Original Research

Verification of chemistry reference ranges using a simple method in sub-Saharan Africa

Irith De Baetselier, Douglas Taylor, Justin Mandala, Kavita Nanda, Christel Van Campenhout, Walter Agingu, Lorna Madurai, Eva-Maria Barsch, Jennifer Deese, Lut Van Damme, Tania Crucitti
African Journal of Laboratory Medicine | Vol 5, No 1 | a404 | DOI: https://doi.org/10.4102/ajlm.v5i1.404 | © 2016 Irith De Baetselier, Douglas Taylor, Justin Mandala, Kavita Nanda, Christel Van Campenhout, Walter Agingu, Lorna Madurai, Eva-Maria Barsch, Jennifer Deese, Lut Van Damme, Tania Crucitti | This work is licensed under CC Attribution 4.0
Submitted: 09 December 2015 | Published: 17 October 2016

About the author(s)

Irith De Baetselier, Institute of Tropical Medicine, Department of Clinical Sciences, STI Reference Laboratory, Nationalestraat, Antwerp, Belgium
Douglas Taylor, FHI 360, Durham, North Carolina, United States
Justin Mandala, FHI 360, Durham, North Carolina, United States
Kavita Nanda, FHI 360, Durham, North Carolina, United States
Christel Van Campenhout, Scientific Institute of Public Health, Brussel, Belgium
Walter Agingu, IMPACT Research and Development Organization, Kisumu City, Kenya
Lorna Madurai, Global Clinical and Viral Laboratory, Kwa-Zulu Natal, South Africa
Eva-Maria Barsch, PathCare Bloemfontein, Quantum Building, Bloemfontein, South Africa
Jennifer Deese, FHI 360, Durham, North Carolina, United States
Lut Van Damme, FHI 360, Durham, North Carolina, United States and Bill & Melinda Gates Foundation, Seattle, Washington, United States
Tania Crucitti, Institute of Tropical Medicine, Department of Clinical Sciences, STI Reference Laboratory, Nationalestraat, Antwerp, Belgium


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Abstract

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.


Keywords

Reference Value; Biochemistry; Sub-Saharan Africa; Women; Clinical Trial

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