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Enterovirus 71 IgM Test Kits

EV71 IgM Dot Assay and Dot-ELISA kits can used in the field as Point-of-Care Test (POCT) device; EV71 IgM ELISA kit is suitable to screen large quantity of blood specimens.

Enterovirus 71 Test kit

EV71 Test Kits

EV-71 IgM DOT ELISA, EV-71 IgM ELISA and EV-71 IgM Dot Filtration Test Kits are a series of immunoassay test kits used for the qualitative detection of the IgM class antibodies to human enterovirus-71 (EV71) in serum or plasma samples, and are used in clinical laboratories for early diagnosis and management of patients infected with EV71, a.k.a. the 'hand-foot-mouth disease (HFMD)'.

The EV71 Dot Assay and Dot-ELISA kits are easy to perform, and no other reagent or equipment is needed, so they can used in the field as Point-of-Care Test (POCT) device; while EV71 IgM ELISA kit is suitable to screen large quantity of blood specimens, especially when the HFMD is epidemic in a region.

Reagents Used

Second antibodies specific to human immunoglobulin M proteins (anti-μ chain) are pre-coated on the micro-well or nitrocellulose membrane as capturer; monoclonal anti-EV71 antibodies conjugated to the enzyme horseradish peroxidase (HRP-conjugate) or to colloidal gold as the color development indicator. If the tested target, EV71 IgM antibody present in the specimen, after the assay procedure, the second antibody-IgM antibody-antigen-HRP-conjugate (or colloidal gold) will accumulate in the test region. And color will be observed direct in the rapid test kit, or after certain color development procedure in the Dot-ELISA and ELISA method.

Enterovirus 71 and HFMD

Human Enterovirus 71 is one of the major causative agents for 'hand-foot-mouth disease (HFMD)', and is notable for its aetiological role in the epidemics of severe neurological diseases in children. The illness usually peaks in June or July. EV71 infection may be asymptomatic or may cause diarrhea and rashes.

Direct detection of virus is the mainstay of diagnosis of EV71 infection. EV 71 can be isolated from throat and stool specimens, as well as from skin vesicle fluid. Our EV71 specific serological assays can help in the diagnosis of the HFMD disease.

EnteroVirus-71 Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
EV71 911 EV-71 IgM Rapid Cassette serum/WB/plasma 25 Bulk: 1600 PCS
Boxed: 40 Boxes
EV71 9113 EV-71 IgM Dot ELISA serum/plasma 48 Bulk: 42 PCS
Boxed: 42 Boxes
EV71 9114 EV-71 IgM ELISA Kit serum/plasma 96 Boxed: 40 Kits
How to Use

EV-71 IgM Rapid Cassette

General Information

(IVD Kit »-» Digestive Track Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:EV71 911
Description:EV-71 IgM Rapid Cassette
Category:Digestive Track Disease
Style:Card
Unit:PCS
Specimen:serum/WB/plasma
No. of Step:One Step
Reading Time:30 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:Lateral Flow Capture

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:40 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1600 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.0 KG
GW per CTN (Bulk):16.5 KG

Materials Provided in the Test Kit

  • Test cassette in single foil pouch with desiccant;
  • Disposable sample dropper;
  • Instruction leaflet.

Specimen

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.

Whole Blood Collection

Whole blood can be collected with blood collection tube with venipuncture into blood collection tube (containing EDTA, citrate or heparin).

Or, by lancet lancing. Clean the area to be lanced with an alcohol swab. Squeeze the end of the fingertip and pierce with a sterile lancet. Wipe away the first drop of blood with sterile gauze or cotton. Take a dropper provided, while gently squeezing the dropper tube, immerse the open end in the blood drop and then gently release the pressure to draw blood into the dropper.

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/WB/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.

Testing Principle of Lateral Flow Capture

GICA Capture Method Illustration

For the detection of IgM-class antibodies, in order to avoid the interference from the IgG class, capture assays technology is usually the best choice.

In capture lateral flow test kit, a secondary antibody, usually antibody directed to human IgM (anti-human IgM), is immobilized in the test band region on the strip membrane. And monoclonal viral antigen or protein conjugated with colloidal gold particle is embedded in the end of membrane strip.

During the testing process, the sample is added to the end of the membrane strip, the embedded antigen conjugate will resolve into the sample, where the target IgM antibody, if present, will react with and bound to the antigen conjugated with colloidal gold particles.

When the IgM-antigen complex moves to the test band region under the capillary effect, the IgM antibody will be captured by the immobilized anti-human IgM antibody. When the colloidal gold particles congregate in the test band region, a red or pink color will develop, indicating a positive result.

If there is no IgM antibody in the specimen, the antigen conjugated with colloidal gold particle can’t be captured by the anti-human IgM secondary antibody, and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

EV-71 IgM Dot ELISA

General Information

(IVD Kit »-» Digestive Track Disease -» Dot Enzyme Linked Immunoadsorbent Assay)

Catalog No.:EV71 9113
Description:EV-71 IgM 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:
Method:Dot ELISA Capture

Packing Specification

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

Materials Provided in the Test Kit

  • 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: 1 copy.

Specimen

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.

Testing Principle of Dot ELISA Capture

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.

Information | Packing | Specimen | Principle

EV-71 IgM ELISA Kit

General Information

(IVD Kit »-» Digestive Track Disease -» Enzyme Linked ImmunoadSorbent Assay)

Catalog No.:EV71 9114
Description:EV-71 IgM ELISA Kit
Category:Digestive Track Disease
Style:Microwell
Unit:Box
Specimen:serum/plasma
No. of Step:Two Step
Reading Time:30-30-15 Minutes
Cut Off:
Specification:96T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:Capture ELISA

Packing Specification

Tests per Kit:96 Tests
Box Dimension:13.5 * 9.0 * 8.0 CM
Kits per CTN:40 Kits
Carton Dimension:59 * 45 * 38 CM
Tests per CTN (BULK):40 Tests
Carton Volume:0.100 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • MICROWELL PLATE: 1 plate;
  • NEGATIVE CONTROL: 1 vial;
  • POSITIVE CONTROL SERUM: 1 vial;
  • SPECIMEN DILUENT: 1 vial;
  • HRP-CONJUGATE REAGENT: 1 vial;
  • WASH BUFFER: 1 bottle;
  • CHROMOGEN SOLUTION A: 1 vial;
  • CHROMOGEN SOLUTION B: 1 vial;
  • STOP SOLUTION: 1 vial;
  • PLASTIC SEALABLE BAG: 1 piece;
  • CARDBOARD PLATE COVER;
  • PACKAGE INSERTS: 1 copy.

Specimen

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.

Testing Principle of Capture ELISA

ELISA Capture Method Illustration

For the detection of IgM-class antibodies, in order to avoid the interference from the IgG class, a solid phase, two-step incubation, antibody capture assays is usually used.

In capture ELISA kit, polystyrene microwell strips are pre-coated with antibodies directed to human IgM (anti-i chain). The patient’s serum/plasma sample is added, and during the first incubation, any IgM antibodies will be captured in the wells, and IgG antibodies on the other hand will not.

After washing out all other components of the sample and in particular IgG antibodies, the target IgM antibodies captured on the solid phase are detected by the addition of viral antigens conjugated to horseradish peroxidase (HRP). During the second incubation, the conjugated antigens will specifically react with the viral specific IgM antibodies.

After washing to remove unbound conjugates, Chromogen solutions are added to the wells. During the third incubation, the colorless chromogens are hydrolyzed by the bound HRP conjugate to a blue colored product. The blue color turns yellow after stopping the reaction with sulfuric acid, indicating a positive result; the amount of color can be measured and is proportional to the amount of antibody in the sample.

Wells containing samples negative for the target IgM antibodies remain colorless, indicating negative result.

Information | Packing | Specimen | Principle