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CEA Whole Blood Test Cassette

Catalog No.          Product Name               

ABT-TM-B21             CEA Whole Blood Test Cassette


INTENDED USE

ACCU-TELL® Rapid CEA 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.


PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® Rapid CEA Test 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® Rapid CEA Test Cassette (Whole Blood /Serum /Plasma) is 98.7%, and the relative specificity is 99.3%.

Method

EIA

Total Results

ACCU-TELL® Rapid CEA Test Cassette

Results

Positive

Negative

Positive

156

3

159

Negative

2

424

426

Total Results

158

427

585

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

* Confidence Interval

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

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

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® Rapid CEA Test 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® Rapid CEA Test Cassette (Whole Blood /Serum /Plasma) has a high degree of specificity for Carcinoembryonic Antigen.

Interfering Substances

ACCU-TELL® Rapid CEA Test 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 2,000 mg/dL Hemoglobin, 30 mg/dL Bilirubin, 700 mg/dl Triglycerides and 1,700 mg/dl Total Lipids.

 

LIMITATIONS

  1. ACCU-TELL® Rapid CEA Test 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® Rapid CEA Test 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® Rapid CEA Test 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.