Bioneovan

Beijing, China

Intended Use:IgM antibodies to EV 71 Rapid Test (Colloidal Gold) is based on the principle of colloidal gold enhanced, rapid immunocharomatographic assay for the determination of IgM antibodies to EV 71 in human whole blood/serum/plasma, as an aid in the clinical assessment of Enterovirus 71 infection. Principle of the Procedure:Blue Cross IgM antibodies to EV 71 Rapid Test (Colloidal Gold) is based on the principle of antibody capture theory. If the sample contains IgM antibodies to EV 71, EV 71 antibody conjugated to colloidal gold reacts with IgM antibodies to EV 71present in whole blood/serum/plasma and EV 71 antigen forming the complex. As the mixture is allowed to migrate along the test strip, the complex is captured by anti-human IgM-µ chain forming a colored test line in the test region. A colored control line in the control region appears at the end of test procedure regardless of test result, This control line is the result of colloidal gold conjugate binding to the anti-mouse IgG polyclonal antibodies immobilized on the membrane, and it indicates that the colloidal gold conjugate is functional.This one step test is very sensitive and only takes about 20 minutes. Test results are read visually without any instrument. Sensitivity: >98%  Specificity: >99%                      Storage : 4-30°C

group a rotavirus antigen rapid test kit is an in vitro immunoassay for the qualitative determination of the detection of group a rotavirus in human faecal specimens in one step. It is for diagnosis of early infection and epidemic survey. The kit is intended only for an initial screening test and reactive samples should be confirmed by a supplemental assay such as commercial anzyme immunoassay (elisa) or rt-pcr.     materials provided   25x1 tests (strip), 20x1 tests (cassette)   each cassette/strip contains a test strip with goat polyclonal anti-rotavirus antibodies on the test region of the membrane and colored mouse monoclonal anti-rotavirus antibodies-gold conjugate pad.       sample collection and preservation   1. Sample collection swab   • to take a portion of feces(about 100mg) , insert the sterile swab into a stool sample that presents the most secretion under visual inspection.• open the sample collection tube and then insert the swab into the sample collection tube containing assay diluents. Swirl the swab at least 10 times until the samples has been dissolved into the assay diluents and discard the swab while squeezing the swab against the wall of tube, replace the cap. Specimen extracted in assay diluents may be stored at 2-8ºc for up to 1 -2 days prior to testing.   2. Specimen transport and storage   • specimen should be tested as soon as possible after collection. Do not use any kind of transport media to store or transport specimens.   • faecal sample may be stored refrigerated (2-8ºc) for 48 hours. If longer storage is required, freezing at -20ºc is recommended.     test procedure   1. Bring membrane plate and samples to room temperature (20-30°c) before use (approximately 30 minutes).   2. Remove the test cassette/strip from the sealed foil pouch and place the plate on flat desk.   3. Bring all materials and specimens to room temperature (8~30℃).   group a rotavirus test cassette   1) to take a portion of feces (about 100mg), insert the sterile swab into a stool sample that presents the most secretion under visual inspection.   2) open the sample collection tube and then insert the swab into the sample collection tube containing assay diluents.   3) swirl the swab at least 10 times until the samples has been dissolved into the assay diluents and discard the swab while squeezing the swab against the wall of tube, replace the cap.   4) deliver 100μl (2~3drops ) of diluted stool sample to the sample well of the test card.   5. Read the result in 5~10 minutes. A strong positive sample may show result earlier.   note: results after 15 minutes may not be accurate.  

intended use this test is a single use, rapid device intended for qualitativedetection of igm-class antibodies to hepatitis a virus (hav)in serum, plasma samples. It is intended tobe used in clinical laboratories for diagnosis of acutehepatitis a and management of patients related to infectionwith hepatitis a virus. summary hepatitis a is a self-limited disease and chronic stage or other complications are rare. Infections occur early in life in areas where sanitation is poor and living conditions are crowded. With improved sanitation and hygiene, infections are delayed and consequently the number of persons susceptible to the disease increases. Because the disease is transmitted through the fecal-oral route in dense populated regions, an outbreak can arise from single contaminated source. The cause of hepatitis a is hepatitis a virus (hav)-non enveloped positive strand rna virus with a linear single strand genome, encoding for only one known serotype. Hav has four major, structural polypeptides and it localizes exclusively in the cytoplasm of human hepatocytes. The infection with hav induces strong immunological response and elevated levels first of igm and then igg are detectable within a few days after the onset of the symptoms. The presence of anti–hav igm is an important serological marker for early detection and observation of the clinical manifestation of the disease. Increasing levels of anti-hav igm are detectable about three weeks after exposure with highest titter after four to six weeks later. Within six months after infection igm concentration declines to non-detectable levels. specimen collection -serum/plasma samples: fresh serum or plasma samples can be used. No special patient preparation required. Care should be taken to ensure blood full clotting and any visible particulate matter in the sample should be removed by centrifugation or filtration. Avoid the use of highly hemolytic, turbid, microorganism contaminated samples or samples stored for over 30days at 2-8°c. Store samples at 2-8°c. Samples not required for assay within 3 days should be stored frozen (-20°c or lower). Avoid sample deterioration by multiple freeze-thaw cycles. -plasma: collect whole blood into a collection tube (containing edta, citrate or heparin, respectively) by venipuncture. Separate the plasma by centrifugation. -serum: collect whole blood into a collection tube (containing no anticoagulants) by venipuncture. Allow the blood to clot. Separate by centrifugation. the original samples cannot be tested directly, must be diluted with sample diluents before testing! storage and stability this test can be stored at room temperature (2-30°c, do not freeze!) for 18 months from the date of manufacture (see label on strip pouch). Use immediately after opening.  

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intended use this test is a single use, rapid device intended for qualitativedetection of igm-class antibodies to hepatitis a virus (hav)in serum, plasma samples. It is intended tobe used in clinical laboratories for diagnosis of acutehepatitis a and management of patients related to infectionwith hepatitis a virus. summary hepatitis a is a self-limited disease and chronic stage or other complications are rare. Infections occur early in life in areas where sanitation is poor and living conditions are crowded. With improved sanitation and hygiene, infections are delayed and consequently the number of persons susceptible to the disease increases. Because the disease is transmitted through the fecal-oral route in dense populated regions, an outbreak can arise from single contaminated source. The cause of hepatitis a is hepatitis a virus (hav)-non enveloped positive strand rna virus with a linear single strand genome, encoding for only one known serotype. Hav has four major, structural polypeptides and it localizes exclusively in the cytoplasm of human hepatocytes. The infection with hav induces strong immunological response and elevated levels first of igm and then igg are detectable within a few days after the onset of the symptoms. The presence of anti–hav igm is an important serological marker for early detection and observation of the clinical manifestation of the disease. Increasing levels of anti-hav igm are detectable about three weeks after exposure with highest titter after four to six weeks later. Within six months after infection igm concentration declines to non-detectable levels. principle of the assay this test employs chromatographic lateral flow device in acassette format. Colloidal gold conjugated recombinantantigens (au-ag) corresponding to hav antigens aredry-immobilized at the end of nitrocellulose membrane strip.anti-human igm (anti-μ chain) are bond at the test zone (t)and goat anti-mouse igg antibodies are bond at the controlzone (c). When the sample is added, it migrates by capillarydiffusion rehydrating the gold conjugate. If present in sample, hav igm antibodies will bind with the gold conjugatedantigens forming particles. These particles will continue tomigrate along the strip until the test zone (t) where they arecaptured by anti-human igm (anti-μ chain) generating a visible red line. If there are no hav igm antibodies in sample, no red line is formed in the test zone (t). The gold conjugatewill continue to migrate alone until it is captured in the controlzone(c) by the goat anti-mouse igg antibodies aggregating in a red line, which indicates the validity of the test. components forty tests/kit 40 hav igm colloidal gold rapid test strips, each placed in white plastic cassette and packed in foil pouch, instructions for use, 1×6 ml vial of sample diluents. Materials required but not provided: clock or timer, safety lancets, alcohol prep-pad, disposable pipettes, specimen collection container, centrifuge, biohazard waste container, sterile gauze or cotton.

introduction: â  hbsag elisa is used for the qualitative determination of hepatitis b surface antigen (hbsag) in human serum or plasma. this test is indicated for the screening of blood and blood products to be used for transfusion and an aid for the diagnosis of existing or previous hepatitis b infection. â  â  sample request: â  serum should be prepared from a whole blood specimen obtained by acceptable medical techniques. either serum or plasma can be used in this test.â  remove serum or plasma from the clot or blood cells as soon as possible to avoid hemolysis.â  specimen with extensive particulate should be clarified by centrifugation prior to use.â  specimen frozen at -20â°c or colder may be used.â  avoid repeated freeze thaw. â  storage and stability: â  unopened test kits should be stored at 2-8â°c. do not freeze kit componnets.â  the microtiter 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. â  â  â  working wash buffer: â  dilute the 20x wash buffer concentrate with deionized or distilled water 1:20. for example, 5 ml of wash buffer concentrate should be diluted to a total volume of 100 ml with deionized or distilled water. â  feature details shelf life: 12 months storage: 2-8â°c no freezingâ â â â â  specimen: serum package: 96 test/kit moq: 10 kits shipping : by air packaging details: express for export lead time: 2-3 weeks after the payment payment terms: t/t, western union, paypal or supply ability: 100 000 kits/month place of origin: beijing, china (mainland) brand name: bioneovan certification: iso13485 & cfda & gmp â 

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• MOQ 1 Box
• Number Of FlowerElisa Kit

Mycobacterium Tuberculosis Specific T Cell Mediated Immune Response Detection Kit（ELISA)   INTENDED USE This kit is an enzyme-linked immunosorbent assay for quantitative detection of Interferon Gamma (IFN-γ) that responds to in-vitro stimulation by Mycobacterium tuberculosis antigens in fresh human whole blood. It is intended for use as an aid in the diagnosis of tuberculosis (TB) infection. SUMMARY Tuberculosis is a communicable disease caused by infection with M.tuberculosis (MTB)complex organisms (M. tuberculosis, M. bovis, M. africanum), which typically spread to new hosts via airborne droplet nuclei from patients with respiratory tuberculosis disease. It is one of the most important health threatening problems worldwide. The World Health Organization estimates that one third of the world’s population is infected with M.tuberculosis. Each person carrying latent TB infection (LTBI) has approximately a 10% chance of progressing to active disease. Interferon Gamma Release Assay (IGRA) measure a person’s immune reactivity to M.tuberculosis. T lymphocytes from most persons that have been infected with M.tuberculosis will release IFN-γ when mixed with special antigens derived from M.tuberculosis. IGRA is whole-blood test that can aid in diagnosing Mycobacterium tuberculosis infection, including both latent tuberculosis infection (LTBI) and tuberculosis (TB) disease. PRINCIPLE OF THE TEST This kit uses the principle of IGRA combined with enzyme linked immunosorbent assay (ELISA) to measure specific antigen mediated immune response strength. The antigens selected for stimulation is specific fragments that pathogenic Mycobacterium tuberculosis have, but BCG vaccine and other Mycobacterium do not have. The patients infected with Mycobacterium tuberculosis have specific T lymphocytes which can identify these antigens and T lymphocytes will be stimulated to proliferate and release cytokines such as IFN-γ. This kit uses ELISA method for quantitative detection the specific IFN-γ released by cells to determine Mycobacterium tuberculosis infection. COMPONENTS In Vitro Diagnostic Use Only This kit contains reagents sufficient for testing of maximum of 28 specimens in a test run. Stimulation Components: 1. Negative Control (Grey lid) 28tests 2. TB Antigen, lyophilized (Purple lid) 28tests 3. TB Antigen Diluent (Purple lid) 0.9mL 4. Positive Control (Red lid) 28tests ELISA Components 1. Microplate Strips 12x 8 well 2. Human IFN-γ Standard, lyophilised (Blue lid) 2 x vial 3. Diluent 1 x 40mL 4. Biotin Labeled Antibody (Yellow cap) 1 x 6mL 5. Enzyme Conjugate 100X Concentrate (Brown bottle) 1 x 130μL 6. Wash Buffer 10X Concentrate 1 x 40mL 7. Chromogen Solution A 1 x 6mL 8. Chromogen Solution B 1 x 6mL 9. Stopping Solution 1 x 6mL

intended use this kit is used to qualitatively detect the existence of mp -igmantibodies in serum or plasma sample, as an auxiliary diagnostic reagent of mp infection in clinic. Mycoplasma pneumoniae(mp) is the common pathogenic microorganisms that caused the primary atypical pneumonia and other respiratory infections diseases. In addition to the respiratory tract that mp can cause other serious complication. Mp infection is widespread and it can cause pharyngitis, tonsillitis, bronchitis, lung abscess, pulmonary bullae and pleurisy and multi system damage. It is not easy to identify the pneumonia is caused by mp, viruses, bacteria and other pathogens infection. And the treatment of mp infection is different to other bacterial or viral infections. Mp –igm is a specific antibody appeared first after mp infection. It can be detected in 7 days while onset.   principle of the test this kit is applying the technology of colloidal gold immunochromatography to qualitative test the mp-igm antibody of serum or plasma samples. The mp-igm antibodies in positive sample can combine with colloidal gold labeled mouse anti human igm immobilized on conjugate pad to form immune complex, and move along the membrane strip by chromatography. Some of the complex is caught by recombinant mp ag pre-coated on t line to form "gold labeled mouse anti human igm- mp igm ab- mp ag" and develop color. The remaining free complex will be caught by the goat anti-mouse igg antibody coated on the c line to develop color. As for negative samples, in which have no mp- igm antibodies, cannot form immune complexes and develop color on the t line, and colorate on c line only.   components test card (coating the recombinant mp antigen on t-line (p1-p30), the goat anti-mouse igg antibody on c-line): 20 test cards/ box 1. The sample diluent: 1 bottle (5 ml ) 2. Product instruction: 1   sample request 1. Serum and plasma samples were collected from the venous blood by conventional method. Plasma sample: add 100ul heparin solution (1%) to 5 ~ 10ml blood; or sodium citrate solution (3.8%) to plasma according to the proportion of 1:9; or edta solution (15%) 0.04ml to 5ml plasma. 2. Serum and plasma samples can be stored at 4 °c if tests will be done within 5 days, otherwise stored at -20 °c. No more than 3 times of freeze-thaw. 3. The test result is invalid for hemolysis sample.   test procedure: 1. Test preparation: 10μl, 100μl micropipettes and matched tips 2. Test process: the temperature of the kit and the test sample should be the same with room temperature before test. Place the test card on a dry horizontal work surface. Add 10μl serum or plasma sample into the sample well, then add 100 μl of sample dilution immediately. Observe the result in 15-20 minutes after the serum or plasma samples added. The observation is invalid after 20 minutes.

Intended Use Total IgE Rapid Test device is an in-vitro rapid immunochromatographic assay for the qualitative detection of totalimmunoglobulin E(IgE) in Whole Blood/Serum/Plasmaspecimens from patients. It is intended to aid in the presumptive diagnosis of allergy.