Borrelia 14kD + OspC IgM ELISA kit can be used for the in-vitro diagnostic semi-quantitative determination of IgM antibodies against the 14 kD and OspC antigens of Borrelia burgdorferi in human serum and CSF. Infections with all three B. burgdorferi subspecies (garinii, afzelii and senso strictu) are detected. The borrelia 14kD + OspC IgM ELISA kit is a solid phase enzyme-linked immunosorbent assay (ELISA) based on the sandwich principle. The wells of the borrelia 14kD + OspC IgM ELISA kit are coated with antigen. Specific antibodies of the sample binding to the antigen coated wells are detected by a secondary enzyme conjugated antibody (E-Ab) specific for human IgM. After the substrate reaction the intensity of the color developed is proportional to the amount of IgM-specific antibodies detected. Results of samples can be determined directly using a cut-off index.
The borrelia 14kD + OspC IgM ELISA kit is shipped at ambient temperature and should be stored at 2-8°C. Keep away from heat or direct sun light. The storage and stability of specimen and prepared reagents is stated in the protocol insert. The microtiter strips of the borrelia 14kD + OspC IgM ELISA kit are stable up to 3 month in the broken, but tightly closed bag when stored at 2–8°C. The test results of this borrelia 14kD + OspC IgM ELISA kit are only valid if the test has been performed following the instructions. Moreover the user must strictly adhere to the rules of GLP (Good Laboratory Practice) or other applicable standards/laws. All borrelia 14kD + OspC IgM ELISA kit controls must be found within the acceptable ranges as stated on the vial labels.
The borrelia 14 kD + OspC ELISA kit shows high sensitivity and specificity for the detection of the early immune response to Borrelia burgdorferi infection. Due to the use of the recombinant 14 kD fragment of Borrelia flagellin and the classical purified OspC, to which the early immune response is mainly directed, this borrelia 14kD + OspC IgM ELISA kit recognizes a Borrelia infection much earlier than other ELISA, hemagglutination or Western Blot techniques which employ an antigen prepared from ultrasonicated Borreliae. During further course of infection antibodies are formed against various other antigens. This results in a decrease of the absolute concentration of antibodies against the 14 kD fragment and the OspC. However, these antibodies will not disappear totally, so that also persisting or chronic infections are detected with high reliability. The borrelia 14 kD + OspC ELISA kit is also suitable for the follow-up control of a successful therapy. In this case it has to be taken into account that antibody titers do not decrease significantly until 2 - 4 months after the infection is cured. The results for the IgM assay may be increased unspecifically in pregnants. In such a case a reconfirmation of the results with a blot and observation of the course after 14 days is advised. The results itself should not be the only reason for any therapeutical consequences. They have to be correlated to other clinical observations and diagnostic tests. It is recommended that each laboratory establishes its own range of normal values.
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