Performance Characteristics - Gima 24530 Bedienungsanleitung

The FOB One Step Fecal Occult Blood Test Device (Feces) has been compared with another leading
commercial rapid test using clinical specimens.
Relative Sensitivity: 93.6% (89.6%- 96.5%)*
Relative Accuracy: 98.0% (96.9%- 98.7%)*
The FOB One Step Fecal Occult Blood Test Device (Feces) can detect levels of Fecal Occult Blood as
low as 50 ng/mL or 6 µg/g feces. Specificity The FOB One Step Fecal Occult Blood Test Device
(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.
1. Simon JB. Occult Blood Screening for Colorectal Carcinoma: A Critical Review, Gastroenterology,
1985; 88: 820.
2. Blebea J, Mcpherson RA. False- Positive Guaiac Testing With Iodine, Arch Pathol Lab Med, 1985;
109: 437-40.
Attention, see
instructions for use
For in vitro diagnostic
use only
Store between 2-30° C
Keep away from
sunlight
Manufacturer

PERFORMANCE CHARACTERISTICS

Accuracy
Sensitivity
BIBLIOGRAPHY
Index of Symbols
Tests per kit
Use by
Lot Number
Keep in a cool,
dry place
GIMA Spa
Via Marconi, 1 - 20060
Gessate (MI) - Italia
Relative Specificity: 99.1% (98.2%- 99.6%)
*95% Confidence Intervals
Manufacturer
Do not reuse
Catalog 24530
Please read instructions
carefully
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