Clinical Diagnostics

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Onar^®Ls - Legionella species Diagnosis

KIT FOR IN VITRO DIAGNOSIS OF LEGIONELLA SPECIES

Onar^®Ls system is an in vitro test for the qualitative and quantitative diagnosis of Legionella species (Ls) in clinical samples. The test is based on the polymerase chain reaction, and thus providing highly sensitive and approx. 100% specific rapid diagnosis. Onar^® is CE-marked and approved for in vitro clinical diagnostics. The test system has undergone extensive internal validation, as well as external clinical evaluations. Onar^®Ls is available as a conventional PCR assay with result evaluation by agarose gel, as well as a quantitative PCR probe system for use on most real-time instruments (Onar^®Ls Type 1 & Type 2).

Ordering

>>> Ordering Information

Instrument Compatibility

+ = recommended kit version
– = not compatible
o = untested but presumed to be compatible
V = validated

Benefits

• Highly sensitive
  Detection of fewer than 10 legionella particles per sample volume.
• Highly specific
  for Legionella species: serogroups 1-14 and SG 16 of Legionella pneumophila, as well as other human pathogenic species of legionella like: L. longbeachae, L. dumoffii, L. bozemanii, L. gormanii, L. anisa, L. cherrii, L. parisiensis, L. tucsonensis, and L. wadsworthii or for Legionella pneumophila
• Reliable
  The kit contains a positive control DNA, and a specific internal control probe for optional PCR quality check.
• Ease of use
  Onar^® allow convenient testing of clinical samples. The easy to follow step-by-step protocol does not require an experienced molecular biologist.
• Convenient
  Reagents aliquoted for 25 reactions for convenient periodic or routine testing.
• Validated
  Clinically and technically validated according to the European In Vitro Diagnostic Directive.
• Results are easily determined

Test Principle

We deploy Onar^®Ls for the qualitative conventional PCR and Onar^®Ls Type 1 & Type 2 for the quantitative qPCR.

Onar^®Ls

The Onar^®Ls test system is an in vitro test for the qualitative diagnosis of legionella in clinical samples. The test is based on the polymerase chain reaction and allows rapid diagnosis of legionella infections. The supplied primerset is specific for a segment of the 16S rRNA region of the legionella genome. The amplified PCR product is approx. 244 bp long and can be rendered visible directly in the agarose gel. The internal control amplicon is 150 bp in size.

Onar^®Ls Type 1 & Type 2

The Onar^®Ls test systems are in vitro test for the quantitative diagnosis of legionella in clinical samples. The supplied primerset and probe are specific for a segment of the 16S rRNA region of the legionella genome. The specific target probe emits fluorescent light at 520 nm. By using the supplied internal control, false-negative results, e.g. due to inhibition of the reaction by the sample matrix, can be excluded individually for each sample. The internal control is detected by another probe emitting fluorescent light at 600 nm.

Background

Legionella spp. ubiquitously colonizes surface water and wet soil, and are the cause of the Legionnaires`disease. Transmission is aerogenic. Typical symptoms are high fever, cough, thorax ache, diarrhea, discomposure, sometimes with heavy progression. The incubation period of Legionnaires' disease is from two to ten days. If the patient is treated with appropriate antibiotics near the onset of pneumonia, the outcome is excellent, especially if the patient has no underlying illness that compromises his/her immune system. For patients whose immune systems are compromised, including transplant recipients, delay of appropriate therapy can result in prolonged hospitalization, complications, and death. The fatality rate of Legionnaires' disease is up to 30%. For those patients who are discharged from the hospital, many will experience fatigue, loss of energy, and difficulty concentrating for several months after discharge from the hospital.

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 legionella (Cat. No. 53-0200).

Onar^® 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.