, especially those that are undertested and socially vulnerable. The decentralised testing model should be part of the core global response towards suppressing COVID-19.

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Market penetration of Xpert MTB/RIF in high tuberculosis burden countries: A trend analysis from 2014 - 2016

Cited by 35 publications

References 10 publications

Near Point-of-Care HIV Viral Load: Targeted Testing at Large Facilities

Near Point-of-Care HIV Viral Load: Targeted Testing at Large Facilities

The transition to Xpert MTB/RIF ultra: diagnostic accuracy for pulmonary tuberculosis in Kampala, Uganda

A decentralised point-of-care testing model to address inequities in the COVID-19 response

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