Tick borne encephalitis virus IgG ELISA Kit

Sample

Cerebrospinal Fluid or Serum

Species Reactivity

Human

Detection Method

iELISA

Intended Use

Tick borne encephalitis virus IgG ELISA Kit is for detection of IgG antibodies to tick-borne encephalitis virus in serum or cerebrospinal fluid.

Contents of Kit

1. ELISA break-away strips coated with specific antigens. 96 wells
2. Standard A, negative control serum, ready to use. 1.3 mL
3. Standard D, calibrator, ready to use. 1.3 mL
4. Standard E, positive control serum, ready to use. 1.3 mL
5. Anti-human IgG antibodies labeled with horseradish peroxidase (Px-conjugate) ready to use. 13 mL
6. Wash buffer concentrate, 10× concentrated. 55 mL
7. Dilution buffer (DB), ready to use. 60 mL
8. Chromogenic substrate (TMB substrate), ready to use. 13 mL
Stop solution, ready to use. 13 mL

Storage

1. Store the kit and the kit reagents at 2 to 10°C, in a dry place and protected from the light. Store unused strips in the sealable pouch and keep the desiccant inside.
2. Store undiluted serum samples at 2 to 10°C up to one week. For longer period make aliquots and keep them at -20°C. Avoid repeated thawing and freezing.
3. If you find damage at any part of the kit, please inform the manufacturer immediately.
4. Expiration date is indicated at the ELISA kit label and at all reagent labels.
5. The ELISA kit should be used within three months after opening.

Performance Characteristics

Validity of the test
The test is valid if:
The background absorbance (the absorbance of the Dilution buffer) is less than 0.150.
The mean absorbance values of standards/ control sera and the ratio between the absorbance values of Standard E/ Standard D are in the ranges stated in the Quality control certificate for this kit lot.

Precision

The intraassay variability (within the test) and the interassay variability (between tests) were determined with samples of different absorbance values.
Intraassay variability
The coefficient of intraassay variability is max. 8%. It is measured for each particular Lot at least on 12 parallels of the same microtitration plate.
Example: (n = number of parallels of the same microtitration plate, SD = standard deviation)

Interassay variability
The coefficient of intraassay variability is max. 15%. It is measured for each particular Lot as comparision of the OD values of the same serum sample in several consecutive tests.
Example: (n = number of an independent examination of the same serum sample, SD = standard deviation):

Sensitivity

The sensitivity was determined with the samples with expected positivity for IgG anti TBEV (vaccinated people, individuals with acute or past TBEV infection). The sensitivity of the test is 98.5%. Agreement with another commercial test was 98.5%.