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

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

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Accu-Tell® AFP Rapid 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.
Product Description

Product Description

CATALOG

Product Name

Specimen

Catalog No.

Quantity per box

Certificate

AFP Cassette

Whole Blood/Serum/Plasma

ABT-TM-B19

           20T


KEY POINTS

Detection for: Alpha-Fetoprotein (AFP) in whole blood, serum or plasma.

Specimen volume: Serum or Plasma specimen: 25μL

                                 Venipucture or fingerstick Whole Blood Specimen: 50μL

Reading time: 10 minutes

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

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

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

 

INTRODUCTION

Alpha-Fetoprotein (AFP) is normally produced during fetal and neonatal development by the liver, yolk sac and in small concentrations by the gastrointestinal tract.By the second year of life, AFP concentrations decrease rapidly, and thereafter only trace amounts are normally detected in serum.

 

INTENDED USE

ACCU-TELL® AFP Rapid 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.

 

TEST PROCEDURE

AFP WB.png


1. Bring the pouch to room temperature before opening it. Remove the test strip/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 40μL) 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 40μL), 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.

3. Wait for the colored line(s) to appear. Read results at 10 minutes.  Do not interpret the result after 20 minutes.


PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® AFP Rapid 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® AFP Rapid Test Cassette (Whole Blood/Serum/Plasma) is 99.3%, and the relative specificity is 99.0%.

Method

EIA

Total Results

ACCU-TELL® AFP Rapid 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%)             

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

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

* 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® AFP Rapid 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® AFP Rapid Test Cassette (Whole Blood/Serum/Plasma) has a high degree of specificity for Alpha-Fetoprotein.

Interfering Substances

ACCU-TELL® AFP Rapid 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® AFP Rapid 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® AFP Rapid 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® AFP Rapid Test Cassette (Whole Blood/Serum/Plasma) cannot detect less than 10ng/ml of AFP in specimens. A negative re sult 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.


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

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