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intended use The BinaxNOW® RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) fusion protein antigen in nasal wash and nasopharyngeal swab specimens from symptomatic patients. This test is intended for in vitro diagnostic use to aid in the diagnosis of respiratory syncytial virus infections in neonatal and pediatric patients under the age of 5. It is recommended that negative test results be confirmed by cell culture. summary and eXplanation of the test RSV is a common cause of upper and lower respiratory tract infections and the major cause of bronchiolitis and pneumonia in infants and children. Infections and outbreaks due to RSV typically occur yearly in the fall, winter and spring. While RSV can cause significant respiratory illness in older children and adults, the disease tends to be milder in these populations than in infants and young children. Rapid identification and diagnosis of RSV has become more important due to the availability of effective antimicrobial therapy. Rapid identification can lead to reduced hospital stays, reduction in antimicrobial use, and reduction in the cost of hospital The BinaxNOW® RSV Test provides a simple, rapid method for the diagnosis of RSV using nasal wash and nasopharyngeal swab specimens. The easy-to-use format and rapid results allow for its use in "STAT" testing where it can provide invaluable information to assist with treatment and hospitalization decisions. principles of the procedure The BinaxNOW® RSV Test is an immunochromatographic membrane assay used to detect RSV fusion protein antigen in nasal wash and nasopharyngeal swab specimens. Anti-RSV antibody, the Sample Line, is adsorbed onto nitrocellulose membrane. Control antibody is adsorbed onto the same membrane as a second stripe. Both anti-RSV and control antibodies are conjugated to visualizing particles that are dried onto an inert fibrous support. The resulting conjugate pad and the striped membrane are combined to construct the test strip. This test strip is mounted on the right side of a cardboard, book-shaped hinged test device. Swab samples (controls and patients) require a preparation step, in which the sample is eluted off the swab into an appropriate solution. Nasal wash samples do not require any preparation. To perform the test, the sample to be tested is added to the white pad at the top of the test strip, and the test device is closed. RSV antigen present in the sample reacts to bind anti-RSV conjugated antibody. The resulting antigen-conjugate complexes are captured by immobilized anti-RSV antibody, forming the Sample Line. Immobilized Control Line antibody captures a visualizing conjugate, forming a pink Control Line. The Control Line is blue in a device that has not been tested. Test results are interpreted by the presence or absence of visually detectable pink-to-purple colored lines. A positive test result, read at 15 minutes, will include the detection of both a Sample Line and a Control Line. A negative test result, read at 15 minutes, will produce only a Control Line, indicating that RSV antigen was not detected in the sample. Failure of the Control Line to appear, or the Control Line remaining blue, indicates an invalid assay, whether the Sample Line is present or not. reagents and materials materials provided Refer to illustrations on pull-out flap. 1 test devices: A membrane coated with mouse antibody specific for RSV antigen and with control line antibody is combined with mouse anti-RSV and control line antibody conjugates in a hinged test device. The membrane of an untested device contains a blue line at the control line area. 2 transfer pipettes: Fixed volume (100 µl) transfer pipettes used to transfer sample to the test devices. Use only pipettes provided by Binax or a calibrated pipette capable of delivering 100 µl sample volume. 3 positive control swab: Inactivated RSV dried onto swab. 4 negative control swab: Inactivated Streptococcus Group A dried onto swab. 5 elution solution vials for control swabs: Vials containing elution solution used to prepare the Control Swabs. Do not use other elution solutions with the BinaxNOW® test. materials not provided Clock, timer or stopwatch; nasal wash collection containers, nasopharyngeal swabs, transport media optional item nasopharyngeal (np) sWab specimen accessory pacK: 6 nasopharyngeal swabs: Sterile foam swabs for use in the BinaxNOW® RSV test. 7 elution solution vials for swab specimens: Vials containing elution solution used to prepare swab specimens for testing. precautions For in vitro diagnostic use. Leave test device sealed in its foil pouch until just before use. Do not use kit past its expiration date. Do not mix components from different kit lots. The white sample pad at the top of the test strip contains reagents that extract the target antigen from the virus. To ensure optimum performance, add the sample sloWly to the middle of this pad such that all of the sample volume absorbs into the pad. 6. The RSV Positive Control Swab has been prepared from RSV-infected tissue culture cells that have been inactivated and subsequently tested by bioassay procedures. Use universal precautions when performing the assay. Samples may be infectious. Proper handling and disposal methods should be established according to local, state, and federal regulations. 7. invalid results can occur when an insufficient volume of specimen is added to the test device. To ensure delivery of an adequate volume, make certain that the lower shaft of the transfer pipette is full and does not contain air spaces before dispensing contents of the pipette onto the Sample Pad of the device. If air spaces are present, expel the specimen back into 1. 2. 3. 4. 5.


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