ANAPLASMA & BABESIA (ANABAB) SYNONYMS: Anaplasma phagocytophilum, Ehrlichia phagocytophilum, Babesia microti, TBD

INTENDED USE Anaplasma and Babesia, performed on the Roche LightCycler 2.0, are laboratory-developed real-time PCR (qPCR) assays for the in vitro, qualitative detection of Anaplasma phagocytophilum and/or Babesia microti. These assays use extracted DNA from whole blood collected from patients with symptoms of a tick-borne disease to aid in the diagnosis of Anaplasmosis and/or Babesiosis, if used in conjunction with other clinical and epidemiological information. A negative result in a patient with tick-borne disease symptoms may indicate infection with an organism not detected by this test. A positive result does not rule out co-infection with other organisms that produce similar symptoms. Therefore, the results of this test should not be used as the sole basis for diagnosis, treatment, or other management decisions.

NOTE: These tests may be ordered individually (ANAPLAPCR or BABPCR) or as part of the Tick-borne Disease panel (TBD2 or TBD3) which also includes Lyme antibody testing. TBD2 excludes testing for Babesia.

METHODOLOGY Real-time PCR

SPECIMEN REQUIREMENTS SPECIMEN VOLUME CONTAINER unshared lavender-top whole blood >2mL (EDTA) tube

Collection  Collect whole blood by standard venipuncture in lavender-top (EDTA) tube.  If additional testing requiring whole blood from an EDTA tube is requested, a separate tube must be drawn. A shared specimen will not be accepted.  Label the tube with patient name, date of birth and date and time of collection before sending to the laboratory.

Transport & Storage  EDTA whole blood can be transported and stored at room temperature for the first 24 hours. If longer storage is required, store the specimens at 2–8ºC.  Samples should be transported to the laboratory as soon as possible and should be no older than 72 hours prior to DNA extraction.

Causes for Rejection  Whole blood collected in anticoagulant other than EDTA  Shared EDTA tube (specimen previously used for other testing)  Unlabeled or mislabeled specimen  Specimen >72 hours old  Grossly lipemic specimen

REFERENCE RANGE NOT DETECTED

ADDITIONAL INFORMATION Tick-borne diseases are becoming an ever-increasing important public health issue as is evidenced by the current national epidemic of Lyme disease. Tick-borne diseases, such as Anaplasmosis and Babesiosis, are caused by a variety of infectious agents transmitted through tick bite. The epidemiology of Anaplasmosis and Babesiosis is similar to that of Lyme disease, all of which have the same tick vector, Ixodese scapularis, and animal reservoir, the white-footed mouse. Transmission of multiple tick-borne pathogens from one tick bite has been documented, as co-infection with multiple organisms can occur within the same tick. Therefore it is prudent to test for all three at the same time. The most common symptoms of tick-related illness include, but are not limited to, fever, chills, body aches, and rash. Cases of tick-borne related illnesses peak in the summer months due to the increased number of the nymphal life stage of the tick, which is the primary life stage that bites and can potentially infect humans.

Anaplasmosis Human Anaplasmosis (HA), formerly known as Human Granulocytic Ehrlichiosis (HGE), is caused by the obligate intracellular, gram-negative bacterium Anaplasma phagocytophilum (formerly Ehrlichia phagocytophilum). It is transmitted primarily through the bite of the deer tick or black-legged tick, Ixodes scapularis, allowing it to enter the vascular system and infect leukocytes. Anaplasmosis cases are mostly found from the upper midwestern to the northeastern United States. Onset of illness occurs 5 to 21 days after exposure to an infected tick. Common signs and symptoms include fever (often over 102ºF), chills, headache, and myalgias. Highly suggestive laboratory findings include leukopenia (WBC <4.5k/µL), thrombocytopenia (platelets <150k/µL), and increased amino- transferase levels. The recommended first-line therapy remains doxycycline. Treatment should be initiated immediately whenever Anaplasmosis is suspected, as it is most effective at preventing severe complications from developing if it is started early.

Babesiosis Babesiosis is caused by an intraerythrocytic protozoan parasite of the genus Babesia, of which most human cases are caused by Babesia microti. This parasite is spread through the bite of the deer tick or black-legged tick, Ixodes scapularis. Babesiosis occurs most frequently in the northeast and upper midwest of the United States during the warm months. Symptoms can range from no symptoms to flu-like symptoms such as fever, chills, body aches, nausea and fatigue. Babesia parasites infect and destroy red blood cells, which can cause hemolytic anemia leading to jaundice and dark urine. Babesiosis is life-threatening in people who do not have a spleen, are immunocompromised, are elderly, or have other serious health problems like kidney or liver disease. In these patients, Babesiosis can present with low blood pressure, hemolytic anemia, DIC, vital organ failure, or death. Laboratory findings include decreased hemoglobin and hematocrit, thrombocytopenia, elevated serum creatinine and BUN, and mildly elevated liver enzymes. Asymptomatic infections do not usually require treatment, while symptomatic patients are treated for 7–10 days with atovaquone plus azithromycin or clindamycin, plus quinine in severe cases. While Babesiosis is primarily transmitted through tick bites, it can be transmitted congenitally and through blood product transfusions.

MEDITECH CODE ANABAB or ANAPLAPCR or BABPCR or TBD2 or TBD3 CPT CODES 87798 X each organism (DOES NOT COVER LYME TITER) LABORATORY Molecular Pathology Department AVAILABILITY Monday–Friday, 7:30 AM–4:00 PM; specimens are batched TURNAROUND TIME 5 days