Ethics committees for biomedical research in some African emerging countries: which establishment for which independence? A comparison with the USA and Canada.

CONTEXT: The conduct of medical research led by Northern countries in developing countries raises ethical questions. The assessment of research protocols has to be twofold, with a first reading in the country of origin and a second one in the country where the research takes place. This reading should benefit from an independent local ethical review of protocols. Consequently, ethics committees for medical research are evolving in Africa. OBJECTIVE: To investigate the process of establishing ethics committees and their independence. METHOD: Descriptive study of 25 African countries and two North American countries. Data were recorded by questionnaire and interviews. Two visits of ethics committee meetings were conducted on the ground: over a period of 3 months in Kigali (Rwanda) and 2 months in Washington DC (USA). RESULTS: 22 countries participated in this study, 20 from Africa and two from North America. The response rate was 80%. 75% of local African committees developed into national ethics committees. During the last 5 years, these national committees have grown on a structural level. The circumstances of creation and the general context of underdevelopment remain the major challenges in Africa. Their independence could not be ensured without continuous training and efficient funding mechanisms. Institutional ethics committees are well established in USA and in Canada, whereas ethics committees in North America are weakened by the institutional affiliation of their members. CONCLUSION: The process of establishing ethics committees could affect their functioning and compromise their independence in some African countries and in North America.

Automated measurement of carbohydrate-deficient transferrin using the Bio-Rad %CDT by the HPLC test on a Variant HPLC system: evaluation and comparison with other routine procedures.

AIMS: In this study, we evaluated the new %CDT by the HPLC method (Bio-Rad, Germany) on a Varianttrade mark HPLC system (Bio-Rad), checked the correlation with well-known methods and calculated the diagnostic value of the test. METHODS: Intra-run and day-to-day precision values were calculated for samples with extreme serum transferrin concentrations, high trisialotransferrin and interfering conditions (haemolysed, lactescent and icteric samples). The method was compared with two routine procedures, the %CDT TIA (Bio-Rad, Hercules, CA, USA) and the Capillarystrade mark CDT (Sebia, France). A total of 350 clinical sera samples were used for a case-control study. RESULTS: Precision values were better in high CDT and medium CDT pools than in low CDT pools. The serum transferrin concentration had no effect on CDT measurement, except in samples with serum transferrin <1 g/L. Haemolysis was the only interfering situation. The method showed high correlation (r(2) > 0.95) with the two other methods (%CDT TIA and CZE %CDT). The global predictive value of the test was >0.90 at 1.9% cut-off. CONCLUSIONS: These results demonstrate that the %CDT by the HPLC test is suitable for CDT routine measurement; the results from the high-throughput Varianttrade mark system are well correlated with other methods and are of high diagnostic value.

Analytical evaluation of a new capillary electrophoresis method for carbohydrate-deficient transferrin measurement.

BACKGROUND: Carbohydrate-deficient transferrin (CDT), the sum of a- and disialotransferrin, is considered the most efficient routine biological marker of alcohol abuse. In recent years, methods based on capillary zone electrophoresis (CZE) have been developed using specialized monocapillary systems. These are characterized by a high analytical detection level, counterbalanced by a poor productivity. We evaluated a new CZE method for CDT measurement on the Sebia Capillarys, an eight-capillary system developed for routine serum capillary electrophoresis. METHODS: Precision and possible biases due to abnormal (low or high) transferrin levels or lipemic samples were assessed. Exactitude and precision were tested by comparison with a HPLC procedure acknowledged to be the most reliable to date. The validity of the manufacturer's cut-off was checked by measuring CDT in a population comprising abstaining patients, moderate alcohol consumers and alcohol abusers. Lastly, the method was compared to the routine %CDT TIA and N Latex CDT methods. RESULTS: The imprecision was 18.5% at the minimum detection level and decreased to 6.1% for high CDT values. No significant shift in the CDT results was observed in relation to abnormally low or high serum transferrin, or in lipemic samples. A high level of concordance was observed with the HPLC method used as reference. The results were strongly correlated with both other routine methods (r>0.90). The diagnostic values were comparable to the literature data, even if differences in the studied populations make difficult a direct comparison of the results. Our data suggested that the cut-off could be raised from 1.3% to 1.4% to reduce the number of false positive values without loss of diagnostic efficiency. CONCLUSIONS: This Capillarys method from Sebia showed good precision as compared to those published using other CZE methods. Capillarys method correlated well with HPLC and two routine methods. However, we noticed significant bias at low CDT concentrations. Therefore, with the advantage of high throughput and full automation, these results indicate that the new method is a consistent alternative to the other methods proposed for routine CDT measurement.