Legionella and pneumococcal urine antigen

Alphabetical Test listing

Legionella and pneumococcal urine antigen-15136

  
Legionella and pneumococcal urine antigen
  
15136
  
LAB15136
  
LPSP
  
Pneumonia urine antigen
  
Legionella antigen
Strep pneumo antigen
  

Presumptive diagnosis of pneumococcal pneumonia caused by S. pneumoniae or Legionella pneumonia (Legionnaires’ disease) caused by L. pneumophila.

  
  • Current American Academy of Pediatrics (AAP) Red Book recommendations note that detection of S. pneumoniae is not useful in children because asymptomatically colonized children may have positive test results. 
  • ImmuView® S. pneumoniae and L. pneumophila Urinary Antigen Test has been validated using urine specimens only. Other specimens (e.g. serum, plasma or other body fluids) can cause false results and should not be tested.
  • A negative result does not exclude the possibility of a Legionella infection, as it can be caused by other serogroups and Legionella species. There is no single satisfactory laboratory test for Legionnaires’ Disease. Therefore, culture results, PCR, serology, and/or antigen detection methods should be used in conjunction with clinical findings to make an accurate diagnosis. 
  • A negative result does not exclude an S. pneumoniae infection. The result of this test as well as culture, serology, or other detection methods should be used in conjunction with clinical findings to make an accurate diagnosis. 
  • S. pneumoniae vaccine may cause false positive results up to 10 days after vaccination. 
  • Administration of antibiotics might influence the test results for S. pneumoniae. 
  • False results may occur from highly basic (pH≥9) urine and give false positive S.pneumoniae results. Water-based personal lubricant might result in false positive or gray L. pneumophila lines when found in the sample at high levels. 




     
  
Urine, random
  
  
1 mL
  
300 ul
  

Freshly voided urine; midstream clean-catch or catheterized

  
  
  

Transfer specimen to a Urine preservative vial/tube, C&S prior to transport

Processing urine specimens with BD Vacutainer collection products

  
  

Refrgerated (preferred) - 7 days

Ambient - 24 hours

  
2 days
  
  • Specimens other than urine
  • Specimens exceeding time or temperature stability
  • Leaking container
  
AHL - Microbiology: M
  
Daily
  
2 hours
  

Lateral flow immunochromatographic assay

  

Legionella antigen: Negative

Strep pneumo antigen: Negative

  

Component

Sensitivity

Specificity

L. pneumophila

87.8% - 97.7%

99.5% - 100%

S. pneumoniae

78% – 98.2%

98.1% - 98.2%

Note: Sensitivity and specificity vary by comparator method.  Positive agreement and negative agreement were highest when this assay was compared to a similar lateral flow assay.

  
Negative results for L. pneumophila antigen, suggests no recent or current infection. Infection due to Legionella cannot be ruled out since other serogroups and species may cause disease, antigen may not be present in urine in early infection, and the level of antigen present may be below the detection limit of the test. Low test sensitivity in patients with mild pneumonia.

Negative results for S. pneumoniae antigen suggest no current or recent pneumococcal infection. Infection due to S. pneumoniae cannot be ruled out since the antigen present in the sample may be below the detection limit of the test.
  
87449 x 2
  
LOINC 77684-9 Legionella pneumophila 1 Ag [Presence] in Urine by Rapid immunoassay
LOINC 77949-6 Streptococcus pneumoniae Ag [Presence] in Urine by Rapid immunoassay
  
06/21/2023
  
12/18/2023