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FOB Feces Test Cassette

Catalog No.        Product Name                 

ABT-FOB-B22         FOB Feces Test Cassette


INTENDED USE

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

 
PERFORMANCE CHARACTERISTICS

Accuracy

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

Method

Other One Step Test

Total Result

ACCU-TELL® One Step FOB Test

 Cassette (Feces)

Results

Positive

Negative

Positive

210

6

216

Negative

12

850

862

Total Result

222

856

1078

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® One Step FOB Test Cassette(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 10 replicates of three specimens: 40ng/ml,80ng/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 three specimens:40ng/ml, 80ng/ml and 10μg/ml positive specimens. Three different lots of ACCU-TELL® One Step FOB Test Cassette(Feces) have been tested using these specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL® One Step FOB 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® One Step FOB Test Cassette(Feces) is for in vitro diagnostic use only.

  2. ACCU-TELL® One Step FOB Test Cassette(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.

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