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The ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test is an in vitro, rapid, lateral flow test, also known as a lateral flow immunochromatographic assay, intended for the qualitative detection of Streptococus pneumoniae and Legionella pneumophila antigens in urine specimens with symptoms of pneumonia. The assay is intended to aid in diagnosis of S. pneumoniae and L. pneumophila serogroup 1 infections. The assay is further intended to aid in the diagnosis of S. pneumoniae infection of S. pneumoniae antigen in cerebrospinal fluid (CSF). Results from the ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test should be interpreted in conjunction with the patient's clinical evaluation and other diagnostic methods.

ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test is a rapid lateral flow test for qualitative detection of S. pneumoniae in human urine and CSF samples and L. pneumophila (primarily serogroup 1) antigens in human urine samples. The test is effective in presumptive diagnosis of pneumococcal pneumonia caused by S. pneumoniae or Legionella pneumonia (Legionnaires' disease) caused by L. pneumophila, in conjunction with culture and other methods. Correct and early treatment is vital for the prognosis of both diseases and therefore quick methods to confirm both diseases in the initial phase are very important in order to initiate the proper antibiotic treatment as soon as possible.

The TRU LEGIONELLA® assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens from patients with symptoms of pneumonia. Test results are to be used as an aid in diagnosis of Legionella serogroup 1 infection. A negative result does not preclude infection with Legionella pneumophila serogroup 1. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.

The TRU LEGIONELLA® assay is an in vitro, rapid, lateral-flow immunoassay.

The TRU Legionella assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. It is designed to test specimens from patients with symptoms of pneumonia. Test results are to be used as an aid in diagnosis of Legionella pneumophila serogroup 1 infection. A negative result does not preclude infection with Legionella pneumophila serogroup 1. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.

The TRU Legionella assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. The assay consists of Test Strips containing anti-Legionella pneumophila serogroup 1 as the capture antibody, Containing anti-Legionella pneumophila serogroup 1 as the detection antibody, Sample Diluent/Negative Control, and Positive Control.

The Clearview Exact II Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. It is recommended that negative test results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

The Clearview® Exact II Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory swab specimens. These antibodies and a control protein are immobilized onto a membrane support as three distinct lines and are combined with other reagents/pads to construct a Test Strip. Nasal swab samples are added to a Coated Reaction Tube to which an extraction reagent has been added. A Clearview Exact II Influenza A & B Test Strip is then placed in the Coated Reaction Tube holding the extracted liquid sample. Test results are interpreted at 10 minutes based on the presence of pink-to-purple colored Sample Lines. The yellow Control Line tums blue in a valid test.

The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for the presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine. This test is intended to aid in the presumptive diagnosis of Legionnaires' disease in conjunction with culture and other methods for patients with signs and symptoms of pneumonia. This test is for prescription use only.

The SAS™ Legionella test utilizes a combination of polyclonal antibodies against the antigens of Legionella pneumophila. The SAS™ Legionella test begins with the addition of urine to the test device. The specimen is absorbed by the sample pad and then moves through the conjugate pad which contains dried gold conjugated antibodies which are specific for Legionella pneumophila antigens; if the Legionella antigens are present in the urine sample, a "half-sandwich" immunocomplex is formed. This immuno-complex then migrates via capillary action along a nitrocellulose membrane containing immobilized antibodies to Legionella pneumophila antigens. The immobilized antibodies bind the "half-sandwich" immuno-complex to form a "whole sandwich" immuno-complex. Thus, when the "whole sandwich" is formed, a visible, pink colored line develops in the specimen zone on the test device. In the absence of a Legionella antigen, a "sandwich" immuno-complex is not formed and a negative result is indicated. To serve as a procedural control, a pink colored control line will always appear in the control zone regardless of the presence or absence of Legionella antigen. The test is available in cassette format.

The Binax NOW® Legionella Urinary Antigen Test is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella serogroup 1 antigen (L. pneumophila serogroup 1 antigen) in urine specimens from patients with symptoms of pneumonia. 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.

The Binax NOW® Legionella Urinary Antigen Test is an immunochromatographic membrane assay to detect Legionella pneumophila serogroup 1 antigen in human urine. A test strip, containing gold-conjugated and immobilized anti-Legionella pneumophila serogroup 1 antibodies, and a swab well are mounted on opposite sides of a cardboard, book-shaped hinged test device. A Dacron swab is dipped into the urine to be tested and then inserted into the swab well. A single reagent is added to the swab well from a dropper bottle before closing the test device. Legionella urinary antigen captured by immobilized anti-Legionella pneumophila antibody reacts to bind anti-Legionella pneumophila conjugated antibody, forming the Sample Line. Immobilized control antibody captures anti-species conjugate, forming the Control Line. There are no transferring steps, the sample is contained, and results are available in 15 minutes.

The BD ProbeTec™ ET Legionella pneumophila (LP) Amplified DNA Assay, for use with the BD ProbeTec ET System, employs Strand Displacement Amplification (SDA) technology for the direct qualitative detection of Legionella pneumophila DNA (serogroups 1-14) in sputum specimens from patients with a clinical suspicion of pneumonia. It is intended to aid in the presumptive diagnosis of Legionnaires' disease in conjunction with culture and other methods.

The BD ProbeTec™ ET LP Amplified DNA Assay is a new test designed for use on the BD ProbeTec™ ET System. The test is indicated for use with sputum specimens from patients with a clinical suspicion of pneumonia as an aid in the presumptive diagnosis of Legionnaires' disease in conjunction with culture and other methods. The BD ProbeTecTM ET LP Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA sequences using nucleic acid primers and fluorescently-labeled detector probes in a process known as strand displacement amplification (SDA). The SDA reagents are dried in two separate disposable microwells. Processed sample containing DNA is added to a Priming Microwell, which contains the amplification primers, fluorescently-labeled detector probes, and other reagents necessary for amplification. Following incubation, the reaction mixture is transferred to an Amplification Microwell, which contains two enzymes (a DNA polymerase and a restriction endonuclease) necessary for SDA. The Amplification Microwells are sealed to prevent contamination and then incubated in a thermally controlled fluorescent reader, which monitors each reaction for the generation of amplified products. Each reaction coamplifies and detects an Internal Amplification Control (IAC), as well as the target DNA. The purpose of the IAC is to verify that proper conditions exist for amplification and to reduce the possibility of reporting a false negative result due to specimen inhibitors. The presence or absence of L. pneumophila DNA is determined by calculating PAT scores (Passes After Threshold) for the specimen based on predefined threshold values. The instrument automatically reports the results as positive, negative or indeterminate.

The Trinity Biotech Captia™ Legionella pneumophila IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of total antibodies (IgG and IgM) to serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease. The assay is not intended to differentiate between the serotypes of Legionella pneumophila.

The Legionella pneumophila IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of total antibodies (IgG and IgM) to Legionella pneumophila serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease. The Legionella pneumophila IgG/IgM ELISA test is an enzyme linked immunosorbent assay to detect IgG/IgM antibodies to legionella. Purified Legionella pneumophila antigen (serogroups 1, 2, 3, 4, 5, 6) is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG/IgM is added to each well. If antibody is present, it will bind to the antibody attached to the antigen on the well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period, the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

Bartels Legionella Urinary Antigen ELISA Test is intended as an adjunct to culture for the presumptive diagnosis of past or current Legionnaires' Disease by qualitative detection of Legionella pneumophila Serogroup 1 antigen in human urine.

Bartels Legionella Urinary Antigen ELISA Test is an enzyme-linked immunoassay intended for the qualitative detection of Legionella pneumophila Serogroup 1 antigen in human urine. The kit consists of microelisa stripwells with lid, positive and negative control reagents, conjugate, wash concentrate, colorimetric substrate (2 components) and stop solution. Sufficient materials are provided to perform 96 analyses. The microelisa wells have been pre-coated with purified rabbit antibodies to Legionella pneumophila Serotype 1 (capture antibody). An undiluted urine specimen (100 µL), or positive or negative controls (100 µL each) are each placed in a single microelisa well followed by the addition of 50 uL of Conjugate (horseradish peroxidase-conjugated rabbit antibodies to L. pneumophila). The loaded microelisa plate is then covered with the lid and incubated for 48 to 52 minutes at 34-37°C followed by 4 cycles of wash/aspiration using diluted Wash Solution (manual or automated wash procedure). Colorimetric substrate (tetramethyl benzidine/H2O2 100 µL/well) is then added and incubated for 10 to 12 minutes at 34-37℃ followed by the addition of Stop Solution (1M Phosphoric acid, 100 uL/well). The stopped plate is then read on a microelisa plate reader at 450 nm against an air blank. For a test to be considered valid, the Negative Control must have an optical density (OD) value of less than 0.100 and the Positive Control must be greater than the Positive Cutoff (pco). The pco is equal to 4X the O.D. value of the Negative Control value. Any specimen with an O.D. value ≥ the pco is considered positive. Any specimen with an O.D. value < the pco is considered negative. Alternatively, the results can be visually read. For this purpose, a visual interpretation card, and written instructions, are provided in the kit for interpretation of results. Any well that produces definite yellow color is considered to be positive.