Test Id : BHSF
Beta-Human Chorionic Gonadotropin, Quantitative, Spinal Fluid
    
        Useful For
            
                
                
                    
                    Suggests clinical disorders or settings where the test may be helpful
                
            
    
    Aiding in the diagnosis of brain metastases of testicular cancer or extragonadal intracerebral germ cell tumors
    
        Highlights
    
    Measurement of human chorionic gonadotropin (hCG) is used as an adjunct in the diagnosis of central nervous system (CNS) metastases or recurrence of tumor in patients with germ cell tumors.
 
Quantitation of the hCG in cerebrospinal fluid (CSF) can be important in guiding treatment and monitoring response to treatment of these tumors.
 
Measurement of hCG in CSF should not be the only parameter used to determine the presence of CNS metastases in patients with germ cell tumors.
    
        Method Name
            
                
                
                    
                    A short description of the method used to perform the test
                
            
    
    Electrochemiluminescent Immunoassay (ECLIA)
    
        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
                
            
    
    Beta HCG, CSF
Beta-HCG (Beta-Human Chorionic Gonadotropins)
CG (Chorionic Gonadotropins)
Chorionic Gonadotropins, Beta-Subunit (QN), Spinal Fluid
Gonadotropins, Chorionic
hCG, Beta Subunit (Chorionic Gonad)
Human Chorionic Gonadotropins (hCG)
    
        Specimen Type
            
                
                
                    
                    Describes the specimen type validated for testing
                
            
    
        CSF
    
        Specimen Required
            
                
                
                    
                    Defines the optimal specimen required to perform the test and the preferred volume to complete testing
                
            
    
    Patient Preparation: For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).
Container/Tube: Sterile vial
Specimen Volume: 1 mL
Collection Instructions: Submit specimen from collection vial number 1.
    
        Forms
    
    If not ordering electronically, complete, print, and send an Oncology Test Request (T729) 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.
                
            
    
    0.75 mL
    
        Reject Due To
            
                
                
                    
                    Identifies specimen types and conditions that may cause the specimen to be rejected
                
            
    
    | Hemolysis | 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 | 
|---|---|---|---|
| CSF | Refrigerated (preferred) | 28 days | |
| Ambient | 14 days | ||
| Frozen | 14 days | 
    
        Useful For
            
                
                
                    
                    Suggests clinical disorders or settings where the test may be helpful
                
            
    
    Aiding in the diagnosis of brain metastases of testicular cancer or extragonadal intracerebral germ cell tumors
    
        Clinical Information
            
                
                
                    
                    Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
                
            
    
    Human chorionic gonadotropin (hCG) is synthesized during pregnancy by syncytiotrophoblast cells. hCG may also be produced by neoplastic cells of testicular tumors (seminomas or nonseminomas), ovarian germ cell tumors, gestational trophoblastic disease, choriocarcinoma, and various nontrophoblastic tumors including breast, ovarian, pancreatic, cervical, gastric, and hepatic cancers.
 
Measurement of hCG is used as an adjunct in the diagnosis of germ cell tumors. The presence of hCG in cerebrospinal fluid (CSF) is suggestive of tumor presence. Pure germinomas are associated with low hCG concentrations in both serum and CSF. A subset of nongerminomatous germ cell tumors contain syncytiotrophoblastic giant cells. These tumors are associated with moderately increased hCG concentrations (<1000 IU/L) in the serum and/or CSF, and the survival rate in patients suffering these tumors is worse than that of patients with pure germinomas. In contrast, choriocarcinomas, another subset of nongerminomatous germ cell tumors, are associated with very high hCG concentrations (>1000 IU/L) in both serum and CSF. Quantification of the hCG in CSF can be important in guiding treatment and monitoring response to treatment of these tumors.
 
The combination of the specific antibodies used in the Roche Beta hCG immunoassay recognize the holo-hormone, "nicked" forms of hCG, the beta-core fragment, and the free beta-subunit.
    
        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.
                
            
    
    < or =1.0 IU/L 
    
        Interpretation
            
                
                
                    
                    Provides information to assist in interpretation of the test results
                
            
    
    Elevated levels of human chorionic gonadotropin in spinal fluid indicate the probable presence of central nervous system metastases or recurrence of tumor in patients with germ cell tumors, including patients with testicular cancer or choriocarcinoma.
    
        Cautions
            
                
                
                    
                    Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
                
            
    
    In pregnancy, elevations of human chorionic gonadotropin (hCG) in cerebrospinal fluid (CSF) may be observed due to blood contamination during CSF collection.
 
In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. The presence of antibodies to streptavidin or ruthenium can also rarely occur and may also interfere in this assay. Caution should be used in interpretation of results and the laboratory should be alerted if the result does not correlate with the clinical presentation.
 
Values obtained with different assay methods or kits may be different and cannot be used interchangeably.
 
Test results cannot be interpreted as absolute evidence for the presence or absence of malignant disease.
 
Measurement of hCG in CSF should not be relied upon exclusively to determine the presence of central nervous system metastases in patients with germ cell tumors.
    
        Clinical Reference
            
                
                
                    
                    Recommendations for in-depth reading of a clinical nature
                
            
    
    1. Tian C, Shi Q, Xiao G, et al. CSF and serum hCG in patients without gestational and neoplastic hCG-secretion. Scand J Clin Lab Invest. 2011;71(4):264-268
2. Tian C, Shi Q, Pu C, et al. Re-evaluation of the significance of cerebrospinal fluid human chorionic gonadotropin in detecting intracranial ectopic germinomas. J Clin Neurosci. 2011;18(2):223-226
3. Gonzalez-Sanchez V, Moreno-Perez O, Sanchez Pellicer PS, et al. Validation of the human chorionic gonadotropin immunoassay in cerebrospinal fluid for the diagnostic work-up of neurohypophyseal germinomas. Ann Clin Biochem. 2011;48(Pt 5):433-437
4. Hu Y, Ni J, Zhang H, et al. An immunoassay for human chorionic gonadotropin in cerebrospinal fluid: validation of a modified-approved method for accreditation by the College of American Pathologists. J Lab Physicians. 2021;14(1):11-15. doi:10.1055/s-0041-1733817.
5. Zhang H, Zhang P, Fan J, et al. Determining an optimal cutoff of serum beta-human chorionic gonadotropin for assisting the diagnosis of intracranial germinomas. PLoS One. 2016;11(1):e0147023. doi:10.1371/journal.pone.0147023
    
        Method Description
            
                
                
                    
                    Describes how the test is performed and provides a method-specific reference
                
            
    
    The Roche human chorionic gonadotropin (hCG) assay is a 2-site immunometric sandwich assay using electrochemiluminescence detection. Patient specimen, biotinylated monoclonal hCG-specific antibody, and monoclonal hCG-specific antibody labeled with a ruthenium react to form a complex. Streptavidin-coated microparticles act as the solid phase to which the complex becomes bound. Voltage is applied to the electrode inducing a chemiluminescent emission from the ruthenium, which is then measured against a calibration curve to determine the amount of hCG in the patient specimen.(Package insert: Elecsys HCG+B. Roche Diagnostics; V1.0. 05/2024)
    
        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 Saturday
    
        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 :
            
                
                
                    
                    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.
                
            
    
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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 was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It 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.
                
            
    
    CPT codes are provided by the performing laboratory.
84702
    
        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 | 
|---|---|---|
| BHSF | Chorionic Gonad Beta-Subunit QN,CSF | 14041-8 | 
| 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.
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|---|---|---|
| BHSF | Chorionic Gonad Beta-Subunit QN,CSF | 14041-8 |