Clinical Diagnostics

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Venor^®Mp & Venor^®Mp-QP - PCR Detection Kits

KIT FOR IN VITRO DIAGNOSIS OF MYCOPLASMA PNEUMONIAE

The Venor^®Mp system is an in vitro test for the qualitative and quantitative diagnosis of Mycoplasma pneumoniae in clinical samples. The test is based on the polymerase chain reaction, and thus providing highly sensitive and 100% specific rapid diagnosis. Venor^®Mp is CE marked and approved for in vitro clinical diagnostics. The test system has undergone extensive internal validation, as well as external clinical evaluations.

Venor^®Mp is available as a conventional PCR assay with result evaluation by agarose gel, as well as a quantitative PCR probe system for use on all real-time instruments (Venor^®Mp-QP).

Ordering

Benefits of Venor^®Mp

• Highly sensitive
  Detection of fewer than 5-10 Mycoplasma pneumoniae particles per sample volume.
• 100% specific
  The primers used in the Venor^®Mp kit were selected to exclusively amplify Mycoplasma pneumoniae subtype I and II DNA encoding the P1 adherent protein.
• Designed for single and routine diagnostics
  Venor^®Mp contains optimized PCR reagents with the primers and nucleotides aliquoted for 25 reactions, which conveniently allows for testing to be performed periodically or routinely.
• Reliable
  The kit contains internal control DNA as an optional PCR quality check and positive control DNA to optimize reproducibility and minimize operator-dependent variability of results.
• Fast and easy
  Venor^®Mp allows convenient testing of patient samples within 5 hours. The easy to follow step by step protocol does not require an experienced molecular biologist. Venor^®Mp-QP allows testing within 1 hour.
• Excellent detection range
  The detection range of the assay is 5 to 10⁷ copies of Mycoplasma pneumoniae genome.
• Samples are easily prepared
  Templates for PCR analysis are prepared by DNA extraction from throat swabs, sputum, bronchoalveolar lavage, pleural fluid, or lung biopsies.
• Results are easily determined
  A "Yes" or "No" result is obtained with one PCR reaction. Venor^®Mp-QP allows the accurate quantitation of the pathogen concentration.

Test Principle

The Venor^®Mp Mycoplasma pneumoniae diagnostic kit uses specific primers to amplify a 207 bp nucleotide sequence within the highly conserved and multiple copy P1 cytadhesin gene. Various standard DNA preparation methods can be used for extraction of microbial DNA from respiratory samples followed by Venor^®Mp PCR amplification. The amplicon is detected by standard agarose gel electrophoresis. To rule out the presence of PCR inhibitors in the patient specimen, an internal control is included in the kit. When there is no target DNA in the sample, a positive result from the internal control demonstrates that the PCR worked.

Quantitative and qualitative PCR assays: We deploy Venor^®Mp for the qualitative conventional PCR or Venor^®Mp-QP for the quantitative real-time PCR. Venor^®Mp-QP is compatible with the LightCycler^®, Opticon^®, ABI Prism^®, SmartCycler^®, Mx3000 p^® and other devices.

Background

Mycoplasma pneumoniae is a continual source of upper respiratory infections throughout the year and accounts for about 20% of community acquired pneumonias. The spread increases within closed populations to 80%. The incidence of infection is greatest in older children, adolescents, and young adults. The initial presenting symptoms of M. pneumoniae infection after a 2-3 week incubation period may include cough, fever, malaise, chills, sore throat, and headache. Asymptomatic infections account for about 20% of cases. Mycoplasma pneumoniae infections tend to be more chronic and indistingishable from viral causes and other atypical pathogens on the basis of clinical symptoms alone. Thus, in many clinical settings, accurate and rapid diagnosis is important for an efficient patient management. Diagnosis of acute infections is usually based on culture and serology, known to be difficult by means of insensitivity, delayed detection, and poor specificity. Venor^®Mp Mycoplasma pneumoniae diagnostic kit incorporates the highly-sensitive PCR technology and overcomes all drawbacks of these other techniques with its unique features.

Kit Components

• primer sets and nucleotides at optimized concentrations
• positive control for easy result verification
• internal control to ensure accurate testing
• instruction manual
• storage box
  

We highly recommend our reliable hot-start MB Taq DNA Polymerase for extreme sensitive PCR detection of mycoplasma (Cat. No. 53-0200).

Venor^®Mp kit components are lyophilized and at +2 bis +8 °C maintainable for at least 12 months. Primer and nucleotides are aliquoted (á 25 tests) to guarantee consistent quality. After rehydratisation the reagents must be stored at -18 °C.