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Human HCV IgM ELISA Test Kit, Export Use Only

Category Name Hepatitis ELISA kits
Test 96
Method ELISA method: Enzyme Linked Immunosorbent Assay
Principle Indirect ELISA: Antigen Coated Plate
Detection Range Qualitative Positive; Negative control & Cut off
Sample 10ul Serum or Plasma
Specificity 99%
Sensitivity 99%
Total Time ~ 150 min
Shelf Life 12 Months from the manufacturing date

Item #:                    1708-6   Quantity:               


HCV IgM 1708-6 (2017-3-9).pdf


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HCV IgM ELISA kit description:

"Export Use Only" (temporary unavailable)
The purpose of the HCV IgM ELISA Test is for clinical lab diagnosis and treatment of patients who are suspected of having a hepatitis C virus infection. This HCV IgM ELISA test is an enzyme-linked immunosorbent assay for qualitative identification of IgM antibodies to hepatitis C virus in human serum/plasma.

Materials Provided with HCV IgM ELISA test kit:
1. Microwell Plate: each well contains recombinant HCV antigens
2. Negative Control: Protein-stabilized buffer tested non-reactive for HCV IgM antibodies
3. Positive Control: HCV IgM antibodies diluted in protein-stabilized buffer
4. Specimen Diluent: Protein-stabilized buffer, casein, and sucrose solution.
5. HRP-Conjugated Reagent: HRP-conjugated rabbit anti-human IgM antibodies
6. Wash Buffer: PH 7.4, 20x PBS (Contains Tween-20 as a detergent)
7. Chromogen Solution A: Urea peroxide solution
8. Chromogen Solution B: TMB solution
9. Stop Solution: Diluted sulfuric acid solution (2.0M H2SO4)
10. Plastic Sealable Bag
11. Cardboard Plate Cover
12. Package Insert

Materials required but not provided:
1. Freshly distilled or deionized water
2. Dispensing system and/or pipette
3. Microshaker for dissolving and mixing conjugate with samples
4. EIA kit Microplate washer
5. EIA kit Microplate Reader with 450nm or dual wavelength 450 & 630nm

HCV IgM ELISA Test Background Information:
For more than 50% of patients, HCV develops into chronic hepatitis and has become the principal cause of cirrhosis of the liver and hepatocellular carcinomas. HCV is now accepted as the major agent for non-A and non-B hepatitis transfusion infection. HCV is defined as an envelope, single stranded positive sense RNA (9.5kb) affiliated with the Flaviviridae family.
Classification of hepatitis C virus is established through six major genotypes and series of subtypes of HCV. Blood donor transmissions of hepatitis C virus have notably decreased since screening started in 1990. Three generations of HCV ELISA tests have been established and each generation has resulted in improvement in sensitivity of detecting anti-HCV. Studies have shown that in a majority of cases, when detectable IgM response to both structural and non-structural HCV antigens occurs, the IgM response happens more frequently to the structural (core) antigen. The manifestation of HCV IgM can be classified into four types: (1) persistent positive; (2) intermittent positive; (3) transient positive; (4) persistent negative. Progressive liver damage is normally indicated by IgM responses types 1 and 2. In order to gauge the extent of progressive liver impairment and in aiding antiviral treatment, it is vitally important and useful for the chronic hepatitis C patients to know the detectable amounts of HCV IgM that are present.

HCV IgM ELISA Test Principle:
The principle of the HCV ELISA test involves a two-step incubation procedure in which an indirect ELISA assay for IgM antibodies to HCV is established. Before incubation, recombinant, highly immunoreactive antigens corresponding to the core and non-structural regions of HCV, are pre-coated to the polystyrene microwell strips.

Notable features of Blood Bank ELISA Kits:
User-friendly directions and explanation of test procedures
Simple and safe reagent preparation
Clear instructions on specimen collection
Comprehensive package of required materials
Explicit quality control and storage guidelines
Reliable and easy-to-read test results

Most Blood Bank ELISA kits follow a similar method. See the HCV Ab ELISA Kit product insert for details on preparation, procedures, quality control, and test result interpretation.

For more information about ELISA Kits, Rapid Tests, IFA Kits, CLIA Test Kits, or Serology tests, please see our website home page, or contact our Customer Service Representative at 818-591-3030.

* Not to be sold, shipped or distributed in The United States.
Product Note:

Blood donor transmissions of hepatitis C virus have notably decreased since screening started in 1990. Three generations of HCV ELISA tests have been established and each generation has resulted in improvement in sensitivity of detecting anti-HCV. This 3rd generation of tests has improved sensitivity.  

Diagnostic Automation Inc. HCV IgM ELISA Test Kit is a time and temperature sensitive method. To avoid incorrect result, strictly follow the test procedure steps and do not modify them.