Versant hcv genotype assay lipa

Manufactured by Bayer

Sourced in United States

The VERSANT HCV genotype assay (LiPA) is a laboratory diagnostic tool used to identify the genotype of the hepatitis C virus (HCV) in patient samples. It is designed to provide information about the specific strain of HCV present, which is important for determining appropriate treatment options.

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Lab products found in correlation

Cobas ampliprep cobas taqman hcv test, by Roche (2 mentions) Salivette, by Sarstedt (1 mentions) Ortho hcv 3.0 elisa, by Ortho Clinical Diagnostics (1 mentions) Axsym hcv version 3, by Abbott (1 mentions) Cobas taqman 48, by Roche (1 mentions) Cobas ampliprep instrument, by Roche (1 mentions) Realtime hcv, by Abbott (1 mentions)

6 protocols using versant hcv genotype assay lipa

HCV Infection Treatment Response

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Serum samples were taken from fifty-eight HCV infected treatment-naïve patients: men-32 and women-26 of median age of 37 years (range 19-57). The HCV genotype-based characteristics of patients and the effect of antiviral therapy are presented in Table 1. The investigation was carried out in accordance with the ICH GCP Standards and approved by Tallinn Medical Research Ethics Committee, Estonia. A written informed consent was obtained from all patients.
The diagnosis of HCV infection was based on the presence of anti-HCV antibodies in the patients sera, detection of serum HCV RNA, histologically verified fibrosis stage and clinical follow-up. The HCV genotype was determined by the hybridization technique using VERSANT HCV genotype assay (LiPA) (Bayer HealthCare LLC, Tarrytown, NY). The range of fibrosis was classified according to the Metavir scoring system from F0 to F4 (cirrhosis). The serum samples were stored in aliquots at -40ºC until use.
HCV infection treatment (pegylated interferon-α-2a plus ribavirin therapy) (IFN-RBV) was conducted according to the National Guidelines approved by the Estonian Society for Infectious Diseases in 2010. The response to therapy was evaluated as a Sustained Virological Response (SVR), No Response (NR) or Relapse (RL) at 24 weeks following the end of treatment.

Kurtenkov O., Jakovleva J., Sergeyev B., & Geller J. (2021). Sialylation of HCV E2 Glycoprotein-Specific and Natural Anti-Glycan (TF, αGal) Antibodies as Signatures of Liver Damage. Journal of Hepatitis Research, 6(1).

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Correlations of AG Antibody Levels with Clinical Parameters in Chronic Hepatitis C

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Clinical parameters were determined according to common guidelines for the health control of chronic HCV-infected patients, observing a standard protocol. Clinical parameters were used for correlations with AG Ab levels. 5 mL venous blood samples was taken from patients during their planned visit to the physician for health control before, during, or after antiviral treatment. Blood serum samples were collected in the Internal Medicine Department of West Tallinn Central Hospital and stored at −60°C in the Virology Department of the National Institute for Health Development. The serum level of HCV RNA (viral load) was determined using the quantitative PCR assay (COBAS® AmpliPrep/COBAS® TaqMan HCV test, Roche). The lower limit of detection was 15 IU/mL. HCV genotypes were determined using the hybridization technique by employing the Versant HCV genotype assay (LiPA) (Bayer HealthCare LLC, Tarrytown, NY). Also, the count/mL of leukocytes, neutrophils, lymphocytes, monocytes, platelets (PLT), and eosinophils and the ratio of neutrophils to lymphocytes were determined and used for correlations with AG Ab levels.

Smorodin E., Sergeyev B., Kurtenkov O., Kuznetsova T, & Geller J. (2018). IgG Antibodies to GlcNAcβ and Asialo-GM2 (GA2) Glycans as Potential Markers of Liver Damage in Chronic Hepatitis C and the Efficacy of Antiviral Treatment. Disease Markers, 2018, 4639805.

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Serological and Molecular Screening of Viral Hepatitis

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Blood samples were collected by venipuncture to obtain serum and saliva using a
commercial device (Salivette, Sarstedt) and processed as previously described⁵^,⁶.
Serum samples were tested for HBsAg (HBsAg One, RADIM, Pomezia, Italy), total
anti-HBc (Diasorin, Italy), anti-HBs (Diasorin, Italy), and anti-HCV (HCVab, Radim,
Pomezia, Italy) using EIA following the manufacturer’s information. Anti-HCV reactive
samples were submitted to real time PCR (Cobas Taqman HCV 2.0, Roche, USA), and
samples with detectable HCV RNA were also genotyped by INNOLIPA (Versant HCV Genotype
Assay – LiPA, Bayer, Germany).
HBsAg and anti-HCV were assayed among saliva samples using commercial EIAs (HCVab,
Radim and HBsAg One, Radim). A total of 61 paired saliva and serum samples were
assayed for anti-HCV using an optimized commercial EIA⁶, and 46 paired saliva and serum samples were tested using a modified
commercial HBsAg EIA⁵.

Cortes V.F., Taveira A., Cruz H.M., Reis A.A., Cezar J.S., Silva B.S., D’Assunção C.F., Lampe E, & Villar L.M. (2017). Prevalence of Hepatitis B and C virus infection among alcoholic individuals: importance of screening and vaccination. Revista do Instituto de Medicina Tropical de São Paulo, 59, e47.

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Serological and Molecular Diagnostics for Hepatitis C

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The presence of anti-HCV was tested using third generation enzyme linked immunosorbent assay (ELISA, ORTHO HCV 3.0 ELISA, Ortho-Clinical Diagnostics, Raritan, NJ) kits. Liver injury biomarkers, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), prothrombin time (PT), total bilirubin (TBIL), direct bilirubin (DBIL), as well as cholesterol (CHOL), triglyceride (TG) fasting blood glucose (FBG), uric acid (UA) and hemoglobin (Hb) levels were performed on an auto-analyzer (Selecta, Germany) using commercial kits. RT-PCR assays were performed using a commercially available kit for the quantification of serum HCV-RNA (CobasAmplicor, Roche Molecular Diagnostic System, Branchburg, NJ, USA); they were expressed in IU/ml (1 IU/ml= 3.4 copies/ml). HCV genotyping was also determined using Versant HCV genotype assay (LiPA, Bayer).

Poortahmasebi V., Emami Aleagha M.S., Amiri M., Qorbani M., Farahmand M., Asayesh H, & Alavian S.M. (2016). Prevalence of hepatic steatosis and associated factors in Iranian patients with chronic hepatitis C. Medical Journal of the Islamic Republic of Iran, 30, 322.

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Molecular Diagnosis of Hepatitis C

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Anti-HCV tests were conducted using a third-generation enzyme immunoassay kit (AxSYM® HCV Version 3.0; Abbott Laboratories, Berkshire, UK). Serum HCV RNA was quantified using a real-time polymerase chain reaction (PCR) assay (COBAS® AmpliPrep Instrument and COBAS® TaqMan® 48; Roche Molecular Systems, Inc., Branchburg, USA), with a detection limit of 15 IU/mL. HCV genotyping was determined using a linear probe assay (VERSANT™ HCV Genotype Assay (LiPA); Bayer Corporation, Tarrytown, NY, USA).
The interleukin-28B (IL-28B) gene single-nucleotide polymorphism (SNP), rs8099917 and rs12979860, were chosen according to previous reports [19 (link)-22 (link)]. The two SNPs, rs8099917 T/G and rs12979860 C/T, gene polymorphism were genotyped using PCR and specific primers as described previously [23 (link)]. The sequences were obtained from the National Center for Biotechnology Information Entrez SNP Database.

Hu C.C., Lin C.L., Chang L.C., Chien C.H., Chen L.W., Liu C.J, & Chien R.N. (2015). Interleukin-28B gene non-TT allele strongly predicts treatment failure for genotype 1 infected chronic hepatitis C patients with advanced fibrosis: a case control study. BMC Infectious Diseases, 15, 156.

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HCV RNA Quantification and Genotyping

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Virologic analyses were performed at the local laboratories. Plasma HCV RNA was determined using Cobas AmpliPrep/COBAS TaqMan HCV Test (Roche Diagnostics, Branchburg, NJ), which quantifies HCV RNA with a limit of detection (LOD) of 15 IU/mL or Abbott RealTime HCV with a LOD of 12 IU/mL (Abbott GmbH, Wiesbaden, Germany).
Viral genotype was determined with a hybridization technique (VERSANT HCV Genotype Assay (LiPA, Bayer HealthCare LLC, Tarrytown, NY, USA)) or by using a primer specific RT-PCR TaqMan method [14 (link)] or Sanger sequencing of the C-E1 region of HCV [15 (link)].

Dalgard O., Weiland O., Noraberg G., Karlsen L., Heggelund L., Färkkilâ M., Balslev U., Belard E., Øvrehus A., Skalshøi Kjær M., Krarup H., Thorup Røge B., Hallager S., Madsen L.G., Lund Laursen A., Lagging M, & Weis N. (2017). Sofosbuvir based treatment of chronic hepatitis C genotype 3 infections—A Scandinavian real-life study. PLoS ONE, 12(7), e0179764.

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