产品名称：JapaneseEncephalitisIgM ELISA Kit

Limitations of procedure:
Not for use in diagnostic procedures.
Since this is an indirect screening method, the presence of false positive and negative results must be considered.
All reactive samples must be evaluated by a confirmatory test.
The reagents supplied in this kit are optimized to measure JERA reactive antibody levels in serum
Serological cross-reactivity across the flavivirus group is common. Certain sera from patients infected with Dengue, West Nile, and Saint Louis virus may give false positive results. Therefore any JE positive sera must be confirmed with other tests.
In areas where JE and dengue are co-existent, JE positive samples should also be assayed for dengue reactivity. Samples with borderline JE positivity and medium to high dengue reactivity could be suspected for dengue infection and require further confirmatory assays.
The assay performance characteristics have not been established for visual result determination.
Results from immunosuppressed patients must be interpreted with caution.
Assay results should be interpreted only in the context of other laboratory findings and the total clinical status of the patient.
This kit has not been optimized for vaccine induced seroconversion studies.
The use of JE Detect IgM kit for vaccine induced seroconvesion studies may lead to many "Equivocal

Bring all kit reagents and specimens to room temperature (approx. 25 °C) before use. Thoroughly mix the reagents and samples before use by gentle inversion.
Note:
All serum, including the experimental, cannot be repeatedly thawed and frozen. For long-term storage, sera should be further aliquoted in a smaller volume and stored at -70 °C. Always quick spin serum sample contained in vials or tubes to collect sample at the bottom.

Preparation of Reagents
Preparation of 1X Wash Buffer: Dilute the 10X Wash Buffer to 1X using Biological or High-Grade Water. To prepare a 1X wash buffer solution, mix 120 mL 10X wash buffer with 1080 mL distilled (or deionized) water and rinse out any crystals. Swirl until well mixed and all crystals are dissolved. After diluting to 1X, store at room temperature for up to 6 months. Check for contamination prior to use.
Microtiter Wells: Select the number of coated wells required for the assay. The remaining unused wells should be placed back quickly into the pouch and stored at 2-8 °C until ready to use or expiration.

Specificity Studies: The following specificity and sensitivity of the Japanese Encephalitis IgM ELISA Kit was derived from two small studies. One was a comparison conducted by the CDC, while the second a JE infected human serum panel provided by CDC. An OD ratio of each sample was calculated (0D450 on JERA/0D450 of control at each dilution). A ratio >10.0 is considered positive for JE infection Positive Convalescent Negative Total JE IgM ELISA + 31 0 0 31 0 1 196 197 Total 31 1 196 228 Note: Specificity panel includes normal and other disease sera, such as sera from patients with autoimmune diseases (ANA, RF, etc, not including Dengue, and WNV, and SLE sera). Limited studies with dengue sera showed cross-reactivity with some sera. One convalescent serum did not show any IgM reactivity. Serological