Nova-Tech Orbeco-Hellige Legionella Single Test Kit - Manual (Page 2)

Overview
This test kit is used to detect the presence of Legionella pneumophila serogroup 1 bacteria in hot and cold water
systems, cooling water, whirlpool spas and in biofilm. The test operates via a Lateral Flow Immuno-Chromato-
graphic Assay (LFICA).
Each Enterprise Test Kit contains the following:
• 1 Individually foil-wrapped test -- contains an exact volume pipette
• 1 Hollow Fiber Filters
• 1 Syringes with Recovery Buffer
• 1 Large Sample Syringes (60 ml)
• 1 250 ml sample container
• 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 ap-
proach and should NOT be used as the sole method for assessing risks associated with Legionella bacteria.
Test Operating Limits
The test has been evaluated for operation between 10-40ºC (50-104ºF).
The test has been validated for samples that filter in less than 10 minutes. Samples requiring more than 10 min-
utes to filter 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.
Technical Information
Limit of Detection
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 filtered. If smaller volumes are processed, the
detection limit will be altered accordingly:
Suspended solid content in the water samples impacts filtration and test performance, including analytical sen-
sitivity. Acutual results will vary. Water samples with high levels of suspened solids may block filtration 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 filtration concentration techniquest used in other
microbiological analysis methods.
limit of detection =
100 CFU
Sample Volume (L)
2