iris tech

iris technologies international gmbh

Onar® Ls:
Legionella species for conventional PCR

 

Cat.-No. 21-1025      25 Tests
Cat.-No. 21-1100      100 Tests
Cat.-No. 21-1250      250 Tests

Description
The Onar®Ls system is an in vitro test for the qualitative diagnosis of Legionella spe cies 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 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 system is an in vitro test for the qualitative 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.

Specificity:
Legionella species
Legionella pneumophila
Legionella bozemanii
Legionella dumoffii
Legionella micdadei
Legionella anisa
Legionella ainthelensis
Legionella israelensis
Legionella birminghamensis
Legionella jordanis
Legionella oakridgensis
Legionella maceachernii
Legionella tusconensis
Legionella wadsworthii
Legionella feelei
Legionella gormanii
Legionella longbeachae
Legionella hackeliae

Sensitive
Detection of less than 10 legionella par ticles per sample volume.

Specific
for Legionella pneumophila serogroups 1-14 and SG 16, as well as other human pathogenic species of legionella.

Reliable
The kit contains a positive control DNA, and a specific internal control probe for optional PCR quality check.

Convenient
The convenient master mix format only requires a few pipetting steps.

Validated
Clinically and technically validated according to the European In Vitro Diagnostic Directive.

Background
A serious cause of disease of atypical pneumoniae is the Legionnaires’ disease, the pontiac-fever is not as serious. Pathogens are vari ous Legionella species. Apart from L. pneumophila there are many dif ferent human pathogenic species (see page 44). Even more Legionella species exist and their effect on hu mans need to be analysed. Legionella ubiquitously colonizes sur face water and wet soil. 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 ap propriate antibiotics near the onset of pneumonia, the outcome is excellent, especially if the patient has no under lying illness that compromises his/her immune system. For patients whose immune systems are compromised, in cluding transplant recipients, delay of appropriate therapy can result in pro longed hospitalization, complications, and death. The fatality rate of Legion naires’ disease is up to 30 %. For those patients who are discharged from the hospital, many will experience fatigue, loss of energy, and difficulty concentrat ing for several months after discharge from the hospital.

Test Principle

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 primer set is specific for a segment of the 16S rRNA region of the legionella genome. The amplified PCR product is approx. 245 bp long and can be rendered visible directly in the agarose gel. The internal control amplicon is 150 bp in size. Detailed clinical studies confirm the high specificity and sensitivity of Onar®Ls, permitting early identification of clinically significant legionella infec tions. The selected template is highly preserved within the Legionella species. Cross reactivity with pharyngeal com mensals does not occur. The detection limit is approx. 10 genome equivalents per sample volume.

 
Fig. Amplified PCR products are visualized by standard gel electrophoresis. A sample containing Legionella pneumophila will produce a distinct 245 bp band. The internal control will produce a 150 bp band. The internal control band is less visible with samples of strong infections.

 

Kit Components

• primer sets and nucleotides at opti-mized concentrations
• 10x reaction buffer optimized for MB Taq DNA Polymerase Only purified DNA and Taq polymerase needs to be added.

Note: Venor®Mp is validated and recommended for use with our reliable hot-start MB Taq DNA Polymerase (Cat.-No. 53-0200).

 

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