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Description

The Clarity Immunoassay Fecal Occult Blood Test Kit (#DTG-FOB01 / 30 per Box) office pack includes (30x) foil pouches (each with a test cassette and desiccant), (35x) sample collection tubes with buffer, a vial of positive control, vial of negative control, and instructions for use.

The Immunoassay Fecal Occult Blood Test (iFOBT) revolutionizes early colorectal cancer detection. As a CLIA Waived product, it enables in-house screenings with superior sensitivity compared to competitors. Notably, it requires no dietary, vitamin/iron, or medicinal restrictions from patients, easing the testing process for both patients and providers.

The iFOBT is user-friendly, coming with external controls and simple room-temperature storage. It boasts a 28-month shelf life and is ten times more sensitive than traditional methods.

Features

Clarity Immunoassay Fecal Occult Blood Test Kit Features

  • Only one sample needed for accurate results.
  • Capable of identifying intermittent bleeding for comprehensive screenings.
  • Designed for hassle-free room temperature storage.
  • Eligible for annual reimbursement for all patients age 45 and older.
  • 10 times more sensitive than the traditional Guaiac Method.
  • Specificity: 100%.
  • Sensitivity: 50 ng/ml.
  • 100% Medicare reimbursement guarantee.
  • 24 month dating.

Frequently asked questions

Is this kit used for colorectal cancer screening?

Yes, the Clarity Immunoassay Fecal Occult Blood Test Kit (iFOBT/FIT) is specifically designed for the early detection of colorectal cancer.

Key benefits include:

  • Superior Accuracy: This kit utilizes advanced iFOBT technology, offering 10 times greater sensitivity (50 ng/ml) and 100% specificity compared to traditional Guaiac methods. It can identify intermittent bleeding using only one sample.
  • CLIA Waived: It is eligible for convenient, in-house screening in facilities meeting CLIA Waived requirements.
  • No Patient Restrictions: Patient compliance is simple as no dietary, vitamin, iron, or medicinal restrictions are required prior to testing.
  • Reimbursement: The test is eligible for annual reimbursement for all patients aged 45 and older, supported by a 100% Medicare reimbursement guarantee.
What components are in the 30-test kit?

The Clarity Immunoassay Fecal Occult Blood Test Kit is a complete office pack, providing materials for 30 total tests and external quality controls.

The box includes:

  • 30x Foil Pouches: Each pouch contains one test cassette and a desiccant.
  • 35x Sample Collection Tubes: These are pre-filled with the necessary buffer solution (5 extra tubes are provided).
  • Positive Control vial
  • Negative Control vial
  • Instructions for Use (Product Insert)
Is the Clarity iFOB Test Kit CLIA waived?

Yes, the Clarity iFOB Test Kit is CLIA waived, making it suitable for in-house screenings.

Is the Clarity iFOB test highly effective at detecting intermittent bleeding?

Yes, this Immunoassay Fecal Occult Blood Test (iFOBT) is highly effective at detecting intermittent bleeding due to its superior technology.

It utilizes an advanced immunoassay method which offers ten times greater sensitivity (50 ng/ml) compared to traditional Guaiac testing. This defined sensitivity, combined with 100% specificity, makes the kit excellent for identifying trace amounts of blood that may indicate sporadic or intermittent internal bleeding.

Is the Clarity test kit highly sensitive?

Yes, the Clarity Immunoassay Fecal Occult Blood Test (iFOBT) is designed for superior sensitivity in early colorectal cancer screening.

It utilizes advanced immunochemical technology (FIT/iFOBT) that significantly outperforms traditional methods:

  • It provides 10 times greater sensitivity than the traditional Guaiac method.
  • Specific performance metrics include a sensitivity of 50 ng/ml and a specificity of 100%.

This high sensitivity allows the test to accurately identify intermittent bleeding while requiring only a single sample.

Are there any dietary restrictions for patients undergoing the Clarity iFOB test?

No, the Clarity iFOB Test Kit is designed for maximum patient convenience. It requires no pre-test dietary or medicinal restrictions for patients, which significantly simplifies the screening process for early colorectal cancer detection.

What is the shelf life of the Clarity Diagnostics Clarity iFOB Test Kit?

The Clarity Diagnostics Clarity iFOB Test Kit has a shelf life of 28 months.

Does this kit offer simple storage and a long shelf life?

Yes, this kit is designed for maximum convenience and extended utility in clinical settings.

  • Simple Storage: The kit only requires room temperature storage, eliminating the need for refrigeration.
  • Long Shelf Life: It offers an impressive shelf life of 28 months, ensuring stock stability and reducing the need for frequent restocking.
How many samples does the iFOB test require?

The Clarity Immunoassay Fecal Occult Blood Test Kit (iFOBT) is designed for efficiency and requires only one sample per test. This single-sample requirement simplifies the collection process for both patients and healthcare providers.

Does the Clarity iFOB Test Kit include validation controls?

Yes, the Clarity iFOB Test Kit includes external controls to help ensure accurate and reliable testing. The kit contains both positive and negative controls:

  • 1 Positive Control
  • 1 Negative Control

These controls are included alongside the 30 IFOB Test Cassettes and 35 Sample Collection Buffer Tubes.