Nova-Tech Orbeco-Hellige Legionella Field Test Kit User Manual

Field Test Kit

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Legionella pneumophila serogroup 1 in Water

Instruction Manual
Part Num ber: L56B00 6001

www.orbeco.com

®

Overview

The Legionella Field Test Kit is for detecting Legionella in a water sample
It is ideal for eld and a variety of industrial applications.

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

Each Systems Test Kit contains the following:
 •10Individuallyfoil-wrappedtests--eachcontainsan
exact volume pipette

 •10SterileSampleBags
 •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 product is intended to be used as part of an overall water treatment,
management, and risk reduction approach and should NOT be used as
the sole method for assessing risks associated with Legionella bacteria.

Disposal

Used test products may be contaminated with bacteria and should be
disposed of in accordance to local laws. The test cannot be reused or
recycled. The packaging materials and this instruction manual can be
recycled.

Test Operating Limits

The test has been evaluated under laboratory conditions to operate effectively within
the limits described in the table below. Use outside of these tolerances requires the
use of a Postitive and Negative Control Kit (call for details).

Test Parameter / Unit Lower Limit Upper Limit

Sample Temperature 10ºC / 50ºC 45ºC / 113ºF
Test Temperature 10ºC / 50ºC 45ºC / 113ºF
pH 5 10
Free Chlorine (ppm) 0 5

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 sys-

tems 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.

Storage

The test is intended for storage at room temperature. Do Not Freeze. When stored
correctly, the test will continue to operate within design specications, until the
specied expiration date. Do not use the test after the stated expiration date

specied on the packaging, Do not use any test where the foil packaging is
damaged.

Take the Sample

IIdentify the water system to be sampled and an appropriate sample point from
which to obtain a representative sample. Large systems may be to be sampled
and tested at multiple locations.

Avoid generating aerosols when collecting or handling samples.

Open the provided sample bags by tearing the perforation just above the white
strip. Open the sample bag by grasping and pulling on the tab on each side of
the bag.

Add system water to the bag. The bag ma have condensation inside before
use, depending on storage conditions.

Add Sample to the Test Strip

Remove the test from its foil wrapping, and place the test on a at surface.

The foil wrapping should not be opened until immediately prior to running
the test. If the foil is opened and then the test is not performed within 60
minutes, discard the test.

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.

Read the Test Strip

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.

Positive Result: Two (2) RED lines across the result window. The red line closest to
the sample window may be very faint (pale pink). Any distinct line, no matter how
faint, should be counted as positive.

Invalid Result:

end closest to the sample window; or if the line furthest from the sample window is
very faint, then the test is invalid. Repeat the test and notify your supplier for technical
support.

If the test does not show any red lines; or if it only shows a line at the

Interpreting the Results

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 viable but non-cultruable bacteria which are not detectable
by traditional laboratory techniques. A positive result does not necessarily mean that
viable bacteria are present.

When a positive result is observed, seek advice from your risk management plan, or
water treatment specialist.

Negative Results:

A negative test result indicates that Legionella pneumophila serogroup 1 bacteria
were not detected or the number of bacteria in the sample were below the detection
limit.

A negative result does not necessarily mean that Legionella bacteria are
absent.

A negative result does not mean that the system is completely free from
risks associated with Legionella bacteria. The test only detects Legionella

pneumophila serogroup 1. The test does not detect the presence of other
Legionella species or serogroups.

Specicity

The test has been shown to be non-reactive with the following bacteria ( at 1 x
108 organisms per sample):

Acinetobacter calcoaceticus,
Aeromonas hydrophila subsp.
hydrophila, Bacillus subtilis,
Burkholderia cepacia, Citrobacter
freudii, Citrobacter koseri,
Escherichia coli, Enterobacter
cloacae, Klebsiella oxytoca, Pseu­domonas

Staphylococcus aureus and Legionella pneumophila serogroups 4 & 7 in

concentrations higher than 1x108 organisms per sample may interfere with
test results in negative samples. These concentrations are higher than woudl
be expected to be present in normal water samples.

aeruginosa, Pseudomonas
uorescens, Pseudomonas putida,
Pseudomonas stutzeri,
Ralstonia pickettii, Raoultella
terrigena, Streptococcus pyro­genes, Yersinia ruckeri

Limit of Detection

The visual detection limit of the test has been determined under labora­tory conditions to be 100 CFU/ml.

Orbeco-Hellige, Inc.
6456 Parkland Drive
Sarasota, FL 34243

Phone: [phone]
Fax: [phone]
Email: [e-mail]
Web: www.orbeco.com

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