Product Manual

ManualsBrandsQuidel ManualsFecal Occult Blood TestQuickVue iFOB Test (Collection and Return Kits)

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FOR INFORMATIONAL USE ONLY



FOR INFORMATIONAL USE ONLY

Not to be used for performing assay. Refer to most current package insert accompanying your test kit.

QuickVue iFOB TEST

CLIA Complexity: WAIVED

INTENDED USE

The QuickVue iFOB (immunochemical Fecal Occult Blood) test is an immunochemical

device intended for the qualitative detection of fecal occult blood by laboratories or

physicians’ offices. It is useful in determining gastrointestinal (GI) bleeding found in a

number of gastrointestinal disorders, such as: diverticulitis, colitis, polyps, and colorectal

cancer. This test is recommended for use in: (1) routine physical examinations or when

hospital patients are first admitted, (2) hospital monitoring for GI bleeding in patients,

and (3) screening for colorectal cancer or gastrointestinal bleeding from any source.

SUMMARY AND EXPLANATION

The American Cancer Society and Centers for Disease Control recommend a fecal occult

blood test annually after age 50 to aid in the early detection of colorectal cancer.

 The Guaiac test is widely available but lacks high accuracy. Guaiac is a naturally

occurring phenolic compound that can be oxidized to quinone by hydrogen

peroxidases with a detectable color change. The sensitivity and specificity of Guaiac

tests are much lower than those of Immunochemical assays. The low accuracy of

the Guaiac dye method is related to dietary peroxidases, including hemoglobin and

myoglobin from meat and uncooked fruits and vegetables. Additionally, iron intake

may cause false positive results with Guaiac tests.

 The QuickVue iFOB test is much more sensitive and has been designed to be

more specific in detecting low levels of human fecal occult blood. It is highly

accurate compared to the Guaiac method. The results of immunochemical FOB

rapid tests are not affected by dietary peroxidases, animal blood or ascorbic acid. A

Japanese study demonstrated using immunochemical FOB tests reduced colorectal

cancer-related mortality by 60%.

Summary of content (12 pages)

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FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. CLIA Complexity: WAIVED INTENDED USE The QuickVue iFOB (immunochemical Fecal Occult Blood) test is an immunochemical device intended for the qualitative detection of fecal occult blood by laboratories or physicians’ offices.
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FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. PRINCIPLE OF THE TEST The QuickVue iFOB test is a one-step lateral flow chromatographic immunoassay. The test strip consists of: (1) a burgundy colored conjugate pad containing mouse anti-hHb antibodies conjugated with colloidal gold and (2) a nitrocellulose membrane strip containing a Test line (T-line) and a Control line (C-line).
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FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. WARNINGS AND PRECAUTIONS  The QuickVue iFOB test is for in vitro diagnostic use.  Do not use the kit contents beyond the expiration date printed on the outside of the box.  Dispose of containers and used contents in accordance with Federal, State and Local requirements.
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FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. SPECIMEN COLLECTION AND STORAGE The specimen used in this assay is feces. In most cases, the patient will collect the specimen at home. In the event that the specimen is collected at the physician’s office or lab, the patient will follow the procedure outlined below. 1. Enter the Patient Identification information on the Collection Tube label.
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FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. 4. With the fecal specimen still on the Collection Paper, randomly pierce the specimen with the grooved end of the Sampler in at least five (5) different sites. Collection Grooves Fecal Specimen Specimen sample inside grooves 5. Insert the Sampler into the Collection Tube and firmly tighten it. 6.
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FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. QUALITY CONTROL Built-in Control Features The QuickVue iFOB test contains a built-in control feature, the Control line (C-line). The presence of this burgundy C-line indicates that an adequate specimen volume was used and that the reagents migrated properly. If a C-line does not form, the test is considered invalid.
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FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit.  Shake the Collection Tube to mix the specimen and the FOB buffer.  Hold the Collection Tube upright, as shown. Tip Screw Cap  Remove the light blue screw cap by turning.  Fully cover tip with absorbent material to avoid potential contact with specimen solution.
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FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit.  QUICKLY snap off tip.  DO NOT TWIST. SNAP AWAY Squeeze Here  Holding the Collection Tube vertically, dispense six (6) drops of specimen solution from the Collection Tube into the center of the Sample Well. x6 T iFO C B Place six (6) drops  READ RESULTS AT 5–10 MINUTES. in center of well Some positive results may be seen earlier.
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FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. LIMITATIONS The QuickVue iFOB test is intended only for the detection of human hemoglobin in feces.  Results cannot be considered conclusive evidence of the presence or absence of gastrointestinal bleeding or pathology.
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FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. 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.
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FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. ASSISTANCE If you have any questions regarding the use of this product, please call Quidel’s Technical Support number, (800) 874-1517 (toll-free in the U.S.A.) or (858) 552-1100, Monday through Friday, between 7:00 a.m. and 5:00 p.m. Pacific Time, U.S.A. If outside the United States, contact your local distributor or technicalsupport@quidel.com.
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FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. Quidel Corporation Worldwide Headquarters 10165 McKellar Court San Diego, CA 92121 USA www.quidel.