Development and field evaluation in African and Asian countries of an hepatitis B virus PCR on open polyvalent platforms to determine treatment eligibility: results from the "Agence Nationale de Recherche sur le Sida et les hépatites" 12327 study

Widespread testing and treatment are essential to eliminate hepatitis B virus (HBV) infection as a public health concern. However, in resource-limited countries, access to HBV PCR is limited. In this study, we developed a quantitative HBV PCR assay on open molecular platforms and evaluate its perfor...

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Vydané v:Clinical microbiology and infection Ročník 30; číslo 8; s. 1067
Hlavní autori: Kania, Dramane, Nouhin, Janin, Bolloré, Karine, Njouom, Richard, Toni, Thomas d'Aquin, Maiga, Almoustapha Issiaka, Toure-Kane, Coumba, Ngo-Giang-Huong, Nicole, Dagnra, Anoumou, Chuong Le, Duy Hoang, Lunel-Fabiani, Françoise, Castera-Guy, Joany, Rubbo, Pierre-Alain, Pisoni, Amandine, Plantier, Jean-Christophe, Tuaillon, Edouard
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: England 01.08.2024
Predmet:
Africa, Central
Africa, Western
Asia, Southeastern
DNA, Viral - analysis
France
Genotype
Hepatitis B - diagnosis
Hepatitis B - drug therapy
Hepatitis B - mortality
Hepatitis B - prevention & control
Hepatitis B virus - genetics
Hepatitis B virus - physiology
Polymerase Chain Reaction
Reference Standards
Africa, Central
Asia, Southeastern
France
Africa, Western
Hepatitis B virus
Asia
Genotypes
PCR
Africa
ISSN:1469-0691, 1469-0691
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Shrnutí:Widespread testing and treatment are essential to eliminate hepatitis B virus (HBV) infection as a public health concern. However, in resource-limited countries, access to HBV PCR is limited. In this study, we developed a quantitative HBV PCR assay on open molecular platforms and evaluate its performance in diagnosing clinically significant HBV DNA thresholds as defined by the WHO (2000 IU/mL, 20 000 IU/mL, and 200 000 IU/mL). We implemented our HBV PCR test in seven African and Asian countries and France, using either an in-house laboratory method or a European conformity for in vitro diagnostic (CE-IVD) marked version of the PCR (Generic HBV Charge Virale, Biocentric). Results were compared with reference tests (Roche Cobas AmpliPrep/Cobas TaqMan and Abbott RealTime on Abbott m2000). There was a good agreement between the HBV DNA results of 1015 samples tested by the PCR on open polyvalent platforms and the results from reference tests (mean difference (bias ± standard deviation [SD]): -0.3 ± 0.7 log IU/mL and -0.2 ± 0.9 log IU/mL when compared with Roche and Abbott tests, respectively). Kappa-Cohen agreements between the HBV PCR on open polyvalent platforms and the Roche/Abbott assays appeared almost perfect for HBV DNA levels ranged from >20 000 to 200 000 IU/mL and >200 000 IU/mL, substantial and moderate for HBV DNA levels ranged from 2000 to 20 000 IU/mL when compared with Abbott and Roche, respectively. The assay's performance was consistent across genotypes A, B, C, D, and E. This field evaluation showed that our HBV PCR test is a valuable alternative to proprietary PCR systems. PCR assays on open platforms contribute to expanding clinical laboratory solutions for diagnosing individuals who meet the viral load criteria for antiviral therapy (>20 000 IU/mL) and mother-to-child prophylaxis (>200 000 IU/mL).
Bibliografia:ObjectType-Article-1
SourceType-Scholarly Journals-1
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ISSN:1469-0691
1469-0691
DOI:10.1016/j.cmi.2024.05.002