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Test Code Urine S Pneumo & Legion Urine Rapid Strep Pneumo & Legionella Ag

Aliases

Urine Strep Pneumo, Urine Legionella

Useful For

It is intended, in conjunction with culture and other methods, to aid in the diagnosis of pneumococcal pneumonia and presumptive diagnosis of Legionella infection (Legionnaires’ Disease) caused by L. pneumophila serogroup 1.

Patient Preparation

No special patient preparation required

Collection Method

Urine in a sterile container

Minimum Volume

1 mL

Container

Sterile Cup

Preferred Specimen

Urine, no additives

Acceptable Specimens

Urine, no additives

Reference or Target Ranges

Negative – See notes

Reportable Units

Positive/Negative

Critical Value

Not defined for this assay

Reasons for Rejection

Hemolysis Threshold N/A
Icterus Threshold N/A
Lipemia Threshold N/A
Other QNS, grossly bloody urine, urine received in an additive (no tiger top urine containers), improperly labeled, improper container.

Specimen Stability

Ambient 24 hours
Refrigerated (2°C to 8°C) 7 days
Frozen (-20°C to -10°C) 7 Days

Performance Information

Days and Time Performed Daily
Expected Turn Around Time Routine: Within 4 hours of arrival in lab
Stat Availabilty No
Performing Bench APG Microbiology
Methodology/Method Description 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 Streptococcus pneumoniae and Legionella pneumophila antigens in urine specimens from patients with symptoms of pneumonia.

Additional Information/Important Notes

Interpretive Data

S. pneumoniae:

Positive:

Presumptive positive for Streptococcus pneumoniae antigen in urine, suggesting current or past infection. Culture is recommended to confirm infection.

Negative:

Presumptive negative for S. pneumoniae antigen in urine, suggesting no recent or current infection.

A negative result does not exclude an S. pneumoniae infection. The result of this test as well as culture, serology, or other antigen detection methods should be used in conjunction with clinical findings to make an accurate diagnosis.

L. pneumophilia:

Positive

Presumptive positive for Legionella pneumophila serogroup 1 antigen in urine, suggesting current or past infection. Culture is recommended to confirm infection.

Negative

Presumptive negative for L pneumophila serogroup 1 antigen in urine, suggesting no recent or current infection. Infection with Legionella cannot be ruled out because:

Other serogroups (other than serogroup 1 which is detected by this assay) and other Legionella species (other than L pneumophila) can cause disease

Antigen may not be present in urine in early infection

The level of antigen may be below the detection limit of the test

Legionella culture is recommended for cases of suspected legionella pneumonia due to organisms other than L pneumophila serogroup 1.

Limitations

Excretion of Legionella antigen in urine may vary depending upon the individual patient. Antigen excretion may begin as early as 3 days after the onset of symptoms and persist for up to 1 year afterwards. A positive Rapid Legionella result can occur due to current or past infection and therefore is not definitive for infection without other supporting evidence.

CPT Codes

87899x2