Intended Use of Legionella pneumophila rapid test device
Legionella pneumophila rapid test device is an in-vitro rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in urine specimens. It is intended to aid in the presumptive diagnosis of Legionella infection (Legionnaires’ disease) caused by L. pneumophila serogroup 1 in conjunction with culture and other methods.
Principle of Legionella pneumophila rapid test device
Anti-Legionella pneumophila serogroup 1 antibody,the test line, is adsorbed onto nitrocellulose membrane.Antibodies of the control line were adsorbed onto the same membrane as a second band.Anti-Legionella pneumophila serogroup 1 antibodies are conjugated to visualizing particles that are dried onto an inert absorbent support.
During testing the sample is allowed to react with conjugate which was pre-adsorbed on the strip test.The mixture then moves upward on the membrane by capillary action.As the sample flows through the test membrane,the coloured particles migrate.In the case of a positive result the specific antibodies present on the membrane will capture the coloured conjugate.L. pneumophila serogroup 1 urinary antigen captured by immobilized anti-.L. pneumophila serogroup 1 antibody reacts to bind conjugated antibody.The other immobilized antibodies also captures visualizing conjugate,forming the control line.Apositive test result is read visually in 10-15 minutes or less depending on the concentration of antigen present in the urine specimen.A negative Legionella pneumopila Device result,read in 15 minutes,indicates that .L. pneumophila serogroup 1 urinary antigen was not detected in the urine sample.
The test is interpreted by the presence or absence of visually redish colored lines.A positive result will include the detection of both a test and control line,while a negative assay will produce only the control line. The control line does not appear,whether the test line is present or not,indicates an invalid assay.
Procedure and Result Reading of Legionella pneumophila rapid test device
Product Image of Legionella pneumophila rapid test device