Test ID: FBAB
Babesia microti Antibodies (IgG, IgM)
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
91608
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Yes
Method Name A short description of the method used to perform the test
Immunofluorescence Assay (IFA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Babesia Microti Antibodies IgG, IgM
Aliases Lists additional common names for a test, as an aid in searching
Babesia Microti IgG/IgM Ab Panel FORWARD
Specimen Type Describes the specimen type needed for testing
Serum
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Container/Tube: Red top
Specimen Volume: 1 mL
Collection Instructions: Serum gel tube is acceptable but must be poured off into plastic vial.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
0.1 mL
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Thawing | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 7 days |
| Frozen | 30 days | |
| Ambient | 8 hours |
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.
Reference Ranges
IgG: <1:64
IgM:<1:20
Elevated antibody levels to B. microti indicate exposure to the organism. Human babesiosis infection is transmitted by the bite of an infected Ixodes tick or less frequently from transfusion with blood from an infected donor. Definitive diagnosis is made by identifying intraerythrocytic organisms in peripheral blood. In patients with low parasitemia, antibody detection by IFA is recommended. IgG levels greater than or equal to 1:1024 can be detected in acute phase patients with parasites in blood smears. The IFA assay can be used as a seroepidemiologic tool to study the frequency and distribution of B. microti in endemic areas especially in persons with mixed infections also involving Borrelia burgdorferi.
Test Performed by:
Focus Diagnostics, Inc.
5785 Corporate Avenue
Cypress, CA 90630-4750
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
1 - 4 days
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
3 - 8 days
Performing Laboratory Location The location of the laboratory that performs the test
Focus Diagnositics, Inc.
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test was developed and its performance characteristics have been determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86753/x2
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| Z0718 | Babesia microti IgG | In Process |
| Z0520 | Babesia microti IgM | In Process |
| Z0521 | Interpretation | In Process |
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