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HBV Rapid and ELISA Kits

Both rapid test kits and ELISA kits are available for all the five regular parameters for HBV testing: HBsAg, HBsAb, HBcAb, HBeAg, HBeAb.

HBsAg ELISA Kit

HBV Test Kits

Atlas Link Technology Co., Ltd supplies both rapid test kits and ELISA kits for all the common five parameters regularly tested in the diagnosis of Hepatitis-B infection, namely HBsAg, HBsAb, HBcAb, HBeAg, HBeAb. All HBV rapid test kits and ELISA kits are all immunoassay kits, and are widely used as an aid in the diagnostic test of hepatitis-B infection; and ELISA kits can also used in mass blood screening of blood such as in blood banks.

Hepatitis B Multi-5 test panel is also widely used, which detect all the five antigen and antibodies important to the diagnosis of Hepatitis B infection in one single test device.

Who Should Get HBV Tested

Hepatitis-B can be transmitted through various infected body fluids, such as blood, semen, and vaginal fluids. As result, HBV usually is considered sexually transmissible disease (STD). It also can be transmitted from a pregnant woman to her child at or near the time of birth. The following persons are exposed to the risk of HBV infection and is advised to take HBV test regularly: those having sex without taking protection; sharing needles to inject drugs; getting a tattoo or piercing with tools that are not disinfected properly; sharing personal items such as razor and toothbrush.

5 Ag/Ab of Hepatitis-B

  1. HBsAg is the earliest indicator of an active HBV infection. HBsAg may be present before any symptom. If its level remains high for over 6 months, the person is regarded as a HBV carrier.
  2. HBsAb usually appears about 4 weeks after HBsAg disappears, indicating the infection is at the end and the patient is not contagious. It also protects from re-infection.
  3. HBcAb is an antibody to HBcAg. It appears about 1 month after an active infection. It usually presents for life long after infection.
  4. HBeAg is an HBV protein that is only present during an active HBV infection. The test of HBeAg can show the contagiousness of the patient. HBeAg can also be used to monitor the effectiveness of the treatment measures.
  5. HBeAb positive result shows that the active stage of the HBV infection is almost over.

Hepatitis B Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
HBV 205 HBV Multi-5 Test Panel serum 20 Bulk: 1000 PCS
Boxed: 32 Boxes
HBV 211 HBsAg Serum Test Strip serum 100 Bulk: 6000 PCS
Boxed: 48 Boxes
HBV 212 HBsAg Test Cassette serum 25 Bulk: 1600 PCS
Boxed: 40 Boxes
HBV 213 HBsAg Whole Blood Strip Whole Blood 100 Bulk: 6000 PCS
Boxed: 48 Boxes
HBV 214 HBsAg WB Test Cassette serum 25 Bulk: 1600 PCS
Boxed: 40 Boxes
HBV 221 HBsAb Test Strip serum 100 Bulk: 6000 PCS
Boxed: 48 Boxes
HBV 222 HBsAb Test Cassette serum 25 Bulk: 1600 PCS
Boxed: 40 Boxes
HBV 231 HBeAb Test Strip serum 100 Bulk: 6000 PCS
Boxed: 48 Boxes
HBV 232 HBeAb Test Cassette serum 25 Bulk: 1600 PCS
Boxed: 40 Boxes
HBV 241 HBeAg Test Strip serum 100 Bulk: 6000 PCS
Boxed: 48 Boxes
HBV 242 HBeAg Test Cassette serum 25 Bulk: 1600 PCS
Boxed: 40 Boxes
HBV 251 HBcAb Test Strip serum 100 Bulk: 6000 PCS
Boxed: 48 Boxes
HBV 252 HBcAb Test Cassette serum 25 Bulk: 1600 PCS
Boxed: 40 Boxes
HBV 2114 HBsAg ELISA Kit (One Step) serum/plasma 96 Boxed: 40 Kits
HBV 2124 HBsAg ELISA Kit (Two Step) serum/plasma 96 Boxed: 40 Kits
HBV 2214 HBsAb ELISA Kit serum/plasma 96 Boxed: 40 Kits
HBV 2224 HBsAb Quantitative ELISA Kit serum/plasma 96 Boxed: 40 Kits
HBV 2314 HBeAb ELISA Kit serum/plasma 96 Boxed: 40 Kits
HBV 2414 HBeAg ELISA Kit serum/plasma 96 Boxed: 40 Kits
HBV 2514 HBcAb ELISA Kit serum/plasma 96 Boxed: 40 Kits
HBV 2524 HBc IGM ELISA Kit serum/plasma 96 Boxed: 40 Kits
HBV 2534 HBV Nucleic Acid AG ELISA serum/plasma 96 Boxed: 40 Kits
How to Use
HBV Rapid Test Kit

HBV Multi-5 Test Panel

General Information

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

Catalog No.:HBV 205
Description:HBV Multi-5 Test Panel
Category:Hepatitis Disease
Style:Panel
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10-20 Minutes
Cut Off:2 ng/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:98.4%
Specificity:98.3%
Method:Lateral Flow Double Sandwich

Packing Specification

Tests per Kit:20 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:32 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1000 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):17.5 KG

Materials Provided in the Test Kit

  • Test card in individual foil pouch;
  • Package insert;
  • Disposable urine container (Optional).

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 Lateral Flow Double Sandwich

It is a simple conbination of double antibody sandwich and double antigen sandwith, in single strips which combined in one single test panel.

Information | Packing | Specimen | Principle

HBsAg Serum Test Strip

General Information

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

Catalog No.:HBV 211
Description:HBsAg Serum Test Strip
Category:Hepatitis Disease
Style:Dipstick
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10 Minutes
Cut Off:2 ng/ml
Specification:3.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99.4%
Specificity:99.8%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:100 Tests
Box Dimension:21.0 * 12.5 * 5.5 CM
Kits per CTN:48 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):6000 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):16.0 KG

Materials Provided in the Test Kit

  • Lateral Flow immunochromatographic assay (GICA) Strip;
  • Instruction leaflet;
  • Disposable urine cup (optional).

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 Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

HBsAg Test Cassette

General Information

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

Catalog No.:HBV 212
Description:HBsAg Test Cassette
Category:Hepatitis Disease
Style:Card
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10 Minutes
Cut Off:2 ng/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99.4%
Specificity:99.8%
Method:Lateral Flow Double Antibody Sandwich

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.

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 Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

HBsAg Whole Blood Strip

General Information

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

Catalog No.:HBV 213
Description:HBsAg Whole Blood Strip
Category:Hepatitis Disease
Style:Dipstick
Unit:PCS
Specimen:Whole Blood
No. of Step:One Step
Reading Time:20-30 Minutes
Cut Off:2 ng/ml
Specification:3.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99.4%
Specificity:99.8%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:100 Tests
Box Dimension:21.0 * 12.5 * 5.5 CM
Kits per CTN:48 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):6000 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):16.0 KG

Materials Provided in the Test Kit

  • Lateral Flow immunochromatographic assay (GICA) Strip;
  • Instruction leaflet;
  • Disposable urine cup (optional).

Specimen

Blood Collection with Venipuncture

Collect the whole blood into the collection tube (containing EDTA, citrate or heparin) by venipuncture.

Blood Collection with Lancet

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.

Whole Blood Storage Condition

It is preferable to test the specimen immediately after blood collection.

If specimens can’t be tested immediately but can be tested within three days, they should be refrigerated at 2 ~ 8°C. For storage periods longer than three days, freezing is recommended.

Before testing, they should be brought to room temperature prior to use.

Storing the specimen for more than three days may lead to non-specific reaction, thus affect the specificity of the testing results.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

HBsAg WB Test Cassette

General Information

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

Catalog No.:HBV 214
Description:HBsAg WB Test Cassette
Category:Hepatitis Disease
Style:Card
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:20-30 Minutes
Cut Off:2 ng/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99.2%
Specificity:99.5%
Method:Lateral Flow Double Antibody Sandwich

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.

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 Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

HBsAb Test Strip

General Information

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

Catalog No.:HBV 221
Description:HBsAb Test Strip
Category:Hepatitis Disease
Style:Dipstick
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10 Minutes
Cut Off:30 mIU/mL
Specification:3.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99.1%
Specificity:94.3%
Method:Lateral Flow Double Antigen Sandwich

Packing Specification

Tests per Kit:100 Tests
Box Dimension:21.0 * 12.5 * 5.5 CM
Kits per CTN:48 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):6000 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):16.0 KG

Materials Provided in the Test Kit

  • Lateral Flow immunochromatographic assay (GICA) Strip;
  • Instruction leaflet;
  • Disposable urine cup (optional).

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 Lateral Flow Double Antigen Sandwich

GICA Double Antigen Sandwich Method Illustration

Double antigen sandwich technology is commonly used to detect total antibody, which include IgM, IgG and IgA antibodies, which all can react and bound to specific antigen. In the lateral flow double antigen sandwich chromatographic rapid test, recombinant or purified antigens are used to capture and detect the total antibodies specifically.

In the test band region, purified or recombinant antigens or proteins are immobilized. In the end of the membrane strip where the samples are supposed to be added, another antigen conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antigen conjugate particles resolve into the specimen, where the antigen conjugate will react and bound to the target antibodies, if present.

This antibody-antigen conjugate complex then moves along the strip to the testing band region, under capillary effect. Where the immobilized antigen captures the complex, and the antigen-antibody-antigen-colloidal gold complex is fixed on test band region. When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target antibody in the specimen, the colloidal gold particles will not congregate on the test band region, and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

HBsAb Test Cassette

General Information

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

Catalog No.:HBV 222
Description:HBsAb Test Cassette
Category:Hepatitis Disease
Style:Card
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10 Minutes
Cut Off:30 mIU/mL
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99.1%
Specificity:94.3%
Method:Lateral Flow Double Antigen Sandwich

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.

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 Lateral Flow Double Antigen Sandwich

GICA Double Antigen Sandwich Method Illustration

Double antigen sandwich technology is commonly used to detect total antibody, which include IgM, IgG and IgA antibodies, which all can react and bound to specific antigen. In the lateral flow double antigen sandwich chromatographic rapid test, recombinant or purified antigens are used to capture and detect the total antibodies specifically.

In the test band region, purified or recombinant antigens or proteins are immobilized. In the end of the membrane strip where the samples are supposed to be added, another antigen conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antigen conjugate particles resolve into the specimen, where the antigen conjugate will react and bound to the target antibodies, if present.

This antibody-antigen conjugate complex then moves along the strip to the testing band region, under capillary effect. Where the immobilized antigen captures the complex, and the antigen-antibody-antigen-colloidal gold complex is fixed on test band region. When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target antibody in the specimen, the colloidal gold particles will not congregate on the test band region, and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

HBeAb Test Strip

General Information

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

Catalog No.:HBV 231
Description:HBeAb Test Strip
Category:Hepatitis Disease
Style:Dipstick
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10-20 Minutes
Cut Off:2 ng/ml
Specification:3.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99%
Specificity:98.6%
Method:Lateral Flow Double Antigen Sandwich

Packing Specification

Tests per Kit:100 Tests
Box Dimension:21.0 * 12.5 * 5.5 CM
Kits per CTN:48 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):6000 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):16.0 KG

Materials Provided in the Test Kit

  • Lateral Flow immunochromatographic assay (GICA) Strip;
  • Instruction leaflet;
  • Disposable urine cup (optional).

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 Lateral Flow Double Antigen Sandwich

GICA Double Antigen Sandwich Method Illustration

Double antigen sandwich technology is commonly used to detect total antibody, which include IgM, IgG and IgA antibodies, which all can react and bound to specific antigen. In the lateral flow double antigen sandwich chromatographic rapid test, recombinant or purified antigens are used to capture and detect the total antibodies specifically.

In the test band region, purified or recombinant antigens or proteins are immobilized. In the end of the membrane strip where the samples are supposed to be added, another antigen conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antigen conjugate particles resolve into the specimen, where the antigen conjugate will react and bound to the target antibodies, if present.

This antibody-antigen conjugate complex then moves along the strip to the testing band region, under capillary effect. Where the immobilized antigen captures the complex, and the antigen-antibody-antigen-colloidal gold complex is fixed on test band region. When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target antibody in the specimen, the colloidal gold particles will not congregate on the test band region, and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

HBeAb Test Cassette

General Information

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

Catalog No.:HBV 232
Description:HBeAb Test Cassette
Category:Hepatitis Disease
Style:Card
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10-20 Minutes
Cut Off:2 ng/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99%
Specificity:98.6%
Method:Lateral Flow Double Antigen Sandwich

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.

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 Lateral Flow Double Antigen Sandwich

GICA Double Antigen Sandwich Method Illustration

Double antigen sandwich technology is commonly used to detect total antibody, which include IgM, IgG and IgA antibodies, which all can react and bound to specific antigen. In the lateral flow double antigen sandwich chromatographic rapid test, recombinant or purified antigens are used to capture and detect the total antibodies specifically.

In the test band region, purified or recombinant antigens or proteins are immobilized. In the end of the membrane strip where the samples are supposed to be added, another antigen conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antigen conjugate particles resolve into the specimen, where the antigen conjugate will react and bound to the target antibodies, if present.

This antibody-antigen conjugate complex then moves along the strip to the testing band region, under capillary effect. Where the immobilized antigen captures the complex, and the antigen-antibody-antigen-colloidal gold complex is fixed on test band region. When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target antibody in the specimen, the colloidal gold particles will not congregate on the test band region, and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

HBeAg Test Strip

General Information

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

Catalog No.:HBV 241
Description:HBeAg Test Strip
Category:Hepatitis Disease
Style:Dipstick
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10 Minutes
Cut Off:2 ng/ml
Specification:3.0 mm
Quan. or Qual.:Qualitative
Sensitivity:97.3%
Specificity:99.4%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:100 Tests
Box Dimension:21.0 * 12.5 * 5.5 CM
Kits per CTN:48 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):6000 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):16.0 KG

Materials Provided in the Test Kit

  • Lateral Flow immunochromatographic assay (GICA) Strip;
  • Instruction leaflet;
  • Disposable urine cup (optional).

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 Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

HBeAg Test Cassette

General Information

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

Catalog No.:HBV 242
Description:HBeAg Test Cassette
Category:Hepatitis Disease
Style:Card
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10 Minutes
Cut Off:2 ng/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:97.3%
Specificity:99.4%
Method:Lateral Flow Double Antibody Sandwich

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.

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 Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

HBcAb Test Strip

General Information

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

Catalog No.:HBV 251
Description:HBcAb Test Strip
Category:Hepatitis Disease
Style:Dipstick
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10-20 Minutes
Cut Off:2 ng/ml
Specification:3.0 mm
Quan. or Qual.:Qualitative
Sensitivity:96.1%
Specificity:98.2%
Method:Lateral Flow Double Antigen Sandwich

Packing Specification

Tests per Kit:100 Tests
Box Dimension:21.0 * 12.5 * 5.5 CM
Kits per CTN:48 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):6000 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):16.0 KG

Materials Provided in the Test Kit

  • Lateral Flow immunochromatographic assay (GICA) Strip;
  • Instruction leaflet;
  • Disposable urine cup (optional).

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 Lateral Flow Double Antigen Sandwich

GICA Double Antigen Sandwich Method Illustration

Double antigen sandwich technology is commonly used to detect total antibody, which include IgM, IgG and IgA antibodies, which all can react and bound to specific antigen. In the lateral flow double antigen sandwich chromatographic rapid test, recombinant or purified antigens are used to capture and detect the total antibodies specifically.

In the test band region, purified or recombinant antigens or proteins are immobilized. In the end of the membrane strip where the samples are supposed to be added, another antigen conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antigen conjugate particles resolve into the specimen, where the antigen conjugate will react and bound to the target antibodies, if present.

This antibody-antigen conjugate complex then moves along the strip to the testing band region, under capillary effect. Where the immobilized antigen captures the complex, and the antigen-antibody-antigen-colloidal gold complex is fixed on test band region. When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target antibody in the specimen, the colloidal gold particles will not congregate on the test band region, and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

HBcAb Test Cassette

General Information

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

Catalog No.:HBV 252
Description:HBcAb Test Cassette
Category:Hepatitis Disease
Style:Card
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10-20 Minutes
Cut Off:2 ng/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:96.1%
Specificity:98.2%
Method:Lateral Flow Double Antigen Sandwich

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.

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 Lateral Flow Double Antigen Sandwich

GICA Double Antigen Sandwich Method Illustration

Double antigen sandwich technology is commonly used to detect total antibody, which include IgM, IgG and IgA antibodies, which all can react and bound to specific antigen. In the lateral flow double antigen sandwich chromatographic rapid test, recombinant or purified antigens are used to capture and detect the total antibodies specifically.

In the test band region, purified or recombinant antigens or proteins are immobilized. In the end of the membrane strip where the samples are supposed to be added, another antigen conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antigen conjugate particles resolve into the specimen, where the antigen conjugate will react and bound to the target antibodies, if present.

This antibody-antigen conjugate complex then moves along the strip to the testing band region, under capillary effect. Where the immobilized antigen captures the complex, and the antigen-antibody-antigen-colloidal gold complex is fixed on test band region. When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target antibody in the specimen, the colloidal gold particles will not congregate on the test band region, and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

HBsAg ELISA Kit (One Step)

General Information

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

Catalog No.:HBV 2114
Description:HBsAg ELISA Kit (One Step)
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/480T
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

HBsAg ELISA Kit (Two Step)

General Information

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

Catalog No.:HBV 2124
Description:HBsAg ELISA Kit (Two Step)
Category:Hepatitis Disease
Style:Microwell
Unit:Box
Specimen:serum/plasma
No. of Step:Two Step
Reading Time:60-30-30 Minutes
Cut Off:
Specification:48T/96T/480T
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

HBsAb ELISA Kit

General Information

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

Catalog No.:HBV 2214
Description:HBsAb 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:Double Antigen 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 Antigen Sandwich ELISA

ELISA Double Antigen Sandwich Method Illustration

In double antigen sandwich ELISA kit, a recombinant or purified antigen is pre-coated on the polystyrene microwell strips, which acts as the capturer. And, a second antigen conjugated to tracer enzyme -horseradish peroxidase (HRP) is used as the detector. Depending on whether the specimen is added together with the HRP conjugate into the microwell or not, double antigen sandwich ELSIA are subdivided to one-step kit and two-step kit.

In one step kit, the sample is incubated in the microwells together with the second antigen HRP conjugate. In case of presence of the target antibody in the sample, the pre-coated and conjugated antigens will be bound to the two variable domains of the antibody during incubation, thus the specific antigen-antibody-antigen-HRP immuno complex will develop and be captured on the solid phase.

After washing to remove unbound sample and conjugates, Chromogen solutions containing tetramethyl benzidine (TMB) and urea peroxide are added to the wells and in presence of the "sandwich" immuno complex, the colorless Chromogens are hydrolyzed by the bound HRP conjugate to a blue colored product, which 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 target antibody remain colorless.

For two-step kit, the antibodies in the sample are first allowed to react with the pre-coated antigens during the first incubation. During this process, the target antibodies, if present, will be captured on the polystyrene microwell strips. In turn, they are detected by the addition of the HRP-conjugated antigens, with the same color development as described for one-step kit.

Information | Packing | Specimen | Principle

HBsAb Quantitative ELISA Kit

General Information

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

Catalog No.:HBV 2224
Description:HBsAb Quantitative 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:96T
Quan. or Qual.:Quantitative
Sensitivity:
Specificity:
Method:Double Antigen 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 Antigen Sandwich ELISA

ELISA Double Antigen Sandwich Method Illustration

In double antigen sandwich ELISA kit, a recombinant or purified antigen is pre-coated on the polystyrene microwell strips, which acts as the capturer. And, a second antigen conjugated to tracer enzyme -horseradish peroxidase (HRP) is used as the detector. Depending on whether the specimen is added together with the HRP conjugate into the microwell or not, double antigen sandwich ELSIA are subdivided to one-step kit and two-step kit.

In one step kit, the sample is incubated in the microwells together with the second antigen HRP conjugate. In case of presence of the target antibody in the sample, the pre-coated and conjugated antigens will be bound to the two variable domains of the antibody during incubation, thus the specific antigen-antibody-antigen-HRP immuno complex will develop and be captured on the solid phase.

After washing to remove unbound sample and conjugates, Chromogen solutions containing tetramethyl benzidine (TMB) and urea peroxide are added to the wells and in presence of the "sandwich" immuno complex, the colorless Chromogens are hydrolyzed by the bound HRP conjugate to a blue colored product, which 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 target antibody remain colorless.

For two-step kit, the antibodies in the sample are first allowed to react with the pre-coated antigens during the first incubation. During this process, the target antibodies, if present, will be captured on the polystyrene microwell strips. In turn, they are detected by the addition of the HRP-conjugated antigens, with the same color development as described for one-step kit.

Information | Packing | Specimen | Principle

HBeAb ELISA Kit

General Information

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

Catalog No.:HBV 2314
Description:HBeAb 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

HBeAg ELISA Kit

General Information

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

Catalog No.:HBV 2414
Description:HBeAg 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: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

HBcAb ELISA Kit

General Information

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

Catalog No.:HBV 2514
Description:HBcAb 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: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

HBc IGM ELISA Kit

General Information

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

Catalog No.:HBV 2524
Description:HBc 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: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

HBV Nucleic Acid AG ELISA

General Information

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

Catalog No.:HBV 2534
Description:HBV Nucleic Acid AG ELISA
Category:Hepatitis Disease
Style:Microwell
Unit:Box
Specimen:serum/plasma
No. of Step:Two Step
Reading Time:60-30-15 Minutes
Cut Off:
Specification:48T/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