REVIEW

10.1111/j.1469-0691.2010.03280.x

Economic evaluation of point-of-care diagnostic technologies for infectious diseases
S. Loubiere1,2,3 and J.-P. Moatti1,2,3 ´ ´ ´ ˆ 1) INSERM, U912 (SE4S), 2) Universite Aix Marseille, IRD, UMR-S912 and 3) ORS PACA, Observatoire Regional de la Sante Provence Alpes Cote d’Azur, Marseille, France

Abstract
We review the growing number of economic evaluations of individual point-of-care (POC) tests for diagnosis of infectious diseases in resource-limited settings that use either cohort studies or mathematical models. We focus on studies that evaluate POC diagnostic tests for the control of human immunodeficiency virus (HIV) and malaria, tools that are central to the WHO prevention guidelines for infectious diseases in developing countries. Although rapid diagnostic tests for HIV and malaria seem to be cost-effective in these standard analyses, these do not take into account the reduction in patients’ waiting time and the number of clinic visits required to receive results, or future benefits from the reduction in antimalarial drug pressure. Those additional cost reductions would be considerably greater with POC rapid tests, and the cost-effectiveness of POC tests would therefore be improved. Findings from cost-effectiveness analyses suggest that, despite the relatively small additional cost incurred, decision-makers should strongly consider using POC tests throughout or during parts of HIV and malaria epidemics, where this is feasible in terms of local human resources and logistical conditions. Keywords: Cost-effectiveness, HIV/AIDS, malaria, point-of-care testing, review
Clin Microbiol Infect 2010; 16: 1070–1076

Corresponding author and reprint requests: S. Loubiere, INSERM U912-ORS PACA, 23, rue Stanislas Torrents, 13006 Marseille, France E-mail: sandrine.loubiere@inserm.fr

Introduction
Recent figures from the WHO [1] suggest that 33 million individuals are living with HIV infection worldwide, more than two-thirds in developing countries with limited resources. The scale-up of antiretroviral therapy (ART) in low-income and middle-income countries has been unprecedented, with more than 4 million people estimated to have had access to ART at the end of 2008 [1]. Despite the global effort to control the AIDS pandemic, human immunodeficiency virus (HIV) infection continues to spread relatively unabated in many parts of the world. The transmission rate for HIV-infected individuals unaware of their infection is up to 3.5-fold higher than that for those who are aware [2]. Identifying those who are acutely HIV-infected is a first priority in order to reduce transmission rates through the use of both behavioural interventions and effective treatment programmes. Expansion of HIV testing is therefore urgently required, and mechanisms must be developed to ensure that

HIV diagnosis occurs early on in the course of disease, at affordable costs, especially for people living in resource-limited countries. The same holds true for malaria. Its diagnosis has traditionally relied on the clinical presentation of disease symptoms and microscopic examination of Giemsa-stained blood films [3]. Diagnosis based on symptoms alone is unreliable, because the symptoms of malaria are non-specific, overlapping with those of other febrile diseases [4]. Studies in Africa have shown that between 50% and 99% of those clinically diagnosed with malaria and then prescribed antimalarial drugs have illnesses attributable to some other cause, depending on endemicity in the clinical setting [5,6]. This results in overdiagnosis of malaria and overprescription of antimalarial drugs, as well as underdiagnosis and inappropriate treatment of non-malarial febrile illnesses [7,8]. In addition, antimalarial drug pressure ultimately contributes to the development and spread of drug resistance [9]. Most victims of malaria still die because the disease is not diagnosed in time by health workers [10].

ª2010 The Authors Journal Compilation ª2010 European Society of Clinical Microbiology and Infectious Diseases

They require less laboratory infrastructure.8–94. a test that can be performed while the patient is at the clinic means that fewer patients are lost to follow-up and the burden on patients is reduced [11].18]. prioritizing and optimizing healthcare services. ‘‘Current technologies are very expensive and require delicate instruments. In addition. In this article. How can high-quality test results be provided in the most cost-effective way? One solution is the use of point-of-care (POC) tests. as compared with 87. the expanded use of POC rapid HIV testing promises to play an important role in HIV prevention. and can be designed to be easy to use and interpret [14–16]. when testing is carried out in centralized laboratories.8% (79. In addition to improving the standard of care. The authors used a decision-analytical model to compare the DNA-PCR and rapid HIV test approaches. instead of the enzyme immunoassay and western blot techniques previously used [20]. as the incremental cost per HIV-infected infant correctly diagnosed using the latter ranges from $559 (95% CI $261–$2702) with low compliance to $7165 (95% CI: $3322–20 127) with perfect compliance. making it possible to evaluate the performance and the cost-effectiveness of POC HIV testing in settings with limited laboratory facilities and where the demand for voluntary counselling testing is likely to increase. In line with this objective. and do not require high precision. are potentially cheaper. involve a limited number of steps. 1070–1076 .5%) for the latter. We focus on studies that evaluate POC diagnostic tests for the control of HIV and malaria.7%) of HIV-infected infants. cold chain. describes the methodological features of each analysis that evaluates the cost-effectiveness of POC diagnostic tests for HIV disease and malaria. Moreover. The study population comprised HIV-exposed children <18 months of age attending two postnatal screening programmes in Uganda between 2005 and 2006. In the face of economic constraints. The comparator that they used was the current diagnosis-testing algorithm DNA-PCR. surveillance. The rapid POC test is therefore more costeffective than the comparator. Instead. cost-effectiveness analysis can serve as one key element to inform decision-makers. the total cost of the POC testing programme was about 40% less than that of DNA-PCR ($59 vs. tools that are central to the WHO prevention guidelines for infectious diseases in developing countries. Although these recommendations were revised as the range of antibody tests expanded. access to immediate HIV test results could improve the application of prophylactic regimens to reduce vertical transmission when used intrapartum or postpartum [21–23]. we review the growing number of economic evaluations of individual POC tests for diagnosis of infectious diseases in resource-limited settings that use either cohort studies or mathematical models. Table 1 provides a summary of the results and ª2010 The Authors Journal Compilation ª2010 European Society of Clinical Microbiology and Infectious Diseases. 16. turn-around times are of the order of several months for specimens sent from rural areas in developing countries [12. We then reviewed citation and reference lists to identify additional studies. the Global Programme on AIDS and the WHO first recommended the use of testing strategies based on combinations of screening tests (including simple. Cost-effectiveness analysis is a well-established methodology for understanding. it is critically important to evaluate how best to utilize available resources [17. rapid tests) for blood screening. and stable electricity.4–90. Second. [24] studied the cost-effectiveness of initiating diagnosis with a rapid HIV test to screen out HIV-uninfected infants. By comparing testing alternatives in terms of their relative advantages and costs. Cost-effectiveness of Rapid POC Diagnostic Tests for the Control of HIV In 1992. For several reasons.3% (91. These advantages can help reduce the workload for laboratories and streamline care in settings where large numbers of patients are treated daily.13].CMI Loubiere and Moatti Economic evaluation of diagnostic technologies for infectious diseases 1071 It appears that existing diagnosis technologies are poorly adapted for use in resource-limited settings. $38 per infant aged 6–9 months). Menzies et al. the use of rapid tests as a tool for prevention strategies promoting the need for awareness of one’s own and one’s partner’s Review of Recent Studies on the Costeffectiveness of ART We used the Medline database to conduct a literature search of articles published between 2006 and 2010. These are diagnostic tests performed close to the patient. in order to define public health policy [19]. First. Because the procedures are very simple (the need for equipment such as centrifuges and electricity being eliminated). they were still intended for serum or plasma testing. which are not available in areas where the majority of the patients reside’’ [11]. CMI. and found that the former identified 94. both in developed and in developing countries. they can be used outside traditional laboratory settings by staff with no formal laboratory training. recently developed rapid tests detect HIV antibodies in whole blood specimens. and diagnosis. as several studies indicate that persons who are aware of their HIV infection more frequently adopt behaviours to reduce the likelihood of transmission [25–27].

when ACT is reduced to <20% of fever patients Reference group In high malaria prevalence: 178 over-treatment errors averted and 82 undertreatment errors averted/ 1000 outpatients. sensitivity and specificity and costs Costs and sensitivity of POC test Vickerman et al. August 2010 ª2010 The Authors Journal Compilation ª2010 European Society of Clinical Microbiology and Infectious Diseases.8 for a test costing $3. $10. sensitivity. CMI. 2008 [35] Saharan Monte Carlo Africa simulations Direct medical care costs and variable costs Disability-adjusted None life years None Provider and patients S1 S2 Traditional counseling and testing Nurse-initiated routine screening with traditional HIV testing and counseling Nurse-initiated routine screening with rapid HIV testing and streamlined counselling Presumptive treatment Microscopy diagnosis Malaria prevalence. Cost-effectiveness of rapid POC test for the diagnosis of HIV and malaria Cost measure Results Effectiveness measure Time horizon Discount Strategy Compared rate Perspective number interventions Sensitivity analysis 1072 References Setting Methods Menzies et al. 2006 [40] Benin Dynamic Medical mathematical costs model. $221.2 for a test costing $4 Reference group HIV prevalence. adherence to ACT. data from SIDA2 project Pre-test counseling + DNAPCR Pre-test counseling + Rapid HIV test + DNA-PCR Currently used syndromic approach to diagnosis Modified syndromic management including POC tests Sanders et al. costs prescription of antibiotics. 2009 [39] Msellem et al. sensitivity and specificity.660/QALY Shillcutt et al. quality-adjusted life-years Lifetime 3% Societal S1 $81.4 for a test costing $2. US 2010 [34] S2 Extended dominance. Uganda 2009 [25] S2 None S2 Health care provider S1 Reference group Decision tree Medical with Monte costs Carlo simulations care Ng/Ct cases None averted and HIV cases averted care HIV-positive None infants correctly diagnosed None Provider S1 $1489/infected infant correctly diagnosed Reference group HIV prevalence. re-attendance rate Kenya Randomized Medical care AL treatment clinical trial. Markov statetransition model Medical costs care Life-years saved. 2008 [46] Direct medical Deaths averted and non medical costs Zanzibar A non randomized Direct medical Prescription of clinical trial and non medical ACT. $151. adherence to treatment. $292. costs None None None Provider S1 S2 Clinical diagnosis Clinical diagnosis + Rapid diagnostic tests Reference group 95% certain that microscopy is cost-effective at prevalence <41% and not cost-effective at prevalence >83% 95% certain that RDTs are cost-effective at prevalence <62% and not cost-effective at prevalence >90%. HIV incidence. sensitivities and specificities. 85% certain that RDTs are costeffective relative to microscopy across all level of prevalence Reference group $257/death averted $-221/death averted Outcomes better in the CD + RDT group CD + RDT is cost saving in patients >15 years. 16. 2009 [27] Nigeria Decision tree model Zurovac et al. 1070–1076 S3 Rapid diagnostic tests (RDTs) None None 14 days None follow-up Consumer S1 and provider S2 S3 Provider S1 S2 Presumptive treatment Microscopy diagnosis Rapid diagnostic tests (RDTs) Clinical diagnosis (CD) Clinical diagnosis + Rapid diagnostic tests (CD + RDT) Malaria prevalence. costs Clinical Microbiology and Infection. Extended dominance Randomized trial. Volume 16 Number 8. In low malaria prevalence: 54 over-treatment errors averted and 5 under-treatment errors averted/1000 outpatients. a cost savings of $-13/1000 outpatients. an additional cost of $+241/1000 outpatients Malaria prevalence.0/HIV infection averted for a test costing $1. SubDecision tree. costs errors Decision tree CMI . costs S3 $16.259/LY. costs Uzochukwu et al.TABLE 1.

[32] examined the costs and benefits of three strategies to improve HIV testing and receipt of results among primary-care patients with unknown HIV status: (i) traditional HIV counselling and testing. Decision tree Methods Medical care costs Life-years lost None None Societal S1 S2 Presumptive treatment Microscopy diagnosis Rapid diagnostic tests (RDTs) In high malaria prevalence: 144 over-treatment errors averted and 13 undertreatment errors averted/ 1000 outpatients. [28] studied the impact of combined Neisseria gonorrhoeae/Chlamydia trachomatis rapid POC tests on the transmission of HIV or sexually transmitted infections among female sex workers. Third. and the cost-effectiveness of POC tests for HIV would therefore be improved. (Continued ) References Lubell et al. response rate (see original paper) Results Cost of life year lost.6). CMI. and was also costeffective as compared with traditional HIV-testing strategies. With rapid testing by nurses. these do not take into account the reduction in patient waiting time and the number of clinic visits required to receive results. a costsavings of $-222/1000 outpatients.87 years or 0. POC tests considerably reduce patient anxiety. However.2 (95% CI 224. Vickerman et al. the authors argued that they used the lower cost range for the combined N. and assumptions when necessary. data from randomized controlled trials. Microscopy sensitivity ª2010 The Authors Journal Compilation ª2010 European Society of Clinical Microbiology and Infectious Diseases. Using a deterministic model and data from the SIDA2 trial [29]. even though they cost up to $4 per test. Those additional costs would be considerably reduced with POC rapid tests. an additional cost of $+109/1000 outpatients Results depend on prevalence. the incremental cost per HIV infection averted being $292. Sanders et al. trachomatis test on the grounds that more expensive tests would no longer be cost-effective. 1070–1076 .31]. In low malaria prevalence: 37 over-treatment errors averted and 7 under-treatment errors averted/1000 outpatients. the authors showed that nurse-initiated routine screening with traditional counselling and testing increased rates of testing and improved receipt of test results. and (iii) nurse-initiated routine screening with streamlined counselling and rapid HIV testing. In a recent study conducted in the USA. life-expectancy was increased by 0.7–472. Failing to explore the potential impact of the higher costs possibly biased their results in favour of POC testing. The rapid POC tests resulted in 10% of N. the adverse effects of waiting for one’s test results. the authors showed that rapid POC tests constitute a cost-effective use of resources for increasing the impact of treatment interventions for sexually transmitted infections in resource-poor settings. making it appear more cost-effective than it may actually be in practice. Benin.63 quality-adjusted life-years as compared with traditional counselling and testing. and also the risk of loss to follow-up [30. On the basis of a Markov model. the additional gains in health benefit with rapid testing cost $10 660/QALY. Sensitivity analysis Clinical diagnosis + Rapid diagnostic tests with a revised practice for artemetherlumefantrine (AL) Strategy number Compared interventions Perspective S3 Discount rate Time horizon Effectiveness measure Cost measure TABLE 1. their clients and the general population in Cotonou. Although rapid diagnostic tests for HIV seem to be costeffective in these standard analyses. 16. gonorrhoeae/C. Including the benefits from reduced transmission. (ii) nurse-initiated routine screening with traditional counselling and testing. gonorrhoeae/C.CMI Loubiere and Moatti Economic evaluation of diagnostic technologies for infectious diseases 1073 infection status could considerably reduce HIV sexual transmission. 2008 [21] Tanzania Setting Randomized clinical trial. and the initial test costing $4. trachomatis cases being averted and 6% of HIV cases being averted.

August 2010 CMI Cost-effectiveness of Rapid POC Diagnostic Tests in the Diagnosis of Malaria As antimalarial drug costs increase. but with higher costs.5% of all patients above 5 years of age). With a presumptive antimalarial treatment strategy. However. The same decision tree used by Shillcutt et al. Further analysis of the cost-effectiveness of rapid POC tests at these informal providers is warranted.37]. there is a scarcity of cost-effectiveness data on rapid POC tests in countries with high malaria endemicity [38]. [41] questioned the impact of malaria prevalence on the cost-effectiveness of diagnostic strategies. [39] conducted a cost-effectiveness analysis in different sub-Saharan settings to compare presumptive. [44] studied the influence of rapid POC tests for malaria diagnosis on drug prescriptions. The incremental cost-effectiveness ratio of rapid POC tests vs. less effective and more costly). [40] compared the cost-effectiveness of rapid POC testing with syndromic diagnosis and microscopy in a hypothetical population of 100 000 patients with a history of fever or of non-specific symptoms or signs suggestive of malaria and clinically diagnosed as having malaria by health workers in urban and rural districts of Nigeria. For example.1% or less. As regards diagnosis of the disease. and the case management algorithm is greatly simplified. and that appropriate management of malaria and non-malarial febrile illnesses is required to reap the full benefits of this type of testing. presumptive treatment has serious disadvantages. Uzochukwu et al. A total of 1887 patients of all ages with reported fever were enrolled in a non-randomized. whereas in many settings a high proportion of care-seekers obtain drugs from private. many febrile cases are diagnosed as malaria even though they have a different pathology) [36. Using a decision tree model. the limited benefits obtained in low-prevalence areas result from the underuse of ACT following the recent introduction of a new treatment policy [42]. the WHO [10] guidelines recommend that parasite-based diagnosis should be used in all cases of suspected malaria. diagnostic methods are becoming a crucial component of malaria control and prevention. and microscopy was a dominated strategy (i. According to the authors. In the same way. In contrast. ACT still costs up to ten times more than chloroquine [34. This review reports results from economic evaluations carried out in developing countries to determine whether the use of rapid POC tests for diagnosis of malaria is cost-effective when compared with clinical and microscopy-based diagnosis. rapid POC tests would improve malaria treatment by reducing the percentage of overtreatment errors. as they require only a minimum level of training for community health workers in charge of diagnosis and prescription. Similarly. the authors acknowledged that little is known about the impact of introducing new diagnostics on patients’ behaviour. as a result of extensive resistance to chloroquine and sulphadoxine–pyrimethamine [33]. especially in terms of facility use and adherence to therapy. as reported by the authors. presumptive treatment was $221 per death averted. health outcomes and costs in primary healthcare settings in Zanzibar. Zurovac et al. Despite these advances. rapid diagnostic POC tests can be performed in settings with no sophisticated infrastructure. field standard microscopy and rapid POC tests in the diagnosis of malaria.e. 1070–1076 . Shillcutt et al. Msellem et al. informal ‘pharmacies’.1074 Clinical Microbiology and Infection. With a malaria prevalence in the hypothetical population of 43. and there is an increased need to ensure that malaria is correctly diagnosed prior to treatment. However. They found that in an area of Kenya with a high rate of malaria transmission (between 30% and 50%). and that this increase coincided with the expansion of rapid POC test capacity [43]. rapid POC tests would yield minor reductions in overtreatment errors. was employed. and the analysis was further stratified by age group. One limit of this model. the rapid POC test is cost-effective when compared with other diagnostic strategies for malaria treatment.35]. A follow-up evaluation in Zambia showed that the frequency of ACT prescriptions increased over 2 years. although primary outcome and costs were not combined in the form of a ª2010 The Authors Journal Compilation ª2010 European Society of Clinical Microbiology and Infectious Diseases. diagnostic sensitivity is maximized. They showed that these latter have the potential to be cost-effective in most parts of sub-Saharan Africa. is that it considers formal outpatient facilities only. Although prices have been reduced recently. artemisinin-based combination therapy (ACT) has been the first-line antimalarial treatment since 2007. The authors concluded that policy-makers and healthcare providers should be aware of the upper limit of malaria prevalence for which the use of rapid POC tests brings about cost savings. including antibiotics. Similar changes in Kenya in the future would inevitably change the current overtreatment and costs. and followed up for 14 days. In an area with a low prevalence of malaria (about 1. to nonmalaria patients. Outcomes were analysed with a multilevel modelling approach. four-centre clinical trial. because of its very poor specificity (that is. The authors wanted to test the hypothesis that prompt testing of febrile patients would lead to better patient healthcare through both improved use of ACT and prescription of more appropriate treatments. with lower costs. CMI. 16. with the possible exception of children in high-prevalence areas and in certain other situations. Volume 16 Number 8. and compared this intervention with symptom-based clinical diagnosis alone. in 39 African countries.

CMI. Crepaz N. Ahmed I. Jones C. In addition. The results showed an overall twofold reduction in the prescription of antimalarial drugs and reattendance of patients because of illness during the 2-week follow-up period in patients within the POC group. 4: S7–S20. Overdiagnosis of malaria in patients with severe febrile illness in Tanzania: a prospective study. Although these models do not address what potential interventions would be needed to improve healthcare providers’ behaviours (e. Such benefits include a deceleration in the development of antimalarial resistance and improved antibiotic drug prescription thanks to enhanced specificity of malaria diagnosis. to those from other studies showing that care providers. strengthening of drug and rapid diagnostic test supplies. when rapid diagnostic test results prove to be negative. 20: 1447–1450. 6(1): e252. Zurovac D et al. 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Towards universal access: scaling up priority HIV/AIDS interventions in the health sector—Progress report. An important piece of information added by this study is that the false-negative results with POC testing (i. Ndhlovu M. similar in the POC and clinical diagnosis groups. POC testing has become increasingly accessible in areas with limited laboratory facilities. Chandler CI. As demonstrated by Lubell et al. the public health improvement inherent in the deployment of POC diagnostic tests might result in either additional immediate expenditures (because of the cost of testing) or significant long-term savings (because of effective control of HIV and malaria). This supports the general recommendation for consistency in not treating rapid POC test-negative patients. UNAIDS. Wongsrichanalai C. and additional personnel) and the costs of such interventions. In this study.658229. Mbatia R. Tolhurst R. Findings from cost-effectiveness analyses suggest that. AIDS 2006. 297: 2227–2231. [47]. decision-makers should strongly consider using POC tests throughout or during parts of HIV and malaria epidemics. Boniface G. if a minimal degree of personnel training. These findings are in contrast. Improved diagnostic testing and malaria treatment practices in Zambia. do not always comply with recommended practices [6.0050202. JAMA 2007. Janssen RS. BMJ 2004. Ndiritu M et al. 2.html (last accessed 6 May 2010). Marks G. doi: 10. Barnwell JW. Brent AJ.e. Further data are required to more accurately define costefficacy-type models. 364: 1896–1898.g. PLoS Med 2009. given their ease of use and interpretation. this would affect the cost-effectiveness of rapid diagnostic tests. 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