External Controls – FOB Rapid Test (Positive & Negative Controls)
$27.60
Positive & Negative
1 mL Each
Ready-to-use positive and negative external controls for FOB rapid testing.
- Includes: 1 mL Positive Control + 1 mL Negative Control
- Format: Ready-to-use liquid controls
- Use: External quality control for FOB rapid testing
- Compatible Kit: Accutest® ValuPak™ CLIA Waived iFOBT Test
- Reference: GEFOB-PNK2
- SKU: DTK-101554
External Controls – FOB Rapid Test Overview
The External Controls – FOB Rapid Test provide ready-to-use positive and negative control materials for use with the Accutest® ValuPak™ CLIA Waived iFOBT Test. The controls are used to help verify proper test procedure and performance of the FOB Rapid Test.
1 mL Each
Ready to Use
FOB Rapid Test Controls
diagnostic use:
Incompatibilities may occur when used with test kits from other manufacturers.
Always follow the manufacturer’s Instructions for Use.
Features and Benefits
Includes both control levels needed to help verify expected FOB Rapid Test performance.
Control solutions are supplied ready for use according to the manufacturer’s control procedure.
Includes a 1 mL positive control bottle and a 1 mL negative control bottle.
The positive control is supplied with a blue cap and the negative control with a white cap.
External controls help verify proper test procedure and performance of the FOB Rapid Test.
Intended specifically for use with the manufacturer’s compatible Accutest® ValuPak™ CLIA Waived iFOBT Test.
GEFOB-PNK2
DTK-101554
Positive + Negative
Product Specifications
| Specification | Details |
|---|---|
| Product type | External positive and negative controls |
| Application | External quality control for the FOB Rapid Test |
| Positive control | 1 × 1 mL bottle with blue cap |
| Negative control | 1 × 1 mL bottle with white cap |
| Compatible test | Accutest® ValuPak™ CLIA Waived iFOBT Test |
| Storage | 2°C-30°C (36°F-86°F); do not freeze |
| Testing temperature | Allow controls and test cassette to reach 15°C-30°C (59°F-86°F) before testing |
| Intended use | For in vitro diagnostic use; prescription use only |
When to Use the External Controls
According to the manufacturer’s Instructions for Use, the external controls should be tested in the following situations:
Run the external controls when beginning use of a new FOB Rapid Test kit lot.
Controls should be tested when a new operator begins performing the test.
Use the external controls when a new shipment of test kits is received.
Periodic control testing can be used to check storage conditions as directed in the Instructions for Use.
How to Use the Controls
Allow the FOB Rapid Test cassette and control solutions to reach 15°C-30°C (59°F-86°F) before testing.
Remove the FOB Rapid Test cassette from its pouch and place it on a clean, level surface.
Use the positive or negative control according to the procedure provided in the manufacturer’s Instructions for Use.
Compare the result with the expected control result described in the Instructions for Use before proceeding with patient testing.
Storage and Handling
Keep the controls within the storage temperature range specified by the manufacturer.
Freezing may affect the control materials and should be avoided.
Do not use the controls beyond the expiration date printed on the product packaging.
Refer to the Instructions for Use for complete handling, precautions, and disposal information.
Instructions and Product Documents
Frequently Asked Questions
What are the External Controls – FOB Rapid Test used for?
The positive and negative external controls are used to help verify proper test procedure and performance of the FOB Rapid Test.
What is included in the control set?
The set includes one 1 mL positive control bottle with a blue cap and one 1 mL negative control bottle with a white cap.
Are the controls ready to use?
Yes. The positive and negative control solutions are supplied ready to use. Follow the manufacturer’s Instructions for Use for the complete control procedure.
Can these controls be used with other FOB rapid tests?
These controls are intended for use with the FOB Rapid Test. The manufacturer states that incompatibilities may occur when the controls are used with test kits from other manufacturers.
How should the FOB controls be stored?
Store the controls at 2°C-30°C (36°F-86°F) and do not freeze them. Follow the manufacturer’s Instructions for Use for complete storage and handling requirements.
When should external controls be run?
The manufacturer’s Instructions for Use directs users to run controls with each new kit lot, each new operator, each new shipment, every 30 days to check storage conditions, and as required by the user’s quality control procedures or applicable requirements.
Are these controls used for patient testing?
No. This product contains external positive and negative control materials used to verify performance of the compatible FOB Rapid Test. It is not itself a patient FOB test.
