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HEV Rapid and ELISA Kits

Atlas Link Technology Co., Ltd supplies various HEV antigen and antibodies test kits, including one-step rapid test method and ELISA method.

anti-HEV Test cassette

HEV Test Kits

Atlas Link Technology Co., Ltd supplies various antigen and antibodies test kits, including one-step rapid test method and ELISA method, which are used to qualitatively detect HEV antigen, HEV IgG antibody, and HEV IgM antibody. All these HEV test kits are intended for professional use only, and used as an aid in the diagnosis of infection of hepatitis E virus.

While HEV IgM rapid test kit is used as a convenient and rapid POCT testing device, the HEV ELISA kits can be used in blood banks and laboratories, where mass blood specimens need to be tested with higher sensitivity and specificity.

Studies on HEV

With the discovery of confirmative epitopes in HEV, HEV serology was further explored and understood. The phenomenon of long-lasting and protective antibodies to HEV was observed which greatly enhance the understanding to the diagnosis, epidemiology, zoonosis-related studies, and vaccine development. The HEV immunoassay test kits supplied by Atlas Link Technology Co., Ltd embody the latest search results in the serology diagnosis of HEV infections.

Hepatitis-E Infection

Hepatitis E virus (HEV) is a non-enveloped, single-stranded RNA virus. Four genotypes of HEV have been reported. HEV is transmitted mainly by fecal contaminated water and food.

Mortality rates of HEV are generally low, and hepatitis E is 'self-limiting' because the disease usually disappears by itself after several weeks. But, it occasionally develops into acute liver disease, and in that case the fatality is about 0.3 to 2%. In pregnant women, the disease is more severe and is associated with a clinical syndrome called fulminant hepatic failure, of which the fatality rate can be as high as 25-30%.

Hepatitis E Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
HEV 291 HEV IGM Rapid Test Cassette serum/plasma 25 Bulk: 1600 PCS
Boxed: 40 Boxes
HEV 2914 HEV IgM ELISA Kit serum/plasma 96 Boxed: 40 Kits
HEV 2924 HEV IgG ELISA Kit serum/plasma 96 Boxed: 40 Kits
HEV 2934 HEV Antigen ELISA Kit serum/plasma 96 Boxed: 40 Kits
How to Use

HEV IGM Rapid Test Cassette

General Information

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

Catalog No.:HEV 291
Description:HEV IGM Rapid Test Cassette
Category:Hepatitis Disease
Style:Card
Unit:PCS
Specimen:serum/plasma
No. of Step:One Step
Reading Time:10 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:98.5%
Specificity:99%
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

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 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

HEV IgM ELISA Kit

General Information

(IVD Kit »-» Hepatitis Disease -» Enzyme Linked ImmunoadSorbent Assay)

Catalog No.:HEV 2914
Description:HEV IgM ELISA Kit
Category:Hepatitis 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

HEV IgG ELISA Kit

General Information

(IVD Kit »-» Hepatitis Disease -» Enzyme Linked ImmunoadSorbent Assay)

Catalog No.:HEV 2924
Description:HEV IgG ELISA Kit
Category:Hepatitis Disease
Style:Microwell
Unit:Box
Specimen:serum/plasma
No. of Step:Two Step
Reading Time:30-30-10 Minutes
Cut Off:
Specification:96T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:Indirect 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 Indirect ELISA

ELISA Indirect Method Illustration

With indirect ELISA kit, polystyrene microwell strips are pre-coated with purified or recombinant viral antigens.

The antibody detection is achieved in two steps. During the first incubation step, the target antibodies, if present, will be bound to the solid phase pre-coated antigens.

The wells are washed to remove unbound serum proteins, and rabbit anti-human IgG antibodies (anti-IgG) conjugated to horseradish peroxidase (HRP) are added. During the second incubation step, these HRP-conjugated antibodies will be bound to any antigen-antibody complexes previously formed.

Then the unbound HRP-conjugate is then removed by washing. Chromogen solutions containing Tetramethyl benzidine (TMB) and urea peroxide are added to the wells. In presence of the antigen-antibody-anti-IgG (HRP) immuno complex, the colorless Chromogens are hydrolyzed by the bound HRP conjugate to a blue colored product which turns blue color turns yellow after stopping the reaction with sulfuric acid, indicating a positive result.

Wells containing samples negative for the target antibodies remain colorless.

Information | Packing | Specimen | Principle

HEV Antigen ELISA Kit

General Information

(IVD Kit »-» Hepatitis Disease -» Enzyme Linked ImmunoadSorbent Assay)

Catalog No.:HEV 2934
Description:HEV Antigen ELISA Kit
Category:Hepatitis Disease
Style:Microwell
Unit:Box
Specimen:serum/plasma
No. of Step:Two Step
Reading Time:60-30-30 Minutes
Cut Off:
Specification:96T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:Double Antibody Sandwich 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 Double Antibody Sandwich ELISA

ELISA Double Antibody Sandwich Method Illustration

With this type of ELISA test kits, the detection target usually is hormone protein or viral antigen.

In the test kit, monoclonal or polyclonal antibodies specific to the target protein or antigen are used as capturer, which are pre-coated on the polystyrene microwell strips. The sample from the patient, such like urine, serum or plasma sample is added to the microwells. And a second antibody conjugated with horseradish peroxidase (HRP) is used as the detector, which then is added to the microwells. Usually, the samples and the second antibody conjugate are added to the microwell in the same time, thus it is a one-step assay process.

During incubation, the specific immuno-complex formed in case of presence of the target antigen or protein in the sample, and is captured on the solid phase.

After washing to remove sample serum proteins and unbound HRP-conjugate, Chromogen solutions containing tetramethyl benzidine (TMB) and urea peroxide are added to the wells. In presence of the antibody-antigen-antibody (HRP) "sandwich" immuno complex, the colorless Chromogens are hydrolyzed by the bounded 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 antigen or protein in the sample.

Wells containing samples negative for the target antigen or protein remain colorless.

Information | Packing | Specimen | Principle