Clostridium Dificile Gdh, Toxin a and Toxin B Combo Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HCDT067G
• Breathing Pattern: None
• Animal Anesthesia Machine Control Method: None
• Assay Time: 5-10 Minutes
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Accpet
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

INTENDED USE
The Clostridium difficile GDH, Toxin A and Toxin B combo Rapid Test is a test for the detection of glutamate dehydrogenase antigen and toxins A and B. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile, and confirms the presence of toxigenic C. difficile by detecting toxins A and B in stool specimens from people suspected of having C. difficile which is a difficult disease. The test will serve as an adjunct to the diagnosis of clostridium difficile. As with other C. difficile tests, the results should be considered in conjunction with the patient's medical history.

MATERIALS

Materials Provided

Individually packed test devices	Package insert
Specimen collection tubes with extraction buffer
Materials Required but Not provided
Specimen collection containers	Timer

 

TEST PROCEDURE

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.
2. SPECIMEN PREPARATION:

Unscrew the cap of the specimen collection tube, then randomly stab the sampling rod into the stool specimen in at least 3 different sites to collect approximately of feces (equivalent to 1/4 of a pea). Hold the Specimen collection tubes with extraction buffer vertically, insert the sampling rod, squeeze the bottom of the tube. Mix stool specimen with the buffer thoroughly by shaking the bottle for a few seconds.

1. ASSAY PROCEDURE:

• Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Leave the tube alone for 2 minutes.
• Remove the small lid at the top.
• Hold the bottle in a vertical position over the sample well of the test card, deliver 3 drops (about 90μl) of diluted stool sample to the sample well (S) and start the timer.

Note: Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the result area in the center of the device.

• Wait for the colored band(s) to appear. Read the result between 5-10 minutes. A strong positive sample may show result earlier. Do not interpret the result after 15 minutes. As the test begins to work, color will migrate across the result area in the center of the device

 

        INTERPRETATION OF RESULTS            

    

• Positive (+) : Two purple red bands appear. One is located in the detection area (T), the other is located in the quality control area (C). 
• Note: The purple red band in the detection area (T) can show the phenomenon of dark and light color. However, during the specified observation time, regardless of the color of the band, even very weak band should be interpreted as a positive result.
• Negative (-) : Only a purple red band appears in the quality control area (C). No purple red bands were found in the detection area (T). A negative result indicates no Clostridium difficile infection.
• Invalid: No purple red band in quality control area (C). Indicates incorrect operation or deterioration of the test. In this case, read the instructions carefully again and retest with a new test. If the problem persists, you should immediately stop using the batch number and contact your local supplier.
• Clostridium difficile Toxin A and Toxin B
• 
• Toxin A Positive : The colored line in the control line region (C) appears, and a colored line appears in test line region T1. The result is positive for Clostridium difficile Toxin A and is indicative of Clostridium difficile infection.
• Toxin B Positive: The colored line in the control line region (C) appears, and a colored line appears in test line region T2. The result is positive for Clostridium difficile Toxin B and is indicative of Clostridium difficile infection.
• Toxin A&B Positive:The colored line in the control line region (C) appears, and two colored lines should appear in test line regions T1 and T2. The color intensities of the lines do not have to match. The result is positive for Toxin A & Toxin B and is indicative of Clostridium difficile infection.
• Negative (-) : Only a purple red band appears in the quality control area (C). No purple red bands were found in the detection area (T1) and (T2). A negative result indicates no Clostridium difficile infection.
• Invalid: No purple red band in quality control area (C). Indicates incorrect operation or deterioration of the test. In this case, read the instructions carefully again and retest with a new test. If the problem persists, you should immediately stop using the batch number and contact your local supplier.

PERFORMANCE CHARACTERISTICS

PERFORMANCE CHARACTERISTICS

Clinical Sensitivity, Specificity and Accuracy

The Clostridium difficile GDH, Toxin A and Toxin B combo Rapid Test used PCR as the reference method. The results showed that the Clostridium difficile GDH, Toxin A and Toxin B combo Rapid Test had high sensitivity and specificity.
Table: Clostridium difficile GDH Antigen Rapid Test vs. RT-PCR  

Method		RT-PCR		Total Results
Clostridium difficile GDH Antigen Rapid Test	Results	Positive	Negative
	Positive	120	3	123
	Negative	6	312	318
Total Result		126	315	441

Relative Sensitivity: 95.24% (95%CI: 89.92%~98.23%)
Relative Specificity: 99.05% (95%CI: 97.24%~99.80%) 
Accuracy: 97.96% (95%CI: 96.16%~99.06%)
Table: The Clostridium toxin A Antigen Rapid Test vs. RT-PCR  

Method		RT-PCR		Total Results
Clostridium toxin A Antigen Rapid Test	Results	Positive	Negative
	Positive	111	5	116
	Negative	9	109	118
Total Result		120	114	234

Relative Sensitivity: 92.50% (95%CI: 86.24%~96.51%)
Relative Specificity: 95.61% (95%CI: 90.06%~98.56%) 
Accuracy: 94.02% (95%CI: 90.17%~96.69%)
Table: The Clostridium toxin B Antigen Rapid Test vs. RT-PCR  

Method		RT-PCR		Total Results
Clostridium toxin B Antigen Rapid Test	Results	Positive	Negative
	Positive	99	4	103
	Negative	4	114	118
Total Result		103	118	221

Relative Sensitivity: 96.12% (95%CI: 90.35%~98.93%)
Relative Specificity: 96.61% (95%CI: 91.55%~99.07%) 
Accuracy: 96.38% (95%CI: 87.43%~95.10%)