Clinical Diagnostics

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Onar^®Lp-QP - Legionella pneumophila Diagnosis

KIT FOR IN VITRO DIAGNOSIS OF LEGIONELLA PNEUMOPHILA

The Onar^®Lp-QP system is an in vitro test for the qualitative and quantitative diagnosis Legionella pneumophila (Lp) in clinical samples. The test is based on the polymerase chain reaction, and thus providing highly sensitive and approx. 100% specific rapid diagnosis. Onar^®Ls-QP 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-QP is available as a quantitative PCR probe system for use on most real-time instruments (Onar^®Lp-QP ).

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

Test Principle

We deploy Onar^®Lp-QP for the quantitative qPCR.

Onar^®Lp-QP

The Onar^®Lp-QP test systems are in vitro test for the quantitative diagnosis of Legionella pneumophila 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. Onar^®Lp-QP are compatible with the LightCycler^®, Opticon^®, ABI Prism^®, SmartCycler^®, Mx3000pT and other devices.

Detailed clinical studies confirm the high specificity and sensitivity of Onar^®Lp , permitting early identification of clinically significant legionella infections. The selected template is highly preserved within the Legionella species. Cross activity with pharyngeal commensals does not occur. The detection limit fewer than 10 genome equivalents per 5 µl sample volume.

Legionellosis: atypical pneumoniae

A serious cause of disease of atypical pneumoniae is the Legionnaires' disease, the pontiac-fever is not as serious. Pathogens are Legionella species. Apart from L. pneumophila there are many different humanpathogenic species, like: L. bozemanii, L. dumoffii and L. micdadei , L. anisa, L. ainthelensis, L. israelensis, L. birminghamensis, L. jordanis, L. oakridgensis, L. maceachernii, L. tusconensis, L. wadsworthii, L. feelei, L. gormanii, L. longbeachae and L. hackeliae. Even more Legionella species exist and their effect on humans need to be analysed.

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.