Test Catalog

Test Id : SPNC

Streptococcus pneumoniae Antigen, Spinal Fluid

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

Rapid diagnosis of pneumococcal meningitis

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, CSF

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

CSF

Additional Testing Requirements

According to the College of American Pathologists (CAP, IMM.41830), cerebrospinal fluid (CSF) samples collected to make an initial diagnosis and submitted for detection of Streptococcus pneumoniae antigen testing should also be submitted for routine bacterial culture. Mayo Clinic Laboratories recommends that CSF bacterial cultures be performed at the originating site.

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

Container/Tube: Sterile vial

Specimen Volume: 1 mL

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

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

Gross hemolysis OK
Gross lipemia OK

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
CSF Refrigerated (preferred) 14 days
Frozen 14 days

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

Rapid diagnosis of pneumococcal meningitis

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, and can also be an agent of bacterial meningitis. 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 being considered prior to culture confirmation, 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

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

A positive result supports a diagnosis of pneumococcal meningitis.

 

A negative result suggests that pneumococcal antigen is absent in the cerebrospinal fluid (CSF). However, infection due to Streptococcus pneumoniae cannot be ruled out since the antigen present in the specimen may be below the lower limit of detection of the test.

 

If pneumococcal meningitis is suspected, bacterial culture and Gram-stain analysis on CSF should be performed.

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 more than 24 hours has not been established.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Plouffe JF, Moore SK, Davis R, et al: 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

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 BinaxNOW Streptococcus pneumoniae test is an immunochromatographic membrane assay used to detect pneumococcal-soluble antigen in cerebrospinal fluid. Rabbit anti-Streptococcus 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-Streptococcus pneumoniae conjugated 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 greater than or equal to 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: BinaxNOW Streptococcus pneumoniae Test. Abbott; 2018)

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.

Monday through Sunday

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 Regional Manager. 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

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