SEKISUI Diagnostics™ OSOM™ iFOB Test

Includes

OSOM iFOB Test (Cat. No. 22-321-109)

• 25-OSOM iFOB Test device in a sealed foil pouch
• 25 Stool collection tube, with sampler, containing extraction buffer solution (PBS)
• 25 Collection paper
• 25 Mailing Envelope
• Instructions for use
• 25 Patient instructions for use
• 25 Biohazard labeled bags with absorbent pads
• Two extra test devices for external QC testing

OSOM iFOBT Control Kit (Cat. No. 22-321-112)
1mL OSOM iFOBT Control Positive Control and 1mL OSOM iFOBT Control Negative Control

OSOM iFOBT Patient Mailers (Cat. No. 22-321-110)
25 Mailers

OSOM iFOBT Stool Collection Tubes (Cat. No. 22-321-111)
25 Collection tubes

OSOM™ iFOB Test is an easy-to-use rapid test that provides quick, accurate results for detection of fecal occult blood or human hemoglobin for simpler diagnosis of gastrointestinal disorders.

The OSOM™ iFOB Test is a rapid qualitative test for the immunochemical detection of fecal occult blood/human hemoglobin (hHb) in human fecal specimens as an aid in the diagnosis of gastrointestinal disorders such as: diverticulitis, colitis, polyps, and colorectal cancer. Convenient take home kit, patients can collect in the privacy of their own home to increase compliance in screening.

• Aids in prevention and helps reduce the risk of developing more serious ulcers and other health issues
• Lower healthcare costs - early diagnosis leads to the reduction of cancer treatment expenses, hospital stays, and long-term care costs
• Improved patient compliance - no dietary or drug restrictions, with an easy-to-use at home sample collection kit and procedure
• Quick turnaround - obtain results in 5 to 10 minutes with less than 1 minute of hands-on time
• Trust your results - highly specific to human hemoglobin with analytical sensitivity of 50 ng hHb/mL buffer or 50 μg hHb/g feces
• QC Inside™ - two extra tests included at no additional charge to run external quality control testing for more confidence in your results

Recommended Storage

Store the kit or kit contents 2° to 30°C until use. Do not freeze.

Content And Storage

Store the kit or kit contents 2°C to 30°C (35.6°F to 86°F) until use. Do not freeze.

CPT Code

Diagnostic 82274QW; Screening G0328QW

Clia Complexity

Waived

Detectable Analytes

Hemoglobin

Format

Cassette

Sample Type

Stool

Sensitivity

50 ng hHb/mL Buffer or 50 μg hHb/g Feces

Type

Rapid Test Kits

For Use With (Application)

Fecal Occult Blood Detection

Includes

25 OSOM iFOB Test device in a sealed foil pouch, 25 Stool collection tube, with sampler, containing extraction buffer solution (PBS), 25 Collection paper, 25 Mailing Envelopes, Instructions for use, 25 Patient instructions for use, 25 Biohazard labeled bags with absorbent pads, Two extra test devices for external QC testing

Specificity

Human hemoglobin

Test Time

5 to 10 min.

Analysis Time

5 to 10 min.

For in vitro diagnostic use only.