recomWell Parvovirus B19 IgG
recomWell Parvovirus B19 IgM
Enzyme immunoassay with antigens produced by recombinant techniques for the detection of IgG and IgM antibodies against the human Parvovirus B19
Human Parvovirus B19 occurs endemically worldwide. At intervals of several years, it causes epidemics in small areas from late fall to early summer, affecting kindergartens and schools in particular. The infection rate in children is between 15 and 30 % and in adults about 60 %.
The virus has a single stranded genome of about 5.6 kB and is packed in an icosahedral capsid, without a lipid layer, with a diameter of 22 nm. The two capsid proteins VP-1 and VP-2 are coded from the same reading frame. VP-1 is distinguished from VP-2 only by an additional N-terminal fragment. Furthermore, a nonstructural protein NS-1 is synthesized, which is required for virus replication and propagation in the cell.
Clinical spectrum of a Parvovirus B19 infection:
- Fifth disease (erythema infectiosum): It progresses in 20 % of cases without symptoms or with flu-like symptoms. Apart from the exanthema, polyarthralgia and a generalized swelling of the lymph nodes can occur occasionally.
- Aplastic crisis in patients suffering from hemolytic anemias.
- Spontaneous abortion/hydrops fetalis after infection during pregnancy.
- Persistent infection in immunosuppressed persons with chronic anemia and bone marrow depression.
Genetically engineered VP-1 antigen as well as VP-2 particles are used in the recomWell Parvovirus B19 tests. With the use of VP-2 particles the presentation of conformational epitopes in addition to the linear epitopes is achieved.
Product advantages
- Recombinant antigens, therefore
- Highest sensitivity and specificity
- No cross reactions
- Excellent discrimination between negative and positive results
- Separate detection of IgG and IgM antibodies possible
- Identical procedure for IgG and IgM determination
- Easy to quantify
- Easy test procedure; automation possible
- Test procedure and reagents identical in all MIKROGEN ELISA - reagents exchangeable
- Break-a-parts: single simple examination possible
- CE label: The recomWell Parvovirus B19 tests meet the high standard of the EC directive 98/79/EC on in vitro diagnostic medical devices.
Testprinciple and procedure
Indirect sandwich test.
Recombinant antigens are bound to the solid phase.
1st Incubation
Add patient samples diluted 1:101 (sample: 10 µl of serum or plasma), incubate for 1 h at 37 °C.
Wash 4 times
2nd Incubation
Add peroxidase conjugated anti-human IgG or IgM antibodies (conjugate), incubate for 30 min at 37 °C.
Wash 4 times
Color reaction
Add ready-to-use TMB solution and incubate for 30 min at room temperature. Stop the substrate reaction with H3PO4 and measure the extinction at 450 nm.
Evaluation
Positive Sera
(selected on the basis of the reactivity in ELISA A)
Signal strength of the recomWell Parvovirus B19 in comparison to two other, commercially available ELISAs. A series of dilutions of the Parvovirus B19 WHO standard was used as samples.
Blood donor sera
*Testing of recomWell Parvovirus B19 IgM using RF absorbent (RF absorbent: DADE-Behring)
