产品名称：JapaneseEncephalitisAntibody(IgG) ELISA Kit

Quality Control:
Each kit contains positive and negative control sera. The negative and positive controls are intended to monitor for substantial reagent failure. The positive control will not ensure precision at the assay cutoff. The test is invalid and must be repeated if the ISR value of either the controls do not meet the specifications. Acceptable Immune Status Ratio (ISR) values for these controls are found on specification table below. If the test is invalid, patient results cannot be reported. Quality control requirements must be performed in conformance with local, state, and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control procedures. It is recommended that the user refer to NCCLS C24-A and 42 CFR 493.1256 for guidance on appropriate QC practices. The results below are given strictly for guidance purposes only. Applicable for raw spectrophotometric readings only. Calculation of the Negative Control: Calculate the mean JE Negative Control values with JERA and with the Control antigen: Example: JE Negative Control OD JERA NCA No1 0.235 0.230 No 2 0.245 0.224 Total 0.480 0.454 Average JERA =0.480 +2 = 0.240 Average NCA = 0.454 + 2 = 0.227 Calculate JERA / NCA ratio: 0.240 + 0.227=1.06 Any JE Negative control Jera / NCA Ratio greater than 1.5 indicates that the test procedure must be repeated. Calculation of the Positive Control: Calculate JE IgG Positive Control values with JERA and with the NCA. OD JERA NCA No1 0.938 0.126 No 2 0.898 0.111 Total 1.836 0.237 Average JERA =1.836+ 2 = 0.918 Average NCA = 0.237 + 2 = 0.119 Calculate JERA / NCA ratio: = 0.918 + 0.119 = 7.71 Any JE Positive Control JERA / NCA Ratio Less than 5.0 indicates that the test procedure must be repeated. Non-fulfillment of these criteria is an indication of deterioration of reagents or an error in the test procedure and the assay must be repeated. Factor (For Assay Verification) Tolerance Mean JE Negative Control OD in JERA <0.400 mean="" je="" igg="" positive="" control="" od="" in="" jera="">0.400 JE IgG Positive Control Immune Status Ratio (ISR) >5.000 JE Negative Control Immune Status Ratio (ISR) <1.500 calculation="" of="" the="" immune="" status="" ratio="" (isr):="" compute="" average="" unknown="" sample="" replicates="" with="" jera,="" and="" nca,="" then="" calculate="" jera="" nca="" (isr).="" .="" an="" isr="" less="" than="" 2.0="" for="" igg="" assay="" should="" be="" presumed="" negative.="" greater="" 5.0="" positive.="" table="" below="" summarizes="" how="" results="" interpreted.="" interpretation="" <2.0="" negative="" no="" detectable="" antibody="" by="" elisa="" test="" 2.0-5.0="" equivocal="" need="" confirmatory="">5.0 Positive Indicates presence of detectable IgG antibody. Recommend supplemental confirmatory testing.
Limitations of procedure:
For export use only.
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.
Repeated freezing and thawing of reagents supplied in the kit and of specimens must be avoided.
This kit has not been optimized for vaccine induced seroconversion studies.

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:
For long-term storage, all serum, including the experimental, cannot be repeatedly thawed and frozen. Sera should be further aliquoted in a smaller volume and stored at -70 °C. Always quick spin serum samples contained in vials or tubes to collect sample at the bottom.

Preparation for Assay:
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 a maximum of 6 months. Use 300 μL/well for each wash cycle. Note: Determine if any precipitate, microbial growth, or turbidity is found in the 1X Wash Buffer solution before use. Do not use the 1X Wash Buffer If such contamination is found.
Coated Micro titer Strips select the number of Coated Microtiter Strips required for the assay. The remaining unused strips should be quickly placed back into the pouch with desiccant, sealed, and stored at 2-8 °C until ready to use or expiration.