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Clinical Diagnostics

 
 

Onar®Ls - Legionella species Diagnosis

KIT FOR IN VITRO DIAGNOSIS OF LEGIONELLA SPECIES

 

and

 

Onar®Lp - Legionella pneumophila Diagnosis

KIT FOR IN VITRO DIAGNOSIS OF LEGIONELLA PNEUMOPHILA

 

 

 

The Onar® system is an in vitro test for the qualitative and quantitative diagnosis of Legionella species (Ls) or 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® 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-QP and Onar®Lp-QP ).



Ordering

Version

Onar®Ls

Tests

25

100

250

Cat. No.

21-1025

21-1100

21-1250

Availability

yes

yes

yes

Devices

agarosegel


Version

Onar®Ls-QP

Tests

25

100

250

Cat. No.

21-2025

21-2100

21-2250

Availability

yes

yes

yes

Devices

real-time PCR cycler


Version

Onar®Lp-QP

Test

25

100

250

Cat. No.

21-3025

21-3100

21-3250

Availability

yes

yes

yes

Devices

real-time PCR cycler

  Onar®Lp - Legionella species Diagnosis


Download

Document Size
Onar®Ls Protocol 476 kb
Onar®Ls-QP Protocol 476 kb
Onar®Lp-QP Protocol 678 kb
MSDS 27 kb
LightCycler® 480 875 kb
Rotor-GeneTM 6000 235 kb

 


Certificate of Analysis

You will find Your CoA of Your specific lot ins the menu below. [Download available as PDF-file].

 
   

 

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®Lp-QP and Onar®Lp-QP for the quantitative real-time PCR.

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-QP/Onar®Lp-QP

The Onar®Ls/Lp-QP 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. Onar®Ls/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.

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.

     
           
 
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