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AMI Test

This series of AMI rapid test kits are used in the diagnosis of Acute Myocardial Infarction.

Acute Myocardial Infarction (AMI) Test Kit

Intended Use

In the diagnosis of the Acute Myocardial Infarction, three rapid test kits are commonly used, which are Troponin-I (cTnI) Rapid Test Kit, CK-MB Rapid Test Kit and Myo Rapid Test Kit. These rapid test kits are all a rapid In-Vitro (IVD) rapid test based on the principle of chromatographic immunoassay for the qualitative detection of human Myoglobin, Creatine Kinase MB (CK-MB) and cardiac Troponin-I in serum or plasma.

These test kits are easy to perform, and takes as short as 10 minutes to be sure of the result, which make them suitable a Point of Care test (POCT) test kits.

AMI Triad Test

MYO/CK-MB/cTnI multi-3 test panel provides a qualitative analytical test result for the three AMI makers with one blood specimen. With this AMI test device, the detection of these three markers is complementary in diagnosis of myocardial infarction, since they detect cardiac tissue damage at different time structure and over a wide range of times after myocardial infarction. So the accuracy of the diagnosis will be higher than any of the three single test result.

What is AMI

Acute myocardial infarction (AMI) is commonly known as a heart attack. Myoglobin (MYO), Creatine Kinase MB (CK-MB) and cardiac Troponin I (cTnI) are the proteins appear in the bloodstream after cardiac injury.

Release Patterns

MYO is released into the blood rapidly due to its relatively small size, the concentration which increases measurably above baseline within 2-4 hours post-infarct, peaking at 9-12 hours, and returning to baseline within 24-36 hours. The release of CK-MB can be detected within 3-8 hours after the onset of symptoms; peaks within 9 to 30 hours, and returns to baseline levels within 48 to 72 hours. The release pattern of cTnI is similar to CK-MB, with a difference that cTnI remains elevated for 6-10 days, thus providing for a longer window of detection for cardiac injury.

AMI Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
CKMB 722 CK-MB Serum Rapid Test serum/plasma 25 Bulk: 1600 PCS
Boxed: 40 Boxes
cTnI 703 Myo/CK-MB/cTnI Test Panel serum/plasma 20 Bulk: 1000 PCS
Boxed: 32 Boxes
cTnI 721 Troponin-I Rapid Test Card serum/WB/plasma 25 Bulk: 1600 PCS
Boxed: 40 Boxes
MYO 723 Myoglobin Serum Test Card serum/plasma 25 Bulk: 1600 PCS
Boxed: 40 Boxes
How to Use
cTnI test cassette and AMI multi-test panel

CK-MB Serum Rapid Test

General Information

(IVD Kit »-» Health Monitoring -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:CKMB 722
Description:CK-MB Serum Rapid Test
Category:Health Monitoring
Style:Card
Unit:PCS
Specimen:serum/plasma
No. of Step:One Step
Reading Time:10 Minutes
Cut Off:5.0 ng/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
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

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 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

Myo/CK-MB/cTnI Test Panel

General Information

(IVD Kit »-» Health Monitoring -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:cTnI 703
Description:Myo/CK-MB/cTnI Test Panel
Category:Health Monitoring
Style:panel
Unit:PCS
Specimen:serum/plasma
No. of Step:One Step
Reading Time:15-30 Minutes
Cut Off:1.0/5.0/80 ng/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:Lateral Flow Double Antibody 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

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 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

Troponin-I Rapid Test Card

General Information

(IVD Kit »-» Health Monitoring -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:cTnI 721
Description:Troponin-I Rapid Test Card
Category:Health Monitoring
Style:Card
Unit:PCS
Specimen:serum/WB/plasma
No. of Step:One Step
Reading Time:10 Minutes
Cut Off:80 ng/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:98.5%
Specificity:98.4%
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.

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 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

Myoglobin Serum Test Card

General Information

(IVD Kit »-» Health Monitoring -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:MYO 723
Description:Myoglobin Serum Test Card
Category:Health Monitoring
Style:Card
Unit:PCS
Specimen:serum/plasma
No. of Step:One Step
Reading Time:10 Minutes
Cut Off:1.0 ng/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
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

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 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