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Background: Laboratory networks provide services through onsite testing or through specimen transport to higher-tier laboratories. This decision is based on the interplay of testing characteristics, treatment characteristics, and epidemiological characteristics. Objectives: Our objective was to develop a generalizable model using the threshold approach to medical decision making to inform test placement decisions. Methods: We developed a decision model to compare the incremental utility of onsite versus send-out testing for clinical purposes. We then performed Monte Carlo simulations to identify the settings under which each strategy would be preferred. Tuberculosis was modeled as an exemplar. Results: The most important determinants of the decision to test onsite versus send-out were the clinical utility lost due to send-out testing delays and the accuracy decrement with onsite testing. When the sensitivity decrements of onsite testing were minimal, onsite testing tended to be preferred when send-out delays reduced clinical utility by >20%. By contrast, when onsite testing incurred large reductions in sensitivity, onsite testing tended to be preferred when utility lost due to delays was >50%. The relative cost of onsite versus send-out testing affected these thresholds, particularly when testing costs were >10% of treatment costs. Conclusions: Decision makers can select onsite versus send-out testing in an evidence-based fashion using estimates of the percentage of clinical utility lost due to send-out delays and the relative accuracy of onsite versus send-out testing. This model is designed to be generalizable to a wide variety of use cases. Highlights: The design of laboratory networks, including the decision to place diagnostic instruments at the point-of-care or at higher tiers as accessed through specimen transport, can be informed using the threshold approach to medical decision making. The most important determinants of the decision to test onsite versus send-out were the clinical utility lost due to send-out testing delays and the accuracy decrement with onsite testing. The threshold approach to medical decision making can be used to compare point-of-care testing accuracy decrements with the lost utility of treatment due to send-out testing delays. The relative cost of onsite versus send-out testing affected these thresholds, particularly when testing costs were >10% of treatment costs. [ABSTRACT FROM AUTHOR]

Objectives: To describe key characteristics (laboratory quality, test volumes, and complexity) of clinical laboratories in Kampala, Uganda (population ~1.7 million). Methods: Cross-sectional survey using a standard questionnaire to document laboratory type and quality, as well as test menus and volumes. Quality was based on the World Health Organization-Africa Region checklist. Results: Of the 954 laboratories identified (a density of one laboratory per 1,781 persons), 779 (82%) performed only simple kit tests or light microscope examinations. The 95% (907/954) of laboratories for whom volumes were obtained performed an average aggregate of 13,189 tests daily, for a test utilization rate of around 2 tests per individual per year. Laboratories could be segregated into eight groups based on quality, test volume, and complexity. However, 90% of the testing was performed by just two groups: (1) low-volume (=100 tests daily), low-quality laboratories performing simple tests or (2) high-volume (>100 tests daily), high- quality laboratories. Each of these two groups did 45% of the daily testing volume (90% combined). Conclusions: Clinical laboratory density in Kampala (1/1,781 persons) is high, approaching that in the United States (1/1,347 persons). Low-volume/low-quality and high-volume/high-quality laboratories do 90% of the daily aggregate testing. Quality improvement (QI) schemes for Africa must be appropriate to low-volume laboratories as well as to the large laboratories that have been the focus of previous QI efforts. [ABSTRACT FROM AUTHOR]

Objectives: A recent survey of laboratories in Kampala, Uganda, demonstrated that only 0.3% of laboratories (3/954) met international quality standards. To benchmark laboratory quality throughout the rest of sub-Saharan Africa (SSA), we compiled a list of SSA laboratories meeting international quality standards. Methods: Accrediting bodies were queried via online registries or direct communication in May 2013. Results: There were 380 laboratories accredited to international standards in SSA. Ninety-one percent were in South Africa. Thirty-seven of 49 countries had no laboratories accredited to international quality standards. Accredited laboratory density (per million people) in South Africa, Namibia, and Botswana were similar to those in many European countries. Single variable linear regression showed a correlation between accredited laboratory density and health expenditures per person (adjusted R² = 0.81, P < .001). Conclusions: Most SSA countries do not have an accredited clinical laboratory. For those that do, there is a strong correlation between country-specific accredited laboratory density and per-capita health expenditures. [ABSTRACT FROM AUTHOR]