You are here: BD › Diagnostic Systems › Product Center › Direct Testing/Serology › BD™ C. difficile Test Kits › ColorPAC™ Toxin A Test Kit
Product Center

ColorPAC™ Toxin A Test Kit
Cat. # Desc. Qty. Unit
274030 ColorPAC™ Toxin A Test Kit 1 EA
Product Image (select to enlarge)
Product Image
Intended Use:

ColorPAC™ Toxin A Test is a rapid chromatographic assay for the qualitative detection of Clostridium difficile toxin A (enterotoxin) in stool specimens from patients suspected of having C. difficile-associated disease. The test can also be used for confirmation of suspect colonies of toxigenic C. difficile from agar plates or BHI broth. This assay is intended for use as an aid in the diagnosis of C. difficile-associated disease.

Catalog # Description Quantity Unit
274030 ColorPAC™ Toxin A Test Kit
(30 tests) C. difficile Toxin A Test containing: one bottle Sample Buffer, Reagent 1 , one bottle Detector A, Reagent 2 , one bottle Detector B, Reagent 3 , one bottle Wash Reagent, Reagent W , one bottle Positive Control Control+ , one bottle Negative Control Control- , 30 Test Devices , 30 SQ-EASYyytubes and fiber tips , 30 applicator sticks , 30 transfer pipets , 1 dropper rod
 1 EA


Click Image to Enlarge
 
BD ColorPAC™ Toxin A
Revision: 0806    Revision Date: 08/01/2006   
Intended Use: «

ColorPAC™ Toxin A Test is a rapid chromatographic assay for the qualitative detection of Clostridium difficile toxin A (enterotoxin) in stool specimens from patients suspected of having C. difficile-associated disease. The test can also be used for confirmation of suspect colonies of toxigenic C. difficile from agar plates or BHI broth. This assay is intended for use as an aid in the diagnosis of C. difficile-associated disease.

Intended Use: » Intended Use:

ColorPAC™ Toxin A Test is a rapid chromatographic assay for the qualitative detection of Clostridium difficile toxin A (enterotoxin) in stool specimens from patients suspected of having C. difficile-associated disease. The test can also be used for confirmation of suspect colonies of toxigenic C. difficile from agar plates or BHI broth. This assay is intended for use as an aid in the diagnosis of C. difficile-associated disease.

Product Summary: «

C. difficile is an important cause of antibiotic-associated diarrhea, which in its most serious form can result in the clinical syndrome of pseudomembranous colitis with significant mortality. Although C. difficile may be part of the normal bacterial intestinal flora, it may become an opportunistic pathogen following the patient's treatment with antibiotics and subsequent alteration of the normal intestinal flora. Under the proper conditions, toxin-producing strains of C. difficile produce two toxins: toxin A, a tissue damaging enterotoxin, and toxin B, an in vitro cytotoxin.1 The literature indicates that both toxin A and toxin B are produced at the same time.2 The clinical symptoms associated with the disease are thought to be mainly due to toxin A, and to date, there is not convincing evidence that toxin B has any important biological activity in naturally-occurring disease.3

The most common clinical diagnostic aids for C. difficile antibiotic-associated colitis have been cell culture cytotoxicity assays (CTA), latex agglutination (LA), and enzyme immunoassays (EIA).4 CTA detects toxin B through the cytopathic effect on cell culture and requires one to two days to complete. Latex agglutination detects the antigens of C. difficile rather than the specific toxins, but is regarded as a valuable rapid assay in establishing whether there is an etiologic role for C. difficile in patients with diarrhea.5 Microwell enzyme immunoassays can detect toxin A, or in some cases, both toxin A and toxin B simultaneously.6

Product Summary: » Product Summary:

C. difficile is an important cause of antibiotic-associated diarrhea, which in its most serious form can result in the clinical syndrome of pseudomembranous colitis with significant mortality. Although C. difficile may be part of the normal bacterial intestinal flora, it may become an opportunistic pathogen following the patient's treatment with antibiotics and subsequent alteration of the normal intestinal flora. Under the proper conditions, toxin-producing strains of C. difficile produce two toxins: toxin A, a tissue damaging enterotoxin, and toxin B, an in vitro cytotoxin.1 The literature indicates that both toxin A and toxin B are produced at the same time.2 The clinical symptoms associated with the disease are thought to be mainly due to toxin A, and to date, there is not convincing evidence that toxin B has any important biological activity in naturally-occurring disease.3

The most common clinical diagnostic aids for C. difficile antibiotic-associated colitis have been cell culture cytotoxicity assays (CTA), latex agglutination (LA), and enzyme immunoassays (EIA).4 CTA detects toxin B through the cytopathic effect on cell culture and requires one to two days to complete. Latex agglutination detects the antigens of C. difficile rather than the specific toxins, but is regarded as a valuable rapid assay in establishing whether there is an etiologic role for C. difficile in patients with diarrhea.5 Microwell enzyme immunoassays can detect toxin A, or in some cases, both toxin A and toxin B simultaneously.6

User Quality Control: « User Quality Control:

The liquid Control + and Control – should be tested when opening each new kit to verify performance of the reagents and test device. Add 2 drops of the Control + or Control – to the sample well. Allow to absorb for 3 min. Proceed to step 2 under "Assay Procedure".

Optional:   Dilution of the Control + with Reagent 1 may be performed and tested to demonstrate a weaker positive reaction as follows:  
  1. Add 1.5 mL of Reagent 1 (Sample Buffer) and one free-falling drop of Control + to a test tube. Mix gently.  
  2. Add 1.0 mL of Reagent 1 (Sample Buffer) to an SQ-EASY tube.  
  3. Using a transfer pipet, transfer 0.5 mL of diluted Control + from the first tube into the SQ-EASY tube.  
  4. Cap the SQ-EASY tube with a filter tip. Ensure that filter snaps into place.  
  5. Vortex the tube for 15 sec at high speed. The diluted sample is now ready for use. Proceed to "Assay Procedure".  

The ColorPAC Toxin A device contains two built-in controls. The appearance of a pink control line in the Assay Window (area "C") provides an internal positive control that validates the immunological reactivity of the device, proper detection reagent function and proper flow characteristics. The membrane area (background) functions as the internal negative control which assures that non-specific color development does not interfere with the test result.

Quality control requirements must be performed in accordance with applicable local, state and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control procedures. It is recommended that the user refer to pertinent CLSI guidance and CLIA regulations for appropriate Quality Control practices.

Patient results should not be reported if positive and negative controls do not yield appropriate results.


Reagents: « Reagents:

ColorPAC Toxin A Test Kit:

Reagent 1   (30.0 mL)   Sample Buffer: Buffered saline with a mucolytic agent, 1% detergent.
Reagent 2   (1.5 mL)   Detector A: Rabbit C. difficile toxin A antibody-coated liposomes.
Reagent 3   (1.5 mL)   Detector B: Rabbit antibody-coated liposomes specific for Detector A.
Reagent W   (2.3 mL)   Wash Reagent: Buffered saline solution with bovine protein stabilizer, 0.1% detergent.
Control +   (1.0 mL)   Positive Control: Buffered saline solution with bovine protein stabilizer, inactivated C. difficile toxin A.
Control –   (1.0 mL)   Negative Control: Buffered saline solution with bovine protein stabilizer.
Reagents and controls each contain 0.2% sodium azide (preservative).
30 Test Devices     Each containing a test strip coated with monoclonal C. difficile toxin A antibody and C. difficile toxin A.

30 SQ-EASY™ Tubes and Filter Tips.

30 each Applicator Sticks and Transfer Pipets.

1 Dropper Rod


Warnings and Precautions: « Warnings and Precautions:

For in vitro Diagnostic Use.

Reagents: Upon receipt, refrigerate the kit or remove the carton of reagents requiring refrigeration and store at 2 – 8°C. DO NOT FREEZE. Reagents should be recapped immediately and returned to refrigeration when not in use, taking care not to mix color-coded caps. Do not use beyond the expiration date. Upon removal from the refrigerator, allow reagents to warm to room temperature before use. Avoid prolonged exposure of reagents to strong light.

Do not interchange, mix, or combine reagents and devices from different kit lots.

To assure proper drop delivery, hold the reagent dispensing bottle vertically, dispensing one free-falling drop at a time.

Warning: Reagents contain sodium azide. Very toxic by inhalation, in contact with skin, and if swallowed. Contact with acids liberates very toxic gas. After contact with skin, wash immediately with plenty of water. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. On disposal, flush with a large volume of water to prevent azide build-up.

Test Devices: Do not remove test device from pouch until just prior to use. Store unopened devices at room temperature (15 – 30°C) or refrigerate (2 – 8°C) if desired. Do not expose unused devices to repeated cycling between refrigerated and room temperatures. Single use; do not reuse.

Controls: Do not use the kit if the positive and negative controls do not yield appropriate results. The positive control is made with inactivated C. difficile toxin A and should be handled as potentially hazardous material.

Transfer Pipets: Single use; do not reuse.

Filter Tips: Tip must contain white filter material to ensure proper test performance. Single use; do not reuse. Ensure that the filter tip snaps into place so that the top rim of the filter tip is flush with the top of the SQ-EASY tube.

Warning: Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. "Standard Precautions"7-10 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids.

Dispose of all materials used in performing the test into a receptable approved for biohazardous waste. The samples may be autoclaved for 60 min at 121°C or by treatment with a 0.05% solution of sodium hypochlorite (1:100 dilution of household bleach) for 30 min. Do not autoclave materials containing sodium hypochlorite.



Information shown on this page is a short summary extracted from the Package Insert, available as a PDF under the Related Documents section of this page.