Product Information

recomWell Parvovirus B19 IgG   CB52/4404

recomWell Parvovirus B19 IgM   CB52/4405

 

RecomWell

Quantitative in vitro Test for the sensitive and safe identification of pathogen specific antibodies. The recomWell is a screening test according to the principle of an indirect sandwich ELISA. Major advantages of the recomWell tests are the exceptional high specificity together with maximum sensitivity. Easy and standardized manual as well as automatic performance guarantees a high throughput of samples and reproducible test results

 

Enzyme immunoassay with recombinant antigens 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.

 

1. Test principle 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

 

2. Product Advantages

• Recombinant antigens, therefore
  • Highest sensitivity and specificity
  • No cross reactions
  • Excellent discriminination 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
• Break-a-parts: single sample 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

 

3. Evaluation

RecomWell Parvovirus B19	IgG Positive	IgM Positive	Interpretation with RecomBlot Parvovirus B19 IgM
Sera (n=100)	81/100	1/100	35U/ml Negative (background)
Inactivated plasma (n=100)	81/100	1/100	40U/ml Positive
Plasma (n=100)	82/100	2/100	29U/ml Equivocal 27U/ml Negative (weak VP-N)

 

 

 

4. Storage and Shelf Life

At 4 °C nine months from the date of production

 

5. Commercial Product

Article No. 4404: recomWell Parvovirus B19 IgG

Reagents for 96 determinations - (Mikrotiter plates: 12 x 8 wells)

Article No. 4405: recomWell Parvovirus B19 IgM

Reagents for 96 determinations - (Mikrotiter plates: 12 x 8 wells)