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NOT AVAILABLE FOR SALE IN THE U.S.

For use with Sofia 2 and Sofia.

The Sofia Legionella Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect Legionella pneumophila serogroup 1 antigen in human urine specimens and is designed to test specimens from patients with symptoms of pneumonia. Legionella pneumophila serogroup 1 antigens, if present, bind to the detection particles. When the sample migrates up the Test Strip to the Test Line, the antigen-conjugate complex is bound to the capture antibody, forming a fluorescent line. If antigens are not present, the fluorescent microparticles will not be trapped by the capture antibodies nor detected by Sofia.

Sofia will scan the test strip and measure the immunofluorescent signal by processing the results using method-specific algorithms and display the test results (Positive, Negative, or Invalid) on its display screen. The test results can also be automatically printed on an integrated printer if this option is selected.

An internal control line helps ensure that the rapid Legionella test has been executed properly, that the kit reagents are performing appropriately, and that adequate flow has occurred through the test strip. Another fluorescent line should form at the Control position on the test strip each time a specimen or control is tested. If no control line is detected, the test will be reported as invalid by Sofia. The enhanced sensitivity of the Sofia Legionella FIA gives you accuracy and confidence in rapid testing.

The Sofia Legionella FIA is one in a growing menu of the fluorescent antibody tests available for use on Sofia. This easy-to-use qualitative fluorescent test can be used as an aid in the rapid diagnosis of Legionella pneumophila serogroup 1 infection.

 

Features & Benefits

FeatureBenefit

Results in 15 minutes

Fast time to results for truly rapid legionella testing

Self-contained test cassette

Clean, easy to use and dispose of

Fixed-volume pipette

Collects and dispenses correct amount of sample needed for testing.

Objective result

Eliminates the subjectivity of a visual result

All components included in kit

Ready to use with Sofia, no need for additional equipment

Room temperature storage

No refrigerator space needed. No need to wait for reagents to warm up. Rapid legionella tests can be run immediately as needed.

Product Specifications

Product Spec NameProduct Spec Data
Sample type

Urine

Time to results

10 minutes

Storage

Room temperature (15°C to 30°C / 59°F to 86°F)

Percent positive agreement*

100%

Percent negative agreement*

91%

Shelf life

24 months from date of manufacture

*Refer to Package Insert for additional performance claims.

Ordering Information

Catalog NumberDescriptionKit Size / Case Size
20244

Test Kit

25/12