دورية أكاديمية

Diagnostic performances of Exacto® Triplex rapid test for diagnosis of HIV/HCV/HBsAg: a multicenter, cross-sectional, field study in the Central African Republic.

التفاصيل البيبلوغرافية
العنوان: Diagnostic performances of Exacto® Triplex rapid test for diagnosis of HIV/HCV/HBsAg: a multicenter, cross-sectional, field study in the Central African Republic.
المؤلفون: Mossoro-Kpinde CD; Laboratoire National de Biologie Clinique et de Santé Publique, Bangui, République Centrafricaine.; Faculté des Sciences de la Santé, Université de Bangui, Bangui, République Centrafricaine., Kalla GCM; Faculty of Medicine and Biomedical Science, University of Yaounde I, Yaounde, Cameroon., Baguida-Bokia C; Laboratoire National de Biologie Clinique et de Santé Publique, Bangui, République Centrafricaine., Sombot-Ndicki S; Laboratoire National de Biologie Clinique et de Santé Publique, Bangui, République Centrafricaine., Bobossi C; Laboratoire National de Biologie Clinique et de Santé Publique, Bangui, République Centrafricaine., Tonen-Wolyec S; Faculté de Médecine et de Pharmacie, Université de Kisangani, Kisangani, République Démocratique du Congo., Mbopi-Kéou FX; Faculty of Medicine and Biomedical Science, University of Yaounde I, Yaounde, Cameroon., Bélec L; Laboratoire de Virologie, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP) et Université Paris Cité, Paris, France.
المصدر: The Pan African medical journal [Pan Afr Med J] 2022 Sep 14; Vol. 43, pp. 21. Date of Electronic Publication: 2022 Sep 14 (Print Publication: 2022).
نوع المنشور: Multicenter Study; Journal Article
اللغة: English
بيانات الدورية: Publisher: African Field Epidemiology Network Country of Publication: Uganda NLM ID: 101517926 Publication Model: eCollection Cited Medium: Internet ISSN: 1937-8688 (Electronic) NLM ISO Abbreviation: Pan Afr Med J Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Kampala, Uganda : African Field Epidemiology Network
مواضيع طبية MeSH: HIV Seropositivity* , HIV-1* , Hepatitis C*/diagnosis , Hepatitis C*/epidemiology, Adult ; Humans ; Hepatitis B Surface Antigens ; Hepacivirus ; Cross-Sectional Studies ; Central African Republic ; Hepatitis C Antibodies ; Antigens, Viral
مستخلص: Introduction: the Exacto® Triplex HIV/HCV/HBsAg (Biosynex, Strasbourg, France) consists in lateral flow, immunochromatographic rapid diagnostic test simultaneously detecting human immunodeficiency virus (HIV)-1 and HIV-2 and hepatitis C virus (HCV)- specific antibodies (IgG and IgM) and hepatitis B virus (HBV) surface antigen (HBsAg) in serum, plasma and whole blood. We herein evaluated its diagnostic performances in the Central African Republic (CAR).
Methods: cross-sectional study was conducted on prospectively collected panel of 550 sera from adult inpatients living in Bangui, including 200 HIV-positive, 100 HBsAg-positive, 50 HCV-positive, 200 negatives to three viruses according to reference immuno-enzymatic serological tests including Murex HCV (Diasorin, Saluggia, Italy) for HCV, Murex HBsAg (Diasorin) for HBV, Genscreen ULTRA HIV Ag-Ab HIV-1/2 Version 2 (Bio-Rad, Marnes-la-Coquette, France) and Murex HIV 1.2.0 Ag/Ab Combination (Diasorin), the 2 tests associated in the parallel algorithm for the reference strategy for the diagnosis of HIV in CAR. Serum samples were tested blindly in duplicate. The findings are reported following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
Results: the Exacto® Triplex showed 99.5% (95% CI; 98.5-100.0), 96.0% [90.6-100.0] and 99.0% [97.1-100.0] sensitivities for HIV, HCV and HBsAg, respectively. The specificity, positive and negative predictive values (PPV and NPV) were 100.0% for all three viruses. The Youden's J index and Cohen's κ coefficient were 0.99 for HIV and HBsAg. For HCV, Youden's J and Cohen's κ coefficient were 0.96 and 0.98, respectively. In the epidemiological context of the CAR, the PPV and NPV for all three viral infections were high (≥99.0% to 100%).
Conclusion: taken together, our STROBE-compliant study demonstrates that the Exacto® Triplex HIV/HCV/HBsAg showed high sensitivity and specificity for HIV and HBsAg (≥99.0%), and relatively high sensitivity (96.0%) and high specificity (100%) for HCV. These analytical performances are within the limits required by the WHO (i.e. sensitivity ≥99.0% and specificity ≥98.0%) for HIV and HBV. The Exacto® Triplex HIV/HCV/HBsAg is user-friendly at low cost, and appears highly desirable for routine use in the CAR, and likely other Central African countries.
Competing Interests: The authors declare no competing interests.
(Copyright: Christian Diamant Mossoro-Kpinde et al.)
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فهرسة مساهمة: Keywords: Central Africa; Human immunodeficiency virus; diagnostic performances; hepatitis B virus; hepatitis C virus; multiplex immunochromatographic rapid test
المشرفين على المادة: 0 (Hepatitis B Surface Antigens)
0 (Hepatitis C Antibodies)
0 (Antigens, Viral)
تواريخ الأحداث: Date Created: 20221201 Date Completed: 20221202 Latest Revision: 20221202
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC9695677
DOI: 10.11604/pamj.2022.43.21.36041
PMID: 36451724
قاعدة البيانات: MEDLINE