Technical information, Overview, Limit of detection – Nova-Tech Orbeco-Hellige Legionella Swab Test Kit User Manual

Page 2: Test operating limits, Disposal, Storage, Specificity

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Overview

Within a water system Legionella usually grow within biofilm (slime) found on the insides of pipe work, shower
heads, cooling tower packing, or water tanks. Bacteria found in the planktonic phase (i.e. suspended in the
water itself) are usually an indicator of colonization of the biofilm.

Since a clean water sample does not equate to a clean system (proliferation of legionella is greater in a biofilm
than in water), this kit can be used to pinpoint the contamination in a system or to demonstrate cleanliness of
an area after a targeted
cleaning. The test operates via a Lateral Flow Immuno-Chromatographic Assay (LFICA).

Each Swab Test Kit contains the following:

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

• 1 bottle of Recovery Buffer, 65 ml (part number L100119)

• 5 Swabs

• 5 Re-suspension Tubes

• Instructions for use

This test is intended for analysis of biofilm 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.

Limit of Detection

The mathematical theoretical limit of detection of the test is equivalent to 200 CFU / swabbed area.

Test Operating Limits

The test has been evaluated for operation between 10-40ºC (50-104ºF).

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 based biocides!

Performance of the Swab Test Kit with samples other than those taken from Cooling Towers, Domestic Hot &
Cold water systems and Whirlpool spas has not been established.

Disposal

The test cannot be reused or recycled. The packaging materials and this instruction manual can be recycled.

Storage

The test is intended for storage at room temperature. Do Not Freeze. When stored correctly, the test will
continue to operate within design specifications, until the specified expiration date. Do not use the test after
the stated expiration date specified on the packaging, Do not use any test where the foil packaging
is damaged.

Specificity

The test has been shown to be non-reactive with the following bacteria ( at 1 x 10

8

organisms per sample):

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

8

organisms per sample may interfere with test results in negative samples.

Acinetobacter calcoaceticus,
Aeromonas hydrophila subsp.
hydrophila, Bacillus subtilis,
Burkholderia cepacia, Citrobacter
freudii, Citrobacter koseri,

Escherichia coli, Enterobacter
cloacae, Klebsiella oxytoca, Pseu-
domonas
aeruginosa, Pseudomonas
fluorescens, Pseudomonas putida,

Pseudomonas stutzeri,
Ralstonia pickettii, Raoultella
terrigena, Streptococcus pyro-
genes, Yersinia ruckeri

Technical Information

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