Zika Virus IgM ELISA Kit

Sample

Serum

Species Reactivity

Human

Detection Method

iELISA

Intended Use

The ELISA test kit provides a semiquantitative in vitro assay for human antibodies of the immunoglobulin class IgM against Zika virus in serum for the diagnosis of Zika virus.

Contents of Kit

1. Microplate wells coated with antigens 12 microplate strips each containing 8 individual break-off wells in a frame, ready for use --- 12 x 8.
2. Calibrator (IgM, human), ready for use dark red 1 x 2.0 ml.
3. Positive control (IgM, human), ready for use blue 1 x 2.0 ml.
4. Negative control (IgM, human), ready for use green 1 x 2.0 ml.
5. Enzyme conjugate peroxidase-labelled anti-human IgM (goat), ready for use red 1 x 12 ml.
6. Sample buffer buffer containing IgG/RF-Absorbent (Anti-human IgG antibody preparation obtained from goat), ready for use green 1 x 100 ml.
7. Wash buffer 10x concentrate colourless 1 x 100 ml.
8. Chromogen/substrate solution TMB/H2O2, ready for use colourless 1 x 12 ml.
9. Stop solution 0.5 M sulphuric acid, ready for use colourless 1 x 12 ml.
10. Protective foil --- 2 pieces.
11. Test instruction --- 1 booklet.

Storage

The test kit has to be stored at a temperature between +2°C to +8°C. Do not freeze. Unopened, all test kit components are stable until the indicated expiry date.
Note: All reagents must be brought to room temperature (+18°C to +25°C) approx. 30 minutes before use. After first use, the reagents are stable until the indicated expiry date if stored at +2°C to +8°C and protected from contamination, unless stated otherwise below. The thermostat adjusted ELISA incubator must be set at +37°C ± 1°C.

1. Coated wells: Ready for use. Tear open the resealable protective wrapping of the microplate at the recesses above the grip seam. Do not open until the microplate has reached room temperature to prevent the individual strips from moistening. Immediately replace the remaining wells of a partly used microplate in the protective wrapping and tightly seal with the integrated grip seam (Do not remove the desiccant bag).
Once the protective wrapping has been opened for the first time, the wells coated with antigens can be stored in a dry place and at a temperature between +2°C and +8°C for 4 months.
2. Calibrator and controls: Ready for use. The reagent must be mixed thoroughly before use.
3. Enzyme conjugate: Ready for use. The enzyme conjugate must be mixed thoroughly before use.
4. Sample buffer: Ready for use. The green coloured sample buffer contains IgG/RF absorbent. Serum samples diluted with this sample buffer are only to be used for the determination of IgM antibodies.
5. Wash buffer: The wash buffer is a 10x concentrate. If crystallisation occurs in the concentrated buffer, warm it to +37°C and mix well before diluting. The quantity required should be removed from the bottle using a clean pipette and diluted with deionised or distilled water (1 part reagent plus 9 parts distilled water).
For example: For 1 microplate strip, 5 ml concentrate plus 45 ml water.
The working strength wash buffer is stable for 4 weeks when stored at +2°C to +8°C and handled properly.
6. Chromogen/substrate solution: Ready for use. Close the bottle immediately after use, as the contents are sensitive to light. The chromogen/substrate solution must be clear on use. Do not use the solution if it is blue coloured.
7. Stop solution: Ready for use.

Detection Limit

The lower detection limit is defined as the mean value of an analyte-free sample plus three times the standard deviation and is the smallest detectable antibody titer. The lower detection limit of the Anti-Zika Virus ELISA (IgM) is ratio 0.016.

General Description

Due to the use of virus-specific NS1 antigen, cross reactions can be virtually excluded. Thus, Zika virus infections can be discriminated from infections with other viruses such as dengue and chikungunya, which cause similar symptoms and are endemic in the same regions. The detection of virus-specific IgM antibodies or a significant increase in the IgG titer in a follow-up sample indicates an acute infection. Further, the determination of specific antibodies is relevant for epidemiological studies and for clarification of possible links between Zika virus infection and other diseases.

General Notes

Infectious Disease ELISA Kits