Test Id : SLFA
Cryptococcus Antigen Screen with Titer, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
Aiding in the diagnosis of cryptococcosis
This test should not be used as a test of cure or to guide treatment decisions.
This test should not be used as a screening procedure for the general populations.
Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| SLFAT | Cryptococcus Ag Titer, LFA, S | Yes | No |
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
If result is positive, Cryptococcus titer will be performed at an additional charge.
Method Name
A short description of the method used to perform the test
Lateral Flow Assay (LFA)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Cryptococcus Ag Screen, S
Cryptococcus gattii
Cryptococcus neoformans
Fungal Serology
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
If result is positive, Cryptococcus titer will be performed at an additional charge.
Specimen Type
Describes the specimen type validated for testing
Serum
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
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.
0.5 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Gross lipemia | 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 |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 14 days | |
| Frozen | 14 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Aiding in the diagnosis of cryptococcosis
This test should not be used as a test of cure or to guide treatment decisions.
This test should not be used as a screening procedure for the general populations.
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
If result is positive, Cryptococcus titer will be performed at an additional charge.
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 only associated with tropical and subtropical regions. More recently, however, this organism has been found to be endemic in British Columbia and the Pacific Northwestern US and is associated with several different tree species.
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 is has a higher predilection for infection of healthy individuals.(1,2)
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.
Negative
Interpretation
Provides information to assist in interpretation of the test results
The presence of cryptococcal antigen in any body fluid (serum or cerebrospinal fluid) is indicative of cryptococcosis. Specimens that are positive by the lateral flow assay screen are automatically repeated with the same method utilizing dilutions to generate a titer value.
Disseminated infection is usually accompanied by a positive serum test.
Higher Cryptococcus antigen titers appear to correlate with more severe infections. Declining titers may indicate regression of infection. However, monitoring titers to cryptococcal antigen should not be used as a test of cure or to guide treatment decisions. Low-level titers may persist for extended periods of time following appropriate therapy and the resolution of infection.(3)
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 cryptococcosis, particularly if only a single specimen has been tested and the patient shows symptoms consistent with cryptococcosis.
A positive result is indicative of cryptococcosis; however, all test results should be reviewed considering other clinical findings
Testing should not be performed as a screening procedure for the general populations and should only be performed when clinical evidence suggests the diagnosis of cryptococcal disease.
Testing hemolyzed serum specimens may lead to false-negative results due to the high background color on the lateral flow assay strip.
Although rare, extremely high concentrations of cryptococcal antigen can result in weak test lines and in extreme instances, yield negative test results.
This assay has not been evaluated for cross-reactivity in patients with trichosporonosis.
Supportive Data
There were 634 serum specimens (632 prospective and 2 archived) tested in a blinded fashion by the IMMY Cryptococcus antigen lateral flow assay (LFA), the Meridian latex agglutination (Meridian Bioscience Inc) assay, and the Meridian Cryptococcus antigen enzyme immunoassay (EIA) within a 24-hour period. Specimens with discordant results after initial testing were repeated by both assays during the same freeze/thaw cycle. The results are summarized in Table 1 and Table 2 below:
Table 1. Comparison of the IMMY LFA to the Meridian latex agglutination assay
| Meridian latex agglutination | |||
| IMMY LFA | Positive | Negative | Total |
| Positive | 9 | 1* | 10 |
| Negative | 0 | 624 | 624 |
| Total | 9 | 625 | 634 |
*This sample showed 1+ reactivity by the Meridian latex agglutination assay upon screening but was interpreted as negative according to the package insert requirement for 2+ reactivity.
Sensitivity: 100% (9/9); 95% CI: 65.5%-100%
Specificity: 99.8% (624/625); 95% CI: 99.0%-99.9%
Overall Percent Agreement: 99.8% (633/634); 95% CI: 99.0%-99.9%
Table 2. Comparison of the IMMY LFA to the Meridian Cryptococcus antigen EIA
| Meridian EIA | |||
| IMMY LFA | Positive | Negative | Total |
| Positive | 5 | 5* | 10 |
| Negative | 0 | 624 | 624 |
| Total | 5 | 629 | 634 |
*These 5 samples were positive by the Meridian latex agglutination assay
Sensitivity: 100% (5/5); CI: 51.7%-100%
Specificity: 99.2% (624/629); CI: 98.1%-99.7%
Overall Percent Agreement: 99.2% (629/634); CI: 98.1%-99.7%
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Speed B, Dunt D: Clinical and host differences between infections with the two varieties of Cryptococcus neoformans. Clin Infect Dis. 1995;21(1):28-34
2. Chen S, Sorrell T, Nimmo G, et al: Epidemiology and host- and variety-dependent characteristics of infection due to Cryptococcus neoformans in Australia and New Zealand. Australasian Cryptococcal Study Group. Clin Infect Dis. 2000;31(2):499-505. doi:10.1086/313992
3. Perfect JR, Dismukes WE, Dromer F, et al: Clinical practice guidelines for the management of cryptococcal disease: 2010 update by the Infectious Diseases Society of America. Clin Infect Dis. 2010;50(3):291-322
4. Perfect JR: Cryptococcosis (Cryptococcus neoformans and Cryptococcus gattii). In: Bennett JE, Dolin R, Blaser MJ, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 9th ed. Elsevier; 2020:3146-3161
5. 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 Aug;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
6. 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-Cryptococcus antigen monoclonal antibodies and gold-conjugated control antibodies deposited on the test membrane. If Cryptococcus antigen is present in the specimen, it binds to the gold-conjugated, anti-Cryptococcus antigen antibodies. This complex wicks up the membrane and interacts with the test line, which has immobilized anti-Cryptococcus 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
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.
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
Indicates the location of the laboratory that performs the test
Fees :
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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.
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 |
|---|---|---|
| SLFA | Cryptococcus Ag Screen w/Titer, S | 29903-2 |
| 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.
|
|---|---|---|
| 62075 | Cryptococcus Ag Screen w/Titer, S | 29903-2 |