Streptococcus pneumoniae Antigen, Urine
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Rapid diagnosis of pneumococcal pneumonia
Immunochromatographic Membrane Assay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Streptococcus pneumoniae Ag, U
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Container/Tube: Plastic, 10-mL urine tube (Supply T068)
Specimen Volume: 2 mL
Collection Instructions: Collect a random urine specimen.
Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Urine||Refrigerated (preferred)||7 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Streptococcus pneumoniae is the most frequently encountered bacterial agent of community-acquired pneumonia (CAP). Because of the significant morbidity and mortality associated with pneumococcal pneumonia, septicemia, and meningitis, it is important to have diagnostic test methods available that can provide a rapid diagnosis. In instances where empirical antibiotics are provided for CAP without culture confirmation of Streptococcus pneumoniae, antigen testing may be useful.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
A positive result is indicative of pneumococcal pneumonia.
A negative result is a presumptive negative for pneumococcal pneumonia, suggesting no current or recent pneumococcal infection. Infection due to Streptococcus pneumoniae cannot be ruled out since the antigen present in the specimen may be below the detection limit of the test.
Pneumococcal pneumonia is best diagnosed by sputum culture.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
A negative result does not exclude Streptococcus pneumoniae infection.
A diagnosis of Streptococcus pneumoniae infection must take into consideration all test results, culture results, and the clinical presentation of the patient.
Streptococcus pneumoniae vaccine may cause false-positive results, especially in patients who have received the vaccine within 5 days of having the test performed.
This assay has not been validated for use with body fluids other than urine or cerebrospinal fluid.
The performance of this assay in patients who have received antibiotics for >24 hours has not been established.
The accuracy of this assay has not been proven in small children.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Plouffe JF, Moore SK, Davis R, Facklam RR: Serotypes of Streptococcus pneumoniae blood culture isolates from adults in Franklin County, Ohio. J Clin Microbiol 1994;32:1606-1607
2. Johnston RB Jr: Pathogenesis of pneumonococcal pneumonia. Rev Infect Dis 1991;13:509-517
Method Description Describes how the test is performed and provides a method-specific reference
The Binax NOW Streptococcus pneumoniae test is an immunochromatographic membrane assay used to detect pneumococcal soluble antigen in human urine and cerebrospinal fluid. Rabbit anti-Streptococcus pneumoniae and antispecies antibodies are conjugated to visualizing particles that are dried onto an inert fibrous support. The resulting conjugate pad and the striped membrane are combined to construct the test strip.
To perform the test, a swab is dipped into the specimen, removed, and then inserted into the test device. Reagent A, a buffer solution is added from a dropper bottle. The device is then closed, bringing the sample into contact with the test strip. Pneumococcal antigen present in the sample reacts to bind anti-Streptococcus pneumonia-conjugated antibody. The resulting antigen-conjugate complexes are captured by immobilized anti-Streptococcus pneumoniae-conjugated antibody. The resulting antigen-conjugate complexes are captured by immobilized anti-Streptococcus pneumoniae antibody, forming the sample line. Immobilized control antibody captures antispecies conjugate forming the control line.
Test results are interpreted by the presence or absence of visually detectable pink-to-purple colored lines. A positive test result, read in > or =15 minutes depending on the concentration of antigen present in the sample, will include the detection of both a sample and control line. A negative test result, read in 15 minutes, will produce only a control line, indicating that Streptococcus pneumoniae antigen was not detected in the sample. Failure of the control line to appear, whether the sample line is present or not, indicates an invalid assay.(Package insert: NOW Streptococcus pneumoniae Test. Binax, Inc., Portland, ME, 1998)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 12 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Same day/1 day
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|83150||Streptococcus pneumoniae Ag, U||24027-5|