EV-71 IgM Antibody Dot ELISA

EV-71 IgM Antibody Dot ELISA (人肠道病毒（EV71）IGM渗滤法检测试剂盒) is a two-step qualitative rapid diagnostic test kit, based on the Capture Dot ELISA principle, which is used to detect human enteroVirus-71 IgM Antibody in human Serum or plasma specimen.

Supplementary information of EV-71 IgM Antibody Dot ELISA

  1. General and Technical information of this EV71 test kit;
  2. Packing specification of this EV71 DOT ELISA style test kit (gross weight in full kit package and in bulk packing);
  3. Specimen used to carry out the assay, and the requirements on specimen collection, storage and processing; and,
  4. Specific immuno assay principle used in this EnteroVirus-71 Test Kit.

Main technical information of this Enterovirus IgM test kit is listed in the following table:

Former Cat. No.:EV71 9113
Description:EV-71 IgM Antibody Dot ELISA
Category:Digestive Track Disease
Style:DOT ELISA
Unit:Box
Specimen:Serum, plasma
No. of Step:Two Step
Reading Time:15-2-2-2-3 Minutes
Cut Off:
Specification:6T/30T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Assay Principle:Capture Dot ELISA

The standard kit size of this EnteroVirus-71 DOT ELISA test kit is 48 tests per box; 42 boxes per carton.

To save freight cost, sometimes bulk packing is used, meaning test strip, cassette or multi-test panel is packed in single aluminum pouch; 50 or 100 pouches in one plastic bag; and then plastic bags are packed in cartons along with the unfolded boxes for the test kits. In this way, the customers can easily pack the tests into test kits after receiving the bulk packed goods.


Tests per Kit:48 Tests
Dimension of Kit Box:13.5 * 9.0 * 8.0 CM
Boxes per Carton:42 Kits
Tests per Carton (BULK):42 Tests
G.W. per Carton (Boxed):15.0 KG
G.W. per Carton (Bulk):15.0 KG
Carton Dimension:55 * 44 * 35 CM
Carton Volume:0.084 CBM

Materials Provided

  • Immuno-filtration device in pouch with desiccant, with an integrated sample flow controller;
  • HRP-conjugate: 1 dropper bottle of 2ml;
  • Sample preservation buffer: 6ml;
  • Wash Buffer: 1 dropper bottle of 6ml;
  • Chromogen Solution: 1 bottle of 1ml;
  • Stop Solution: 1 dropper bottle of 1ml;
  • Sample collection tube: 6 tubes/kit;
  • Sample Lysis Bottle: 6 pieces/kit;
  • Measuring Pipette: 6 pieces/kit;
  • Plastic sealable bag: 1pcs (store the cards not in use);
  • Instruction For Use (IFU): 1 copy.

To carry out the assay with a EV-71 IgM Antibody Dot ELISA, Serum or plasma should be collected according to the instructions given in the Instruction For Use included in the test kit. After collecting, it is preferable to perform the testing as early as possible; if not viable, the specimen should be stored properly. A general introduction about the collection, and storage of the specimens is given below.

Plasma Collection

Collect blood specimen into a lavender, blue or green top blood collection tube, containing EDTA, citrate or heparin, respectively, by vein puncture.

Separate the plasma by centrifugation.

Carefully withdraw the plasma into a new pre-labeled tube.

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

Serum, Plasma Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 3 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing. Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Capture Dot ELISA method is used in this EV-71 IgM Antibody Dot ELISA to detect the human enteroVirus-71 IgM Antibody in human Serum or plasma specifically. The introduction of this Capture Dot ELISA testing principle is given blow.

Dot ELISA Capture Method Illustration

IgM-class antibodies usually are connected with primary infections or acute infections, their diagnosis has a special meaning to the clinical diagnosis. In order to avoid false positive caused by the IgG class, capture testing method is often used to detect IgM antibodies.

In capture dot ELISA kit, millipore filtering membrane (usually nitrocellulose，NC) is pre-coated with secondary antibodies directed to human IgM (anti-μ chain) in test dot area. The patient’s serum/plasma sample is added to the membrane, which filtrates through the latter. During the minutes of filtration process, the IgM antibodies, if present, will be captured by the immobilized anti-IgM antibodies, while IgG antibodies will not.

The IgG antibodies will be washed away completely after wash buffer is added.

Then, viral antigens conjugated to horseradish peroxidase (HRP) are added, which will specifically react with the captured viral specific IgM antibodiesn and antigen conjugate will be captured.

After washing to remove unbound conjugates, Chromogen solutions are added to the membrane, then stop solution is added. When HRP present, the colorless chromogens are hydrolyzed to a blue color product at the testing dot area, indicating a positive result.