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.
Contents of Kit
1. MICROWELL PLATE: 8×12/12×8-well per plate. Blank microwell strips fixed on white strip holder. The plate is sealed in aluminum pouch with desiccant. Each well contains recombinant HCV antigens. The microwell strips can be broken to be used separately. Place unused wells or strips in the provided plastic sealable storage bag together with the desiccant and return to 2-8°C. Once open, stable for one month at 2-8°C. 2. NEGATIVE CONTROL: 1×0.2ml. Blue-colored liquid filled in a vial with green screw cap. Protein-stabilized buffer tested nonreactive for HCV antibodies. Ready to use as supplied. Once open, stable for one month at 2-8°C. 3. POSITIVE CONTROL: 1×0.2ml. Red-colored liquid filled in a vial with red screw cap. Anti-HCV antibodies diluted in proteinstabilized buffer. Ready to use as supplied. Once open, stable for one month at 2-8°C. 4. HRP-CONJUGATE: 1×13ml. Red-colored liquid in a white vial with red screw cap. Horseradish peroxidase-conjugated rabbit anti-human IgG antibodies. Ready to use as supplied. Once open, stable for one month at 2-8°C. 5. SPECIMEN DILUENT: 1×13ml. Green-colored in a vial with blue screw cap. Serum base, casein, and sucrose solution. 6. WASH BUFFER: 1×50ml. Colorless liquid filled in a clear bottle with white screw cap. PH 7.4, 20 × PBS 7. CHROMOGEN SOLUTION A: 1×8ml. Colorless liquid filled in a white vial with green screw cap. Urea peroxide solution. Ready to use as supplied. Once open, stable for one month at 2-8°C. 8. CHROMOGEN SOLUTION B: 1×8ml. Colorless liquid filled in a black vial with black screw cap.TMB solution (Tetramethyl benzidine dissolved in citric acid). Ready to use as supplied. Once open, stable for one month at 2-8°C. 9. STOP SOLUTION: 1×8ml. Colorless liquid in a white vial with yellow screw cap. Diluted sulfuric acid solution (0.5M H2SO4). Ready to use as supplied. Once open, stable for one month at 2-8°C. 10. PLASTIC SEALABLE BAG: 1 unit. For enclosing the strips not in use. 11. PACKAGE INSERT: 1 copy. 12. CARDBOARD PLATE COVER: 2sheets. To cover the plates during incubation and prevent evaporation or contamination of the wells.
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. Performance on BBI low and mixed titers anti-HCV panels. 2. HCV genotype antibody testing
Sensitivity
Human Anti-Hepatitis C Virus Antibody ELISA Kit
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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Background
HCV is a small, enveloped, positive single-stranded RNA virus that belongs to the Flaviviridae family, genus Hepacivirus. Analysis of viruses from plasma and from cell culture supernatant indicated that enveloped particles are icosahedral and 56-65 nm in diameter, while and the viral core is about 45 nm. Viral spikes on the membrane of the virion are about 6 nm and they are formed by heterodimers of E1 and E2 glycoproteins. In fact, the population of the extracellular HCV particles is heterogeneous. Particles are pleomorphic and size, buoyant density, and infectivity might differ significantly. A large majority of particles is noninfectious. Interestingly, the buoyant densities of infectious particles isolated from serum and from cell culture medium are different. A significant amount of the particles are associated with cellular lipoproteins making that a hallmark mark of HCV. The pattern of virus associated lipoproteins might differ and several of those are associated with HCV most frequently: low density lipoproteins (LDL), very low-density lipoproteins (VLDL) and apolipoproteins (Apo) A1, B, C and E.
Figure 1. A model of hepatitis C virus lipoviral particle. (Source: World J Hepatol. 2018.)
HCV infection is an escalating global health issue. HCV is endemic in many countries and is a growing bur den for society and healthcare systems. The inexor able increases in long term sequelae such as cirrhosis and h epatocellular carcinoma (HCC) are a particular problem. For some people, hepatitis C is a short-term illness, but for more than half of people who become infected with the hepatitis C virus, it becomes a long-term, chronic infection. Chronic hepatitis C can result in serious, even life-threatening health problems like cirrhosis and liver cancer. People with chronic hepatitis C can often have no symptoms and don't feel sick. When symptoms appear, they often are a sign of advanced liver disease. There is no vaccine for hepatitis C. The best way to prevent hepatitis C is by avoiding behaviors that can spread the disease, especially injecting drugs. Getting tested for hepatitis C is important, because treatments can cure most people with hepatitis C in 8 to 12 weeks. Despite this revolution in the HCV-treatment, one of major challenge to achieve a global eradication of HCV remains to reduce the under diagnosis. The low rate of diagnosis is a major obstacle in resources limited countries and is mainly due to the cost of molecular tools, that are essential to diagnose and follow chronic HCV infection.
Figure 2. Recommended Testing Sequence for Identifying Current Hepatitis C Virus (HCV) Infection. (Source: CDC. Testing for HCV infection: An update of guidance for clinicians and laboratorians. MMWR 2013;62(18).)
References
1. Morozov VA, et al.. Hepatitis C virus: Morphogenesis, infection and therapy. World J Hepatol. 2018, February 27; 10(2): 186-212.
Q: Whether the ELISA kits you have available are suitable to be used with elutions generated from DBS testing
A: HIV, HCV, and Syphilis antibody detection kits can all use DBS samples, but attention should be paid to the storage temperature and elution solution type of the samples. Tween20-PBS elution solution can be used.
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References
Improving Hepatitis c diagnosis by implementing statistical quality control
International Journal of Chemical and Biochemical Sciences.
Authors: Farwa Batool, Awais Altaf, Muhammad Idrees Jilani, Imran Riaz Malik, Shahid Nadeem, Sameer Hassan, Muhammad Arif, Amer Jamil.
Hepatitis C (HCV) is the RNA-enveloped virus belonging to the flavivirus family, causing severe hepatic problems worldwide. While screening for HCV, many results are false negative or false positive, reaching chronic stages of the infection and eventually cancer. This study aimed to estimate various parameters like sensitivity, specificity, accuracy, and likelihood ratios for HCV by reverse transcriptions-quantitative Polymerase Chain Reaction (RT-qPCR) and Enzyme-linked Immunosorbent Assay (ELISA). This study was conducted at the Molecular Biochemistry Laboratory (MBL), University of Agriculture Faisalabad, Pakistan. Four cities (Gojra, Samundri, Toba and Kamalia) of Faisalabad were targeted. Samples of the participants were obtained from the PINUM Cancer Hospital and Allied Hospital Faisalabad. One thousand one hundred male and female participants pre- diagnosed with HCV infection were selected for this comparative study. All collected samples were centrifuged to separate serum and stored at -20 0C to -80 0C with the assigned codes until testing. This study compared the sensitivity and specificity of a modified third-generation ELISA kit with the SYSTAAQ HCV RT-qPCR assay. HCV antibodies were assessed with the Abnova hepatitis C virus Ab ELISA kit on the stored samples. According to the manufacturer's instructions, the cut-off index < 1.000 was considered NON-REACTIVE or negative and ≥ 1.000 is considered reactive or positive. HCV viral load was measured on real-time PCR of < 101 IU/mL were considered as low levels of virus and >101 IU/mL showed positive results, indicating the presence of the virus. SPSS version 22.0 for Windows was used for the statistical summary and data analysis. The results of specificity and sensitivity were obtained in the form of percentages. The community benefits from statistical quality control in hepatitis C diagnosis by promoting trust in the healthcare system, assuring accurate and reliable testing, improving treatment results, and increasing diagnostic effectiveness. All parameters for both diagnostic tools were compared. The sensitivity for HCV-RNA PCR was 96%, but for ELISA, it was 57%. The specificity for ELISA was 95%, whereas 98% for HCV-RNA PCR. The positive predictive value (PPV) of the HCV RNA was calculated as 80% for ELISA and 94% for RT-qPCR. Accuracy for both results also varied, showing their efficiency and capacity. Results showed that HCV-RNA PCR was quite accurate and more reliable than ELISA. ELISA detects the HCV antibody while the HCV virus remains inactive, pertaining to false positive or negative results. In contrast, PCR can detect HCV's presence, absence and load in subjects' blood more accurately and sensitively.
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Figure 1. A model of hepatitis C virus lipoviral particle. 
Figure 2. Recommended Testing Sequence for Identifying Current Hepatitis C Virus (HCV) Infection.
