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25230 Babesia microti, Nucleic Acid Test

Babesia microti, Nucleic Acid Test
Test Code: BABNAT
Synonyms/Keywords
Babesia PCR, Babesiosis PCR
Useful For
Useful as an initial screening method for suspected babesiosis during the initial flu-like stage of infection in patients from endemic areas, especially when the Giemsa-stained peripheral blood smear does not reveal any organisms. For patients who are past the acute stage of infection, serologic tests for these organisms should be ordered prior to PCR testing. Babesia microti shares a tick vector with Borrelia burgdorferi and Anaplasma phagocytophilum, the causative agents of Lyme disease and human granulocytic anaplasmosis (HGA), respectively. Recent studies suggest that exposure to Babesia microti is quite common in areas endemic for Lyme disease and anaplasmosis, so it is often prudent to test for all 3 diseases concurrently. The majority of patients with babesiosis have a mild illness or are asymptomatic, but some develop a severe illness that may result in death. Patient symptoms may include fever, chills, extreme fatigue, and severe anemia. Symptoms are easily confused with those of Lyme disease. The high frequency of Lyme seropositivity in patients with babesiosis may provide misleading evidence of active infection with Borrelia burgdorferi. Failure to respond to antimicrobials that should eradicate Borrelia burgdorferi might otherwise be interpreted as a Lyme disease treatment failure, when in fact,concurrent infection with Babesia microti may be responsible for the persistence of symptoms. The most severe cases occur in asplenic individuals and those over 50 years of age. Rare cases of chronic parasitemia, usually in immunocompromised patients, have been described. Recent evidence suggests that babesial infections have an immunosuppressive effect. This immunosuppression may be most evident in a patient infected with both Babesia microti and Borrelia burgdorferi. While this assay is designed to detect only Babesia microti infection of clinical significance, it may detect low grade asymptomatic parasitemia in individuals exposed to babesiosis-endemic areas. Thus, it should be used for patients with a clinical history and symptoms consistent with babesiosis. This test should not be used to screen asymptomatic patients or blood transfusion units.
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
​No ​Whole blood ​EDTA Lavender Top Tube (LTT) ​ ​1.0 mL ​0.5 mL ​0.3 mL
Collection Processing Instructions

​Draw a separate tube for this test; can be combined with Anaplasma/Ehrlichia Nucleic Acid Test in same tube.

Sample cannot be entered for another test under conditions where cross contamination may occur.

Specimen Stability Information
Specimen Type Temperature Time
​Whole Blood EDTA ​ Refrigerated 7 days​
Rejection Criteria
Hemolysis Mild OK; Gross OK
Lipemia​ Mild OK; Gross reject​
Other​ Anticoagulants other than EDTA​
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Marshfield ​Monday through Friday ​1 day z480, Roche Diagnostics
Test Information
 
This test was developed and its performance characteristics determined by Marshfield Labs.  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.  This test is for clinical purposes.  It should not be regarded as investigational or for research.  This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical testing.
​
Reference Range Information
Performing Location Reference Range
​Marshfield ​Negative for Babesia microti
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​87798 ​ ​ ​ ​
Classification
 
This test was developed and its performance characteristics determined by Marshfield Labs.  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.  This test is for clinical purposes.  It should not be regarded as investigational or for research.  This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical testing.
​
Synonyms/Keywords
Babesia PCR, Babesiosis PCR
Ordering Applications
Ordering Application Description
​Centricity ​None
​Cerner ​Babesia microti NAT
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
​No ​Whole blood ​EDTA Lavender Top Tube (LTT) ​ ​1.0 mL ​0.5 mL ​0.3 mL
Collection Processing

​Draw a separate tube for this test; can be combined with Anaplasma/Ehrlichia Nucleic Acid Test in same tube.

Sample cannot be entered for another test under conditions where cross contamination may occur.

Specimen Stability Information
Specimen Type Temperature Time
​Whole Blood EDTA ​ Refrigerated 7 days​
Rejection Criteria
Hemolysis Mild OK; Gross OK
Lipemia​ Mild OK; Gross reject​
Other​ Anticoagulants other than EDTA​
Useful For
Useful as an initial screening method for suspected babesiosis during the initial flu-like stage of infection in patients from endemic areas, especially when the Giemsa-stained peripheral blood smear does not reveal any organisms. For patients who are past the acute stage of infection, serologic tests for these organisms should be ordered prior to PCR testing. Babesia microti shares a tick vector with Borrelia burgdorferi and Anaplasma phagocytophilum, the causative agents of Lyme disease and human granulocytic anaplasmosis (HGA), respectively. Recent studies suggest that exposure to Babesia microti is quite common in areas endemic for Lyme disease and anaplasmosis, so it is often prudent to test for all 3 diseases concurrently. The majority of patients with babesiosis have a mild illness or are asymptomatic, but some develop a severe illness that may result in death. Patient symptoms may include fever, chills, extreme fatigue, and severe anemia. Symptoms are easily confused with those of Lyme disease. The high frequency of Lyme seropositivity in patients with babesiosis may provide misleading evidence of active infection with Borrelia burgdorferi. Failure to respond to antimicrobials that should eradicate Borrelia burgdorferi might otherwise be interpreted as a Lyme disease treatment failure, when in fact,concurrent infection with Babesia microti may be responsible for the persistence of symptoms. The most severe cases occur in asplenic individuals and those over 50 years of age. Rare cases of chronic parasitemia, usually in immunocompromised patients, have been described. Recent evidence suggests that babesial infections have an immunosuppressive effect. This immunosuppression may be most evident in a patient infected with both Babesia microti and Borrelia burgdorferi. While this assay is designed to detect only Babesia microti infection of clinical significance, it may detect low grade asymptomatic parasitemia in individuals exposed to babesiosis-endemic areas. Thus, it should be used for patients with a clinical history and symptoms consistent with babesiosis. This test should not be used to screen asymptomatic patients or blood transfusion units.
Reference Range Information
Performing Location Reference Range
​Marshfield ​Negative for Babesia microti
For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Marshfield ​Monday through Friday ​1 day z480, Roche Diagnostics
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​87798 ​ ​ ​ ​
Classification
 
This test was developed and its performance characteristics determined by Marshfield Labs.  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.  This test is for clinical purposes.  It should not be regarded as investigational or for research.  This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical testing.
​
For most current information refer to the Marshfield Laboratory online reference manual.