Home > Products > ELISA test > blood testing reagent Antibody HCV ELISA test Kit
blood testing reagent Antibody HCV ELISA test Kit
- 10000 Box / Boxes per Month
- tianjin or beijing
- T/T Credit Card PayPal
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Product Details
Type: | Pathological Analysis Equipments | Brand Name: | Bioneovan | Place of Origin: | Beijing, China |
Model Number: | In Vitro Diagnostic(IVD) |
Product Description
Specifications
1.Designed for the qualitative determination of antibody to HCV (anti-HCV) concentration2.human serum or plasma
3.EIA kit
Certificate |
GMP |
SFDA |
ISO13485 |
ISO9001:2008 |
INTRODUCTION |
Hepatitis C virus (HCV), which was formerly described as the parent rally transmitted form of non-A, non-B hepatitis (NANBH)1, becomes a chronic disease in 50% of the cases.2 HCV can also be transmitted through intravenous drug abuse, sexual , and household contact.3 Hepatitis C virus is a single stranded RNA virus with some structural relations to the flavivirus family. Nucleic acid sequences of HCV cDNA clones provided the basis for the construction of recombinant peptides representing putative hepatitis C virus proteins.4,5 Anti-hepatitis C virus antibody screening of blood using synthetic or recombinant proteins, helped to identify apparently healthy blood donors with anti-HCV antibodies who otherwise might have transmitted the virus.6
This is an enzyme linked immunosorbent assay using recombinant proteins derived from core regions of HCV virus to detect the presence of HCV antibodies in human sera.
PRINCIPLE OF THE ASSAY |
Multiple epitomes’ of HCV proteins (Core, NS3, NS4 and NS5) are bound to the micro titer wells. When antibodies to HCV are present in the test sample, they react with recombinant proteins and attach to the solid-phase. Non-reactive antibodies are removed with the wash buffer. Human IgGs bound to the antigen are reacted with anti-human IgG peroxidase conjugate and visualized by subsequent reactions with a chromogenic substrate. Positive sample generates a medium to dark blue color. No color or very pale blue color indicates a negative reaction. The intensity of the reaction is photo metrically quantities.
SPECIMEN COLLECTION AND PREPARATION |
Serum should be prepared from a whole blood specimen obtained by acceptable medical techniques. Either serum or plasma can be used in this test. Remove serum or plasma from the clot or blood cells as soon as possible to avoid hemolytic. Specimen with extensive particulate should be clarified by centrifugation prior to use. Specimen frozen at -20°C or colder may be used. Avoid repeated freeze thaw.
STORAGE OF TEST KIT |
Unopened test kits should be stored at 2-8C upon receipt and the micro titer plate should be kept in a sealed bag to minimize exposure to damp air. Use up the reagents as soon as possible after the kit is unpacked.
ASSAY PROCEDURE |
It is strongly advised to analyze each specimen and controls in duplicate. All the reagents should equilibrate to room temperature before use.
- 1. Dispense 100ml(or 3 drops) of specimen diluents into individualtest wells.
- 2. Dispense 100ml positive control and negative control duplicate into individual wells.
- 3. Add 10ml of each test sample into duplicate test wells; vortex to mix.
TEST PERFORMANCE AND EXPECTED RESULTS |
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 kit was 99.55%
Manufactures | - | + | False pos. | Specificity |
Manufacture 1* | 2896 | 38 | 14 | 99.52 |
Manufacture 2* | 2895 | 38 | 15 | 99.48 |
Clinical Sensitivity: Among 480 clinical hepatitis C patients confirmed positive by RIBA3.0, 479 were positive when tested with this anti-HCV ELISA kit. The sensitivity was 99.79%.
Analytical Specificity:
- 1. No cross reactivity observed with samples from patients infected with HAV, HIV, HBV, CMV, and TP No interference was observed from rheumatoid factors up to 2000U/ml.
- 2. These assay performance characteristics are unaffected from elevated concentrations of bilirubin, hemoglobin, and triolein.
- 3. Frozen specimens have been tested to check for interferences due to collection and storage.
Analytical Sensitivity: The lowest detection limit of this assay is 1NCU (National Current Unit, MOH, China).
- 4. If, after retesting of the initially reactive samples, the assay results are negative, these samples should be considered as non-repeatable (false positive) and interpreted as negative. As with many very sensitive ELISA assay, false positive results can occur due to the several reasons, most of which are related but not limited to inadequate washing step. For more information regarding BIONEOVAN.CO.LTD ELISA Troubleshooting, please refer to BIONEOVAN.CO.LTD ELISAS and Troubleshooting Guide. Or contact Beijing BIONEOVAN.CO.LTD technical support for further assistance.
- 5. The prevalence of the marker will affect the assay’s predictive values.
- 6. This kit is intended only for testing of individual serum or plasma samples. Do not use it for testing of cadaver samples, saliva, urine or other body fluids, or pooled (mixed) blood.
- 4. Incubate for 60 minutes at 37°C
- 5. Wash each well 5 times by filling each well with diluted wash buffer, then inverting the plate vigorously to get all water out and blocking the rim of wells on absorbent paper for a few seconds.
- 6. Add 100ml of Enzyme Conjugate to each well. Mix it gently by swirling the micro titer plate on flat bench for 1 minute. Do not add Enzyme Conjugate to the blank well.
- 7. Incubate for 30 minutes at 37°C
- 8. Wash the plate 5 times as step 5.
- 9. Add one drop (50ml) of Substrate Solution A (HRP-substrate) to each well, then add one drop (50ml) of Substrate Solution B (TMB) to each well. Mix gently and incubate at 37°C for 30 minutes. .
- 10. Add one drop (50ml) of Stop Solution to each well to stop the color reaction. Read the OD value at 450 nm/630 nm with dual filter plate reader. It is option to read the OD value at 450 nm with single filter plate reader. (using the OD value of the blank well to correct all the OD reading from all wells)
Q:Can I get a sample before bulk order? How can I get it?
A:Sample is free, but freight collect.
You could prepay the freight cost by PayPal or Western union, we will send out sample ASAP once getting your payment.
Q:How about supply ability?
A:100,000 pcs per week for cassette, 500,000pcs per week for strip.
Q: Do you have minimum order requirements?
A: No, according to client’s need.
Q: Can we visit your factory?
A: Certainly. Welcome your visit.
Q: How to ensure the cargo quality?
A: We will supply bulk sample before shipping. They can represent the cargo quality.
Q: Why choose Bioneovan?
A: We are the professional factory not trading company, so the price is quite competitive in the market.
We have ISO13485 & CFDA & GMP certificate. Products quality can be guaranteed.
Q: What’s the payment method?
A: T/T: Accept USD.
Western Union/Money Gram/PayPal: Quickly to the account, Priority in delivery
Behalf Paying: Your Chinese friends or your Chinese agent can pay for in RMB
Q: How to contact us?
Email: Linda@bioneovan.net
Tel: +86-10-69255832-8005
Skype: zou.linda2
QQ: 2773605132
Contact Us
- Bioneovan Co., Ltd.
- Contact nameSteven Tan
- Phone86-010-69255832
- AddressNo. 18, Keyuan Road, Industry Development Zone
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