Accu-Tell^® FOB/Transferrin Rapid Test Cassette (Feces)

Product Description

CATALOG

KEY POINTS

Detection for: Human Hemoglobin and Transferrin in feces

Reading time: 5 minutes

Relative Sensitivity: for Transferrin: 98.1%; for Human Hemoglobin: 97.7%

Relative Specificity: 99.6%

Accuracy: 99.2%

INTRODUCTION

Many diseases can cause hidden blood in the feces. This is also known as Fecal Occult Blood (FOB), Human occult Blood, or Human Hemoglobin. In the early stages, gastrointestinal problems such as colon cancer, ulcers, polyps, colitis, diverticulitis, and fissures may not show any visible symptoms, only occult blood.

Transferrin is a blood plasma protein for iron ion delivery. Transferrin imbalance can have serious health effects for those with high serum transferring levels. A patient with an increased serum transferring level suffers from iron deficiency anemia that is one of the most important symptoms when a tumor has caused chronic occult bleeding.

INTENDED USE

ACCU-TELL^® FOB/Transferrin Rapid Test Cassette (Feces) is a rapid chromatographic immunoassay for the qualitative detection of Human Hemoglobin and Transferrin in feces.

TEST PROCEDURE

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30℃) prior to testing.

To collect fecal specimens:

Collect feces in a clean, dry specimen collection container. Best results will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8℃ if not tested within 6 hours.

To process fecal specimens:

Unscrew the cap of the specimen collection tube, then randomly stab the specimen collection applicator into the fecal specimen in at least 3 different sites. Do not scoop the fecal specimen.

Screw on and tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Specimens prepared in the specimen collection tube may be stored for 6 months at -20℃ if not tested within 1 hour after preparation.

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.

2. Hold the specimen collection tube upright and open the cap onto the specimen collection tube. Invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approximately 80 µL) separately to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.

3. Read results at 5 minutes. Do not read results after 10 minutes.

PERFORMANCE CHARACTERISTICS

Accuracy

ACCU-TELL^® FOB/Transferrin Rapid Test Cassette (Feces) has been compared with another leading commercial rapid test using clinical specimens.

Note: * There were two samples that they both showed a TF line and a FOB line.

Sensitivity for Transferrin: 52/53=98.1% (95%CI*: 89.9%~100.0%);

Sensitivity for Human Hemoglobin: 173/177=97.7% (95%CI*: 94.3%~99.4%);

Specificity: 916/920=99.6% (95%CI*: 98.9%~99.9%);

Accuracy:1141 /1150=99.2% (95%CI*: 98.5%~99.6%).

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 10 replicates of six specimens: Human Hemoglobin(10ng/ml, 20ng/ml, 10µg/ml), Transferrin (4ng/ml, 8ng/ml and 10µg/ml) positive specimens. The specimens were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 10 independent assays on the same six specimens: Human Hemoglobin(10ng/ml, 20ng/ml, 10µg/ml), Transferrin (4ng/ml, 8ng/ml and 10µg/ml) positive specimens. Three different lots of ACCU-TELL^® FOB/Transferrin Rapid Test Cassette (Feces) have been tested using these specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL^® FOB/Transferrin Rapid Test Cassette (Feces) is specific to human hemoglobin. Specimens containing the following substances were diluted in the extraction buffer to a concentration of 1.0 mg/ml, and tested on both positive and negative controls with no effect on test results: Bovine hemoglobin, Chicken hemoglobin, Pork hemoglobin, Goat hemoglobin, Horse hemoglobin, Rabbit hemoglobin and Turkey hemoglobin.

LIMITATIONS

1. ACCU-TELL^® FOB/Transferrin Rapid Test Cassette (Feces) is for in vitro diagnostic use only.

2. ACCU-TELL^® FOB/Transferrin Rapid Test Cassette (Feces) will only indicate the presence of Human Hemoglobin and/or Transferrin, the presence of blood in feces does not necessarily indicate colorectal bleeding.

3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.

4. Other clinically available tests are required if questionable results are obtained.

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