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BIOTICA: Bioalarm Legionella Kit,
Pack 10 analysis and suitcase, Order No. 311-10-00

Pack for 10 tests: Order No. 311-10-01
Support with 2 cuvettes, Order No. 311-10-RA

 

The Bioalarm Legionella Kit is a fast and reliable test tool to detect the level of free-living Legionella pneumophila in filterable water samples. Using this kit, it is possible to prevent harmful levels at risk environments for the human health.  

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Download video demo Bioalarm Legionella Kit
FASTER. Time to result is only one hour, faster than culture method that takes 10-15 days (plate cuture).  
     
SIMPLICITY. Biótica is focused on providing the user with bacterial detection systems based on simple and fast analytical protocols. Analysis is carried out simply by following the protocol steps. Protocol Kit.   Fast detection of Legionella Pneumophila in cooling towers by ESTAPOR® immunomagnetic microsphers by Guillermo Rodrígueza, Fabrice Sultanb, Begoña Bedrinaa, and Inmaculada Solísc:

Download publication Medlab Magazine
Issue 2: 28-32, 2010

Download poster: 8th International Conference on the Scientific and Clinical Applications of Magnetic Carriers Rostock, Germany, May 25-29, 2010
   
PREVENTION. Legionella species are naturally present in water environments. Infective levels can be reached in only 2-3 days at colonized installations. Corrective actions adjusted to the actual risk can be taken by the use of the Bioalarm Legionella kit as a fast test.
     
VALIDATED METHODS. The Bioalarm Legionella kit has been validated by two external laboratories ISO 17025, both of them recognized by National Entity of Accreditation accredited by ENAC.
Validation quick guide. 		  SEMIQUANTITATIVE RESULTS. The kit is intended to provide a semi-quantitative meaure of Legionella pneumophila concentration, by comparing the color of the test sample and the colors in the supplied color chart. That way, the range of L. pneumophila concentration can be determined.
     

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WHY TO DETECT Legionella pneumophila? Legionella pneumophila is a main cause of severe atypical pneumonia. It can be found in natural aquatic habitats and anthropogenic ecological niches, such as potable water systems, cooling towers and evaporative condensers. Its presence in this kind of habitat is a danger to human health. Its mortality is 12-15% but it can easily reach 30-50% in immuno-compromised patients. L. pneumophila specie is the most virulent pathogen Legionella species, responsible for 90-98% of the cases. It persists in artificial aquatic environments from where it can be transmitted to humans. L. pneumophila detection in environmental samples is an important challenge to public health.

HOW DOES BIOALARM LEGIONELLA KIT WORK? It is based on the Legionella pneumophila selective capture by magnetic particles that present a capture antibody immobilized on the surface. The Legionella pneumophila-particle complexes obtained, are retained by a magnet, and after a simple wash steps are marked with an antibody to reading, this antibodies give color to add the appropriated reagents.

WHAT TO DETECT THE BIOALARM LEGIONELLA KIT? The Bioalarm kit analyze Legionella pneumophila viable cells because they keep full surface, where the antigens are present and accessible. The culture underestimates the organism concentration because it directs its analysis to the fraction of viable and cultivable (able to growing in laboratory medium). The PCR overestimates the organism concentration because it directs its analysis to the determination of nucleic acids, presents in both viable (cultivable or not), such as damaged or dead cells (not viable), including nucleic acid contaminants.

HOW OFTEN SHOULD BE MONITORED A RISK INSTALLATION BY THE BIOALARM KIT? The Legionella pneumophila can resist adverse conditions (low temperatures, lack of nutrients, biocidas presence, chloration, etc). In these situations it can enter a viable but nonculturable state and not be detectable by culture. If the environmental conditions are favorable, can increase, in only 2-3 days, of a population of 102cfu/L to one of 104cfu/L. Therefore, it's essential to identify the representative point of each installation (tanks, cisterns, showers, taps, towers, condensers, baths, swimming pools, fountains, etc), to establish effective prevention plans that include sampling frequency, the appropriate determinations number and the applicable decision criteria, established by a prevention expert.

CAN THE KIT BIOALARM LEGIONELLA BE USED IN THE SURVEILLANCE AND CONTROL PROGRAMS TO MONITOR Legionella pneumophila? Yes. Ubiquity of the bacterium and also the characteristics of the process, make very difficult to pursuit a total absence of L. pneumophila at risk installations. In fact, proportion of positive samples is considered by some authors as a better risk indicator that the quantification of the bacteria by culture method. A correlation between culture counts and legionellosis cases has not been demonstrated, while a relationship between proportion of positive samples (> 30%) and cases has been reported (Best et al. Lancet 1983; 307-310, Kool JL, et al. Infect Control Hosp Epid 1999; 20:797-05). Kit Bioalarm Legionella can be used to simultaneously analyze a high number of water samples, obtaining in real-time the proportion of positive samples.

WHAT IS THE ADDED VALUE BY THE KIT BIOALARM LEGIONELLA ON THE CULTURE METHOD OF LEGIONELLA PNEUMOPHILA? Isolation of the bacteria by culture technique in selective media is the conventional method used to detect Legionella pneumophila (norm ISO 11731). However, this method requires long incubation times due to the slow growth rate of the bacterium (time to result is (10-14 days). Then, the obtained results represent past information over the Legionella presence in our installation. Moreover, culture do not permits the detection of viable but non-culturable bacteria (VBNC), what still represents a public health hazard, and it is difficult to isolate legionellae in samples containing high levels of other microbiota. In this context, fast detection of Legionella pneumophila at risk environments is needed as a routine control, for example at cooling towers among others, and also in outbreaks. Kit can be used as fast screening method to take opportune actions, before isolating bacterium by culture technique. Fast diagnostic tests are essential to take both corrective and preventive measures, with a periodically verification. A fast and reliable test is a key issue for the surveillance of the quality control and the prevention of the Legionella outbreaks.

HOW DOES FAST DETECTION BY THE KIT BIOALARM COMPLEMENT THE CULTURE OF Legionella pneumophila? Kit Bioalarm Legionella is designed to provide a fast visualization of the Legionella pneumophila level in a filterable water sample. Intensity of the produced color is related with the level of L. pneumophila in the sample. In consequence, the kit provides a very usefull information to the user, as a semi-quantitative significance. For example, it does permit a good estimation of the accomplishment degree of the mandatory regulations.

HOW DO I INTERPRET THE BIOALARM LEGIONELLA RESULTS? The results interpretation is made with a color chart, comparing the sample color obtained and the negative control color with it. If the color of the sample is similar to the negative control, the concentration is below of the detection limit of the Kit. If the color of the sample is higher than the color of the negative control, compare it with the color chart.

The Biolarm Legionella kit provides a useful information for the user, with a semi-quantitative value. It allows a good estimation of the degree of legislation applicable to cooling towers compliance.

Actions for cooling towers and similar devices according to Legionella's concentration (Table 3 RD865/2003)

Legionella (cfu/L) Proposed action
> 100 < 1.000 Review the maintenance program and make the necessary corrections.

> 1.000 < 10.000

 Resampling at 15 days. The maintenance program will be review in order to establish corrective actions to decrease the Legionella's concentration. Cleaning and disinfection according with Annex 4b. To confirm count after 15 days. If the concentration is below of 100 cfu/l, to take a new sample after a month. If the second sample result is <100 cfu/l to continue with the maintenance program. If one of the two previous samples giving values >100 cfu/l, to check the Maintenance program and to introduce the necessary structural reforms. If the concentration sample is higher than 1000 cfu/l, to proceed to realize a cleaning and disinfection according with Annex 4c. and make a new sampling at 15 days.
> 10.000 Stop the installation operation and empty the system if necessary. To clean and to make a shock treatment according with Annex 4c, before restarting the service. And re-sampling at 15 days.

 

Ordering Information:

Reagents

Bioalarm Legionella Kit, Pack 10 analysis and suitcase, Order No. 311-10-00
L0 Used to elute the filter and will be the negative control on each analysis battery 100 ml
L1 Contains inmunoparticule with the Legionella pneumophila antibodies 11 ml
L2 Used in all "washing steps" (objective is to clean the sample) 200 ml
L3 Contains a conjugated antibody specific of L. pneumophila 1 ml X 10 vials
L4 + L5 Works like the substrat of L3. Their degradation is the reason of obtaining colour.  
L4 solid 1,3 mg
L5 liquid 15 ml
L6 Used to stop the degradation colour at the correct moment 4 ml
L7 Used to disinfect the cuvettes 11ml
  1 support with 2 cuvettes  
  Cooling plate 1
  Suitcase to transport 1
 

Pack for 10 tests: Order No. 311-10-01
Contains reagents L0 to L7
 

Support with 2 cuvettes, Order No. 311-10-RA


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