The test operates via a Lateral Flow Immuno-Chromatographic Assay (LFICA).

Each Systems Test Kit contains the following:

 •5Individuallyfoil-wrappedtests--eachcontainsanexactvolumepipette

 •5HollowFiberFilters

 •5SyringeswithRecoveryBuffer

 •1SampleCollectionBottle

 •1Samplepointpipeadapter

 •Instructionsforuse

This test is intended for analysis of water samples only. This product is not intended for clinical or medical

diagnostic use.

Thetesthasbeenvalidatedforsamplesthatlterinlessthan10minutes.Samplesrequiringmorethan10min-

utestoltermaygiveerroneousresults.Samplesthatrequirelongtimestosamplemaybeindicativeofpoor

systemmaintenance.Awiderangeofnon-oxidizingbiocidesandbiodispersantshavebeencheckedforcross

reaction and inference with the test. This test should not be used on systems treated with biguanide or

THPS based biocides!

PerformanceofthetestwithsamplesotherthanthosetakenfromCoolingTowers,DomesticHot&Coldwater

systemsandWhirlpoolspashasnotbeenestablished.

Thetest,lter,syringeandcapscannotbereusedorrecycled.Thepackagingmaterialsandthisinstruction

Laboratoryanalysishasdemonstratedthat98-100%(91%Cl)oftestsarepositiveforcleanwatersamples

containing100CFU/LiterLegionella pneumophilaserogroup1.Thetheoreticalmathematicallimitofdetec-

tionofthetestisequivalent100CFU/Lwhena250mlsampleisltered.Ifsmallervolumesareprocessed,the

detectionlimitwillbealteredaccordingly:

Suspendedsolidcontentinthewatersamplesimpactsltrationandtestperformance,includinganalyticalsen-

sitivity.Acutualresultswillvary.Watersampleswithhighlevelsofsuspenedsolidsmayblockltrationentirely.

Legionella pneumophilaserogroup1bacteriarecoveryfromwatersamplescanrangefrom<10to100%,

dependingonwatersamplecomposition.Thisissimilartoltrationconcentrationtechniquestusedinother

sample.Largesystemsmayneedtobesampledandtestedatmultiplelocations.Attachthesamplepoint

adaptertothepointinthesystemtobetested.Itisrecommendedthatasamplepointadapterbettedand

retained to each sample point to avoid cross contamination. The sample line pressure should not exceed 6

bar (87 psi).

Disconnectthelterfromthesamplepointadapterbytwistingthelockringandpullingthelterfromthet-

ting.Removethewhitescrewcapfromthelterandreplaceitontheoppositeendofthelter.

 •Pullthesyringebacktothe0.5mlmarktosuspendtherecoverybuffer,thenpushthesyringeall

 thewaytothe0mlmark.

 •Repeatthisprocesstwo(2)additionaltimes.

Beforeuse,thetestshouldhave2palebluelinesacrosstheresultwindow.Ifthesearenotpresent,notifyyour

suppliertoreplacethetestkit.Takethepipettefromthefoilwrapping.

Placethesyringeoverthesmallsamplewindowattheendoftheteststrip,andpresstheplungersothat0.1ml

of sample is dispensed onto the test strip. Record the time.

Leavetheteststripsittingonaatsurfaceduringincubation.Foroptimumresultsthetestresultsshouldbe

performed at room temperature. After waiting 25 minutes, examine the test strip in good lighting. If the

testisnotreadwithin60minutesofaddingthewatersample,itshouldbediscardedandanewtestshouldbe

run. The test should show one of the following results on the large result window on the test strip:

Negative Result:One(1)REDlineacrosstheresultwindowattheendfurthestfromthesamplewindow.

Beforetakingthesample,ushthesampleportfor15seconds.Attachtheltertothesamplepointadapter;

pushtheopenendofthelterintotheplasticluerttingandtwistthelockingringtosecure.Holdthesample

collectionbottleundertheoutletportofthelter.

Openthesystemvalvetoallowtheltrationtostart,lter250mlofthewaterandcloseoffthevalve.

Ifthesampletakeslongerthan10minutestolter,thenstoptheltrationprocessandmeasuretheamountof

liquidinthecollectionbottlebeforeproceedingtothenextstep(thedetectionlimitwillbeaffected,seLimitof

Detectionsection).

Positive Results:

A positive test result indicates that Legionella pneumophilaserogroup1bacteriawerepresentinthesample

abovethedetectionlimit.

Thetestdoesnotdifferentiatebetweenviable(living)andnon-viable(dead)organisms.Thetestwilldetectvi-

ablebutnon-cultruablebacteriawhicharenotdetectablebytraditionallaboratorytechniques.Apositiveresult

doesnotnecessarilymeanthatviablebacteriaarepresent.

AnegativeresultdoesnotmeanthatthesystemiscompletelyfreefromrisksassociatedwithLegionella bacte-

ria. The test only detects Legionella pneumophilaserogroup1.Thetestdoesnotdetectthepresenceofother

Legionella species or serogroups.

Staphylococcus aureus and Legionella pneumophilaserogroups4&7inconcentrationshigherthan1x10

Burkholderia cepacia, Citrobacter

freudii, Citrobacter koseri,

aeruginosa, Pseudomonas

uorescens, Pseudomonas putida,

genes, Yersinia ruckeri