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Description

The LifeSign Status iFOBT (#38030-DTM / 30 Tests) includes 30 test devices, 50 mailing envelopes, and 50 sample collection tubes.

The Status iFOBT Immunoassay was designed as an easy to use, non-invasive rapid test kit for the qualitative detection of immunochemical fecal occult blood (human hemoglobin) in human fecal specimens as an aid in the diagnosis of gastrointestinal disorders such as: diverticulitis, colitis, polyps, and colorectal cancer.

Note: Physician’s licensing required. This is NOT an at-home test and should only be completed in a lab facility.

The Status iFOBT test is suitable for use in laboratories and physician's offices as well as for home use. It is recommended for use in routine physical examination, new patient screening at admission, and screening and monitoring any suspected colorectal cancer and/or gastrointestinal bleeding from any source.

Features

LifeSign Status iFOBT Features

  • CLIA waived.
  • Superior sensitivity and specificity.
  • Human hemoglobin specific to reduce false positives.
  • No dietary or drug restrictions for iFOBT.
  • Simple and easy one-step test procedure.
  • Specimen can be collected in the office or at home.
  • Collection method is non-invasive.
  • Patient friendly with easy-to-follow instructions.
  • Increased patient compliance.
  • Only one test device is needed.
  • Visual read of results.
  • Tests stool sample.
  • Five to 10 minute results (Note: Do not read results after 10 minutes).

Accessories

LifeSign Status iFOBT Accessories

The following accessories are compatible and commonly purchased with the Status iFOBT:

  • #38050-DT: Status iFOBT Cassettes and Tubes.
  • #38050-M: Status iFOBT Mailing Envelopes Refill.
  • #38050-T: Status iFOBT Sample Collection Tube Refill.
  • #200020: Status iFOBT Control Set - POS & NEG.

Frequently asked questions

What is included in the LifeSign Status iFOBT kit?

The LifeSign Status iFOBT kit includes:

  • 30 test devices
  • 50 mailing envelopes
  • 50 sample collection tubes

These components provide everything needed to perform the fecal occult blood tests and securely send samples for analysis.

What conditions does the LifeSign Status iFOBT diagnose?

The LifeSign Status iFOBT is intended as an aid in diagnosing various gastrointestinal disorders. It achieves this by performing qualitative detection of immunochemical fecal occult blood (human hemoglobin) in human fecal specimens.

The test specifically helps screen and monitor for:

  • Colorectal cancer
  • Polyps
  • Colitis
  • Diverticulitis
Is the LifeSign Status iFOBT CLIA waived?

Yes, the LifeSign Status iFOBT is CLIA Waived, making it suitable for use in various healthcare settings, including laboratories and physician’s offices.

What are the main advantages of this iFOBT test?

The LifeSign Status iFOBT test offers several significant advantages, focusing on both laboratory efficiency and patient convenience:

  • Human Hemoglobin Specificity: This test utilizes immunochemistry to specifically detect human hemoglobin, which significantly reduces the chance of false positive results compared to non-specific tests.
  • No Restrictions Required: Patients benefit from increased convenience as there are no dietary or drug restrictions necessary before collection.
  • Simplified Collection and Compliance: The collection method is non-invasive and patient-friendly, promoting higher patient compliance since the specimen can be collected at home or in the office.
  • CLIA Waived and Rapid: The kit is CLIA waived, streamlining administrative requirements. Results are generated quickly through a simple one-step procedure, with visual results available within five to ten minutes.
How quickly does the LifeSign Status iFOBT provide results?

The LifeSign Status iFOBT provides rapid visual results within 5 to 10 minutes.

Is the sample collection process for the LifeSign Status iFOBT invasive?

No, the LifeSign Status iFOBT method of sample collection is non-invasive, which enhances patient comfort and compliance.

Who is the LifeSign Status iFOBT recommended for?

The LifeSign Status iFOBT test kit is primarily used as an aid in diagnosing and screening for various gastrointestinal disorders. It is typically recommended for the following applications:

  • Routine Physical Examinations: Integrating into standard wellness checks.
  • New Patient Screening: Screening patients upon admission to healthcare facilities.
  • Monitoring and Screening: Used for patients suspected of having colorectal cancer or gastrointestinal bleeding.
  • Diagnostic Aid: Assisting in the diagnosis of conditions such as diverticulitis, colitis, and polyps.
How are the results of the LifeSign Status iFOBT interpreted?

The LifeSign Status iFOBT uses a visual readout of results. This means the results are interpreted visually without the need for specialized equipment.

Is a physician's license required for this iFOBT kit?

Yes, physician licensing is required for the use of the LifeSign Status iFOBT kit. The test is intended for use in laboratory or physician office settings.

While the non-invasive specimen collection can be performed by the patient at home for convenience, the actual test process must only be completed in a lab facility.

Does this test offer high accuracy?

The LifeSign Status iFOBT is designed to provide superior sensitivity and specificity to ensure accurate results. It is human hemoglobin specific, which helps to reduce false positives, making the diagnostic process more reliable.