Campylobacter Antigen Rapid Test Campylobacter Treatment Test

• Customization: Available
• Type: Detection Card
• Specimen: Human Stool
• Model NO.: HCP032G
• Assay Time: 5-10 Minutes
• Customized: Accpet
• Storage Temperature: 2-30°c
• Payment: T/T, Western Union, Paypal
• Delivery Time: 3~5days After Get Payment
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

Introduction

INTENDED USE
Campylobacter Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Campylobacter spp. antigen in human stool specimen. The test results are intended to aid in the early-stage diagnosis of Campylobacter infection for patients with the symptoms of suspected gastroenteritis caused by the Campylobacter.  



 

Materials

MATERIALS

Materials Provided

Individually packed test devices	Assay buffer tube
Disposable pipettes	Package insert

Materials Required but Not provided

Specimen collection container

Timer

 

Test Procedure

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. 

2. SPECIMEN PREPARATION
3. ASSAY PROCEDURE

3.1 Hold the assay buffer tube upright with the tip point toward the direction away from the test performer, snap off the tip.
3.2. Hold the bottle in a vertical position over the sample well of the test card, deliver 3 drops (120-150 μL) of diluted stool sample to the sample well (S) and start the timer.
3.3. Wait for the colored band(s) to appear. Read the result between 5 - 10 minutes. Do not interpret the result after 10 minutes.

INTERPRETATION OF RESULTS            

    

• POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
  NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).
  INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

Performance

PERFORMANCE CHARACTERISTICS
Table: Campylobacter Antigen Rapid Test vs. Culture  

Method		Culture		Total Results
Campylobacter Antigen Rapid Test	Results	Positive	Negative
	Positive	66	7	73
	Negative	1	325	326
Total Result		67	332	399

Relative Sensitivity: 98.51% (95%CI: 91.25%~>99.99%)  
Relative Specificity: 97.89% (95%CI:95.62%~99.06%) 
Accuracy: 97.99% (95%CI:96.02%~99.05%)


 

Certifications