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AFP Whole Blood Test Cassette

Catalog No.        Product Name

ABT-TM-B19          AFP Whole Blood Test Cassette


INTENDED USE

ACCU-TELL® Rapid AFP Test Cassette(Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of AFP in whole blood, serum or plasma to aid in the diagnosis of Hepatocellular Carcinoma or fetal open neural tube defects.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® Rapid AFP Test Cassette(Whole Blood/Serum/Plasma)  has correctly identified a panel of specimens and has been compared to a leading commercial AFP EIA test using clinical specimens. The results show that the relative sensitivity of ACCU-TELL® Rapid AFP Test Cassette(Whole Blood/Serum/Plasma) is 99.3%, and the relative specificity is 99.0%.

Method

EIA

Total Results

ACCU-TELL® Rapid AFP Test Cassette(Whole Blood/Serum/Plasma)

Results

Positive

Negative

Positive

299

5

304

Negative

2

478

480

Total Results

301

483

784

Relative Sensitivity: 99.3% (95%CI*: 97.6%-99.9%)              * Confidence Interval  

Relative Specificity: 99.0% (95%CI*: 97.6%-99.6%)  

Accuracy: 99.1% (95%CI*: 98.2%-99.6%)  

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 AFP 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 HAMA, Carcinectomy and Rheumatoid factor (RF) have been tested. No cross-reactivity was observed, indicating that ACCU-TELL® Rapid AFP Test Cassette(Whole Blood/Serum/Plasma) has a high degree of specificity for Alpha-Fetoprotein.  

Interfering Substances  

ACCU-TELL® Rapid AFP 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 2,000mg/dl Hemoglobin, 1,000mg/dl Bilirubin, and 2,000mg/dl human serum Albumin.


LIMITATIONS

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

  2. ACCU-TELL® Rapid AFP Test Cassette(Whole Blood/Serum/Plasma) will only indicate the presence of AFP in the specimen and should not be used as the sole criteria for the diagnosis of Hepatocellular Carcinoma or fetal open neural tube defects.

  3. ACCU-TELL® Rapid AFP Test Cassette(Whole Blood/Serum/Plasma) cannot detect less than 10ng/ml of AFP in specimens. A negative result at any time does not preclude the possibility of Hepatocellular Carcinoma or fetal open neural tube defects.

  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 Hepatocellular Carcinoma or fetal open neural tube defects.