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ABSTRACT
Background. Molecular biology quantification of plasma viral Ribonucleic Acid (RNA) is a biological marker of treatment failure or success through Viral Load (VL). The Human immunodeficiency virus type 1 (HIV-1) genetic diversity is important and is steadily increasing, mainly due to genetic recombination phenomena and drug pressure. The aim of this study was to compare two platforms of HIV-RNA quantification targeting two different regions. Methods. The performance of the Generic HIV-RNA assay from Biocentric (Bandol – France) was compared to the Abbott m2000 Real-Time HIV-1 (Abbott Molecular Inc. Des Plaines, USA) in Laquintinie Hospital. A total of 84 HIV-1 plasma samples were tested, the Cohen’s Kappa concordance, spearman correlation, Bland-Altman analysis, and Lin’s concordance were analyzed using Statistical Package for the Social Sciences (SPSS) 20.0 software; the significance was set at 5%. Results. The proportion of patients with no detectable viral load was 44.0% (37/84) with Abbott versus 65.5% (55/84) with Biocentric. The Cohen’s Kappa coefficient was 0,16 (95% CI: -0,08 to 0,39) showing slight agreement. The results were clinically concordant for 64/84 samples. The Bland Altman analysis revealed a bias of -0.49 (CI=-1.51-0.54) Log10 copies/mL in favor of Biocentric indicating an underestimation of Viral Load (VL) by the Abbott technique. The range of 95% limits of agreement of (-3.50 to 2.51) Log10 copies/mL was wide compared to the clinically acceptable threshold (+/-0.5 Log10 copies/mL). Conclusion. The two methods used to quantify viral load in our context are not well correlated and there is a poor agreement, sequencing should be done routinely and reagent adapted. 
RÉSUMÉ
Contexte. La quantification par biologie moléculaire de l'acide ribonucléique (ARN) viral plasmatique est un marqueur biologique de l'échec ou du succès du traitement par détermination de la charge virale (CV). La diversité génétique du virus de l'immunodéficience humaine de type 1 (VIH-1) est importante et en augmentation constante, principalement en raison des phénomènes de recombinaison génétique et de la pression médicamenteuse. Le but de cette étude était de comparer deux plates-formes de quantification de l'ARN-VIH ciblant deux régions différentes. Méthodes. Les performances du test Generic HIV-RNA de Biocentric (Bandol – France) ont été comparées à celles du test Abbott m2000 Real Time HIV-1 (Abbott Molecular Inc. Des Plaines, USA) à l'hôpital Laquintinie. Au total, 84 échantillons de plasma VIH-1 ont été testés, la concordance Kappa de Cohen, la corrélation de Spearman, l'analyse de Bland-Altman et la concordance de Lin ont été analysées à l'aide du logiciel Statistical Package for the Social Sciences (SPSS) 20.0 ; la significativité a été fixée à 5 %. Résultats. La proportion de patients sans charge virale détectable était de 44,0 % (37/84) avec Abbott versus 65,5 % (55/84) avec Biocentric. Le coefficient Kappa de Cohen était de 0,16 (IC à 95 % : -0,08 à 0,39) montrant une très légère concordance. Les résultats étaient cliniquement concordants pour 64/84 échantillons. L'analyse de Bland Altman a révélé un biais de -0,49 (IC=-1,51-0,54) Log10 copies/mL en faveur de Biocentric indiquant une sous-estimation de la charge virale (CV) par la technique d'Abbott. La plage des limites d'accord à 95 % de (-3,50 à 2,51) Log10 copies/mL était large par rapport au seuil cliniquement acceptable (+/-0,5 Log10 copies/mL). Conclusion. Les deux méthodes utilisées pour quantifier la charge virale dans notre contexte ne sont pas bien corrélées et il y a un mauvais accord, le séquençage doit être fait en routine et les réactifs adaptés.

Keywords

Humans RNA HIV Seropositivity Molecular Biology Recombination Humains ARN Séropositivité VIH Biologie Moléculaire Recombinaison

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Medi Sike CI, Mbebi Enone JP, Lobe SA, Voundi Voundi E, Ngogang MP, Ndoumba Mintya A, … Luma Henry. (2023). Comparative Performance of the Biocentric Generic Viral Load, and M2000 Abbott Assays for Quantifying HIV-1 in Cameroon. HEALTH SCIENCES AND DISEASE, 24(3). https://doi.org/10.5281/hsd.v24i3.4257
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