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      How to Estimate the Cost of Point-of-Care CD4 Testing in Program Settings: An Example Using the Alere Pima™ Analyzer in South Africa

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          Abstract

          Integrating POC CD4 testing technologies into HIV counseling and testing (HCT) programs may improve post-HIV testing linkage to care and treatment. As evaluations of these technologies in program settings continue, estimates of the costs of POC CD4 tests to the service provider will be needed and estimates have begun to be reported. Without a consistent and transparent methodology, estimates of the cost per CD4 test using POC technologies are likely to be difficult to compare and may lead to erroneous conclusions about costs and cost-effectiveness. This paper provides a step-by-step approach for estimating the cost per CD4 test from a provider's perspective. As an example, the approach is applied to one specific POC technology, the Pima™ Analyzer. The costing approach is illustrated with data from a mobile HCT program in Gauteng Province of South Africa. For this program, the cost per test in 2010 was estimated at $23.76 (material costs = $8.70; labor cost per test = $7.33; and equipment, insurance, and daily quality control = $7.72). Labor and equipment costs can vary widely depending on how the program operates and the number of CD4 tests completed over time. Additional costs not included in the above analysis, for on-going training, supervision, and quality control, are likely to increase further the cost per test. The main contribution of this paper is to outline a methodology for estimating the costs of incorporating POC CD4 testing technologies into an HCT program. The details of the program setting matter significantly for the cost estimate, so that such details should be clearly documented to improve the consistency, transparency, and comparability of cost estimates.

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          Most cited references30

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          Performance evaluation of the Pima™ point-of-care CD4 analyser using capillary blood sampling in field tests in South Africa

          Background Point-of-care CD4 testing can provide immediate CD4 reporting at HIV-testing sites. This study evaluated performance of capillary blood sampling using the point-of-care Pima™ CD4 device in representative primary health care clinics doing HIV testing. Methods Prior to testing, prescribed capillary-sampling and instrument training was undertaken by suppliers across all sites. Matching venous EDTA samples were drawn throughout for comparison to laboratory predicate methodology (PLG/CD4). In Phase I, Pima™ cartridges were pipette-filled with EDTA venous blood in the laboratory (N = 100). In Phase II (N = 77), Pima™ CD4 with capillary sampling was performed by a single operator in a hospital-based antenatal clinic. During subsequent field testing, Pima™ CD4 with capillary sampling was performed in primary health care clinics on HIV-positive patients by multiple attending nursing personnel in a rural clinic (Phase-IIIA, N = 96) and an inner-city clinic (Phase-IIIB, N = 139). Results Pima™ CD4 compared favourably to predicate/CD4 when cartridges were pipette-filled with venous blood (bias -17.3 ± STDev = 36.7 cells/mm3; precision-to-predicate %CV < 6%). Decreased precision of Pima™ CD4 to predicate/CD4 (varying from 17.6 to 28.8%SIM CV; mean bias = 37.9 ± STDev = 179.5 cells/mm3) was noted during field testing in the hospital antenatal clinic. In the rural clinic field-studies, unacceptable precision-to-predicate and positive bias was noted (mean 28.4%SIM CV; mean bias = +105.7 ± STDev = 225.4 cells/mm3). With additional proactive manufacturer support, reliable performance was noted in the subsequent inner-city clinic field study where acceptable precision-to-predicate (11%SIM CV) and less bias of Pima™ to predicate was shown (BA bias ~11 ± STDev = 69 cells/mm3). Conclusions Variable precision of Pima™ to predicate CD4 across study sites was attributable to variable capillary sampling. Poor precision was noted in the outlying primary health care clinic where the system is most likely to be used. Stringent attention to capillary blood collection technique is therefore imperative if technologies like Pima™ are used with capillary sampling at the POC. Pima™ CD4 analysis with venous blood was shown to be reproducible, but testing at the point of care exposes operators to biohazard risk related to uncapping vacutainer samples and pipetting of blood, and is best placed in smaller laboratories using established principles of Good Clinical Laboratory Practice. The development of capillary sampling quality control methods that assure reliable CD4 counts at the point of care are awaited.
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            From HIV diagnosis to treatment: evaluation of a referral system to promote and monitor access to antiretroviral therapy in rural Tanzania

            Background Individuals diagnosed with HIV in developing countries are not always successfully linked to onward treatment services, resulting in missed opportunities for timely initiation of antiretroviral therapy, or prophylaxis for opportunistic infections. In collaboration with local stakeholders, we designed and assessed a referral system to link persons diagnosed at a voluntary counselling and testing (VCT) clinic in a rural district in northern Tanzania with a government-run HIV treatment clinic in a nearby city. Methods Two-part referral forms, with unique matching numbers on each side were implemented to facilitate access to the HIV clinic, and were subsequently reconciled to monitor the proportion of diagnosed clients who registered for these services, stratified by sex and referral period. Delays between referral and registration at the HIV clinic were calculated, and lists of non-attendees were generated to facilitate tracing among those who had given prior consent for follow up. Transportation allowances and a "community escort" from a local home-based care organization were introduced for patients attending the HIV clinic, with supportive counselling services provided by the VCT counsellors and home-based care volunteers. Focus group discussions and in-depth interviews were conducted with health care workers and patients to assess the acceptability of the referral procedures. Results Referral uptake at the HIV clinic averaged 72% among men and 66% among women during the first three years of the national antiretroviral therapy (ART) programme, and gradually increased following the introduction of the transportation allowances and community escorts, but declined following a national VCT campaign. Most patients reported that the referral system facilitated their arrival at the HIV clinic, but expressed a desire for HIV treatment services to be in closer proximity to their homes. The referral forms proved to be an efficient and accepted method for assessing the effectiveness of the VCT clinic as an entry point for ART. Conclusion The referral system reduced delays in seeking care, and enabled the monitoring of access to HIV treatment among diagnosed persons. Similar systems to monitor referral uptake and linkages between HIV services could be readily implemented in other settings.
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              Point-of-care diagnostics for HIV and tuberculosis: landscape, pipeline, and unmet needs.

              Early diagnosis and rapid initiation of treatment remains a key strategy to control both HIV and tuberculosis (TB). However, HIV and TB control programs have had completely contrasting successes, especially with the development and deployment of point-of-care (POC) diagnostics. Clinicians, researchers, and public health staff who work at the frontlines of HIV care and control have had access to an outstanding array of POC diagnostics at their disposal, including those used for screening, initial diagnosis, staging, treatment monitoring, and early infant diagnosis. The field has also advanced to consider over-the-counter, self-testing options for HIV and the use of multiplexed platforms that allow for simultaneous detection of infections associated with HIV. In sharp contrast to HIV, suboptimal and delayed diagnosis of TB has perpetuated the epidemic in many high-burden countries. Although the TB diagnostics pipeline is substantially better today than it was even five years ago, absence of a simple POC test continues to be a gaping hole in the pipeline. In this review, we compare the POC diagnostics landscape and pipelines for these two important infectious diseases, and highlight gaps and unmet needs.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                1932-6203
                2012
                20 April 2012
                : 7
                : 4
                : e35444
                Affiliations
                [1 ]Center for Global Health and Development, Boston University, Boston, Massachusetts, United States of America
                [2 ]Health Economics and Epidemiology Research Office, Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
                [3 ]Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, United States of America
                [4 ]Department of International Health, Boston University School of Public Health, Boston, Massachusetts, United States of America
                University of Cape Town, South Africa
                Author notes

                Analyzed the data: BL KS BN LL MF SR. Contributed reagents/materials/analysis tools: BL KS BN LL MF SR. Wrote the paper: BL KS BN LL MF SR.

                Article
                PONE-D-11-22958
                10.1371/journal.pone.0035444
                3331987
                22532854
                c6531531-362c-4cb4-ac7b-bedb4f4e840f
                Larson et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
                History
                : 21 November 2011
                : 16 March 2012
                Page count
                Pages: 8
                Categories
                Research Article
                Medicine
                Diagnostic Medicine
                Test Evaluation
                Infectious Diseases
                Sexually Transmitted Diseases
                AIDS
                Viral Diseases
                HIV
                HIV diagnosis and management
                Public Health
                Health Screening
                Science Policy
                Technology Development
                Social and Behavioral Sciences
                Economics
                Health Economics
                Cost Effectiveness
                Health Care Sector

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