IMED License

Multiplex EBV / CMV / VZV detection kit

Features:

Simultaneous qualitative detection of 3 viruses: CMV, EBV, and VZV in one vial, including an internal positive control gene, in various clinical samples.

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

Possesses 100% diagnostic sensitivity and specificity.

Description

Multiplex EBV/CMV/VZV PCR Detection Kit (Real-time)

The Multiplex EBV/CMV/VZV Detection Kit is for the simultaneous qualitative detection of Human Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), and Varicella-Zoster Virus (VZV). This kit is supplied in one vial, including an internal positive control gene, for use with various clinical samples.

CMV is a double-stranded DNA virus with the ability to establish persistent and latent infections in humans. Symptomatic CMV disease is of great importance in immunocompromised individuals and can affect almost all body organs. Clinical manifestations include fever of unknown origin (FUO), pneumonia, hepatitis, encephalitis, myelitis, colitis, uveitis, retinitis, and neuropathy.

EBV is one of the most common human viruses, with approximately 90-95% of the adult population having antibodies indicating current or past exposure. The most common clinical manifestation of primary infection with this organism is acute infectious mononucleosis, a self-limiting clinical syndrome that often affects adolescents and young adults. Classic symptoms include sore throat, fever, splenomegaly, and lymphadenopathy. EBV has been reported as the first virus associated with human malignancies, particularly non-Hodgkin lymphoma and nasopharyngeal carcinoma.

VZV is a DNA virus transmitted via airborne droplets or direct contact with skin lesions. Varicella-Zoster virus infection leads to two distinct clinical forms of disease: primary disease or chickenpox, which typically affects children and adults, and secondary infection or shingles, which is rarely seen in children but common in adults. VZV infection causes a mild fever. In children, chickenpox presents with fever and irritability, followed by a large number of vesicular rashes (itchy, maculopapular) that transform into dry, non-infectious crusts over a period of 3 to 7 days. Severe VZV infections involve reactivation of the latent virus, leading to painful skin rashes often accompanied by pain throughout the rash (postherpetic neuralgia), which is characteristic of the disease and frequently observed in immunocompromised patients, and can lead to dangerous complications such as pneumonia and encephalitis.

Amir Pielan Pajoohesh va Tose’eh (AP-RAD) Company has designed and manufactured the EBV/CMV/VZV Multiplex Detection Kit to achieve rapid, sensitive, and specific identification of common human viruses, including Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), and Varicella-Zoster Virus (VZV). This kit is intended for the simultaneous qualitative detection of CMV, EBV, and VZV in a single vial, along with an internal positive control gene, for use with various clinical samples.

اطلاعات کیت
Description Real-Time Amplification Kit with Viral DNA Extraction of Specimen
Method Real-Time
Type Qualitative
Regulatory Status IVD
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, ROX and Cy5 Channels
Result Display Time 1.5hours
Validated Specimens Peripheral Blood
CSF
Skin Vesicles
Sample Volume 5µL
Analytical Sensitivity (Copy/µL)s 0.04 (CMV), 0.03 (EBV) , 0.07 (VZV)
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
REF: AP6PBMRK1
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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
REF: AP5PBPRK1
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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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REF: APMEAVK1
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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