One step medical diagnostic rapid test Hepatitis E Virus HEV Test Cassette Rapid Antibody Test Kit IVD Diagnostic Kit
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- Supplier: Changchun ZYF Science And Technology Co. Ltd.
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Product Overview
Description
Product Description
Specification
Product Name
Diagnostic Kit for IgM Antibody to Hepatitis E Virus（Immunochromatography）
Intended Use
The reagent is used to detect the Hepatitis E Virus IgM Antibody in serum / plasma qualitatively.
Hepatitis E is a kind of intestinal infectious disease caused by hepatitis E virus (HEV) with a worldwide
distribution.HEV showed a spherical particles shape with 27~34 nm in diameter, icosahedral symmetry
consisted of 20 shell particles, containing linear single-strand RNA. The incubation period of hepatitis E
virus is 2 to 11 weeks, and on an average of 6 weeks. HEV is a disease with high mortality, mainly
transmitted by digestive tract, and the clinical manifestations of which are similar to other acute
hepatitis. All people are susceptible to the HEV. There are severe symptoms and high mortality of HEV.
Hepatitis IgM is a specific antibody of hepatitis E virus, which can be detected early and disappear
quickly. HEV IgM antibody can be detected in a short time later after infected, continue to rise very
rapidly, decreasing significantly in 1-2 months, disappear in 5 months.
Detection of HEV-IgM antibody can diagnose HEV infection in early stage. Both the immunological
detection and virus nucleic acid detection can be used as the basis for laboratory diagnosis of hepatitis
E virus.
Diagnostic Kit for IgM Antibody to Hepatitis E Virus（Immunochromatography）
Intended Use
The reagent is used to detect the Hepatitis E Virus IgM Antibody in serum / plasma qualitatively.
Hepatitis E is a kind of intestinal infectious disease caused by hepatitis E virus (HEV) with a worldwide
distribution.HEV showed a spherical particles shape with 27~34 nm in diameter, icosahedral symmetry
consisted of 20 shell particles, containing linear single-strand RNA. The incubation period of hepatitis E
virus is 2 to 11 weeks, and on an average of 6 weeks. HEV is a disease with high mortality, mainly
transmitted by digestive tract, and the clinical manifestations of which are similar to other acute
hepatitis. All people are susceptible to the HEV. There are severe symptoms and high mortality of HEV.
Hepatitis IgM is a specific antibody of hepatitis E virus, which can be detected early and disappear
quickly. HEV IgM antibody can be detected in a short time later after infected, continue to rise very
rapidly, decreasing significantly in 1-2 months, disappear in 5 months.
Detection of HEV-IgM antibody can diagnose HEV infection in early stage. Both the immunological
detection and virus nucleic acid detection can be used as the basis for laboratory diagnosis of hepatitis
E virus.
Principle
The test utilizes antibodies including a recombinant protein HEV-Ag and goat anti-mouse IgG antibody
on the nitrocellulose membrane with colloidal gold marked mouse anti-human IgM as an mark tracer.
The reagent is used to detect the HEV IgM antibody in serum / plasma according to the principle of
double antibody sandwich method and gold immunochromatography assay.
The sample mixing up mouse anti-human IgM antibody –marker move along the membrane to the T
line, and form the T line when the sample contains HEV-IgM antibody, which a positive result.
Conversely, it is a negative result.
Main Components
The test utilizes antibodies including a recombinant protein HEV-Ag and goat anti-mouse IgG antibody
on the nitrocellulose membrane with colloidal gold marked mouse anti-human IgM as an mark tracer.
The reagent is used to detect the HEV IgM antibody in serum / plasma according to the principle of
double antibody sandwich method and gold immunochromatography assay.
The sample mixing up mouse anti-human IgM antibody –marker move along the membrane to the T
line, and form the T line when the sample contains HEV-IgM antibody, which a positive result.
Conversely, it is a negative result.
Storage and Expiry
Store as packaged in the sealed pouch at 4-30°C, avoid hot and sunshine, dry place, valid for 24 months.
DO NOT FREEZE. Some protective measures should be taken in hot summer and cold winter to avoid
high temperature or freeze-thaw.
The test utilizes antibodies including a recombinant protein HEV-Ag and goat anti-mouse IgG antibody
on the nitrocellulose membrane with colloidal gold marked mouse anti-human IgM as an mark tracer.
The reagent is used to detect the HEV IgM antibody in serum / plasma according to the principle of
double antibody sandwich method and gold immunochromatography assay.
The sample mixing up mouse anti-human IgM antibody –marker move along the membrane to the T
line, and form the T line when the sample contains HEV-IgM antibody, which a positive result.
Conversely, it is a negative result.
Main Components
The test utilizes antibodies including a recombinant protein HEV-Ag and goat anti-mouse IgG antibody
on the nitrocellulose membrane with colloidal gold marked mouse anti-human IgM as an mark tracer.
The reagent is used to detect the HEV IgM antibody in serum / plasma according to the principle of
double antibody sandwich method and gold immunochromatography assay.
The sample mixing up mouse anti-human IgM antibody –marker move along the membrane to the T
line, and form the T line when the sample contains HEV-IgM antibody, which a positive result.
Conversely, it is a negative result.
Storage and Expiry
Store as packaged in the sealed pouch at 4-30°C, avoid hot and sunshine, dry place, valid for 24 months.
DO NOT FREEZE. Some protective measures should be taken in hot summer and cold winter to avoid
high temperature or freeze-thaw.
Sample Requirement
1. The reagent can be used for the serum, plasma samples.
2. A serum / plasma sample must be collected in a clean and dry container. EDTA, sodium citrate,
sodium oxalate, heparin can be used as the anticoagulants. 3. Samples may be stored at 2-8℃ for 1
week prior to assay, and at -20 ℃ for 2 years. Frozen refrigerated samples should be recovered to
room temperature before detection and thoroughly mixed. Repeat freeze and thaw for no more than
3 times. Samples exhibiting visible precipitates, stink or muddy should not be used.
1. The reagent can be used for the serum, plasma samples.
2. A serum / plasma sample must be collected in a clean and dry container. EDTA, sodium citrate,
sodium oxalate, heparin can be used as the anticoagulants. 3. Samples may be stored at 2-8℃ for 1
week prior to assay, and at -20 ℃ for 2 years. Frozen refrigerated samples should be recovered to
room temperature before detection and thoroughly mixed. Repeat freeze and thaw for no more than
3 times. Samples exhibiting visible precipitates, stink or muddy should not be used.
Limitations
1. This reagent is designed for the qualitative screening test. Concentration of HEV-IgM cannot be
determined by this qualitative test.
2. The results of the reagent are only for clinical reference, which is not the only basis for clinical
diagnosis and treatment. A confirmed diagnosis and treatment should only be made by a physician
after all clinical and laboratory findings have been evaluated.
3. Sensitivity can be lowered by the competition between high titers of HEV-IgG and HEV-IgM antibody
to the antigen binding site. Results of this kind of samples should be analyzed cautiously.
4. Negative result may occur when detecting short-term infected samples, indicate that the specific
antibodies of HAV does not exist or the concentration is below detection limit. If HAV infection is still
suspected, the sample should be collected 1-2 weeks later and carry the parallel detection with the first
sample.
5. Positive results of the patients who used to receive blood transfusions or other blood products
therapy,should be analyzed cautiously.
6. Abnormal results may occur according to operator error or drug use. If HAV infection is still
suspected, the sample should be collected later and carry the parallel detection with the first sample.
1. This reagent is designed for the qualitative screening test. Concentration of HEV-IgM cannot be
determined by this qualitative test.
2. The results of the reagent are only for clinical reference, which is not the only basis for clinical
diagnosis and treatment. A confirmed diagnosis and treatment should only be made by a physician
after all clinical and laboratory findings have been evaluated.
3. Sensitivity can be lowered by the competition between high titers of HEV-IgG and HEV-IgM antibody
to the antigen binding site. Results of this kind of samples should be analyzed cautiously.
4. Negative result may occur when detecting short-term infected samples, indicate that the specific
antibodies of HAV does not exist or the concentration is below detection limit. If HAV infection is still
suspected, the sample should be collected 1-2 weeks later and carry the parallel detection with the first
sample.
5. Positive results of the patients who used to receive blood transfusions or other blood products
therapy,should be analyzed cautiously.
6. Abnormal results may occur according to operator error or drug use. If HAV infection is still
suspected, the sample should be collected later and carry the parallel detection with the first sample.
Manufacturing procedure
Packing & Delivery
Company Profile
Established in Year 2014,CHANGCHUN ZYF SCIENCE AND TECHNOLOGY Co., Ltd. is a high-tech enterprise devoted to the R&D, manufacturing, and sales of high-quality diagnostic products including laboratory equipment and clinical diagnostic reagents.
We can offer more than 30 kinds of urine analysis strips sold well and enjoyed high reputation from both domestic and overseas markets. Based on the principle of "customer first, quality first", our products continue to cover world-wide markets with the advantages of stable performance and high accuracy.
We registered MR International Healthcare Technology Co., Ltd. in Hong Kong for overseas sales. Through MR, we also possess some manufacture facilities in Zhejiang, Guangdong and Jiangsu provinces of China in order to help reduce the cost while caring about the quality.
We are committed to provide most reliable medical devices and solutions to people in every corner of the earth. Accomplishing the mission of "maximizing the reliability of medical products" is our goal. We do care about obtaining the trust from our partners and patients. We are dedicated to innovation in the fields of Rapid Test, POCT, In-Vitro Diagnostics, and Medical Consumables, such as vacuum tubes, tube holders, etc.
We can offer more than 30 kinds of urine analysis strips sold well and enjoyed high reputation from both domestic and overseas markets. Based on the principle of "customer first, quality first", our products continue to cover world-wide markets with the advantages of stable performance and high accuracy.
We registered MR International Healthcare Technology Co., Ltd. in Hong Kong for overseas sales. Through MR, we also possess some manufacture facilities in Zhejiang, Guangdong and Jiangsu provinces of China in order to help reduce the cost while caring about the quality.
We are committed to provide most reliable medical devices and solutions to people in every corner of the earth. Accomplishing the mission of "maximizing the reliability of medical products" is our goal. We do care about obtaining the trust from our partners and patients. We are dedicated to innovation in the fields of Rapid Test, POCT, In-Vitro Diagnostics, and Medical Consumables, such as vacuum tubes, tube holders, etc.
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