IMED License

Clostridium difficile Multiplex Detection Kit

Features:

  • Results obtained in the shortest possible time (90 minutes)

  • Detection of C. difficile bacteria and differentiation of Toxin A and Toxin B producing strains in two reactions

  • 100% diagnostic sensitivity and specificity

  • Contains internal, positive, and negative controls to confirm the extraction process and PCR test

Description

Clostridium difficile Multiplex Real Time PCR Kit | Clostridium difficile Multiplex Detection Kit

The bacterium Clostridium difficile (C. difficile) is a gram-positive, spore-forming, double-stranded DNA pathogen that can cause a spectrum of clinical symptoms ranging from mild diarrhea to severe diarrhea and more serious diseases such as pseudomembranous colitis and severe large intestine inflammation. This bacterium is the most common cause of healthcare-associated infectious diarrhea in hospitals and medical centers and plays a significant role in increasing patient hospitalization duration and mortality.

C. difficile infection primarily occurs in patients following long-term or high-dose use of certain antibiotics. These drugs disrupt the microbiome balance by eliminating the normal flora and beneficial gut bacteria, creating conditions for the overgrowth of C. difficile. During the proliferation of this bacterium in the intestine, pathogenic toxins Toxin A and Toxin B are secreted, which damage the intestinal epithelial cells, causing diarrhea, inflammation, and in severe cases, tissue necrosis. However, in some individuals, the presence of the bacterium occurs without clinical symptoms, and the person is considered an asymptomatic carrier.

Given the importance of rapid and accurate detection of C. difficile infection and the decisive role of Toxin A and Toxin B in disease severity, ap-rad has designed and manufactured the Clostridium difficile Multiplex Real Time PCR Kit. This kit enables the simultaneous, rapid, sensitive, and specific detection of C. difficile bacteria and the genes associated with Toxin A and Toxin B, aiding in its precise differentiation from other intestinal bacteria. This plays an effective role in early diagnosis, appropriate treatment decision-making, and the control of hospital-acquired infections.

اطلاعات کیت
Description Real-Time Amplification Kit with Bacterial DNA Extraction of Specimen
Method Real-Time
Type Qualitative
Regulatory Status RUO
Storage & Transfer Condition (˚C) 20-
Number of Reactions 25 & 50
Controls Positive & Negative
Applicable Instruments All Type of Real-Time PCR Machines with FAM, JOE and ROX Channels
Result Display Time 1.5hours
Validated Specimens Stool
Sample Volume 10µL
Analytical Sensitivity (Copy/µL)s 2.6Copy/µL
Analytical Specificity 100%
Clinical Sensitivity 100%
Clinical Specificity 100%
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Detection Capability:

  • Mycoplasma (M. hominis / M. genitalium)
  • Chlamydia trachomatis
  • Ureaplasma (U. urealyticum / U. parvum)
  • Herpes simplex virus 2 (HSV-2)
  • Herpes simplex virus 1 (HSV-1)
  • Trichomonas vaginalis
  • Treponema pallidum
  • Neisseria gonorrhoeae
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Detection of 10 bacteria including:

  • Streptococcus pneumoniae
  • Staphylococcus aureus
  • Haemophilus influenzae
  • Mycoplasma pneumoniae
  • Chlamydia pneumoniae
  • Legionella pneumophila
  • Pseudomonas aeruginosa
  • Klebsiella pneumoniae
  • Bordetella pertussis
  • Bordetella parapertussis

and one fungus including:

  • Pneumocystis jirovecii
6-Plex Bacterial Meningitis
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6-Plex Bacterial Meningitis-AP6PBMRK1 includes:

  • Streptococcus pneumoniae
  • Neisseria meningitidis
  • Haemophilus influenzae
  • Escherichia coli
  • Listeria monocytogenes
  • Streptococcus agalactiae (GBS)
5 Bacterial Pneumonia Detection Real Time PCR Kit
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Detection capability for five pneumonia bacteria including:

  • Streptococcus pneumoniae
  • Staphylococcus aureus
  • Haemophilus influenzae
  • Klebsiella pneumoniae
  • Pseudomonas aeruginosa
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  • Results obtained in the shortest possible time (2 hours)
  • 100% diagnostic sensitivity and specificity
  • Performed in a one-step reaction (no need for cDNA synthesis)
  • Contains internal, positive, and negative controls to confirm the extraction process and PCR test
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  • Results obtained in the shortest possible time (2 hours)
  • 100% diagnostic sensitivity and specificity
  • Performed in a one-step reaction (no need for cDNA synthesis)
  • Contains internal, positive, and negative controls to confirm the extraction process and PCR test