Rubella virus IgG ELISA Kit

Sample

Serum, Plasma

Species Reactivity

Human

Detection Method

ELISA

Intended Use

Enzyme immunoassay for the quantitative determination of IgG-class antibodies against Rubella Virus in human serumor plasma (citrate, heparin).

Contents of Kit

1. Rubella Virus Coated Microplate (IgG): 12 break apart 8-well snap-off strips coated with Rubella Virus antigens; in resealable aluminium foil.
2. IgG Sample Diluent Buffer: 1 bottle containing 100 ml of phosphate buffer (10 mM) for sample dilution; pH 7.2 ± 0.2; colored yellow; ready to use; white cap. ≤0.0015% (v/v) CMIT/MIT (3:1)
3. Stop Solution: 1 bottle containing 15 ml sulphuric acid, 0.2 mol/L; ready to use; red cap.
4. Washing Buffer (20x conc.): 1 bottle containing 50 ml of a 20-fold concentrated phosphate buffer (0.2 M), pH 7.2 ± 0.2, for washing the wells; white cap.
5. Rubella Virus anti-IgG Conjugate: 1 bottle containing 20 ml of peroxidase labelled antibody to human IgG in phosphate buffer (10 mM); colored blue; ready to use; black cap.
6. TMB Substrate Solution: 1 bottle containing 15 ml 3,3',5,5'-tetramethylbenzidine (TMB), < 0.1%; ready to use; yellow cap.
7. Rubella Virus IgG Standards: 4 vials, each containing 2 ml standard; colored yellow; ready to use. ≤0.02% (v/v) MIT.
Standard A: 0 IU/ml; blue cap
Standard B: 10 IU/ml; green cap
Standard C: 50 IU/ml; yellow cap
Standard D: 100 IU/ml; red cap.
The standards are calibrated in accordance with the WHO International Standard; Anti Rubella Immunoglobulin Human. NIBSC code: RUBI-1-94
8. Cover foil: 1.
9. Instruction for use (IFU): 1.
10. Plate layout: 1.
For potential hazardous substances please check the safety data sheet.

Storage

Store the kit at 2 - 8°C. The opened reagents are stable up to the expiry date stated on the label when stored at 2 - 8°C.

Precision

Detection Range

0.45 IU/ml - 100 IU/ml

Sensitivity

Analytical Sensitivity
The analytical sensitivity (according to CLSI EP17-A) is defined as the apparent concentration of the analyte that can be distinguished from the zero calibrator. It is 0.45 IU/ml.