商品编号


20244



品牌


Quidel



公司


Quidel,inc.



公司分类


Legionella



Size

25/12

商品信息

Description:
Test Kit
Features & Benefits:






NOT AVAILABLE FOR SALE IN THE U.S.

The Sofia Legionella Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect
Legionella pneumophila

SERO
group 1 antigen in human urine specimens and is designed to test specimens from patients with symptoms of pneumonia.
Legionella pneumophila

SERO
group 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

SERO
group 1 infection.

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Feature
Benefit



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 Name
Product Spec Data



Sample type
Urine



Time to results
10 minutes



Storage
At or below –70°C



Percent positive agreement*
100%



Percent negative agreement*
91%



Shelf life
24 months from date of manufacture








*Refer to Package Insert for additional performance claims.