High Accuracy Cytomegalovirus Antibody IGM Rapid Test ,CMV IgM Test
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- Supplier: Changchun ZYF Science And Technology Co. Ltd.
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Product Overview
Description
Product Description
Specification
Product Name
(CMV) Cytomegalovirus IgM Antibody Rapid Test Kit (Immunochromatography)
Intended Use
The reagent is used to detect the cytomegalovirus IgM antibody in serum/plasma qualitatively.It is used as an aid in the diagnostic of past infection and epidemiological investigation.
Principle
The test utilizes antibodies including a recombinant CMV antigen and goat anti-mouse IgG antibody on the nitrocellulose membrane with colloidal gold marked anti-human IgM as a mark tracer. The reagent is used to detect the CMV IgM according to the principle of capture method and gold immunochromatography assay.
The sample mixing up anti-human IgM–marker move along the membrane to the T line, and form the T line with recombinant CMV antigen when the sample contains CMV IgM, which is a positive result. Conversely, it is a negative result.
Main Components
Basic components: Sample pad, colloidal gold marked pad, nitrocellulose membrane, absorbent paper and PVC board. Colloidal gold marked pad coated with anti-human IgM, nitrocellulose membrane coated with recombinant CMV antigen，control line coated with goat anti-mouse IgG antibody.
Storage and Expiry
Store as packaged in the sealed pouch at 4-30°C, keep out of hot and direct sunlight, keep in 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 product is humidity-sensitive and should be used immediately after being opened.
Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
(CMV) Cytomegalovirus IgM Antibody Rapid Test Kit (Immunochromatography)
Intended Use
The reagent is used to detect the cytomegalovirus IgM antibody in serum/plasma qualitatively.It is used as an aid in the diagnostic of past infection and epidemiological investigation.
Principle
The test utilizes antibodies including a recombinant CMV antigen and goat anti-mouse IgG antibody on the nitrocellulose membrane with colloidal gold marked anti-human IgM as a mark tracer. The reagent is used to detect the CMV IgM according to the principle of capture method and gold immunochromatography assay.
The sample mixing up anti-human IgM–marker move along the membrane to the T line, and form the T line with recombinant CMV antigen when the sample contains CMV IgM, which is a positive result. Conversely, it is a negative result.
Main Components
Basic components: Sample pad, colloidal gold marked pad, nitrocellulose membrane, absorbent paper and PVC board. Colloidal gold marked pad coated with anti-human IgM, nitrocellulose membrane coated with recombinant CMV antigen，control line coated with goat anti-mouse IgG antibody.
Storage and Expiry
Store as packaged in the sealed pouch at 4-30°C, keep out of hot and direct sunlight, keep in 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 product is humidity-sensitive and should be used immediately after being opened.
Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
Limitation
1. This reagent is designed for the qualitative screening test. Concentration of analytes 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. Negative result may occur when detecting short-term infected samples, indicate that the specific antibodies of CMV does not exist or the concentration is below detection limit. If CMV infection is still suspected, the sample should be collected 2 weeks later and carry the parallel detection with the first sample.
4. Negative results may occur at the beginning of acute infection, other testing method and analysis with clinical symptoms are suggested.
5. Results of patients who used to receive immunosuppressive therapy or with immune function damage (for example HIV), may have a low serology reference value.
6. Positive results of the patients who used to receive blood transfusions or other blood products therapy, should be analyzed cautiously.lyzed cautiously.
1. This reagent is designed for the qualitative screening test. Concentration of analytes 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. Negative result may occur when detecting short-term infected samples, indicate that the specific antibodies of CMV does not exist or the concentration is below detection limit. If CMV infection is still suspected, the sample should be collected 2 weeks later and carry the parallel detection with the first sample.
4. Negative results may occur at the beginning of acute infection, other testing method and analysis with clinical symptoms are suggested.
5. Results of patients who used to receive immunosuppressive therapy or with immune function damage (for example HIV), may have a low serology reference value.
6. Positive results of the patients who used to receive blood transfusions or other blood products therapy, should be analyzed cautiously.lyzed cautiously.
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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