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Vikia hbs ag

Manufactured by bioMérieux
Sourced in Brazil

VIKIA HBs Ag is a rapid test for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum or plasma samples. It is used as an aid in the diagnosis of hepatitis B infection.

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6 protocols using vikia hbs ag

1

Evaluation of Four HBsAg Rapid Tests

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We evaluated four HBsAg RDTs: DetermineTM HBsAg (Alere International Limited, Ballybrit Galway, Ireland), SD Bioline HBsAg WB® (Standard Diagnostics Inc, Korea), Standard Q HBsAg® (SD Biosensor, India) and Vikia HBsAg® (Biomérieux, Marcy l'étoile, France). These qualitative tests are based on immunochromatographic techniques for lateral association of monoclonal and polyclonal antibodies specific for HBsAg. We performed the test according to manufacturer's procedure. All these tests give visual readout.
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2

Investigating Occult Hepatitis B Infection

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To explore possible OBI, residual samples from 500 blood donors collected in 2007, with volumes greater than 2 mL and known negative results for HBV, HIV, HCV, and syphilis were selected to investigate the presence of HBV DNA using a commercial quantitative PCR assay (Abbott RealTime HBV® Abbott Molecular Inc., Des Plaines, IL, USA). Samples with detectable HBV DNA were retested for HBsAg using a different commercial RDT (VIKIA®HBsAg/bioMérieux, Rio de Janeiro, Brazil), and a quantitative HBsAg assay (Liaison® XL HBsAg Quant/DiaSorin, Saluggia, Italy), in addition to the anti-HBc testing (IgG and IgM) performed with commercial assays (Liaison XL®/DiaSorin S.p.A., Italy).
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3

Optimized Blood Collection Protocol

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In order to obtain better safety and comfort for the study participant, as well as technical precision in performing the tests, we chose to collect peripheral blood in detriment of the digital puncture. The strategy also offers the advantage of avoiding a new collection procedure in case of invalid test and for the reactive samples that were sent for the respective confirmatory tests.
Peripheral blood was collected in tube with anticoagulant additive (BD Vacutainer PPT Plasma Preparation Tube, ref. 362788). The screening tests were performed from whole blood, following the procedures indicated by the manufacturers: Anti-HIV (BioEasy HIV test, ref. 03FK10), Anti-Syphilis (Alere Syphilis, ref. 06FK10), Anti-HCV (Alere HCV, ref. 02FK10) and HBsAg (VIKIA HBs Ag-Biomérieux). According to the Brazilian guidelines, the reactive samples in the first Anti-HIV test were submitted to a second rapid test (ABON HIV 1/2/ O Tri-Line). For each of the participating centers, a new, certified, and calibrated micropipette was provided, aiming for greater accuracy in the sample volume added.
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4

Rapid Diagnostic Assays for HIV, HBV, and Syphilis

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The determination of infections caused by human immunodeficiency virus (HIV), hepatitis B (HBV), and Treponema pallidum, the causative agent of syphilis, was carried out by the following rapid tests: HIV Test Bioeasy (Standard Diagnostics, Inc., South Korea), Vikia® HBsAg (Biomerieux, France), and TR DPP Sífilis DUO Bio Manguinhos (Oswaldo Cruz Foundation, Brazil), respectively. All three tests are qualitative, based on immunochromatographic techniques, and approved by the National Health Surveillance Agency (ANVISA) responsible for regulating, controlling, and supervising products and services involving risks to public health in Brazil.
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5

Prevalence of SARS-CoV-2 Antibodies in Pre-pandemic Sera

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In this study, we selected 135 sera from healthy subjects, collected five (5) years before the first case of coronavirus disease 2019 (COVID‐19) in Gabon. The participants were initially screened for latent TB infection (QuantiFERON‐TB Gold), HIV, HVB (VIKIA HBs Ag bioMerieux), HCV (VIKIA anti HCV, bioMerieux) and syphilis. Clinical histories including Bacillus Calmette–Guérin vaccination and chronic diseases were recorded from all subjects.2Using the Elecsys Anti‐SARS‐CoV‐2 immunoassay (Roche Diagnostics France) for the qualitative detection of antibodies reactive against SARS‐CoV‐2, we screened selected sera for pre‐existing humoral cross‐reactive immunity to SARS‐CoV‐2. The tests were performed following the manufacturer's instructions. The Elecsys Anti‐SARS‐CoV‐2 immunoassay detects predominantly immunoglobulin G (IgG), but also immunoglobulin A and immunoglobulin M. Sera showing an index (cutoff index [COI]) ≥ 1.0 was said to be reactive illustrating the presence of antibodies reactive against SARS‐CoV‐2 in the sera. Reactive samples were re‐assayed in an independent experiment for confirmation. We also screened all reactive samples for cytomegalovirus (CMV) and herpes simplex virus‐1/2 antibodies (IgM and IgG). All participants signed written informed consent before enrollment.
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6

Rapid Screening for STIs Panel

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Rapid tests were used according to the manufacturer’s recommendations to screen for syphilis (Alere Syphilis), via the qualitative detection of IgG, IgM, and IgA antibodies against Treponema pallidum, characterized as a treponemal test (Importer Alere S / A, São Paulo, Brazil), hepatitis B (Vikia ® HBsAg, BioMérieux SA, France), via the qualitative detection of HBs antigen, and for hepatitis C (anti−HCV; Alere, Standard Diagnostics Inc, Republic of Korea).
Chlamydia trachomatis, Neisseria gonorrhoeae, and high- and low-risk HPV were performed through polymerase chain reaction (PCR). HPV detection by PCR was accomplished using two sets of non-degenerate primers, PGMY09/11, followed by typing using Reverse Line Blotting (RLB) and Restriction Fragment Length Polymorphism (RFLP) methodologies.21 , 22 , 23 (link) Real-time PCR was performed for the diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae (COBAS 4800 CT/NG – Roche Molecular Systems, Branchburg, NJ).
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