Human CMV IgG(CSF) ELISA Kit

Sample

Serum

Species Reactivity

Human

Detection Method

sELISA

Intended Use

Human CMV (CSF) ELISA Kit is intended for in vitro diagnosis of CMV-associated diseases, i.e. infectious mononucleosis, CMV syndrome, hepatitis in infants, intersticial pneumonitis or other forms of active CMV infection in immunocompromised patients, including their neurological complications (encephalitis, neuritis, syndrome Guillain-Barré). It may also contribute to differential diagnosis of autoimmune or neurological diseases.
For serological examination of CMV, this assay should be supplemented with CMV-specific IgM antibody detection, eventually with the determination of CMV-specific IgA and CMV IgG avidity.

Contents of Kit

1. ELISA break-away strips
2. Standard A
3. Standard B
4. Standard C
5. Standard D
6. Standard E
7. Standard F
8. Anti-human IgG antibodies
9. Washing solution
10. Diluting solution
11. TMB substrate
12. Stop Solution

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 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. Do not store diluted samples. Always prepare fresh.
3. Kits are shipped in cooling bags, the transport time of 72 hours have no influence on expiration.
4. If you find damage at any part of the kit, please inform the manufacturer immediately.
5. Expiration date is indicated at the ELISA kit label and at all reagent labels.

Precision

Intra assay variability: 2.4-4.3%
Inter assay variability: 5.3-10.1%
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. 5%. 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, σ = standard deviation)

Interassay variability
The coefficient of interassay variability is max. 15%. It is measured for each particular Lot as comparison 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, σ = standard deviation)

Detection Limit

The limit of quantification is defined as the lowest measurable concentration which can be 95% sure distinguished from zero. This value is 1.4 AU/mL.

Sensitivity

To assess of diagnostic effectivity 14 CMV-negative and 30 CMV-positive serum samples were tested in double-blinded multilaboratory study. The results were confirmed using independent commercial IVD diagnostic tests. Diagnostic sensitivity was 96.7%.