Verification of chemistry reference ranges using a simple method in sub-Saharan Africa
| Autor: | Eva-Maria Barsch, Lut Van Damme, Lorna Madurai, Kavita Nanda, Christel Van Campenhout, Tania Crucitti, Jennifer Deese, Justin Mandala, Irith De Baetselier, Douglas Taylor, Walter Agingu |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Sub saharan
Sub-Saharan Africa business.industry lcsh:Public aspects of medicine 030231 tropical medicine Clinical Biochemistry Public Health Environmental and Occupational Health Human immunodeficiency virus (HIV) lcsh:RA1-1270 medicine.disease_cause Biochemistry Clinical Trial 03 medical and health sciences Medical Laboratory Technology 0302 clinical medicine Statistics Medicine Local population Reference Value Women 030212 general & internal medicine Alanine aminotransferase business Simulation Original Research |
| Zdroj: | African Journal of Laboratory Medicine, Vol 5, Iss 1, Pp e1-e8 (2016) African Journal of Laboratory Medicine African Journal of Laboratory Medicine, Volume: 5, Issue: 1, Pages: 1-8, Published: 2016 |
| ISSN: | 2225-2010 2225-2002 |
| Popis: | Background: Chemistry safety assessments are interpreted by using chemistry reference ranges (CRRs). Verification of CRRs is time consuming and often requires a statistical background. Objectives: We report on an easy and cost-saving method to verify CRRs. Methods: Using a former method introduced by Sigma Diagnostics, three study sites in sub- Saharan Africa, Bondo, Kenya, and Pretoria and Bloemfontein, South Africa, verified the CRRs for hepatic and renal biochemistry assays performed during a clinical trial of HIV antiretroviral pre-exposure prophylaxis. The aspartate aminotransferase/alanine aminotransferase, creatinine and phosphorus results from 10 clinically-healthy participants at the screening visit were used. In the event the CRRs did not pass the verification, new CRRs had to be calculated based on 40 clinically-healthy participants. Results: Within a few weeks, the study sites accomplished verification of the CRRs without additional costs. The aspartate aminotransferase reference ranges for the Bondo, Kenya site and the alanine aminotransferase reference ranges for the Pretoria, South Africa site required adjustment. The phosphorus CRR passed verification and the creatinine CRR required adjustment at every site. The newly-established CRR intervals were narrower than the CRRs used previously at these study sites due to decreases in the upper limits of the reference ranges. As a result, more toxicities were detected. Conclusion: To ensure the safety of clinical trial participants, verification of CRRs should be standard practice in clinical trials conducted in settings where the CRR has not been validated for the local population. This verification method is simple, inexpensive, and can be performed by any medical laboratory. |
| Databáze: | OpenAIRE |
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