{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,12]],"date-time":"2025-11-12T21:11:58Z","timestamp":1762981918844,"version":"3.41.2"},"reference-count":28,"publisher":"American Society for Microbiology","issue":"8","license":[{"start":{"date-parts":[[2024,8,6]],"date-time":"2024-08-06T00:00:00Z","timestamp":1722902400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,8,6]],"date-time":"2024-08-06T00:00:00Z","timestamp":1722902400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Microbiol Spectr"],"published-print":{"date-parts":[[2024,8,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:sec>\n            <jats:title\/>\n            <jats:p>\n              Emerging tick-borne illnesses, such as anaplasmosis, babesiosis, or ehrlichiosis, are caused by obligate intracellular pathogens that have clinically comparable presentations. Diagnostics used in laboratories today are serologic assays and blood smear analyses, which have known diagnostic limits. This study evaluated the performance of a sample-to-answer direct real-time PCR laboratory-developed test for the multiplex qualitative detection of\n              <jats:italic>Anaplasma<\/jats:italic>\n              ,\n              <jats:italic>Babesia<\/jats:italic>\n              , and\n              <jats:italic>Ehrlichia<\/jats:italic>\n              DNA in whole-blood specimens. Compared to two standard-of-care (SOC) methods, the DiaSorin tick-borne laboratory-developed test for\n              <jats:italic>Anaplasma<\/jats:italic>\n              detection demonstrated a positive percent agreement (PPA) and negative percent agreement (NPA) of 100% (95% CI, 0.80 to 1.0) and 89% (95% CI, 0.74 to 0.97), respectively with a discordant rate of 9.3% against microscopy. After discordant resolution, the NPA increased to 100%. For\n              <jats:italic>Babesia<\/jats:italic>\n              , the test demonstrated a PPA of 100% (95% CI, 0.90 to 1.0) and NPA of 100% (95% CI, 0.90 to 1.0). Compared to a SOC PCR method\n              <jats:italic>Anaplasma<\/jats:italic>\n              samples showed a PPA of 100% (95% CI, 0.66 to 1.0) and NPA of 100% (95% CI, 0.90 to 1.0).\n              <jats:italic>Ehrlichia<\/jats:italic>\n              results showed a PPA of 100% (95% CI, 0.69 to 1.0) and NPA of 100% (95% CI, 0.90 to 1.0). The total percent agreement was 98% (95% CI, 0.95 to 0.99) with a \u03ba statistic of 0.95 (95% CI, 0.90 to 0.99) or almost perfect agreement compared to SOC methods. This laboratory-developed test for detecting\n              <jats:italic>Anaplasma<\/jats:italic>\n              ,\n              <jats:italic>Babesia<\/jats:italic>\n              , and\n              <jats:italic>Ehrlichia<\/jats:italic>\n              DNA provides rapid and reliable detection of tick-borne infections without nucleic acid extraction.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>IMPORTANCE<\/jats:title>\n            <jats:p>This work demonstrates that detection of tick-borne illnesses, such as anaplasmosis, babesiosis, or ehrlichiosis, can be performed directly from whole blood with no extraction. The assay described here has a high positive and negative percent agreement with existing methods and is used as the standard of care. An increasing incidence of tick-borne illness combined with shortage of well-trained technologists to perform traditional manual testing, testing options that can be adapted to various lab settings, are of the utmost importance.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1128\/spectrum.00655-24","type":"journal-article","created":{"date-parts":[[2024,7,9]],"date-time":"2024-07-09T13:02:05Z","timestamp":1720530125000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":2,"title":["Sample-to-answer direct real-time PCR detection of\n            <i>Anaplasma phagocytophilum<\/i>\n            ,\n            <i>Ehrlichia<\/i>\n            spp., and\n            <i>Babesia<\/i>\n            spp. infections in whole-blood specimens"],"prefix":"10.1128","volume":"12","author":[{"given":"Georgia","family":"Colasante","sequence":"first","affiliation":[{"name":"HNL Lab Medicine, Allentown, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keana","family":"Makari","sequence":"additional","affiliation":[{"name":"HNL Lab Medicine, Allentown, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tara I.","family":"Hummel","sequence":"additional","affiliation":[{"name":"HNL Lab Medicine, Allentown, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6873-1836","authenticated-orcid":true,"given":"Caitlin","family":"Murphy","sequence":"additional","affiliation":[{"name":"HNL Lab Medicine, Allentown, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/hvaa040"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm6717e1"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)60103-7"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.pt.2012.07.003"},{"key":"e_1_3_2_6_2","unstructured":"Centers for Disease Control and Prevention National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) Division of Vector-Borne Diseases (DVBD). Available from: https:\/\/www.cdc.gov\/ncezid\/dvbd\/index.html. Accessed 20 September 2023"},{"key":"e_1_3_2_7_2","unstructured":"Centers for Disease Control and Prevention website. Tickborne diseases of the United States. Available from: http:\/\/www.cdc.gov\/ticks\/diseases\/index.html. Accessed 20 September 2023"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1086\/319347"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1099\/jmm.0.001206"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.3949\/ccjm.84a.16110"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.14745\/ccdr.v45i04a02"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-ento-052720-094533"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11756-021-00927-2"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cll.2009.10.004"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1093\/ajcp\/aqy067"},{"key":"e_1_3_2_16_2","first-page":"124","volume-title":"Immunoassays for the diagnosis of infectious diseases","author":"Theel ES","year":"2019","unstructured":"Theel ES. 2019. Manual of clinical microbiology, p 124\u2013138. In Carrol KC, Pfaller MA, Landry ML, McAdam AJ, Patel R, Richter SS, Warnock DW (ed), Immunoassays for the diagnosis of infectious diseases. Vol. 1. 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