Parvovirus B19 IgM ELISA Kit

Full Name: Parvovirus B19 IgM ELISA Kit
Reactivity: Human
Sample Type: Serum
Sensitivity: 0.63 DU/ml

BACKGROUND

Parvovirus B19 is a member of the genus Erythrovirus and family Parvoviridae, it is a small single stranded DNA virus which only infects humans. Majority of the virus is transfected via the respiratory secretions, however, some is found to go through blood transfusions, from mother to baby via the placenta and bone marrow transplants. There is zero chance of this virus to be transferred from humans to pet animals since it displays no cross reactivity whatsoever. Parvovirus B19 has been associated with a number of autoimmune diseases, immunocytopenia in immunocompromised patients, however, one of the commonest infections discovered is erythema infectiosum that is present in children.

INTENDED USE

Human parvovirus B19 IgM ELISA kit is intended for analysis of IgM class of antibodies against parvovirus B19 in serum. This assay has a minimum analytical sensitivity limit of 0.63 DU/ml.

CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

Microtiterwells (96 wells): Wells coated with recombinant Parvovirus B19 antigen (VP1-s protein).
Sample Diluent.
Negative Control (Calibrator A).
Cut-off Control (Calibrator B).
Positive Control (Calibrator C).
Enzyme Conjugate.
TMB Substrate Solution.
Stop Solution: Contains 0.2 mol/L H2SO4.
Wash Solution (20x Concentrated).

SENSITIVITY

The minimum detection sensitivity level of IgM antibodies to parvovirus B19 using current parvovirus IgM ELISA kit was 0.63 DU/ml. The dynamic range for this assay was to a specific cut-off point.

ASSAY CHARACTERSTICS

– Positive: >12 DU. [Mean OD patient > 1.2 × CO]
– Grey Zone: 9 – 12 DU. [0.90 × CO ≤ Mean OD patient ≤ 1.2 × CO]
– Negative: <9 DU. [Mean OD patient < 0.90 × CO.]
– Cut-Off: 10 DU
– Assay Dynamic Range: 0.63 – 60 DU/mL
– Specificity of Antigen (Cross Reactivity): No cross reactivity with HSV 1 and 2, Varicella zoster Virus and Epstein Barr Virus (VCA), RSV, CMV and TBE.
– Analytical Sensitivity: 0.63 DU/mL (OD450 = 0.034).
– Diagnostic Specificity: 100%
– Diagnostic Sensitivity: 100%

REFERENCES

Assessment of the specificity of a commercial human parvovirus B19 IgM assay. Clin Diagn Virol. (1997) 7 (3): 133-7. Jensen I.P. and Vestergaard B.F.
Comparative evaluation of three recombinant antigen-based enzyme immunoassays for detection of IgM and IgG antibodies to human parvovirus_B19. Clin Diagn Virol. (1998) 9 (1): 57-63. Pickering J.W., et al.
Comparison of three enzyme immunoassays used to detect human parvovirus B19-specific IgM antibodies in sera of people suspected of measles. Med Sci Monit. (2010) 16 (5): BR154-9. Siennicka J. and Trzcińska A.
Differential IgM response to conformational and linear epitopes of parvovirus B19 VP1 and VP2 structural proteins. J Med Virol. (2001) 64 (1): 67-73. Manaresi E., et al.
Evaluation of 4 commercial test kits for parvovirus B19-specific IgM. J Virol Methods. (1995) 55 (1): 11-25. Cohen B.J. and Bates C.M.

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