TBEV IgM ELISA Kit (Tick-Borne Encephalitis Virus)

Full Name: TBEV IgM ELISA Kit (Tick-Borne Encephalitis Virus)
Reactivity: Human
Sample Type: Plasma, Serum
Sensitivity: 1.37 U/ml

BACKGROUND

Tick-borne encephalitis virus (TBEV) is a pathogen which can be inactivated by ether or sodium desoxycholate and it is a single stranded RNA. It belongs the genus Flavivirus, other family member are Alkhurma virus, Kyasanur forest disease virus, Louping ill virus and Omsk hemorrhagic fever virus. The standard incubation period for a TBE infection can be between 7-14 days and it is found most frequently in rural areas during the summer months.

The virus is able to replicate within the cytoplasma of the cells which it infects. The diagnosis of a fresh infection is usually carried out in the laboratory by analysing the levels of specific IgM antibodies, the measurement of IgG levels can be useful to follow the course of the infection or to measure the immune status after active vaccination protection.

INTENDED USE

Human TBEV IgM ELISA kit can be used for determining in-vitro levels of human IgM antibodies against Tick-borne encephalitis virus (TBEV-IgM)(FSME) virus in serum or plasma. This assay has a minimum analytical sensitivity limit of 1.37 U/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.

• TBEV Antigen Coated Microtiter Strips
• Calibrator A (Negative Control).
• Calibrator B (Cut-Off Standard).
• Calibrator C (Weak Positive Control).
• Calibrator D (Positive Control).
• Sample Diluent.
• Enzyme Conjugate.
• TMB Substrate Solution.
• Washing Buffer (10x Conc.).
• Stop Solution.

SENSITIVITY

The minimum detection sensitivity level of human IgM antibodies to Tick-borne encephalitis virus (TBEV-IgM) using current TBEV IgM ELISA kit was 1.37 U/ml. The dynamic range for this assay is 10.0 – 1,000.0 U/ml.

ASSAY CHARACTERISTICS

– Intra-Assay-Precision: 8.1 %
– Inter-Assay-Precision: 9.5 %
– Inter-Lot-Precision: 2.0 – 9.8 %
– Analytical Sensitivity: 1.37 U/mL
– Recovery: 98 – 102 %
– Linearity: 105 – 136 %
– Cross-Reactivity: No cross-reactivity to Borrelia and Measles.
– Interferences: No interferences to bilirubin up to 0.3 mg/mL, triglycerides up to 5.0 mg/mL and hemoglobin up to 8.0 mg/mL.
– Clinical Specificity: 98 %
– Clinical Sensitivity: 100 %

REFERENCES

1. Serological diagnosis of acute tick-borne encephalitis by demonstration of antibodies of the IgM class. J Med Virol. (1981) 7 (1): 41-50. Roggendorf M., et al.
2. Test based on subtype-specific μ-capture IgM immunoassay can distinguish between infections of European and Siberian subtypes of tick-borne encephalitis virus. J Clin Virol. (2015) 73: 81-83. Levanov L., et al.
3. Vaccine failures after active immunisation against tick-borne encephalitis. Vaccine. (2010) 28 (16): 2827-31. Andersson C.R., et al.
4. Tick-borne viruses: a review from the perspective of therapeutic approaches. Ticks Tick Borne Dis. (2014) 5 (5): 457-65. Review. Lani R., et al.

OTHER RELATED ELISA KITS

• TBEV IgG ELISA Kit
• RSV IgM ELISA Kit
• Parvovirus B19-IgM ELISA Kit