Product Manual

Page 10 of 12
FOR INFORMATIONAL USE ONLY
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FOR INFORMATIONAL USE ONLY
Not to be used for performing assay. Refer to most current package insert accompanying your test kit.
QuickVue iFOB TEST
PERFORMANCE CHARACTERISTICS
Sensitivity
The sensitivity of the test is 50 ng hHb/mL buffer or 50 µg hHb/g feces.
Accuracy
Reference Laboratory and Physicians' Office Laboratory (POL) Studies
One hundred (100) hHb-free feces extraction specimens collected in-house were divided
into 5 groups of 20 each. The five groups of extraction specimens were spiked with
hHb for five different concentrations, respectively: 0, 37.5 ng hHb/mL, 50 ng hHb/mL,
62.5 ng hHb/mL, and 2000 ng hHb/mL. Those specimens were blind labeled and tested
with the QuickVue iFOB test at three (3) Physicians' Office Laboratories and a Reference
Laboratory.
The results obtained from the three POL sites by persons with diverse educational
background and work experience were 97.7% accurate, and the results from the
Reference Laboratory were 99% accurate. Thus, overall the accuracy of the QuickVue
iFOB test is 98%.
Specificity
The QuickVue iFOB test is specific to human hemoglobin. The following substances, when
spiked in both positive and negative specimens, did not interfere with the test results.
Substance Concentration (µg/mL)
Beef Hemoglobin 2,000
Chicken Hemoglobin 500
Fish Hemoglobin (meat extract) 100
Horse Hemoglobin 500
Goat Hemoglobin 500
Pig Hemoglobin 500
Rabbit Hemoglobin 60
Sheep Hemoglobin (meat extract) 100
Horseradish Peroxidase 20,000
Red radish Aqueous extract
Raw turnip Aqueous extract
Cauliflower Aqueous extract
Broccoli Aqueous extract
Parsnip Aqueous extract
Cantaloupe Aqueous extract
Vitamin C (ascorbic acid) Dietary supplement
Iron Dietary supplement