Establishing a simple and sustainable quality assurance program and clinical chemistry services in Eritrea

Background: As chronic diseases become more prevalent in developing nations, establishment of sustainable clinical chemistry services will become increasingly important. The complexity of automated instruments, coupled with a lack of resources and skilled workers, will present a challenge for these countries. Methods: A system emphasizing simplified instrumentation, single source reagents, technical education and support, and simple QC algorithms was established in the small African nation of Eritrea. The same reagents were used on different analyzers, as well as the same lot numbers of QC material. To allow traceability of Eritrea results to an accredited US laboratory, the reagents and QC materials were identical to those used in a large university hospital in the US, and patient samples were frequently exchanged between locations. Results: QC values for 23 clinical chemistry tests in the Eritrean National Health Laboratory compared well to values obtained in the US, showing some statistically different values but no clinically significant differences. QC values were also stable over time in Eritrea. Patient sample values from Eritrea correlated well to values from the US, with r values ranging from 0.71 to 0.99. For 9 chemistry tests, small regional laboratories in Eritrea produced QC and patient values that usually compared well to those from the Eritrea National Health Laboratory, but markedly discrepant values were occasionally observed that prompted investigation. Conclusion: A simple but sustainable national laboratory system has been established in the developing nation of Eritrea.