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HAV Rapid Test Kits

HAV rapid test kits and ELISA kits are intended to be used to detect HAV specific IgG & IgM antibodies in human serum specimen.

HAV IGM DOT Assay kit

HAV Rapid Test Kits

The HAV rapid test kits that Atlas Link Technology Co., Ltd is supplies include one-step HAV IgG & IgM Rapid test kits, HAV IgG & IgM dot assay kits; they are all rapid test kits that used to detect IgG or IgM antibodies in human serum or plasma, and are used as a convenient aid in the diagnosis of HAV infections. All these HAV rapid test kits are easy to perform and there is no need of other reagents or instrument; because of this convenience, these test kits are suitable to be used on the point of care (POCT).

HAV ELISA Kits

HAV IgM ELISA and HAV IgG ELISA are used to detect IgM and IgG antibodies to hepatitis A infection in human serum specimen, and can be used in mass blood screening settings, such as hospital laboratories.

Clinical Value of HAV IgG & IgM Testing

Detection of HAV IgG in the absence of HAV IgM, indicates either a previous infection with HAV or a successful vaccination. A titer of 10 IU/L HAV IGG is considered to be the minimal concentration of a valid immunization. While HAV IgM positive and HAV IgG negative may indicate a new infection.

Hepatitis A Disease

Hepatitis A is a strong infectious disease caused by hepatitis-A virus, it usually spreads from the mouth or the feces of an infected patient, and usually with strong infection characteristic. Hepatitis. Following a 14-40 day incubation period, HAV infection most commonly manifests itself by jaundice due to acute inflammation of the liver and subsequent elevated blood bilirubin concentrations.

Hepatitis A Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
HAV 260 HAV IgG/IGM Rapid Test Card serum/WB/plasma 25 Bulk: 1600 PCS
Boxed: 40 Boxes
HAV 261 HAV IGM Rapid Test Cassette serum/plasma 25 Bulk: 1600 PCS
Boxed: 40 Boxes
HAV 2612 HAV IgM Dot Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
HAV 2622 HAV IgG Dot Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
HAV 2614 HAV IGM ELISA Kit serum/plasma 96 Boxed: 40 Kits
HAV 2624 HAV IGG ELISA Kit serum/plasma 96 Boxed: 40 Kits
How to Use

HAV IgG/IGM Rapid Test Card

General Information

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

Catalog No.:HAV 260
Description:HAV IgG/IGM Rapid Test Card
Category:Hepatitis Disease
Style:Card
Unit:PCS
Specimen:serum/WB/plasma
No. of Step:One Step
Reading Time:10 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

HAV IGM Rapid Test Cassette

General Information

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

Catalog No.:HAV 261
Description:HAV 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:
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

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

HAV IgM Dot Assay

General Information

(IVD Kit »-» Hepatitis Disease -» Dot Immuno Gold Filtration Assay)

Catalog No.:HAV 2612
Description:HAV IgM Dot Assay
Category:Hepatitis Disease
Style:DOT Card
Unit:PCS
Specimen:serum
No. of Step:Two Step
Reading Time:3 Minutes
Cut Off:
Specification:25T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:DGFIA Capture

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:36 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1200 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • Filtration assay device;
  • Washing buffer Gold colloidal Conjugate solution;
  • Disposable dropper for sample transfer;
  • Instruction for use.

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.

serum Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 5 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 DGFIA Capture

DGFIA Capture Method Illustration

For the detection of IgM-class antibodies, capture technique has its advantage in that it can reduce the interference from the IgG class, thus increase the specificity of the test kit.

In a capture dot filtration test kit, antibodies directed to human IgM antibody (anti-i chain) are pre-coated in the test region on the millipore filtering membrane. When specimen is added, the IgM, if present, will be captured by this secondary antibody, anti-IgM.

After washing away the specimen, especially the IgG antibody, the antigen conjugated with colloidal gold particle will be added. If the IgM antibody was captured in the prior step, the IgM will bind to the antigen conjugate. When the colloidal gold particles congregate, a red or pink color will develop, indicating a positive result.

If no IgM in the specimen, this complex will not develop, the antigen conjugated colloidal gold particles will not congregate, and no color will develop in the test region, indicating a negative result.

Information | Packing | Specimen | Principle

HAV IgG Dot Assay

General Information

(IVD Kit »-» Hepatitis Disease -» Dot Immuno Gold Filtration Assay)

Catalog No.:HAV 2622
Description:HAV IgG Dot Assay
Category:Hepatitis Disease
Style:DOT Card
Unit:PCS
Specimen:serum
No. of Step:Two Step
Reading Time:3 Minutes
Cut Off:
Specification:25T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:DGFIA indirect

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:36 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1200 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • Filtration assay device;
  • Washing buffer Gold colloidal Conjugate solution;
  • Disposable dropper for sample transfer;
  • Instruction for use.

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.

serum Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 5 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 DGFIA indirect

DGFIA Indirect Method Illustration

With indirect Dot filtration test kit, the millipore filtering membrane is pre-coated with purified or recombinant viral antigens. The detecting conjugate reagent is stored in a vial, whose main component is rabbit anti human IgG (anti-IgG) antibodies, which is conjugated with colloidal gold particles.

During the first step, sample is added to the sample well in the test cassette. The target IgG antibodies, if present, will be captured by the pre-coated antigens.

The wells are washed to remove unbound serum proteins. Then, the colloidal gold conjugate is added. If the target IgG antibodies have been captured in the first step, the IgG antibody will react with the added secondary antibody, anti-IgG conjugate, and red color will develop, indicating a positive result.

Information | Packing | Specimen | Principle

HAV IGM ELISA Kit

General Information

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

Catalog No.:HAV 2614
Description:HAV IGM ELISA Kit
Category:Hepatitis Disease
Style:Microwell
Unit:Box
Specimen:serum/plasma
No. of Step:Two Step
Reading Time:20-40-15 Minutes
Cut Off:
Specification:48T/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

HAV IGG ELISA Kit

General Information

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

Catalog No.:HAV 2624
Description:HAV IGG ELISA Kit
Category:Hepatitis Disease
Style:Microwell
Unit:Box
Specimen:serum/plasma
No. of Step:One Step
Reading Time:60-15 Minutes
Cut Off:
Specification:48T/96T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:Competitive Binding 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 Competitive Binding ELISA

ELISA Competitive Method Illustration

ELISA kit based on competitive principle is one-step test kit, in which a fixed amount of purified viral specific antigens is pre-coated in the microwell strips.

During the testing process, the sample and monoclonal antibodies conjugated to horseradish peroxidase (HRP) is added to the microwells together. During incubation, the target antibodies, if present in the sample, compete with the HRP conjugated antibodies to bind to the pre-coated antigens. When no target antibodies present in the sample, the HRP labeled antibodies will bind with the antigens inside the wells and any unbound HRP-Conjugate is removed during washing.

Chromogen A and B solutions are added into the wells and during the second 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 NEGATIVE result.

No or low color developing suggests the presence of the target antibodies in the sample. So the color developed on the microwell strips is negatively related to the concentration of the target antibodies.

Information | Packing | Specimen | Principle