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Case Reports
. 2021 Jul 8;10(1):1264.
doi: 10.4102/ajlm.v10i1.1264. eCollection 2021.

Cross-validation of a high-performance liquid chromatography nevirapine plasma assay in a resource-limited setting in Zimbabwe

Faithful Makita-Chingombe  1 , Anthony T Podany  2 , Timothy Mykris  2 , Farai Muzambi  1 , Richard W Browne  3 , Andrew J Ocque  3 , Robin DiFrancesco  3 , Lee C Winchester  2 , Courtney V Fletcher  2 , Tinashe Mudzviti  1 , Charles C Maponga  1   3 , Gene D Morse  3
Affiliations
Case Reports

Cross-validation of a high-performance liquid chromatography nevirapine plasma assay in a resource-limited setting in Zimbabwe

Faithful Makita-Chingombe et al. Afr J Lab Med. .

Abstract

An international HIV pharmacology specialty laboratory (PSL) was established at the University of Zimbabwe to increase bioanalytical and investigator capacities. Quantitation of plasma nevirapine in samples from the AIDS Clinical Trials Group protocol 5279 was compared between the University of Nebraska Medical Center PSL and the University of Zimbabwe PSL. Both PSLs employed internally developed methods utilising reverse-phase high-performance liquid chromatography with ultraviolet detection. Eighty-seven percent of the cross-validation results exhibited ± 20% difference.

Keywords: HIV; cross-validation; high-performance liquid chromatography; root-cause analysis.

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Conflict of interest statement

The authors declare that they have no financial or personal relationships that may have inappropriately influenced them in writing this article.

Figures

FIGURE 1
FIGURE 1
Differences in nevirapine concentrations assayed at UNMC-PSL (Omaha, Nebraska, United States, October 2017) and UZ-IPSL (Harare, Zimbabwe, May 2018); (a) Scatter plot (n = 95 data points). (b) Deming regression plot of 87 data points (outliers excluded). Boxes in (a) indicate UNMC upper limit of quantitation (dashed) and UZ-IPLS upper limit of quantitation (solid lines). UZ-IPSL, University of Zimbabwe International HIV Pharmacology Specialty Laboratory; UNMC-PSL, University of Nebraska Medical Center Pharmacology Specialty Laboratory.
FIGURE 2
FIGURE 2
Differences in nevirapine samples (n = 87) assayed at UNMC-PSL (Omaha, Nebraska, United States, October 2017) and UZ-IPSL (Harare, Zimbabwe, May 2018). (a) Bland-Altman difference plot indicating proportionally higher difference at high concentrations (mean difference = −430). (b) Bland-Altman percentage difference on normalisation by concentration, correlation not significant (mean % deviation = −4.49). Shaded areas present confidence interval limits for mean (green shade) and agreement limits (red shade). UZ-IPSL, University of Zimbabwe International HIV Pharmacology Specialty Laboratory; UNMC-PSL, University of Nebraska Medical Center Pharmacology Specialty Laboratory.
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References

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