TBE virus (FSME) IgM ELISA Kit

Sample

Serum or plasma (citrate, heparin)

Species Reactivity

Human

Detection Method

iELISA

Intended Use

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

Contents of Kit

1. Microtiterplate (MTP): 12 break-apart 8-well snap-off strips coated with TBE/FSME Virus antigens; in resealable aluminium foil.
2. Enzyme Conjugate(ENZCONJ): 1 bottle containing 20 mL of peroxidase labelled antibody to human IgM in phosphate buffer (10 mM); coloured red; ready to use; black cap.
3. Positive Control(CONTROL +): 1 vial containing 2 mL control (human serum or plasma); coloured yellow; ready to use; red cap.
4. Negative Control(CONTROL -): 1 vial containing 2 mL control (human serum or plasma); coloured yellow; ready to use; blue cap.
5. Cut-off Control(CONTROL CO): 1 vial containing 3 mL control (human serum or plasma); coloured yellow; ready to use; green cap.
6. Sample Diluent(SAMPLEDIL): 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.
7. TMB Substrate Solution(TMB SUBS): 1 bottle containing 15 mL 3,3',5,5'-tetramethylbenzidine (TMB), < 0.1 %; ready to use; yellow cap; < 5% NMP.
8. Washing Solution (20× conc.)(WASHBUF 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.
9. Stop Solution(TMB STOP): 1 bottle containing 15 mL sulphuric acid, 0.2 mol/L; ready to use; red cap.
10. 1 Cover foil
11. 1 Instruction for use (IFU)
For potential hazardous substances please check the safety data sheet.

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.

Precision

General Description

Tick-borne encephalitis (TBE) virus is a flavivirus of the family Togaviridae. It is an enveloped single-stranded RNA virus with cubic icosahedral symmetry and ranges in size from 20-80nm in diameter. Three subtypes can be distinguished which show only little differences in their structural proteins. TBE virus is mainly transmitted by ticks. The degree of contamination of ticks (and thus humans) in central Europe increases from west to east, and anybody may be affected. Specific antibody development yields a life-long immunity. TBE is the most important tick-transmitted disease of man -beside Lyme disease, which is caused by the spirochete Borrelia burgdorferi. The clinical course of the disease depends on the immune status of the infected persons. A high virus production in the primary infected tissues is required for the passage of the blood-brain barrier and the resulting severe manifestations in the central nervous system.

The presence of virus resp. infection may be identified by:
Serology: e.g. ELISA, Neutralization, Hemagglutination Inhibition, Complement Fixation