25 шт Высокоточный тест IVD для быстрого анализа кассеты Rota/adenoвирус
- Category: Custom Chemical Services >>>
- Supplier: Biocare Diagnostics Ltd.
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Product Overview
Description
Specification
Brand Name | YIYOU Biotech |
Product name | Rota/Adenovirus Rapid Cassette Test |
Package Size | 25tests/kit, 50tests/kit |
Specimen | stool |
Brand Name | YIYOU Biotech or OEM |
Shelf Life | 24months |
Certificate | CE, ISO13485 |
Storage | 4-30℃ |
Product Description
【Intended Use】
The Rota/Adenovirus Rapid Cassette Test is an in vitro qualitative immunochromatographic assay for the rapid detection of rotavirus and adenovirus antigen in feces. It offers a simple and highly sensitive screening assay to make a presumptive diagnosis of Rotavirus and/or Adenovirus infection.
【Summary】
Rotavirus is the primary causative agent of acute gastro-enteritis, especially in children less than 2 years old. Its discovery in 1973 and its association with infantile gastro-enteritis represented a very important advance in the study of gastro-enteritis not caused by acute bacterial infection. Rotavirus is transmitted by oral-faecal contact with an incubation period of 1-3 days etc.
The Adenovirus is the second most common cause of viral gastro-enteritis in children (10-15%). This virus may also cause respiratory diseases and, depending on the serotype, also diarrhoea, conjunctivitis, cystitis, etc. At least 47 serotypes of adenovirus have been described, all sharing a common hexon antigen. Serotypes 40 and 41 are the ones associated with gastro-enteritis, whose main symptom is diarrhoea that may last between 9 and 12 days associated with temperature and vomits.
【Test Principle】
The test uses new homogenous immunochromatographic system with gold particules. It is a ready to use test which only needs a faecal sample dilution with the supplied ready to use dilution buffer. Specificity is ensured by using a monoclonal antibody conjugated with gold particules and directed against specific human genus-specific Rotavirus antigen or Adenovirus antigens. The immunochromatographic stick is coated with a polyclonal immunoreagent specific for genus-specific Adenovirus hexon antigens or rotavirus VP6 antigen. Liquid sample and gold conjugate both migrate by capillarity and reach the first specific anti-Adenovirus polyclonal reagent. If Adenovirus is present in the sample, it is blocked and immunoreaction appears as a red-pink line. As sample still migrates, it reaches the second specific reagent line against Rotavirus, then migrate to the non-specific anti-mouse IgG which gives rise to a third red-pink line. This line indicates that the chromatography has been developed without hindrance. It appears also with negative samples.
The Rota/Adenovirus Rapid Cassette Test is an in vitro qualitative immunochromatographic assay for the rapid detection of rotavirus and adenovirus antigen in feces. It offers a simple and highly sensitive screening assay to make a presumptive diagnosis of Rotavirus and/or Adenovirus infection.
【Summary】
Rotavirus is the primary causative agent of acute gastro-enteritis, especially in children less than 2 years old. Its discovery in 1973 and its association with infantile gastro-enteritis represented a very important advance in the study of gastro-enteritis not caused by acute bacterial infection. Rotavirus is transmitted by oral-faecal contact with an incubation period of 1-3 days etc.
The Adenovirus is the second most common cause of viral gastro-enteritis in children (10-15%). This virus may also cause respiratory diseases and, depending on the serotype, also diarrhoea, conjunctivitis, cystitis, etc. At least 47 serotypes of adenovirus have been described, all sharing a common hexon antigen. Serotypes 40 and 41 are the ones associated with gastro-enteritis, whose main symptom is diarrhoea that may last between 9 and 12 days associated with temperature and vomits.
【Test Principle】
The test uses new homogenous immunochromatographic system with gold particules. It is a ready to use test which only needs a faecal sample dilution with the supplied ready to use dilution buffer. Specificity is ensured by using a monoclonal antibody conjugated with gold particules and directed against specific human genus-specific Rotavirus antigen or Adenovirus antigens. The immunochromatographic stick is coated with a polyclonal immunoreagent specific for genus-specific Adenovirus hexon antigens or rotavirus VP6 antigen. Liquid sample and gold conjugate both migrate by capillarity and reach the first specific anti-Adenovirus polyclonal reagent. If Adenovirus is present in the sample, it is blocked and immunoreaction appears as a red-pink line. As sample still migrates, it reaches the second specific reagent line against Rotavirus, then migrate to the non-specific anti-mouse IgG which gives rise to a third red-pink line. This line indicates that the chromatography has been developed without hindrance. It appears also with negative samples.
【Storage and Shelf Life】
The Rota/Adeno Rapid Test Strip can be stored at 4-30°C. Do not freeze. The stability period of the kit under these storage conditions is 24 months. Use up the reagents as soon as possible after the kit is unpacked.
【Specimen Collection and Preparation】
Stool samples must be taken as soon as the symptoms appear. Viral particles decrease in number after one week, making the diagnosis more difficult. The samples can be stored in the refrigerator for 1 to 2 days. For longer storage they must be kept frozen at -20ºC. In this case, the sample should be totally thawed, and brought to room temperature and homogenised before testing.
Allow all reagents and samples to equilibrate to room temperature before proceeding with the test. Write the specimen number on the cassette and sample preparation device.
【Test Method】
1. Unscrew the cap of the Sample Extraction Vial. Collect sample by immersing the applicator stick into the faeces ensuring that the sample has impregnated the stick surface properly. (about 50mg). For liquid or semi-solid stools add 100 microliters of stool using an appropriate pipette into the vial
2. Reinsert the applicator stick into the vial and screw the cap tightly. Shake the vial to release the virus into diluent.
3. Break the tip off. Add 3 drops to the sample well of the test device.
4. Incubate the test at room temperature and read the test after 5-15 minutes.
The Rota/Adeno Rapid Test Strip can be stored at 4-30°C. Do not freeze. The stability period of the kit under these storage conditions is 24 months. Use up the reagents as soon as possible after the kit is unpacked.
【Specimen Collection and Preparation】
Stool samples must be taken as soon as the symptoms appear. Viral particles decrease in number after one week, making the diagnosis more difficult. The samples can be stored in the refrigerator for 1 to 2 days. For longer storage they must be kept frozen at -20ºC. In this case, the sample should be totally thawed, and brought to room temperature and homogenised before testing.
Allow all reagents and samples to equilibrate to room temperature before proceeding with the test. Write the specimen number on the cassette and sample preparation device.
【Test Method】
1. Unscrew the cap of the Sample Extraction Vial. Collect sample by immersing the applicator stick into the faeces ensuring that the sample has impregnated the stick surface properly. (about 50mg). For liquid or semi-solid stools add 100 microliters of stool using an appropriate pipette into the vial
2. Reinsert the applicator stick into the vial and screw the cap tightly. Shake the vial to release the virus into diluent.
3. Break the tip off. Add 3 drops to the sample well of the test device.
4. Incubate the test at room temperature and read the test after 5-15 minutes.
【Interpretation of Results】
All positive: a color band appears in the test area (R, A) and quality control area (C), and the test result is Rotavirus and Adenovirus positive.
Rotavirus positive: a color band appears in the test area (R) and the quality control area (C), and the test result is Rotavirus positive.
Adenovirus positive: a color band appears in the test area (A) and the quality control area (C), and the test result is Adenovirus positive.
Negative: only one color band appears in the quality control area (C), and the test result is negative.
Invalid: no color band appears in the quality control area (C) or only one color band appears in the detection area (R or A), indicating that the test is invalid and should be tested again.
【Components】
Component | 25 tests/kit | 50 tests/kit |
Rota/adeno Card | 25 pcs | 50 pcs |
Sample Diluent | 1.5 ml × 25 | 1.5 ml × 50 |
Instruction for use | 1 | 1 |
【Precautions】
1. For in-vitro diagnostic use only.
2. Handle all specimens as if they contain infectious agents. When the assay procedure is completed, dispose of specimens carefully after autoclaving for at least one hour. Alternatively, treat with a 0.5 or 1% solution of sodium hypochlorite for one hour before disposal.
3. Wear protective clothing (laboratory coats and disposable gloves) when assaying samples.
4. Do not eat, drink or smoke in areas where specimens and kit reagents are handled.
5. Avoid contact between hands and eyes or nose during specimen collection and testing.
1. For in-vitro diagnostic use only.
2. Handle all specimens as if they contain infectious agents. When the assay procedure is completed, dispose of specimens carefully after autoclaving for at least one hour. Alternatively, treat with a 0.5 or 1% solution of sodium hypochlorite for one hour before disposal.
3. Wear protective clothing (laboratory coats and disposable gloves) when assaying samples.
4. Do not eat, drink or smoke in areas where specimens and kit reagents are handled.
5. Avoid contact between hands and eyes or nose during specimen collection and testing.
Company Profile
Biocare was founded by scientists and investers, to design, develop and manufacture monoclonal antibody, antigen and lateral flow colloidal gold tests and ELISA kits for infectious disease, cardiac marker, tumor marker, fertility, specific proteins. Like fecal calprotectin, pepsinogen I, pepsinogen II, AMH, vwf, GDH, NGAL, fFN, rotavirus, adenovirus, rota/adenovirus, H pylori antigen, faecal transferrin, fecal occult blood, lactoferrin, PROM IGFBP-1, troponin I, myoglobin, HBsAg, HIV, HCV, HAV, HCG, LH.
Biocare is one of the high quality IVD raw materials supplier in China. Over 100 kinds of paired antiobdy is available. All these monoclonals was developed by our scientits.
Because of the using of the REEL-TO-REEL production technology for lateral flow tests, the produced tests have a better batch to batch and intra-batch accuracy. This can improve the accuracy and efficiency of POC diagnostic testing to help increase patient safety.
Biocare is one of the high quality IVD raw materials supplier in China. Over 100 kinds of paired antiobdy is available. All these monoclonals was developed by our scientits.
Because of the using of the REEL-TO-REEL production technology for lateral flow tests, the produced tests have a better batch to batch and intra-batch accuracy. This can improve the accuracy and efficiency of POC diagnostic testing to help increase patient safety.
Certifications
FAQ
Q1. What is the advantage about your company?
A1. Our company was founded by professional scientists and investors. Have over twenty years experience for In Vitro Diagnostics Reagents to serve customer all over the world.
Q2. Why should I choose your products?
A2. Our products are high quality and low price.
Q3. The logo can be customized?
A3.Yes, We provide customized services.
Q4. How do you make our business long-term and good relationship?
A4. 1. We keep good quality and competitive price to ensure our customers‘benefit
2. We respect every customer as our friends and we sincerely do business.
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