Test Catalog

Test Id : SPNEU

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Streptococcus pneumoniae Antigen, Random, Urine

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Rapid diagnosis of pneumococcal pneumonia

Method Name
A short description of the method used to perform the test

Immunochromatographic Membrane Assay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Streptococcus pneumoniae Ag, U

Aliases
Lists additional common names for a test, as an aid in searching

Pneumococcal Pneumonia

Pneumococcus Antigen

S. pneumoniae

Streptococcus pneumoniae

Specimen Type
Describes the specimen type validated for testing

Urine

Ordering Guidance

Pneumococcal pneumonia is best diagnosed by sputum culture. For more information, see SPUTS / Bacterial Culture, Aerobic, Respiratory with Antimicrobial Susceptibilities, Varies.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Urine Tubes, 10 mL (T068)

Container/Tube: Plastic, 10-mL urine tube

Specimen Volume: 2 mL

Collection Instructions:

1. Collect a random urine specimen.

2. No preservative.

3. Excessively bloody or very turbid specimens containing protein, cells, or particulates will be canceled as they can inhibit the function of the test.

4. Centrifuging to remove particulates is not approved.

5. Specimens with any dyes or unnatural color are not acceptable and will be canceled.

Forms

If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.25 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Turbid Dyes/unnaturally colored Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Urine Refrigerated (preferred) 14 days
Frozen 14 days
Ambient 24 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

Rapid diagnosis of pneumococcal pneumonia

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 S 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.

Negative

Interpretation
Provides information to assist in interpretation of the test results

A positive result is indicative of pneumococcal pneumonia.

 

Negative:

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 sample may be below the detection limit of the test.

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 S pneumoniae infection must take into consideration all test results, culture results, and the clinical presentation of the patient.

 

S 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 more than 24 hours has not been established.

 

The accuracy of this assay has not been proven in small children.

Clinical Reference
Recommendations for 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 Jun;32(6):1606-1607

2. Johnston RB Jr: Pathogenesis of pneumococcal pneumonia. Rev Infect Dis. 1991 May-Jun;13 Suppl 6:S509-S517. doi: 10.1093/clinids/13.supplement_6.s509

3. Janoff EN, Musher DM: Streptococcus pneumoniae. In Bennett JE, Dolin R, Blaser MJ, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 9th ed. Elsevier; 2020:2473-2491

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-S pneumoniae and anti-species 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-S pneumonia-conjugated antibody. The resulting antigen-conjugate complexes are captured by immobilized anti-S pneumoniae-conjugated antibody. The resulting antigen-conjugate complexes are captured by immobilized anti-S pneumoniae antibody, forming the sample line. Immobilized control antibody captures anti-species 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 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 S 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: BinaxNOW Streptococcus pneumoniae Antigen Card. Abbott Diagnostics; 01/2020)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Sunday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 day

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US 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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87899

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
SPNEU Streptococcus pneumoniae Ag, U 77949-6
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
83150 Streptococcus pneumoniae Ag, U 77949-6

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports