{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,5]],"date-time":"2025-11-05T06:10:38Z","timestamp":1762323038754},"reference-count":22,"publisher":"American Society for Microbiology","issue":"4","license":[{"start":{"date-parts":[[2006,4,1]],"date-time":"2006-04-01T00:00:00Z","timestamp":1143849600000},"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":["J Clin Microbiol"],"published-print":{"date-parts":[[2006,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            The accuracy of diagnostic tests is critical for successful control of epidemic outbreaks of syphilis. The reliability of syphilis serology in the nonspecialist laboratory has always been questioned, but actual data dealing with this issue are sparse. Here, the results of eight proficiency testing sentinel surveys for diagnostic laboratories in Germany between 2000 and 2003 were analyzed. Screening tests such as\n            <jats:italic>Treponema pallidum<\/jats:italic>\n            hemagglutination assay (mean accuracy, 91.4% [qualitative], 75.4% [quantitative]),\n            <jats:italic>Treponema pallidum<\/jats:italic>\n            particle agglutination assay (mean accuracy, 98.1% [qualitative], 82.9% [quantitative]), and enzyme-linked immunosorbent assays (ELISAs) (mean qualitative accuracy, 95%) were more reliable than Venereal Disease Research Laboratory (VDRL) testing (mean accuracy, 89.6% [qualitative], 71.1% [quantitative]), the fluorescent treponemal antibody absorption test (FTA-ABS) (mean accuracy, 88% [qualitative], 65.8% [quantitative]), and immunoblot assays (mean qualitative accuracy, 87.3%). Clearly, immunoglobulin M (IgM) tests were more difficult to manage than IgG tests. False-negative results for samples that have been unambiguously determined to be IgM and anti-lipoid antibody positive accounted for 4.7% of results in the IgM ELISA, 6.9% in the VDRL test, 18.5% in the IgM FTA-ABS, and 23.0% in the IgM immunoblot assay. For negative samples, the mean percentage of false-positive results was 4.1% in the VDRL test, 5.4% in the IgM ELISA, 0.7% in the IgM FTA-ABS, and 1.4% in the IgM immunoblot assay. On average, 18.3% of participants misclassified samples from patients with active syphilis as past infection without indicating the need for further treatment. Moreover, 10.2% of laboratories wrongly reported serological evidence for active infection in samples from patients with past syphilis or in sera from seronegative blood donors. Consequently, the continuous participation of laboratories in proficiency testing and further standardization of tests is strongly recommended to achieve better quality of syphilis serology.\n          <\/jats:p>","DOI":"10.1128\/jcm.44.4.1335-1341.2006","type":"journal-article","created":{"date-parts":[[2006,4,6]],"date-time":"2006-04-06T13:42:51Z","timestamp":1144330971000},"page":"1335-1341","update-policy":"http:\/\/dx.doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":43,"title":["Is Serological Testing a Reliable Tool in Laboratory Diagnosis of Syphilis? Meta-Analysis of Eight External Quality Control Surveys Performed by the German Infection Serology Proficiency Testing Program"],"prefix":"10.1128","volume":"44","author":[{"given":"Iris","family":"Mu\u0308ller","sequence":"first","affiliation":[{"name":"Central Laboratory of the Bacteriologic Infection Serology Study Group of Germany (BISSGG), Institute of Medical Microbiology, University Hospital of Frankfurt, Paul-Ehrlich-Str. 40, D-60596 Frankfurt\/Main, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Volker","family":"Brade","sequence":"additional","affiliation":[{"name":"Central Laboratory of the Bacteriologic Infection Serology Study Group of Germany (BISSGG), Institute of Medical Microbiology, University Hospital of Frankfurt, Paul-Ehrlich-Str. 40, D-60596 Frankfurt\/Main, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hans-Jochen","family":"Hagedorn","sequence":"additional","affiliation":[{"name":"Central Laboratory of the Bacteriologic Infection Serology Study Group of Germany (BISSGG), Institute of Medical Microbiology, University Hospital of Frankfurt, Paul-Ehrlich-Str. 40, D-60596 Frankfurt\/Main, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erich","family":"Straube","sequence":"additional","affiliation":[{"name":"Central Laboratory of the Bacteriologic Infection Serology Study Group of Germany (BISSGG), Institute of Medical Microbiology, University Hospital of Frankfurt, Paul-Ehrlich-Str. 40, D-60596 Frankfurt\/Main, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christoph","family":"Scho\u0308rner","sequence":"additional","affiliation":[{"name":"Central Laboratory of the Bacteriologic Infection Serology Study Group of Germany (BISSGG), Institute of Medical Microbiology, University Hospital of Frankfurt, Paul-Ehrlich-Str. 40, D-60596 Frankfurt\/Main, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthias","family":"Frosch","sequence":"additional","affiliation":[{"name":"Central Laboratory of the Bacteriologic Infection Serology Study Group of Germany (BISSGG), Institute of Medical Microbiology, University Hospital of Frankfurt, Paul-Ehrlich-Str. 40, D-60596 Frankfurt\/Main, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harald","family":"Hlobil","sequence":"additional","affiliation":[{"name":"Central Laboratory of the Bacteriologic Infection Serology Study Group of Germany (BISSGG), Institute of Medical Microbiology, University Hospital of Frankfurt, Paul-Ehrlich-Str. 40, D-60596 Frankfurt\/Main, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerold","family":"Stanek","sequence":"additional","affiliation":[{"name":"Central Laboratory of the Bacteriologic Infection Serology Study Group of Germany (BISSGG), Institute of Medical Microbiology, University Hospital of Frankfurt, Paul-Ehrlich-Str. 40, D-60596 Frankfurt\/Main, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Klaus-Peter","family":"Hunfeld","sequence":"additional","affiliation":[{"name":"Central Laboratory of the Bacteriologic Infection Serology Study Group of Germany (BISSGG), Institute of Medical Microbiology, University Hospital of Frankfurt, Paul-Ehrlich-Str. 40, D-60596 Frankfurt\/Main, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","unstructured":"Bundesministerium fuer Gesundheit (BMFG). 2000. Bekanntmachung (AKZ 117-456000-02\/2) zur EG-Richtlinie \u00fcber in vitro Diagnostika (98\/79\/EG). Bundesgesetzblatt 118 : 12077."},{"key":"e_1_3_2_3_2","unstructured":"Center for Disease Control. 1977. Guidelines for evaluation and acceptance of new syphilis serology tests for routine use. Center for Disease Control Atlanta Ga."},{"key":"e_1_3_2_4_2","unstructured":"Centers for Disease Control and Prevention and Association of State and Territorial Public Health Laboratory Directors (ASTPHLD). 1994. Proceedings of the 2nd National Conference on Serologic Diagnosis of Lyme Disease (Dearborn MI). ASTPHLD Washington D.C."},{"key":"e_1_3_2_5_2","first-page":"1","volume":"51","year":"2002","unstructured":"Centers for Disease Control and Prevention. 2002. Sexually transmitted diseases treatment guidelines 2002. Morb. Mortal. Wkly. Rep.51:1-80. [Online.] http:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/rr5106a1.htm . Accessed 1 December 2005.","journal-title":"Morb. Mortal. Wkly. Rep."},{"key":"e_1_3_2_6_2","first-page":"1117","volume":"52","year":"2003","unstructured":"Centers for Disease Control and Prevention. 2003. Primary and secondary syphilis\u2014United States, 2002. Morb. Mortal. Wkly. Rep.52:1117-1120.","journal-title":"Morb. Mortal. Wkly. Rep."},{"key":"e_1_3_2_7_2","first-page":"158","volume":"3","year":"2000","unstructured":"Egglestone, S. I., and A. J. L. Turner. 2000. Serological diagnosis of syphilis. Comm. Dis. Public Health3:158-162.","journal-title":"Comm. Dis. Public Health"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1006\/biol.1997.0098"},{"key":"e_1_3_2_9_2","unstructured":"Gibbs J. N. 1998. Regulations and standards. ASRs: FDA issues final rule. IVD Technol. [Online.] http:\/\/www.devicelink.com\/ivdt\/archive\/98\/01\/009.html\n. Accessed 12 December 2005."},{"key":"e_1_3_2_10_2","unstructured":"Hagedorn H.-J. 2000. MIQ. Qualit\u00e4tsstandards in der mikrobiologisch-infektiologischen Diagnostik. Heft 16 Syphilis. Urban & Fischer M\u00fcnchen Germany."},{"key":"e_1_3_2_11_2","first-page":"448","volume":"255","year":"1983","unstructured":"Hofmann, H., F. X. Heinz, and H. Dippe. 1983. ELISA for IgM and IgG antibodies against tick-borne encephalitis virus: quantification and standardization of results. Zentralbl. Bakteriol. Mikrobiol. Hyg. 1 Abt. Orig. A255:448-455.","journal-title":"Zentralbl. Bakteriol. Mikrobiol. Hyg. 1 Abt. Orig. A"},{"key":"e_1_3_2_12_2","first-page":"235","volume":"99","year":"2000","unstructured":"Hsu, W. S., J. T. Kao, and S. W. Ho. 2000. Quality assurance in clinical laboratories in Taiwan. J. Formos. Med. Assoc.99:235-242.","journal-title":"J. Formos. Med. Assoc."},{"key":"e_1_3_2_13_2","first-page":"135","volume":"10","year":"2000","unstructured":"Hunfeld, K.-P., and V. Brade. 2000. Proficiency testing in bacteriological infection serology-state of the art and results of proficiency testing trial X\/99. Mikrobiologe10:135-144.","journal-title":"Mikrobiologe"},{"key":"e_1_3_2_14_2","first-page":"591","volume":"114","year":"2002","unstructured":"Hunfeld, K. P., G. Stanek, E. Straube, H. J. Hagedorn, C. Schoerner, F. Muehlschlegel, and V. Brade. 2002. Quality of Lyme disease. Lessons from the German Proficiency Testing Program 1999-2001. Wien. Klin. Wochenschr.114\/13:591-600.","journal-title":"Wien. Klin. Wochenschr."},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.8.1.1"},{"key":"e_1_3_2_16_2","first-page":"13","volume":"41","year":"1975","unstructured":"Neimeister, R. P., R. Teschemacher, I. J. Yankevitch, and J. Cocklin. 1975. Proficiency testing, trouble schooting and quality control for the RPR test. Am. J. Med. Technol.41:13-17.","journal-title":"Am. J. Med. Technol."},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1086\/315603"},{"key":"e_1_3_2_18_2","unstructured":"Place J. F. 2004. The coming age of in vitro testing. IVD Technol. [Online.] http:\/\/www.devicelink.com\/ivdt\/archive\/00\/09\/002.html\n. Accessed 1 November 2005."},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.1136\/sti.79.1.3"},{"key":"e_1_3_2_20_2","first-page":"155","year":"2005","unstructured":"Robert Koch Institut. 2005. Syphilis, p. 155-160. InInfektionsepidemiologisches Jahrbuch f\u00fcr 2004. Mercedes-Druck, Berlin, Germany.","journal-title":"Infektionsepidemiologisches Jahrbuch f\u00fcr 2004"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1136\/jcp.35.1.82"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.8.4.388-395.1978"},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.13.2.356-368.1981"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/JCM.44.4.1335-1341.2006","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/JCM.44.4.1335-1341.2006","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,3,5]],"date-time":"2022-03-05T05:03:41Z","timestamp":1646456621000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/JCM.44.4.1335-1341.2006"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2006,4]]},"references-count":22,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2006,4]]}},"alternative-id":["10.1128\/JCM.44.4.1335-1341.2006"],"URL":"https:\/\/doi.org\/10.1128\/jcm.44.4.1335-1341.2006","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2006,4]]},"assertion":[{"value":"2005-07-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2006-01-27","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2006-04-01","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}