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CEA Rapid Test Kits

CEA rapid test strip and cassette kits are intended to be used as an aid in the medical diagnosis of various cancers such as colorectal cancer, breast cancer, lung cancer and pancreas cancer.

AFP Serum Test Cassette

CEA Rapid Test Strip & Cassette

Intended Use

CEA rapid test kits, also referred to as one step CEA tests, are a rapid direct binding immunoassay medical testing kits for the qualitative detection of tumor marker Carcinoma Embryonic Antigen (CEA) in human serum specimens. CEA rapid test kits are used as an aid in the medical diagnosis of cancers such as colorectal cancer, breast cancer, lung cancer and pancreas cancer.

Why CEA Test Matters

Carcinoembryonic antigen (CEA) is normally produced during the development of a fetus. The production of CEA will stop before deliver of the baby, and usually it cannot be found in the blood of an adult without cancers. When a cancer develops in one's body, CEA protein will emerge again in his blood. Because of the correlation between cancers and the CEA level, CEA protein is regarded as one of the tumor marker substances, and are used as the subject of cancer screening test. CEA tumor marker rapid test kits measure the concentration of the CEA protein in human serum and plasma specimens, so they are used as CEA medical diagnostic devices in the diagnosis of certain kinds of cancers, especially large colon cancer and rectal cancer.

NOVAtest ® CEA Rapid Test

In our NOVAtest ® CEA rapid test strip and Cassette, monoclonal and polyclonal antibodies are employed to identify carcinoembryonic antigen (CEA) specifically. Atlas Link Technology Co., Ltd would like to offer quality IVD CEA test cassettes and strips at competitive prices.

The normal range for CEA in an adult non-smoker is less than 3 ng/ml, and for smokers less than 5.0 ng/ml. Once cancer is identified, before therapy, CEA levels can be higher than 20 ng/ml, which is associated with cancer which maybe have already spread (metastatic disease). Benign disease does not usually cause an increase above 10 ng/ml.

The sensitivity of NOVAtest CEA rapid testing kits is made at 5.0 ng/ml, which means if this one-step testing kit indicate a positive result, the chance is that testee's cancer CEA level is not normal, and certain cancer, such as colon cancer, breast cancer, lung cancer and ovarian cancer, may have spread.

About Tumor Marker CEA

Tumor marker CEA, stands for carcinoembryonic antigen, which is a protein highly correlated with some cancers. A high CEA level in one's blood sends a signal of certain cancers, which makes CEA protein concentration a well-known tumor marker, and is one of several most important testing objects in the cancer medical diagnostic tests.

Cancers such as colon cancer, breast cancer, lung cancer and ovarian cancer can make the level of this protein increase. Because CEA can be produce by a number of cancers, the elevation of CEA concentration in the bloodstream will prompt doctors to evaluate further for the real source. During the treatment process of a cancer, the CEA levels can be monitored to determine a recurrence before other tests would show positive.

Carcinoembryonic Antigen (CEA) Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
CEA 541 CEA Rapid Serum Test Strip serum 100 Bulk: 6000 PCS
Boxed: 48 Boxes
CEA 542 CEA Rapid Serum Test Cassette serum 25 Bulk: 1600 PCS
Boxed: 40 Boxes
How to Use

CEA Rapid Serum Test Strip

General Information

(IVD Kit »-» Tumor Marker -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:CEA 541
Description:CEA Rapid Serum Test Strip
Category:Tumor Marker
Style:Dipstick
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10-20 Minutes
Cut Off:5 ng/ml
Specification:3.0 mm
Quan. or Qual.:Qualitative
Sensitivity:95.3%
Specificity:
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

CEA Rapid Serum Test Cassette

General Information

(IVD Kit »-» Tumor Marker -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:CEA 542
Description:CEA Rapid Serum Test Cassette
Category:Tumor Marker
Style:Card
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10-20 Minutes
Cut Off:5 ng/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:95.3%
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

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