Human Anti-Hepatitis C Virus Antibody, Anti-HCV ELISA Kit (DEIA015s)

Regulatory status: For research use only, not for use in diagnostic procedures.

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Size
96T
Sample
serum, plasma
Species Reactivity
Human
Intended Use
Anti-HCV ELISA is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of antibodies to hepatitis C virus in human serum or plasma. It is intended for screening blood donors and diagnosing patients related to infection with hepatitis C virus.
Storage
The components of the kit will remain stable through the expiration date indicated on the label and package when stored between 2-8°C, do not freeze. To assure maximum performance of this Anti-HCV ELISA, during storage, protect the reagents from contamination with microorganism or chemicals.
Performance Characteristics
1. Clinical Specificity: A blood donor population of 2948 individuals was tested with 3 different kits from different manufacturers. The specificity of this Anti-HCV ELISA was 99.55%.

2. Clinical Sensitivity: Among 480 clinical hepatitis C patients confirmed positive by RIBA 3.0, 480 were positive when tested with this Anti-HCV ELISA. The sensitivity was 100%.
3. Analytical Specificity:
- No cross reactivity observed with samples from patients infected with HAV, HBV, HIV, CMV and TP. No interference was observed from rheumatoid factors up to 2000U/ml.
- The performance characteristics of this assay are unaffected from elevated concentrations of bilirubin, hemoglobin, and triolein.
- Same day and frozen specimens have been tested to check for interferences due to collection and storage.
4. Performance on BBI low and mixed titers anti-HCV panels.


5. HCV genotype antibody testing

6. Reproducibility
General Description
Hepatitis C virus (HCV) is an envelope, single stranded positive sense RNA (9.5 kb) virus belonging to the family of Flaviviridae. Six major genotypes and series of subtypes of HCV have been identified. Isolated in 1989, HCV is now recognized as the major cause for transfusion associated non-A, non-B hepatitis. The disease is characterized with acute and chronic form although more than 50% of the infected individuals develop severe, life threatening chronic hepatitis with liver cirrhosis and hepatocellular carcinomas. Since the introduction in 1990 of anti-HCV screening of blood donations, the incidence of this infection in transfusion recipients has been significantly reduced. The first generation of HCV ELISAs showed limited sensitivity and specificity and was produced using recombinant proteins complementary to the NS4 (c100-3) region of the HCV genome as antigens. Second generation tests, which included recombinant / synthetic antigens from the Core (c22) and nonstructural regions NS3 (c33c, c100-3) and NS4 (c100-3, c200) resulted in a remarked improvement in sensitivity and specificity. Clinical studies show that significant amount of HCV infected individuals develop antibodies to NS5 non-structural protein of the virus. For this, the third generation tests include antigens from the NS5 region of the viral genome in addition to NS3 (c200), NS4 (c200) and the Core (c22). Third generation tests have improved sensitivity and shorten the time between infection with HCV and the appearance of detectable antibodies (window period) to 60 days.

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References


Real-world efficacy and safety of 12-week sofosbuvir/velpatasvir treatment for patients with decompensated liver cirrhosis caused by hepatitis C virus infection

HEPATOLOGY RESEARCH

Authors: Takaoka, Yoshinari; Miura, Kouichi; Morimoto, Naoki; Ikegami, Tadashi; Kakizaki, Satoru; Sato, Ken; Ueno, Takashi; Naganuma, Atsushi; Kosone, Takashi; Arai, Hirotaka; Hatanaka, Takeshi; Tahara, Toshiyuki; Tano, Shigeo; Ohtake, Takaaki; Murohisa, Toshimitsu; Namikawa, Masashi; Asano, Takeharu; Kamoshida, Toshiro; Horiuchi, Katsuhiko; Nihei, Takeshi; Soeda, Atsuko; Kurata, Hidekazu; Fujieda, Takeshi; Ohtake, Toshiya; Fukaya, Yukimura; Iijima, Makoto; Watanabe, Shunji; Isoda, Norio; Yamamoto, Hironori

Aim This study aimed to evaluate the real-world efficacy and safety of 12-week sofosbuvir/velpatasvir (SOF/VEL) treatment for patients with decompensated liver cirrhosis caused by hepatitis C virus (HCV) infection. Methods A total 72 of patients with Child-Pugh (CP) class B or C were enrolled. We evaluated the sustained virologic response at 12 weeks after the end of treatment (SVR12), adverse events (AEs), and changes in the liver function. Results All participants had genotype 1 or 2 HCV infection. At baseline, the numbers of patients with CP class B and C were 59 and 13, respectively. The overall SVR12 rate was 95.8% (69/72); 94.9% (56/59) in CP class B and 100% (13/13) in CP class C. The serum albumin level, prothrombin time and ascites were significantly improved (P < 0.01); however, the serum bilirubin level and encephalopathy did not improve. Among patients who achieved SVR12, 75.0% showed an improvement in their CP score, while 5.9% showed a worsening. The presence of large portosystemic shunt (diameter >= 6 mm) and hyperbilirubinemia (>= 2.0 mg/dL) were independent factors that interfered with the improvement in the CP score (P < 0.05). The most common AEs were encephalopathy (15.3%) and skin symptoms (7.9%). Two patients discontinued SOF/VEL due to AEs. Conclusions Treatment with SOF/VEL for 12 weeks was relatively safe and effective for patients with decompensated cirrhosis. An SVR provided an improvement of the liver function in the majority of patients. However, large portosystemic shunt and hyperbilirubinemia were independent factors that interfered with the improvement in the CP score.

Remnant cholesterol as a risk factor for cardiovascular, cancer or other causes mortality: A competing risks analysis

NUTRITION METABOLISM AND CARDIOVASCULAR DISEASES

Authors: Bonfiglio, Caterina; Leone, Carla M.; Silveira, Liciana V. A.; Guerra, Rocco; Misciagna, Giovanni; Caruso, Maria G.; Bruno, Irene; Buongiorno, Claudia; Campanella, Angelo; Guerra, Vito M. B.; Notarnicola, Maria; Deflorio, Valentina; Franco, Isabella; Bianco, Antonella; Mirizzi, Antonella; Aballay, Laura R.; Cisternino, Anna M.; Sorino, Paolo; Pesole, Pasqua L.; Osella, Alberto R.

Background and aims: Cardiovascular diseases (CVDis) are leading causes of morbidity and mortality. Even after the introduction of pharmacological therapy to lower Cholesterol, there is still a residual risk that may be ascribed to remnant cholesterol (RC). We aimed, by analyzing two prospective cohort studies, to estimate the effect of RC on risk and hazard of cardiovascular deaths ( CVDs), while accounting for competing risks such as cancer ( CDs) and other-causes deaths (OCDs). Methods and results: Cohorts were enrolled in 1992 and 2005. Personal data history was recorded. A fasting venous blood sample was obtained, and RC was calculated at baseline. Cause of Death was coded by using ICD-10th version. Follow-up ended on December 31, 2017. Flexible parametric competing-risks models were applied, with age at death as time-axis. In total, 5729 subjects were enrolled. There were 861 (15.1%) deaths: 234 CVDs (27.2%), 245 CDs (28.5%), 271 OCDs (31.5%) and 111 unknown causes of death (12.8%). RC exposure was a strong risk factor only for CVDs (Risk 2.54, 95% Confidence Interval 1.21; 5.34; Trend 1.26 (1.00; 1.58) for >= 1.29 mmol/L). Conclusions: RC is a strong independent risk factor for cardiovascular mortality. Competing risk analysis is demonstrably a useful tool to disentangle associations among different competing events with a common risk factor. (C) 2020 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

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