Mumps virus (Parotitis) IgM ELISA

Sample

Serum or plasma (citrate, heparin)

Species Reactivity

Human

Detection Method

iELISA

Intended Use

The Mumps virus (Parotitis) IgM ELISA is intended for the qualitative determination of IgM class antibodies against Mumps Virus in human serum or plasma (citrate, heparin).

Contents of Kit

Microtiter Plate: 12 break-apart 8-well snap-off strips coated with Mumps Virus antigens; in resealable aluminium foil.
Conjugate: 1 bottle containing 20 mL of peroxidase labelled antibody to human IgM in phosphate buffer (10 mM); coloured red; ready to use; black cap.
Positive Control: 1 vial containing 2 mL control; coloured yellow; ready to use; red cap; ≤ 0.02% (v/v) MIT.
Negative Control: 1 vial containing 2 mL control; coloured yellow; ready to use; blue cap; ≤ 0.0015% (v/v) CMIT/ MIT (3:1).
Cut-off Control: 1 vial containing 3 mL control; coloured yellow; ready to use; green cap; ≤ 0.02% (v/v) MIT.
Sample Diluent: 1 bottle containing 100 mL of phosphate buffer (10 mM) for sample dilution; pH 7.2 ± 0.2; anti-human IgG (RF Absorbent); coloured green; ready to use; white cap; ≤ 0.0015% (v/v) CMIT/ MIT (3:1).
TMB Substrate Solution: 1 bottle containing 15 mL 3,3',5,5'-tetramethylbenzidine (TMB), < 0.1 %; ready to use; yellow cap.
Washing Solution (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.
Stop Solution: 1 bottle containing 15 mL sulphuric acid, 0.2 mol/L; ready to use; red cap.

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.

Performance Characteristics

The diagnostic specificity is defined as the probability of the assay of scoring negative in the absence of the specific analyte. It is 97.68% (95% confidence interval: 95.03% - 99.15%).
The diagnostic sensitivity is defined as the probability of the assay of scoring positive in the presence of the specific analyte. It is 94.44% (95% confidence interval: 72.71% - 99.86%).

Precision

The results refer to the groups of samples investigated; these are not guaranteed specifications.

General Description

Mumps viruses are RNA viruses of the family Paramyxoviridae. The virions are spherical particles of 150-250 nm in diameter consisting of a ribonucleoprotein with helical symmetry and enveloped by matrix protein and a lipid bilayer which contains two spikeline structures: viral hemagglutinin (H) and viral neuraminidase (N). Mumps virus involves primarily the parotid and related salivary glands; however infection can lead to CNS disease and accumulation of the virus in CSF. Mumps (Epidemic Parotitis) is an acute contagious viral disease mostly occuring in children. Nearly 50% of all infections are subclinical. The highest incidence of clinical manifestations is found in the age group of 4 to 15 years. Secondary infections are rare because of longlasting immunity. 10 to 35 % of mumps cases develop orchitis which occurs nearly always after puberty. The process is mostly unilateral and the prognosis usually good. Mumps virus has been one of the most important causes of viral CNS disease (meningitis and encephalitis) in USA; vaccine administration has greatly reduced its incidence.