Special Order Item

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Description

Quidel Quickvue Ifob Test Kit. Immunochemical device intended for the qualitative detection of fecal occult blood. More sensitive than traditional guaiac-based methods. No dietary restrictions and requires only one specimen collection from patient. Analytical sensitivity: 50 ng hHb/mL buffer or 50 µg hHb/g feces, specific to human hemoglobin, POL analytical accuracy 98%. 20-test kit contains everything needed for testing. Specimen Collection Tube doubles as convenient/sanitary dispenser. Room temperature storage with up to 24-month shelf life from date of manufacture. Additional Patient Specimen Collection and Return Kits available separately. External kit controls (positive and negative) available separately. CLIA waived.
SKU MPN OPTION DESCRIPTION EST. TO SHIP
QDE-20194 20194 QuickVue iFOB 20 Test Kit QuickVue iFOB 20 Test Kit, Includes:1 Pkg Insert, 1 Procedure Card, 20 Individually Wrapped Test Cassettes, 20 Specimen Collection & Return Kits Each Containing 1 Collection Tube with 2mL FOB Buffer, 1 Collection Paper with Adhesive, 1 Pouch, 1 Absorbent (Continental US Only - including Alaska & Hawaii) 1-2 Weeks
QDE-20204 20204 QuickVue iFOB 40 Specimen Collection Kit QuickVue iFOB 40 Specimen Collection Kit, Includes: 40 Collection Kits Each Containing 1 Collection Tube with 2mL FOB Buffer, 1 Collection Paper with Adhesive, 1 Pouch, 1 Absorbent Sleeve, 1 Return Mail Box & 1 Patient Instructions (Continental US Only - including Alaska & Hawaii) 1-2 Weeks
QDE-20201 20201 QuickVue iFOB 50-Tray Pack, Includes: 50 ea Test Cassettes, & Specimen Collection Tube, 1 Package Insert, 2mL FOB Buffer & Patient ID Label, CLIA Waived QuickVue iFOB 50-Tray Pack, Includes: 50 ea Test Cassettes, & Specimen Collection Tube, 1 Package Insert, 2mL FOB Buffer & Patient ID Label, CLIA Waived (Continental US Only - including Alaska & Hawaii) 1-2 Weeks
QDE-20205 20205 QuickVue iFOB 100 Test Kit, Test Cassettes Only, Includes 1 Package Insert, 6 kt/cs QuickVue iFOB 100 Test Kit, Test Cassettes Only, Includes 1 Package Insert, 6 kt/cs (Continental US Only - including Alaska & Hawaii) 4-5 Weeks

Frequently asked questions

Does the iFOB test ensure high analytical accuracy?

Yes, the Quidel QuickVue iFOB Test Kit is engineered for highly accurate screening, leveraging an advanced immunochemical detection method that is significantly more sensitive than conventional guaiac-based tests.

Key performance specifications include:

  • Analytical Accuracy: The test achieves a robust 98% POL analytical accuracy rate.
  • High Specificity: The system is specific to human hemoglobin (hHb), which helps ensure reliable results.
  • Enhanced Sensitivity: It offers superior analytical sensitivity, reaching 50 ng hHb/mL buffer or 50 µg hHb/g feces.
Does the QuickVue iFOB test offer high sensitivity?

Yes, the Quidel QuickVue iFOB Test Kit is an advanced immunochemical screening device known for its high analytical sensitivity and accuracy, which surpasses conventional guaiac-based tests. The test is specific for detecting only human hemoglobin (hHb).

Key performance specifications are:

  • Analytical Sensitivity: Reaches 50 ng hHb/mL buffer or 50 µg hHb/g feces.
  • Analytical Accuracy (POL): 98%.

This high sensitivity provides a major advantage as it requires only a single specimen collection and eliminates the need for pre-test dietary restrictions.

Does this test require only one specimen?

Yes, the Quidel Quickvue iFOB Test Kit is designed to maximize patient convenience by requiring only a single specimen collection.

This streamlined approach enhances patient compliance and offers several key benefits:

  • No Dietary Restrictions: Unlike traditional methods, patients are not required to follow any dietary restrictions before testing.
  • Simplified Process: Only one sample is needed to complete the test.
  • Reliable Results: The immunochemical device is highly accurate, boasting a POL analytical accuracy of 98% for detecting human hemoglobin.
What is included in the 20-Test Kit?

The QuickVue iFOB 20 Test Kit (QDE-20194) is a CLIA-waived configuration that provides all components necessary for 20 high-sensitivity fecal occult blood tests.

This specific kit configuration includes:

  • 20 Individually Wrapped Test Cassettes
  • 20 Specimen Collection & Return Kits, each containing:
    • 1 Collection Tube (with 2mL FOB Buffer, which serves as a sanitary dispenser)
    • 1 Collection Paper with Adhesive
    • 1 Pouch
    • 1 Absorbent
  • 1 Package Insert (for detailed instructions)
  • 1 Procedure Card
Is the QuickVue iFOB Test CLIA-waived?

Yes, the Quidel QuickVue iFOB Test Kit is confirmed to be CLIA waived.

This designation is a major benefit, as it means the test is approved for use in facilities certified under the Clinical Laboratory Improvement Amendments (CLIA) without requiring stringent regulatory oversight. This makes it ideal for simplified, point-of-care screening.

Is the iFOB test highly sensitive?

Yes, the Quidel Quickvue iFOB Test Kit offers high analytical sensitivity because it utilizes an advanced immunochemical detection method that is highly specific to human hemoglobin (hHb).

This technology provides superior detection capabilities compared to traditional guaiac-based tests.

Key performance metrics include:

  • Analytical Sensitivity: Reaches 50 ng hHb/mL buffer (or 50 µg hHb/g feces).
  • Analytical Accuracy (POL): A high accuracy rate of 98%.
Can I purchase external positive/negative controls?

Yes, external positive/negative controls are available for purchase separately. These controls are essential for quality assurance, helping to ensure the accuracy and validity of your testing procedures with the QuickVue iFOB Test Kit.

Does this iFOB test require special dietary restrictions?

No, the Quidel QuickVue iFOB Test Kit is designed for maximum patient convenience and requires absolutely no dietary restrictions prior to specimen collection. This simplifies patient preparation compared to traditional methods.

This immunochemical device also enhances ease of use with the following features:

  • Single Specimen Collection: Only one fecal specimen is necessary for accurate results.
  • Integrated Dispenser: The Specimen Collection Tube functions as a convenient and sanitary dispenser.
  • Regulatory Status: The test kit is CLIA waived, allowing use in various clinical settings.
What is the shelf life of this iFOB test?

The Quidel Quickvue iFOB Test Kit provides a significant shelf life of up to 24 months from the date of manufacture. Importantly, the kit is designed for convenient room temperature storage.

Does the collection tube dispense samples easily?

Yes, the Specimen Collection Tube is designed to streamline the testing process by simplifying both collection and dispensing.

This integrated component offers significant benefits:

  • Dual Purpose: The tube serves as both the initial collection vessel and a convenient and sanitary dispenser for the test buffer.
  • Efficiency: The entire procedure requires only one specimen collection, enhancing ease of use and patient compliance.