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

Product Description

CATALOG

KEY POINTS

Detection for: Human Occult Blood in feces.

Reading time: 5 minutes

Sensitivity: 40ng/ml

Relative Sensitivity: 94.6%

Relative Specificity: 99.3%

Accuracy: 98.3%

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. Traditional guaiac-based methods lack sensitivity and specificity, and also have diet restrictions prior to testing.

INTENDED USE

ACCU-TELL^® FOB Rapid Test Cassette/Strip (Feces) is a One Step chromatographic immunoassay for the qualitative detection of Human Occult Blood in feces.

TEST PROCEDURE

For Cassette:

For Strip:

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) 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°C 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°C if not tested within 1 hour after preparation.

For Cassette:

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 80μL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration above.

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

For Strip:

1. Bring the pouch to room temperature before opening it. Remove the test strip 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. Fix the reaction tube, hold the specimen collection tube upright and break off the tip of the specimen collection tube. Invert the specimen collection tube and transfer 8-10 full drops of the extracted specimen (approx. 500 μL) to the reaction tube, then with arrows pointing toward the exaction buffer, immerse the strip and start the timer. Do not immerse the strip past the maximum line. See illustration above.

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

PERFORMANCE CHARACTERISTICS

Accuracy

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

Relative sensitivity: 210/222=94.6% (95%CI*: 90.7%~97.2%);  

Relative specificity: 850/856=99.3% (95%CI*: 98.5%~99.7%);

Accuracy: (210+850)/(210+6+12+850) =98.3% (95%CI*: 97.4%~99.0%).      

*Confidence Intervals

Sensitivity

ACCU-TELL^® FOB FOB Rapid Test Cassette/Strip (Feces) can detect levels of Fecal Occult Blood as low as 40 ng/mL or 6 μg/g feces.

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of three specimens: 50ng/ml, 100ng/ml and 10μg/ml positive specimens. The specimens were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 15 independent assays on the same three specimens: 50ng/ml, 100ng/ml and 10μg/ml positive specimens. Three different lots of ACCU-TELL^® FOB Rapid Test Cassette/Strip (Feces) have been tested using these specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

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

2. ACCU-TELL^® FOB Rapid Test Cassette/Strip (Feces) will only indicate the presence of Fecal Occult Blood, 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.

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.