Accu-Tell® CEA Rapid Test Cassette (Whole Blood/Serum/Plasma)

Home > Products > Tumor Marker Rapid Tests > CEA Rapid Test

Accu-Tell® CEA Rapid Test Cassette (Whole Blood/Serum/Plasma)

Share
Accu-Tell® CEA Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of CEA in whole blood, serum or plasma to aid in monitoring of cancer patients.
Product Description

Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per boxCertificate
CEA CassetteWhole Blood/Serum/PlasmaABT-TM-B21           20T


KEY POINTS

Detection for: CEA in whole blood, serum or plasma to aid in monitoring of cancer patients.

Specimen volume: Serum or Plasma Specimen: 25μL

                                 Venipuncture or Fingerstick Whole Blood Specimen: 50μL

Reading time: 5 minutes

Relative Sensitivity: 98.7% (95%CI*: 95.5%-99.8%)         

Relative Specificity: 99.3% (95%CI*: 98.0%-99.9%)

Accuracy: 99.1% (95%CI*: 98.0%-99.7%)

 

INTRODUCTION

Carcinoembryonic Antigen (CEA) is a tumor-associated antigen characterized as an oncofetal glycoprotein.CEA is expressed in a variety of malignancies, particularly pulmonary or gastrointestinal tumors (e.g. colon cancer, liver cancer and lung cancer). CEA normally occurs in fetal gut tissue with detectable serum levels essentially disappearing after birth. Therefore, elevated levels of CEA can be of significant value in the diagnosis of primary carcinomas.

 

INTENDED USE

ACCU-TELL® CEA Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of CEA in whole blood, serum or plasma to aid in monitoring of cancer patients.

 

TEST PROCEDURE

CEA WB Cassette.png

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.

2. Place the cassette on a clean and level surface.

For Serum or Plasma specimen:

Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25μL) to the specimen well of test Cassette, then add 1 drop of buffer (approximately 40ul) and start the timer. See illustration below.

For Venipuncture Whole Blood specimen:

Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μL) to the specimen area, then add 1 drop of buffer (approximately 40 μL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

To use a capillary tube: Fill the capillary tube and transfer approximately 50μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40μL) and start the timer. See illustration below.

3. Wait for the colored line(s) to appear. Read results at 5 minutes.  Do not interpret the result after 20 minutes


PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® CEA Cassette (Whole Blood/Serum/Plasma) has correctly identified a panel of specimens and has been compared to a leading commercial CEA EIA test using clinical specimens. The results show that the relative sensitivity of ACCU-TELL® CEA Cassette (Whole Blood/Serum/Plasma) is 98.7%, and the relative specificity is 99.3%.

MethodEIATotal Results
ACCU-TELL® CEA Cassette (Whole Blood /Serum /Plasma)ResultsPositiveNegative
Positive1563159
Negative2424426
Total Results158427585

Relative Sensitivity: 98.7% (95%CI*: 95.5%-99.8%)         

Relative Specificity: 99.3% (95%CI*: 98.0%-99.9%)

Accuracy: 99.1% (95%CI*: 98.0%-99.7%)

* Confidence Interval

 

Precision

Intra-Assay

Within-run precision has been determined by using 10 replicates of three specimens: a negative, a low positive and a high positive. The negative, low positive and high positive values were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 10 independent assays on the same three specimens: a negative, a low positive and a high positive. Three different lots of ACCU-TELL® CEA Cassette (Whole Blood/Serum/Plasma) have been tested using negative, low positive and high positive specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

Specimens positive for HCV, HBV, HIV, AFP and Rheumatoid factor (RF) have been tested. No cross-reactivity was observed, indicating that ACCU-TELL® CEA Cassette (Whole Blood /Serum/Plasma) has a high degree of specificity for Carcinoembryonic Antigen.

Interfering Substances

ACCU-TELL® CEA Cassette (Whole Blood/Serum/Plasma) has been tested for possible interference from visibly hemolyzed and lipemic specimens. No interference was observed. In addition, no interference was observed in specimens containing up to 2,000mg/dL Hemoglobin, 30mg/dL Bilirubin, 700mg/dl Triglycerides and 1,700mg/dl Total Lipids.

and to verify proper test performance.

 

LIMITATIONS

1. ACCU-TELL® CEA Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of CEA in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in CEA concentration can be determined by this qualitative test.

2. ACCU-TELL® CEA Cassette (Whole Blood/Serum/Plasma) will only indicate the presence of CEA in the specimen and should not be used as the sole criteria for the diagnosis of gastrointestinal tract tumors or other cancer.

3. ACCU-TELL® CEA Cassette (Whole Blood/Serum/Plasma) cannot detect less than 5ng/ml of CEA in specimens.

4. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

5. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of gastrointestinal tract tumors or other cancer.

 

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.

Tags:
cea

View More

  • wechat

    AccuBioTech: AccuBioTech

Chat with Us