{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T15:52:27Z","timestamp":1786117947539,"version":"build-2736575974"},"reference-count":22,"publisher":"American Society for Microbiology","issue":"8","license":[{"start":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T00:00:00Z","timestamp":1785801600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T00:00:00Z","timestamp":1785801600000},"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":[[2026,8,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      Serodiagnosis is important in Lyme disease (LD). Until recently, this commonly required two separate tests termed the standard two-tier tests (STTTs). One-step immunoblot (IB) tests utilizing recombinant protein targets from multiple\n                      <jats:italic toggle=\"yes\">Borrelia<\/jats:italic>\n                      species and strains that may simplify the serodiagnosis of LD are now described. Specificity of the IB tests was established with 425 sera from healthy persons and 387 sera from persons with potentially confounding infections and medical conditions. Test sensitivities were determined with (i) 90 sera from patients with different stages of LD from the US Centers for Disease Control and Prevention (CDC), and (ii) 290 prospectively banked sera from patients with acute-stage LD from the Bay Area Lyme Foundation\u2019s Lyme Disease Biobank (BALDB). The IgG IB test was more sensitive than a US Food and Drug Administration (FDA)-cleared STTT for detecting IgG antibodies in stage 1 LD sera from the CDC\u2019s test panel (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = 0.002). The diagnostic performance of the IgG and IgM IB tests demonstrated significantly greater overall sensitivity than the comparable FDA-cleared STTTs for detecting IgG and\/or IgM antibodies in the 290 BALDB sera (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = 0.00004). The IgG IB test was also more sensitive than the IgG STTT for detecting IgG antibodies in the 290 BALDB sera (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; 0.000001). The IgG and IgM IB tests were additionally more sensitive than IgG and IgM STTTs for detecting IgG and\/or IgM antibodies in BALDB sera from 189 patients with erythema migrans (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = 0.03). The IB tests described here form the basis for one-step IgG and IgM IB tests, termed iDart IgG and IgM IB tests, cleared by the FDA for LD diagnosis.\n                    <\/jats:p>\n                    <jats:sec>\n                      <jats:title>IMPORTANCE<\/jats:title>\n                      <jats:p>The immunoblot (IB) tests described here are one-step tests that separately detect IgG and IgM antibodies for the serological diagnosis of Lyme disease in the United States. The IB tests are more sensitive than a common standard two-tier test for detecting antibodies in early-stage Lyme disease. This can assist in the diagnosis of Lyme disease when antibodies have not yet reached their maximum concentration in patient sera.<\/jats:p>\n                    <\/jats:sec>\n                  <\/jats:sec>","DOI":"10.1128\/spectrum.00199-26","type":"journal-article","created":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T13:46:42Z","timestamp":1784123202000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":0,"title":["Single-step immunoblot tests with recombinant protein antigens for detecting IgG and IgM antibodies in Lyme disease"],"prefix":"10.1128","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9890-366X","authenticated-orcid":false,"given":"Jyotsna S.","family":"Shah","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03zqwq749","id-type":"ROR","asserted-by":"publisher"}],"name":"ID-FISH Technology","place":["Milpitas, USA"]},{"name":"IGeneX","place":["Milpitas, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Song","family":"Liu","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03zqwq749","id-type":"ROR","asserted-by":"publisher"}],"name":"ID-FISH Technology","place":["Milpitas, USA"]},{"name":"IGeneX","place":["Milpitas, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Calalo-Ramos","sequence":"additional","affiliation":[{"name":"IGeneX","place":["Milpitas, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mumu","family":"Myint","sequence":"additional","affiliation":[{"name":"IGeneX","place":["Milpitas, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"Lee","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03zqwq749","id-type":"ROR","asserted-by":"publisher"}],"name":"ID-FISH Technology","place":["Milpitas, USA"]},{"name":"IGeneX","place":["Milpitas, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iris","family":"Cruz","sequence":"additional","affiliation":[{"name":"IGeneX","place":["Milpitas, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5928-9652","authenticated-orcid":true,"given":"Elizabeth J.","family":"Horn","sequence":"additional","affiliation":[{"name":"Lyme Disease Biobank","place":["Portland, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0246-7053","authenticated-orcid":true,"given":"Ranjan","family":"Ramasamy","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03zqwq749","id-type":"ROR","asserted-by":"publisher"}],"name":"ID-FISH Technology","place":["Milpitas, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","unstructured":"Centers for Disease Control and Prevention. 2024. Lyme disease. Available from: https:\/\/www.cdc.gov\/lyme\/index.html. Retrieved 18 Sep 2024."},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/175.1.98"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01061-10"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.3390\/diagnostics14232704"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00018-19"},{"key":"e_1_3_3_7_2","first-page":"590","article-title":"Notice to readers: Recommendations for test performance and interpretation from the second national conference on serologic diagnosis of Lyme disease","volume":"44","author":"Centers for Disease Control and Prevention","year":"1995","unstructured":"Centers for Disease Control and Prevention. 1995. Notice to readers: Recommendations for test performance and interpretation from the second national conference on serologic diagnosis of Lyme disease. 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Retrieved 8 Feb 2026."},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.18.3.484-509.2005"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.03394-15"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1086\/591529"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/170.1.115"}],"container-title":["Microbiology Spectrum"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.00199-26","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.00199-26","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T14:42:42Z","timestamp":1786027362000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/spectrum.00199-26"}},"subtitle":[],"editor":[{"given":"Travis","family":"Bourret","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,8,4]]},"references-count":22,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2026,8,4]]}},"alternative-id":["10.1128\/spectrum.00199-26"],"URL":"https:\/\/doi.org\/10.1128\/spectrum.00199-26","relation":{},"ISSN":["2165-0497"],"issn-type":[{"value":"2165-0497","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,4]]},"assertion":[{"value":"2026-03-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-20","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-15","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00199-26"}}