Test Catalog

Test Id : PLFAT

Cryptococcus Antigen Titer, Lateral Flow Assay, Pleural Fluid

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

Diagnosis of infection with Cryptococcus species

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

Only orderable as a reflex. For more information see PLFA / Cryptococcus Antigen Screen, Lateral Flow Assay, Pleural Fluid.

 

Lateral Flow Assay (LFA)

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

Cryptococcus Ag Titer, LFA, PF

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

Crypto

Thoracentesis Fluid

Specimen Type
Describes the specimen type validated for testing

Pleural Fluid

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

Only orderable as a reflex. For more information see PLFA / Cryptococcus Antigen Screen, Lateral Flow Assay, Pleural Fluid.

 

Container/Tube: Sterile vial

Specimen Volume: 0.5 mL

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

  All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

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
Pleural Fluid Refrigerated (preferred) 21 days
Frozen 30 days

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

Diagnosis of infection with Cryptococcus species

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Cryptococcosis is an invasive fungal infection caused by Cryptococcus neoformans or Cryptococcus gattii. C neoformans has been isolated from several sites in nature, particularly weathered pigeon droppings. C gattii was previously associated with tropical and subtropical regions only; however, more recently this organism has also been found to be endemic in British Columbia, along the Pacific Northwest and in the Southeastern US.

 

Infection is usually acquired via the pulmonary route. Patients are often unaware of any exposure history. Approximately half of the patients with symptomatic disease have a predisposing immunosuppressive condition such as AIDS, steroid therapy, lymphoma, or sarcoidosis. Symptoms may include fever, headache, dizziness, ataxia, somnolence, and cough. While the majority of C neoformans infections occur in immunocompromised patient populations, C gattii has a higher predilection for infection of healthy individuals.

 

In addition to the lungs, cryptococcal infections frequently involve the central nervous system (CNS), particularly in patients infected with HIV. Mortality among patients with CNS cryptococcosis may approach 25% despite antibiotic therapy. Untreated CNS cryptococcosis is invariably fatal. Disseminated disease may affect any organ system and usually occurs in immunosuppressed individuals.

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.

Only orderable as a reflex. For more information see PLFA / Cryptococcus Antigen Screen, Lateral Flow Assay, Pleural Fluid.

Interpretation
Provides information to assist in interpretation of the test results

The presence of cryptococcal antigen in pleural fluid is indicative of infection with Cryptococcus species.

 

Monitoring cryptococcal antigen levels to determine response to therapy is discouraged, as antigen levels may persist despite adequate treatment and disease resolution.

 

A negative result indicates lack of infection; however rare cases of false-negative results have been reported. Fungal culture should always be ordered alongside antigen testing.

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 preclude diagnosis of cryptococcal infection, particularly if the patient is at risk for cryptococcosis and shows symptoms consistent with this disease.

 

False-positive results may occur in patients with trichosporonosis or infection with Capnocytophaga species.

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

1. Binnicker MJ, Jespersen DJ, Bestrom JE, Rollins LO. Comparison of four assays for the detection of cryptococcal antigen. Clin Vaccine Immunol. 2012;19(12):1988-1990. doi:10.1128/CVI.00446-12

2. Howell SA, Hazen KC, Brandt ME. Candida, cryptococcus, and other yeast of medical importance. In: Manual of Clinical Microbiology. 11th ed. ASM Press; 2015:1984-2014

3. Chang CC, Harrison TS, Bicanic TA, et al. Global guideline for the diagnosis and management of cryptococcosis: an initiative of the ECMM and ISHAM in cooperation with the ASM. [published correction appears in Lancet Infect Dis. 2024;24(8):e485. doi:10.1016/S1473-3099(24)00426-2]. Lancet Infect Dis. 2024;24(8):e495-e512. doi:10.1016/S1473-3099(23)00731-4

4. Perfect JR, Bicanic T. Cryptococcosis diagnosis and treatment: What do we know now. Fungal Genet Biol. 2015;78:49-54. doi:10.1016/j.fgb.2014.10.003

Method Description
Describes how the test is performed and provides a method-specific reference

The Cryptococcus antigen (CrAg) lateral flow assay is a sandwich immunochromatographic assay. Specimens and diluent are added to a test tube and the lateral flow device is added. The test uses specimen wicking to capture gold-conjugated anti-cryptococcal antigen monoclonal antibodies and gold-conjugated control antibodies deposited on the test membrane. If cryptococcal antigen is present in the specimen, it binds to the gold-conjugated, anti-cryptococcal antigen antibodies. This complex wicks up the membrane and interacts with the test line, which has immobilized anti-cryptococcal antigen monoclonal antibodies. The antigen-antibody complex forms a sandwich at the test line causing a visible line to form. A valid test shows a visible line at the control line. Positive test results create 2 lines (control and specimen), while negative results form only the control line.(Package insert: CrAg Lateral Flow Assay. IMMY; Rev 06/27/2019)

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.

2 days

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

7 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 modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

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
PLFAT Cryptococcus Ag Titer, LFA, PF 11473-6
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.
48431 Cryptococcus Ag Titer, LFA, PF 11473-6

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